Consumable data integration management system and platform

Abstract

To provide a method, device and system for associating consumable data with an assay consumable used for a biological assay.SOLUTION: An assay system controls one or more steps of an assay protocol on the basis of consumable data peculiar to a consumable. Even a method using various types of consumable data and data related when performing an assay by an assay system is explained. The present invention relates even to a consumable (for example, a kit and a reagent vessel) for performing an automated biological assay, software, a data expandable bundle, a computer readable medium, a loading cart, a meter, a system and a method.SELECTED DRAWING: None

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This international patent application is the subject of application Ser. No. PCT / US2016 / 043755, filed on July 22, 2016, entitled "Integrated Consumable Data The company claims priority from an international patent application entitled "Technical Solution for a Novel Coronavirus Disease 2019 (COVID-19) Management System and Platform."

[0002] Reference is also made to co-pending U.S. Application No. 12 / 844,345, filed July 27, 2010, U.S. Provisional Application No. 61 / 400,411, filed July 27, 2010, and U.S. Provisional Application No. 61 / 462,024, filed January 27, 2011. Reference is also made to U.S. Application No. 13 / 191,000, filed July 26, 2011, now U.S. Patent No. 8,770,471, and U.S. Application No. 14 / 719,818, filed May 22, 2015, and U.S. Provisional Application entitled "Integrated Consumable Data Management System and Platform" bearing Application No. 62 / 195,956, filed July 23, 2015. The entire contents of each of these applications are incorporated herein by reference.

[0003] Technical Field The present teachings relate to methods, devices, and systems for associating consumable data with assay consumables used in biological assays. The present teachings also relate to consumables (e.g., kits and reagent containers), software, data deployable bundles, computer readable media, loading carts, instruments, systems, and methods for performing automated biological assays. [Background technology]

[0004] Numerous methods and systems for performing assays have been developed. These methods and systems are essential in a variety of applications including medical diagnostics, veterinary testing, food and beverage testing, environmental monitoring, manufacturing quality control, drug discovery, and basic scientific research. During the manufacture and use of reagents and other consumables used in biological assays, the reagents and consumables are typically coded and labeled by the manufacturer to track the reagents and consumables. Furthermore, to understand the analytical results of any given assay, a myriad of analytical parameters must be tracked, often requiring the input of multiple parallel tracking systems supplied by the manufacturer, the customer, or both. Summary of the Invention [Problem to be solved by the invention]

[0005] Automation of immunoassays presents its own set of challenges: repeatability and / or reproducibility remains a goal for all automated assay systems. [Means for solving the problem]

[0006] One aspect of the present invention is an automated assay system for performing biological assays, such as immunoassays, and more particularly electrochemiluminescence (ECL) immunoassays. The automated assay system of the present invention is capable of performing assay runs with reproducible results. Random human or machine errors that may occur during preparation for an assay run (e.g., diluting samples or calibrators), loading assay consumables onto the instrument, and during the assay run have been identified and minimized. Other aspects include automated assay systems that include consumables, instruments, loading carts, software, data deployable bundles, computer-aided testing, and the like for performing biological assays. The present invention includes a computer-readable medium, and a method.

[0007] Variables that have been minimized in different aspects of the invention include one or more of the following: Variation in sample concentration between wells in a multi-well assay tray caused by evaporation of liquid during incubation is minimized. The position and location of the gripper pads of the robotic system and the pipettors for a particular assay system are trained with a precision training plate. A heat exchanger is provided to maintain a selected operating temperature of the assay system. Identical assay runs are completed substantially within an expected time period to ensure reproducibility. Consumables for a particular assay are provided in kits to ensure that appropriate consumables and quantities are available for an assay run. Loading of consumables into the assay system is standardized to minimize error. Specialized assay consumable storage units (e.g., plate hotels, plate carriers, spare pipette tip container carriers, trough carriers) on the assay instrument minimize loading errors and assay execution errors. For example, the configuration and location of the plate hotel minimizes loading errors due to user safety considerations, ergonomic considerations, or consumable handling considerations. A user interface guides the user in loading consumables and selecting the assay protocol to run. A loading cart serves as an intermediate consumable loading station to assist the user in properly loading consumables into the assay system. Operational qualification and performance qualification of the assay system of the present invention are automated, and a validation kit is provided to ensure that the qualification is performed properly and is reproducible. The automated assay steps are performed with tight timing tolerances to ensure run-to-run and plate-to-plate reproducibility. A specialized plate reader is configured to read the assay plates in a sequence that minimizes differences in timing of addition of read buffer relative to the time to read signal from one well to another well within a single plate. Various background signal noises at the ECL reader are measured and offset from the actual ECL readings. The dispense and / or aspirate capabilities of the pipettor and plate washer are calibrated.

[0008] Other improvements include, but are not limited to, software architectures that minimize revalidation of software when the software system receives software updates, and creation of generic protocols applicable to multiple assays paired with instrument parameter files unique to a particular assay that turn on or off specific components of the generic protocol to customize the protocol to a particular assay.Specialized lids are provided to minimize loss of reagents from containers due to evaporation while maintaining the ability of the pipettor to access the reagents.

[0009] One embodiment of the present invention is an assay system configured to use an assay consumable in performing an assay, the assay consumable comprising an assay consumable identifier comprising a data deployable bundle (DDB) for the assay consumable, the assay system comprising: (a) a storage medium including a consumable data repository including consumable local data and a data registry; (b) a consumable identifier controller adapted to read and install the DDB on the storage medium; (c) a consumable data services processor adapted to query the data registry and one or more remote consumable data databases to identify and download consumable data needed for performance of an assay by an assay system using the assay consumable; Includes.

[0010] Additional embodiments of the present invention include assay consumables and assay consumables in assay systems. A data deployable bundle (DDB) including one or more data files including consumable data related to the use of the consumable, the one or more data files including a DDB unique identifier, a DDB version, a DDB xml file, consumable static information, consumable processing information, and combinations thereof.

[0011] An additional embodiment includes a computer readable medium having stored thereon a computer program which, when executed by a computer system operatively connected to an assay system, causes the assay system to perform a method of performing an assay on the assay system, the assay system being configured to use an assay consumable in performing the assay, the assay consumable including an assay consumable identifier including a DDB as described herein, and the assay system: (a) a storage medium containing a consumable data repository including local consumable data and a data registry; (b) a consumable identifier controller adapted to read and install the DDB on the storage medium; (c) a consumable data services processor adapted to query the data registry and one or more remote consumable data databases to identify and download consumable data needed for performance of an assay by an assay system using the assay consumable; Including, The method comprises: (a) reading a DDB from the consumable identifier; (b) storing the DDB in the consumable data repository; (c) identifying consumable data from said consumable data repository and optionally downloading consumable data from one or more remote consumable data databases; (d) adjusting one or more actions performed by the system before, during, and / or after performance of the assay based on the consumable data; (e) performing the assay on the assay system using the assay consumable. Includes.

[0012] Another embodiment relates to a holder for assay reagents, comprising at least two regions configured to receive at least one or two reagent containers and at least one or two holes or windows configured to view at least one or two consumable identifiers located at the bottom of the reagent containers. The at least two regions may be of at least two different sizes to receive at least two reagent containers of different sizes. The at least two regions and the at least two holes or windows may be circular and the at least two holes or windows may be smaller in diameter than the at least two regions, or the at least two regions and the at least two holes or windows may be rectilinear and the holes or windows may be smaller than the at least two regions.

[0013] The holder may include a frame, at least one optional insert, and at least one optional mask. The mask may be attached to the top of the frame, and the insert may be positioned in the frame and below the mask. The two regions of the holder may include cylindrical holes in the frame or the optional insert or both. The at least two regions may include holes in the mask. The at least two holes may be clear plastic coated holes in the frame.

[0014] The footprint dimensions of the holder preferably match the ANSI-SLAS dimensions of the multiwell plate. The height of the holder also matches the ANSI-SLAS height of the multiwell plate. They may be combined.

[0015] In one embodiment, the insert is a foam and is inserted into the at least two cylindrical holes of the frame for filling the at least two reagent containers. The insert may be positioned between a reagent container of the at least one or two reagent containers and a region larger than the reagent container of the at least two regions. The insert may define the cylindrical holes of the assay reagent containers and fills the frame.

[0016] The mask may define a number of mask regions, which may be the same or less than the number of regions on the container, frame, or insert, and the mask may limit the number of assay containers that can be accommodated by the assay reagent container. Preferably, the mask includes labels for at least one or two reagent containers.

[0017] The holder may have an assay consumable identifier affixed thereto. The assay consumable identifier is located on a bottom, side, or top surface of the container. The holder may also include one additional reagent container. The additional reagent container includes assay reagents. The assay reagents may be reagents for a V-PLEX assay, a U-PLEX assay, an immunogenicity (IG) assay, a pharmacokinetic (PK) assay, or a custom assay. The label may define the assay reagents for a V-PLEX assay, a U-PLEX assay, an immunogenicity (IG) assay, a pharmacokinetic (PK) assay, or a custom assay.

[0018] The assay reagent container or frame may be made from a conductive plastic. The holder may have a lid. The lid may be completely or substantially. The reagent container may include an assay consumable identifier located at a bottom of the container that is visible from the bottom of the container. The at least two regions are configured to receive at least one tube and at least one vial.

[0019] The holder may have (a) a frame having a bottom and sides, the bottom being generally rectangular in shape and having dimensions conforming to ANSI-SLAS standards and defining a hole or window in the holder; (b) an insert that fits within the frame sized to hold a tube or vial and having an insert hole positioned to align the tube or vial with the hole or window in the holder; (c) a mask positioned above the insert, the mask hole aligning with the insert hole to allow insertion of the tube or vial into the insert and providing identification information about the tube or vial; and (d) optionally, a lid for enclosing the vial in the holder.

[0020] The consumable identifier may be, but is not limited to, a 2D or 1D barcode that can be printed on a plastic pack that is inserted into a recess in the bottom of the tube or vial, or printed on a foil disc that is heat sealed to the recess in the bottom of the tube or vial.

[0021] The assay tubes or vials include one or more tubes or vials having one or more of the following assay reagents: (i) calibration material, (ii) control material, (iii) capture reagent, (iv) detection reagent, (v) diluent, or (vi) linker reagent.

[0022] The present invention also relates to an assay kit comprising any of the holders described above in a cardboard container. Preferably, the kit has an assay consumable identifier in the cardboard container. The kit also has at least one assay consumable plate in the cardboard container. The assay consumable plate may be a multi-well plate and may have an assay consumable identifier. The kit may also have at least one trough or tube or both.

[0023] The present invention also relates to a lid configured to cover an upper surface of a multiwell plate including a skirt corresponding to a top surface of the lid, the skirt adapted to fit around a perimeter of the top surface of the multiwell plate, the top surface of the plate being sized and dimensioned to contact the perimeter of the multiwell plate, and the lid may have a plurality of recesses extending from a top surface of the lid toward the multiwell plate, the plurality of recesses corresponding to and configured to extend into the plurality of wells of the multiwell plate, the top surface of the lid adapted to contact an upper lip of at least one of the plurality of wells.

[0024] The present invention also relates to a lid configured to cover the top surface of a multiwell plate, including a skirt corresponding to the top of the lid, the skirt adapted to fit around the perimeter of the top surface of the multiwell plate, the top surface of the plate sized and dimensioned to contact the perimeter of the multiwell plate. The lid is optionally hydrophobic. The lid may be made from a hydrophobic polymer, or the bottom surface of the top of the lid can be made hydrophobic. The bottom surface can be microetched to create a rough surface to trap air, such that the bottom surface exhibits Cassie-Baxter behavior as a barrier to moisture.

[0025] Alternatively, the bottom surface can be coated with a hydrophobic coating or a surfactant. The lid can also have a number of recesses extending from a top of the lid towards the multiwell plate, the multiple recesses corresponding to the multiple wells of the multiwell plate, the multiple recesses being configured to extend into the multiple wells.

[0026] The lids that cover the multi-well plates are preferably not made from a compliant plastic or elastomeric material, they are preferably made from a rigid plastic, and more preferably polystyrene.

[0027] The invention also relates to another lid adapted for attachment to a reagent container and for allowing the entrance and exit of a probe, the lid including a top surface including a pattern of cuts separating the top surface into segments, the segments bending downwards when the probe enters the reagent container and returning to their original orientation when the probe exits, the probe may be at least one pipette tip.

[0028] The cut pattern may include at least one curvilinear line, at least one serpentine line, at least one substantially looped line, or parallel straight lines. The lid may be made from a non-elastomeric or elastomeric material. The lid may be used to cover the reagent trough.

[0029] The present invention also relates to a loading cart adapted for use with an assay system, the loading cart including a computer screen and a movable body including at least one shelf and a support for the computer screen, the shelf including at least one tray, a plurality of slots defined in the tray, the slots sized and dimensioned to receive a plurality of consumables for performing an assay, the computer screen adapted to display a user interface illustrating a first arrangement of a plurality of containers of the consumables on the at least one tray.

[0030] The computer screen may be the screen of a tablet computer or may be connected to a personal computer or laptop computer. The computer screen may be controlled by a processor on the assay machine. The computer screen may be connected to the processor on the assay machine by a WiFi or Bluetooth connection. In one embodiment, a mobile computing device is associated with the computer screen.

[0031] The slots on the loading cart can be defined on a top or both sides of at least one tray, i.e., the tray can be inverted. The slots can be of different sizes adapted to receive a plurality of consumables of different sizes.

[0032] The support for the computer screen may be an adjustable support. The adjustable support may be rotatable about a substantially vertical axis and / or tiltable about an axis substantially perpendicular to the vertical axis. The at least one shelf is an upper shelf. The cart may also have a bottom shelf and / or a central shelf. The cart may have a compartment below the at least one tray or the upper tray, the compartment adapted to store a coolant. The compartment may also have a drain and a bottom surface of the compartment may be concave. The movable body of the cart should be supported by at least one caster wheel, which may be a hubless caster wheel.

[0033] The loading cart may pierce a plurality of consumables, such as at least one multi-well plate, which may include at least one assay plate or at least one dilution plate. The plurality of consumables may include at least one container of a reagent. The plurality of consumables may include at least one tube or at least one trough. Examples of trays are shown in Figures 19(a) through 19(j).

[0034] The present invention also relates to an assay preparation system for preparing assay components, the preparation system comprising: (a) an assay system having a processor that contains information about components needed to perform an assay run; (b) a loading cart including a shelf for assembling components used in the assay and a support for holding a mobile computing device; (c) a mobile computing device that includes a computer screen; Including, The mobile computing device includes networking capabilities for accessing the information on the processor, and a graphical user interface for presenting that information to a user on a computer screen and guiding the placement of assay components on a loading cart.

[0035] The loading cart may be a loading cart as described above and / or below, and may include a consumable identifier reader, and the graphical user interface is configured to use the reader when placing assay components on the cart, to accept identifier information provided by a user, to use the information to validate the components, and to forward the identification information to the processor.

[0036] The present invention also relates to a method of instructing a user to load consumables into an assay system comprising using a loading cart as described above and / or below. The method may comprise arranging a plurality of consumables in a loading station according to a first arrangement displayed on a screen by a user interface.

[0037] The present invention further comprises: a. receiving a plurality of consumable items; b. placing a plurality of consumables at the intermediate consumable loading station according to a first configuration displayed by a user interface on a screen positioned at the intermediate consumable loading station; c. moving the intermediate consumable loading station to the assay system; d. transferring a plurality of consumables to the assay system according to a second configuration; a transferring step, the first configuration being substantially the same as the second configuration; The present invention also relates to a method for loading consumables for performing an assay into an assay system, comprising:

[0038] Preferably, the intermediate consumable loading station includes a movable cart and the screen is a computer screen. The computer screen may be movably mounted on the cart or may be substantially rotatable about a vertical axis and / or tiltable relative to a vertical axis. The method may also include cooling at least one consumable of the plurality of consumables. Step (b) may include placing the plurality of consumables in a plurality of slots defined in an upper surface of the movable cart. The plurality of consumables may include at least one multi-well plate or at least one container of reagent.

[0039] This method of loading consumables can be used with the loading carts described above and / or below.

[0040] The present invention also relates to a plate sized and dimensioned to match the size and dimensions of an ANSI-SLAS format assay plate, comprising a rectangular perimeter and at least one support member connecting a first side of the rectangular perimeter to a second side of the perimeter, at least one reference pad located on a first major surface of the plate and corresponding to a location of at least one well of the ANSI-SLAS format assay plate, the location of the at least one reference pad in one dimension of a three dimensional coordinate system being measurable by a probe of an assay system when the plate is positioned in a plate carrier of the assay system.

[0041] The probe is capable of measuring capacitance between the probe and at least one reference pad. The plate is preferably conductive. The ANSI-SLAS format assay plate is an 8x12 multi-well plate, and the at least one reference pad corresponds to a corner well on the ANSI-SLAS format assay plate.

[0042] The plate may also have at least two opposing gripping areas located on sides connecting two major surfaces of the plate, the gripping areas adapted to be gripped by a gripper arm of a robotic system, the rectangular perimeter adjacent the first major surface being smaller than the rectangular perimeter adjacent the second major surface, and the first major surface and the second major surface being substantially parallel.

[0043] The at least two opposing gripping areas in one embodiment are bordered by raised tracks. In another embodiment, the at least two opposing gripping areas include at least one pair of divots sized and dimensioned to receive a corresponding pair of protrusions on the gripper arms. The pair of protrusions may include terminal ends of removable screws attached to the gripper arms. The at least one pair of divots may include an upper pair and a lower pair. When the gripper arms grip the upper pair, the upper surfaces of the gripper arms are substantially flush with the first major surface of the plate. When the gripper arms grip the lower pair, the bottom surfaces of the gripper arms are substantially flush with the surface opposite the first major surface of the plate.

[0044] The plates are preferably made from cast aluminum and / or can be machined from cast aluminum and anodized.

[0045] An additional embodiment relates to a plate for teaching or training an automated instrument, the plate being sized and dimensioned to match the size and dimensions of an ANSI-SLAS format assay plate, including a rectangular perimeter and at least one support member connecting a first side of the rectangular perimeter to a second side of the perimeter, and at least one reference pad located on a first major surface of the plate. corresponding to the location of at least one well of an ANSI-SLAS format assay plate; The location of the at least one reference pad in one dimension of a three-dimensional coordinate system is measurable by a probe of an assay system when the plate is positioned in a plate carrier of the assay system.

[0046] An additional aspect relates to a method of training or teaching a robotic gripper or pipetter comprising using the plate described above. The method of training or teaching a robotic gripper using the plate described above comprises the steps of: commanding a robotic gripper arm to move to a specific location in X-space, Y-space, and Z-space corresponding to an area on the plate; commanding a robotic gripper arm to rotate to a specific location corresponding to an area on the plate; commanding the robot gripper arm to open or close its gripper to a particular width or length corresponding to an area on the plate; using the specific location of the gripper arm relative to the plate to estimate a fixed location throughout the automated setup; using the specific location of the gripper arm relative to the plate to calculate the location and robot training positions of other relevant pieces of lab equipment; Includes at least one of the following.

[0047] A method for training or teaching an automated dispense arm using the plate described above comprises the following steps: commanding the automated dispense arm to move to a specific location in X-space, Y-space, and Z-space corresponding to an area on the plate; using the specific location of the automated dispense arm relative to the plate to estimate a fixed location throughout the automated setup; using the specific location of the automated dispense arm relative to the plate to calculate locations and robotic training positions of other associated pieces of laboratory equipment; Includes at least one of the following.

[0048] Another aspect of the present invention is a method for producing a positioning a plate sized and dimensioned to match the size and dimensions of an ANSI-SLAS format assay plate in a plate carrier within the assay system, the position of the plate being known in a three-dimensional coordinate system; moving a robotically controlled probe towards reference pads on the plate, the reference pads corresponding to wells of the ANSI-SLAS plate; obtaining a first location of the reference pad using a capacitance between a probe in the three-dimensional coordinate system and the reference pad; assigning the first location as one dimension in the three-dimensional coordinate system for a robotically controlled probe; The present invention relates to a method for training a robotically controlled probe of an assay system, the method comprising:

[0049] Also directed to an aspect of the invention is an assay consumable storage unit adapted to be mounted to a platform of an assay system including a shelf assembly having a base and a plurality of sets of vertically aligned storage units, each storage unit sized and dimensioned to receive a consumable for performance of an assay by the assay system; The shelf assembly includes a plurality of horizontal members connected by a plurality of upstanding vertical supports; The base is cantilevered to the platform and the shelf assembly is removably attached to the base by at least two locating pins and by at least one threaded connector having a finger-actuable head.

[0050] The shelf assembly may include an MxN linear array of vertically aligned sets of storage units, where M and N are integers. The upper horizontal member of the shelf assembly may include alignment features for an ANSI SLAS compliant container bottom. The upper horizontal member also includes alignment features for an assay reagent holder lid that is larger than the ANSI SLAS compliant container bottom.

[0051] An additional aspect relates to an assay system configured to use an assay consumable in performing an assay, the assay consumable including an assay consumable identifier associated with a data deployable bundle (DDB) for the assay consumable, the assay system comprising: (a) a storage medium including a consumable data repository and a data registry including local consumable data; (b) a consumable identifier controller adapted to read and install the DDB on the storage medium; (c) a consumable data services processor adapted to query the data registry and at least one remote consumable data database to use the assay consumables and to identify and download consumable data required for performance of an assay by the assay system; Includes.

[0052] Additional assays include an assay system including a housing, the housing comprising a continuous glass member, a touch screen for a computer display formed by a first portion of the continuous glass member and an array of pressure transducers, and a sound emitter formed by a second portion of the continuous glass member and at least one sound exciter.

[0053] The invention further includes an automated assay system adapted to receive consumables in performing an assay, the automated assay system including a robotically controlled pipettor and a robotically controlled gripper arm, an assay reader, a plate washer, and at least one optional heatable shaker, at least one heat exchanger, and at least one processor adapted to execute at least one instruction to minimize potential errors in loading the consumables and in performing the assay, the consumables include at least one assay test plate, at least one dilution plate, at least one set of pipette tips, at least one sample plate, and a plurality of containers containing at least one of a calibrator, a diluent, and an antibody; At least one instruction must be instructions for a user interface that guides a user to load the consumable into the assay system; instructions to the robotic gripper arm to place a lid on the at least one assay test plate when the at least one assay test plate is placed on the shaker; instructions to at least one heat exchanger to maintain a selected temperature within the assay system; instructions for running an assay for at least one assay test plate, the at least one assay plate including a plurality of assay test plates, each assay test plate being completed substantially contemporaneously; Includes at least one of the following.

[0054] The instructions for the user interface in the automated assay system may further include instructions to load consumables from a kit and / or to load consumables into an intermediate consumable loading station, which may include a movable cart. The instructions may further include instructions for a robotically controlled pipetter, which may include instructions to obtain its horizontal position, to use a training plate and obtain its vertical position. The instructions may further include instructions for a robotically controlled gripper arm, which may include instructions to obtain its horizontal position, to use a training plate and obtain its vertical position.

[0055] The at least one instruction further includes instructions for performing a qualification procedure. The qualification procedure includes the following steps: (i) validating an assay reader, preferably an ECL reader; (ii) verifying the aspiration function of the plate washer; (iii) verifying the dispensing functionality of the plate washer; (iv) verifying the dispense function of the pipettor; Includes at least one of the following.

[0056] Validation of an ECL reader involves the following steps: (a) reading the electronic plate with an ECL reader to verify current flow in the ECL reader; (b) reading the blank assay test plate with an ECL reader to ascertain background electronic noise; (c) reading the assay test plate, where the wells in the plate are filled with free tag buffer to ensure that the ECL reader reads the expected counts; Includes at least one of the following.

[0057] The at least one processor preferably executes at least two instructions, preferably at least three instructions, or preferably at least four instructions.

[0058] An additional aspect of the invention relates to a method for operating an automated assay system to minimize potential errors in loading consumables for an assay and running the assay, comprising: The assay system includes a robotically controlled pipetter and a robotically controlled gripper arm, an assay reader, a plate washer, and at least one shaker and incubator, at least one heat exchanger, and at least one processor; The assay system is configured to receive consumables, the consumables including at least one assay test plate, at least one dilution plate, at least one set of pipette tips, at least one sample plate, and a plurality of containers including at least one of calibrators, controls, diluents, antibodies, reagents, and buffers; The method comprises the steps of: instructing a user interface to guide a user to load a consumable into the assay system; commanding a robotic gripper arm to place a lid on the at least one assay test plate when the at least one assay test plate is placed on the shaker and incubator; directing at least one heat exchanger to maintain a selected temperature within the assay system; At least one assay test plate is to be run for the assay. instructing at least one processor to perform the assays, wherein the at least one assay plate includes a plurality of assay test plates, each assay test plate being completed substantially simultaneously; Includes at least one of the following.

[0059] The instructions to the user interface in this method may further include instructions to load the consumable from a kit and / or to load the consumable into an intermediate consumable loading station, which may include a movable cart. The instructions may further include instructions to a robotically controlled pipetter, which may include instructions to obtain its horizontal position, to use a training plate and obtain its vertical position. The instructions may further include instructions to a robotically controlled gripper arm, which may include instructions to obtain its horizontal position, to use a training plate and obtain its vertical position.

[0060] The at least one instruction further includes instructions for performing a qualification procedure. The qualification procedure includes the following steps: (i) validating an assay reader, preferably an ECL reader; (ii) verifying the aspiration function of the plate washer; (iii) verifying the dispensing functionality of the plate washer; (iv) verifying the dispense function of the pipettor; Includes at least one of the following.

[0061] Validation of an ECL reader involves the following steps: (a) reading the electronic plate with an ECL reader to verify current flow in the ECL reader; (b) reading the blank assay test plate with an ECL reader to ascertain background electronic noise; (c) reading the assay test plate, where the wells in the plate are filled with free tag buffer to ensure that the ECL reader reads the expected counts; Includes at least one of the following.

[0062] The at least one processor preferably executes at least two instructions, preferably at least three instructions, or preferably at least four instructions.

[0063] The present invention also relates to an automated assay system configured to use an assay consumable in performing an assay, the assay system including at least one processor and at least one storage medium; the storage medium storing instructions for performing the assay by the processor; The instructions are divided into a plurality of components, the plurality of components comprising: A security component; A user interface component; an instrument control component; A data service component; Including, Each component operates substantially independently of the others and has substantially no interaction with each other; The components are connected to a master organizer, which instructs each component when to operate.

[0064] The automated assay system includes multiple components, and updates to one component do not require revalidation of all components. At least one of these components is further divided into subcomponents, each of which operates substantially independently of and has no substantial interaction with each other, and a submaster organizer is connected to the subcomponents, the submaster organizer instructing each subcomponent when to operate. Preferably, an update to one subcomponent, preferably a software update, does not require revalidation of all subcomponents.

[0065] The present invention further relates to an assay system configured to use an assay consumable in performing a first assay, the first assay including a unique assay identifier, the assay system comprising: a reader adapted to read the unique assay identifier; a processor having access to a general protocol file and an instrument parameter file; Including, the general protocol file includes assay steps that are applicable to a plurality of assays, including the first assay; The instrument parameter file contains a number of flags that are either on or off, The processor turns on or off the testing steps of the general assay protocol according to the flag to perform the first assay.

[0066] The general assay protocol may include assay steps for a V-PLEX assay, a U-PLEX assay, an immunogenicity assay, a pharmacokinetic assay, or a custom sandwich assay. The general assay protocol may also include assay steps for a serology assay to identify antibodies in serum or other body fluids.

[0067] An additional assay system relates to an automated assay system configured to minimize user, instrument, and assay method variability, the system comprising: Measures to minimize user error in system load; and A means for minimizing user error when selecting an automated workflow; and A means for minimizing sample dilution errors; a means for minimizing system plate handling errors; Measures to minimize system dispensing errors; A means for minimizing temperature fluctuations; a means for minimizing evaporation or condensation in the assay consumable; means for controlling the shaking frequency of at least one shaker; Measures to minimize the complexity of maintenance procedures and Includes at least one of the following.

[0068] In an additional aspect, the automated assay system is configured to minimize user, instrument, and assay method variability, the system comprising a robotic gripper arm and a robotic pipetter; performing a sample dilution step; Selecting and executing the correct assay workflow for a given assay; controlling an air cooling processing system, thereby maintaining a defined temperature in an assay workflow area of ​​the system with defined tolerances; Maintaining consistent timing between runs, plates, and wells; Allowing a user to run different assay workflows without having to reconfigure or revalidate the workflow software; The present invention also includes software and instrument components for at least one of the above.

[0069] Additional embodiments include a robotic gripper arm and a robotic pipetter, and include the following additional components: (a) a plate carrier, (b) a tip box carrier, (c) five optional heatable shakers, (d) an air cooling handling system, (e) an assay consumable storage unit for assay reagents, (f) an assay consumable storage unit for ready-to-use tips, (g) an assay consumable storage unit for spare tips, (h) an assay consumable storage unit for plates, (i) an assay consumable storage unit for tubes and troughs, and (ii) an assay consumable storage unit for tubes and troughs. a position for securing an item storage unit, and (j) a platform or table, or both, wherein components (a)-(c) and (e)-(h) are located on the platform or table in the system in substantially the same positions relative to each other as shown in Figure 10(a), Figure 10(b), Figure 10(c), Figure 10(l), Figure 10(n) or Figure 10(o), and component (d) is located on the back panel of the instrument substantially as shown in Figure 10(l), Figure 10(m) or Figure 10(n).

[0070] The assay system may further include a plate washer located below the platform and / or table, the platform or table having an opening for accessing the plate washer. The platform may be attached to and supported by the table. The assay system may further include an assay reader, preferably an ECL reader, located below the platform or table. The platform or table also has an opening for disposal of waste and a chute for solid waste extending from above, through and below the waste opening.

[0071] Preferably, at least one waste container is located below the platform or table. Preferably, a laptop computer is provided for controlling the robotic gripper, the robotic pipetter, and the components (c) and (d). The assay system may also include containers for wash buffers and liquid waste below the plate washer.

[0072] Preferably, the components of the assay system may be positioned relative to one another substantially as shown in Figures 10(c), 10(l), and 10(n). The components may also be positioned relative to one another as shown in one or a combination of Figures 10(a) to 10(d), 10(l) to 10(p), 10(s), and 10(u). The components may have dimensions within 10% of the dimensions shown in any of the figures or described in the specification.

[0073] The electrical and data wiring of the assay system may follow one or a combination of the wiring diagrams in Figures 10(v) to 10(y). One or more universal power systems (UPS) may be provided below the platform or deck. The components below the platform or deck are preferably divided into compartments as shown in Figure 10(a), 10(b) or 10(c).

[0074] The present invention further includes an automated method of performing an assay comprising any of the sequences and timing of Figures 9(d), 12(m)-12(p), 12(r)-12(s), 13(d)-13(f), 14(d), 14(f)-14(l), 15(b), 15(d)-15(h), 16(b), 17(b), 17(d)-17(h).

[0075] In a further aspect, the present invention provides a method for producing a method for treating a cancer cell comprising: (a) A single robotically controlled 8-channel pipettor; (b) a single robotically controlled assay plate gripper arm; (c) a single 96-channel assay plate washer; and (d) a single plate reader; and (e) one or more plate shakers having a total capacity of at least five plate shaking stations; (f) a processor adapted to execute an assay process for analyzing a plurality of samples in a 96-well plate, the processor comprising the following operations: (i) a blocking step including the addition of blocking buffer with a pipettor, incubation for a blocking period (b), and washing with a plate washer; (ii) a sample binding step comprising adding one of the samples using a pipettor while shaking at one of the plate shaking stations and washing using a plate washer, followed by incubation for a sample incubation period(s); (iii) a detector binding step, which includes adding detection reagent using a pipettor while shaking at one of the plate shaking stations and washing using a plate washer, and incubating for a detector incubation period (d); (iv) adding read buffer using a pipettor; (v) measuring the assay signal with a reader; is performed on each well of the plate; Including, Up to five plates can be run, The steps are performed as shown in Figure 9(d), Figures 12(m)-12(p), Figures 12(r)-12(s), Figures 13(d)-13(f), Figures 14(d), Figures 14(f)-(l), Figures 15(b), Figures 15(d)-15(h), Figures 16(b), Figures 17(b), and Figures 17(d)-17(h). Regarding automated assay systems.

[0076] The system process consists of the following steps: (vi) using a pipettor to dilute the calibrator stock solution to form a plurality of calibration standards, the calibration standards being included in the plurality of samples, e.g., samples to be tested, and accessible to control a software automated assay system or stored, e.g., in a memory; (vii) using a pipettor to pre-dilute one or more of the samples prior to adding the samples to the wells of the plate; (viii) combining the plurality of detection reagent components using a pipettor to form a detection reagent; The composition may further include one or more of the following:

[0077] The steps are preferably carried out under temperature control capable of maintaining 20-24° C.±1° C., and the measurement is an ECL measurement. The measurement may also be a multiplexed measurement.

[0078] Additional automated assay systems include (a) a processing deck for holding assay components providing a generally rectangular surface with a front end, a first lateral end, a second lateral end, and a rear edge; (i) an assay consumable hotel approximately centered and cantilevered on the front end of the deck having a plurality of consumable slots sized to hold consumables that meet the ANSI-SLAS specifications for width and length of a 96-well assay plate; (ii) a plurality of pipette tip locations for holding pipette tip containers located on a first side of the deck; (iii) a plurality of plate shaker locations located along the aft edge of the deck; (iv) a set of processing stations located approximately centrally on the deck between the hotel and a shaker configured to hold consumables having dimensions conforming to ANSI-SLAS; (v) a barcode scanner located on a first side of the deck behind the pipette tip location, the barcode scanner having a scanning surface large enough to scan a bottom surface of a consumable having dimensions in accordance with ANSI-SLAS; said deck supporting said (b) a plate washer located below the deck and accessible through an opening in the deck between the pipette location and the assay plate processing location; (c) a gantry located above the deck that movably supports the robotic plate gripper so that the gripper can move to access locations (i) to (v) and that movably supports the robotic 8 channel pipetter so that the pipetter can access locations (ii) and (iv); (d) an assay reader positioned adjacent a first side of the deck on a platform that is at a lower vertical height than the deck, the highest point on the reader being lower than the lowest point to which the robotic grabber can travel; and (e) an enclosure surrounding components (a)-(d), having a temperature controller for maintaining the components under temperature control and having a door providing a user with access to the front of the deck and a consumable hotel located thereon; The present invention relates to an automated assay system comprising:

[0079] An additional aspect is (a) A single robotically controlled 8-channel pipettor; (b) a single robotically controlled assay plate gripper arm; (c) a single 96-channel pre-assay plate washer; (d) a single plate reader; and (d) one or more plate shakers having a total capacity of at least five plate shaking stations; (e) a processor adapted to execute an assay process for analyzing a plurality of samples in a 96-well plate, the processor comprising the following operations: a blocking step including (i) adding a blocking buffer using a pipettor, incubating for a blocking period (b), and (c) washing using a plate washer; (ii) a sample binding step comprising adding one of the samples using a pipettor while shaking at one of the plate shaking stations and washing using a plate washer, and incubating for a sample incubation period(s); (iii) a detector binding step including adding detection reagent using a pipettor and incubating for a detector incubation period (d) while shaking at one of the plate shaking stations and washing using a plate washer; (iv) adding read buffer with a pipettor; (v) measuring the assay signal using a reader; a processor which executes the process for each well of the plate; Including, Up to 5 plates can be processed in a run Regarding automated assay systems. [Brief description of the drawings]

[0080] [Figure 1] FIG. 13 is a diagram showing generation and storage of consumables data, and consumables data by a consumables manufacturer. [Diagram 2] FIG. 13 illustrates distribution of consumable data to customers in response to inquiries about the consumable data. [Diagram 3] FIG. 1 illustrates the use of consumable data to verify authorized use of consumables in an assay system. [Figure 4] FIG. 1 illustrates the master repository on a CD server, its contents, and / or an interface to additional vendor directories. [Figure 5(a)] FIG. 1 shows an assay reader as described herein. [Figure 5(b)] FIG. 1 shows an assay reader as described herein. [Figure 5(c)] FIG. 1 shows an assay reader as described herein. [Figure 5(d)] FIG. 1 shows an assay reader as described herein. [Figure 6(a)] FIG. 2 is an alternative diagram of an assay reader as described herein. [Figure 6(b)] FIG. 2 is an alternative diagram of an assay reader as described herein. [Figure 6(c)] FIG. 2 is an alternative diagram of an assay reader as described herein. [Figure 7] FIG. 2 is an additional diagram of an assay reader as described herein. [Figure 8] FIG. 1 shows an assay system as described herein. [Figure 9(a)]FIG. 1 illustrates an assay system and various subsystems included therein. In particular, the system includes multiple subsystems positioned on a table or platform, each operatively connected to a robotic subsystem configured to access and move one or more consumables, such as multi-well assay plates, from one subsystem of the assay system to another. [Figure 9(b)] FIG. 1 shows an assay system and the various subsystems contained within the system. [Figure 9(c)] FIG. 1 shows an assay system and the various subsystems contained within the system. [Figure 9(d)] 1 shows a schedule of operations performed in the system during the performance of an assay. [Figure 10(a)] 10(a)-10(b) depict one embodiment of an assay system and various subsystems therein, The assay system shown in Figures 10(a)-10(b) is configured to perform on-board all sample processing steps as well as all assay processing steps required in performing an assay, and the assay system is operatively connected to a user interface configured to display to a user step-by-step instructions for appropriate sample / reagent preparation steps that must be performed manually before the system can perform an assay. [Figure 10(b)] FIG. 1 illustrates one embodiment of an assay system and various subsystems therein. [Figure 10(c)] FIG. 10(a)-(d) shows another iteration of the assay system shown in FIG. [Figure 10(d)] FIG. 1 shows the top view of a table supporting equipment for an assay system. [Figure 10(e)] FIG. [Figure 10(f)] FIG. [Figure 10(g)] FIG. 13 is a perspective view showing a pipette tip entering the lid of a reagent trough. [Figure 10(h)]10(g) is a top view of various cut patterns of the lid shown in FIG. 10(g). [Figure 10(i)] FIG. 2 is a perspective view of the lid and assay plate. [Figure 10(j)] FIG. 10(i) is a cross-sectional view of the lid and assay plate of FIG. [Figure 10(k)] FIG. 10(j) is an enlarged view of FIG. [Figure 10(l)] FIG. 13 is a front view of the assay system shown in FIGS. 10(a)-10(c) with its inner door closed. [Figure 10(m)] FIG. 1 shows cooling patterns in an assay system. [Figure 10(n)] FIG. 1 shows cooling patterns in an assay system. [Figure 10(o)] FIG. 1 shows cooling patterns in an assay system. [Figure 10(p)] FIG. 1 illustrates a cooling pattern for an electronic enclosure. [Figure 10(q)] FIG. 13 shows an adjustable hinge for the door of the assay system with two degrees of freedom. [Figure 10(r)] FIG. 13 is a top perspective view of an assay consumable storage unit. [Figure 10(s)] FIG. 1 shows the dimensions of the frame of the assay system. [Figure 10(t)] FIG. 1 shows the dimensions of the frame of the assay system. [Figure 10(u)] FIG. [Figure 10V] FIG. 1 shows a portion of the wiring diagram of the assay system (1000). [Figure 10V-a] This is an enlarged portion of FIG. 10V. [Figure 10V-b] This is an enlarged portion of FIG. 10V. [Figure 10V-c] This is an enlarged portion of FIG. 10V. [Figure 10V-d] This is an enlarged portion of FIG. 10V. [Figure 10W] FIG. 1 shows a portion of the wiring diagram of the assay system (1000). [Figure 10W-a]This is an enlarged portion of Figure 10W. [Figure 10W-b] This is an enlarged portion of Figure 10W. [Figure 10W-c] This is an enlarged portion of Figure 10W. [Figure 10W-d] This is an enlarged portion of Figure 10W. [Figure 10W-e] This is an enlarged portion of Figure 10W. [Figure 10W-f] This is an enlarged portion of Figure 10W. [Figure 10W-g] This is an enlarged portion of Figure 10W. [Figure 10W-h] This is an enlarged portion of Figure 10W. [Figure 10X] FIG. 1 shows a portion of the wiring diagram of the assay system (1000). [Figure 10X-a] This is an enlarged portion of FIG. 10X. [Figure 10X-b] This is an enlarged portion of FIG. 10X. [Figure 10X-c] This is an enlarged portion of FIG. 10X. [Figure 10X-d] This is an enlarged portion of FIG. 10X. [Figure 10X-e] This is an enlarged portion of FIG. 10X. [Figure 10Y] FIG. 1 shows a portion of the wiring diagram of the assay system (1000). [Figure 10Y-a] This is an enlarged portion of FIG. 10Y. [Figure 10Y-b] This is an enlarged portion of FIG. 10Y. [Figure 10Y-c] This is an enlarged portion of FIG. 10Y. [Figure 10Y-d] This is an enlarged portion of FIG. 10Y. [Figure 10(z)] FIG. 10 is a top view showing the plate carrier (1036) and the tip carrier (1026). [Figure 10(aa)] FIG. 10(f) is a top perspective view of another embodiment of the training plate shown in FIG. [Figure 10(bb)] FIG. 10(aa) is a bottom perspective view of the embodiment of FIG. [Figure 10(cc)] FIG. 10(u) is another top view of the platform shown in FIG. [Figure 11a] FIG. 1 illustrates a particular embodiment of a data association workflow, a process by which particular data is associated with a consumable identifier. [Figure 11(b)] FIG. 1 illustrates the interaction between the assay system's computer system and a customer's computer system. [Figure 11(c)] FIG. 2 is a diagram of components of the computer system of the assay system. [Figure 11(d)] 4 is a flow chart of the instrument control portion of the software. [Figure 11E] FIG. 2 illustrates an example of a software architecture. [Figure 12(a)] FIG. 1 illustrates one embodiment of a software architecture for deployment and use of Data Deployable Bundles (DDBs). [Figure 12(b)] FIG. 1 illustrates one embodiment of a software architecture for deployment and use of Data Deployable Bundles (DDBs). [Figure 12(c)] FIG. 1 illustrates one embodiment of a software architecture for deployment and use of Data Deployable Bundles (DDBs). [Figure 12(d)] FIG. 1 illustrates one embodiment of a software architecture for deployment and use of Data Deployable Bundles (DDBs). [Figure 12(e)] FIG. 1 illustrates one embodiment of a software architecture for deployment and use of Data Deployable Bundles (DDBs). [Figure 12(f)] FIG. 1 illustrates one embodiment of a software architecture for deployment and use of Data Deployable Bundles (DDBs). [Figure 12(g)] FIG. 1 illustrates one embodiment of a software architecture for deployment and use of Data Deployable Bundles (DDBs). [Figure 12(h)] FIG. 1 illustrates one embodiment of a software architecture for deployment and use of Data Deployable Bundles (DDBs). [Figure 12(i)]FIG. 1 illustrates one embodiment of a software architecture for deployment and use of Data Deployable Bundles (DDBs). [Figure 12(j)] FIG. 1 illustrates one embodiment of a software architecture for deployment and use of Data Deployable Bundles (DDBs). [Figure 12(k)] FIG. 1 illustrates one embodiment of a software architecture for deployment and use of Data Deployable Bundles (DDBs). [Figure 12(l)] FIG. 1 illustrates one embodiment of a software architecture for deployment and use of Data Deployable Bundles (DDBs). [Figure 12M-a] FIG. 1 illustrates a script showing an exemplary general protocol. [Figure 12M-b] FIG. 1 illustrates a script showing an exemplary general protocol. [Figure 12N-a] FIG. 12C illustrates the script of FIG. 12M with selected steps of the protocol turned off. [Figure 12N-b] FIG. 12C illustrates the script of FIG. 12M with selected steps of the protocol turned off. [Figure 12O-a] FIG. 12C illustrates the script of FIG. 12M with selected steps of the protocol turned off. [Figure 12O-b] FIG. 12C illustrates the script of FIG. 12M with selected steps of the protocol turned off. [Figure 12P] FIG. 12C illustrates the script of FIG. 12M with selected steps of the protocol turned off. [Figure 12Q-a] FIG. 1 illustrates an example instrument parameter file showing the on / off status of specific steps in a protocol. [Figure 12Q-b] FIG. 1 illustrates an example instrument parameter file showing the on / off status of specific steps in a protocol. [Figure 12R-a] FIG. 13 illustrates another example of a general protocol. [Figure 12R-b] FIG. 13 illustrates another example of a general protocol. [Figure 12S-a] FIG. 1 illustrates a generic script with certain steps turned off. [Figure 12S-b] FIG. 1 illustrates a generic script with certain steps turned off. [Figure 13(a)] FIG. 1 illustrates one embodiment of the use of data deployable bundles and consumable / system data to operate an assay system in performing an assay. [Figure 13(b)] FIG. 1 illustrates one embodiment of the use of data deployable bundles and consumable / system data to operate an assay system in performing an assay. [Figure 13C] FIG. 1 illustrates one embodiment of the use of data deployable bundles and consumable / system data to operate an assay system in performing an assay. [Figure 13D-a] FIG. 1 illustrates one embodiment of the use of data deployable bundles and consumable / system data to operate an assay system in performing an assay. [Figure 13D-b] FIG. 1 illustrates one embodiment of the use of data deployable bundles and consumable / system data to operate an assay system in performing an assay. [Figure 13E-a] FIG. 1 illustrates one embodiment of the use of data deployable bundles and consumable / system data to operate an assay system in performing an assay. [Figure 13E-b] FIG. 1 illustrates one embodiment of the use of data deployable bundles and consumable / system data to operate an assay system in performing an assay. [Figure 13(f)] FIG. 1 illustrates one embodiment of the use of data deployable bundles and consumable / system data to operate an assay system in performing an assay. [Figure 14(a)] FIG. 1 shows the implementation of a V-PLEX assay on an assay system using the software described herein. [Figure 14(b)]FIG. 1 shows the implementation of a V-PLEX assay on an assay system using the software described herein. [Figure 14(c)] FIG. 1 shows the implementation of a V-PLEX assay on an assay system using the software described herein. [Figure 14(d)] FIG. 1 shows the implementation of a V-PLEX assay on an assay system using the software described herein. [Figure 14(e)] FIG. 1 shows the implementation of a V-PLEX assay on an assay system using the software described herein. [Figure 14(f)] FIG. 1 shows the implementation of a V-PLEX assay on an assay system using the software described herein. [Figure 14(g)] FIG. 1 shows the implementation of a V-PLEX assay on an assay system using the software described herein. [Figure 14(h)] FIG. 1 shows the implementation of a V-PLEX assay on an assay system using the software described herein. [Figure 14(i)] FIG. 1 shows the implementation of a V-PLEX assay on an assay system using the software described herein. [Figure 14J-a] FIG. 1 shows the implementation of a V-PLEX assay on an assay system using the software described herein. [Figure 14J-b] FIG. 1 shows the implementation of a V-PLEX assay on an assay system using the software described herein. [Figure 14K-a] FIG. 1 shows the implementation of a V-PLEX assay on an assay system using the software described herein. [Fig. 14K-b] FIG. 1 shows the implementation of a V-PLEX assay on an assay system using the software described herein. [Figure 14(l)] FIG. 1 shows the implementation of a V-PLEX assay on an assay system using the software described herein. [Figure 15A] FIG. 1 shows the implementation of a U-PLEX assay on an assay system using the software described herein. [Figure 15B] FIG. 1 shows the implementation of a U-PLEX assay on an assay system using the software described herein. [Figure 15C-a] FIG. 1 shows the implementation of a U-PLEX assay on an assay system using the software described herein. [Figure 15C-b] FIG. 1 shows the implementation of a U-PLEX assay on an assay system using the software described herein. [Figure 15D-a] FIG. 1 shows the implementation of a U-PLEX assay on an assay system using the software described herein. [Figure 15D-b] FIG. 1 shows the implementation of a U-PLEX assay on an assay system using the software described herein. [Figure 15E-a] FIG. 1 shows the implementation of a U-PLEX assay on an assay system using the software described herein. [Figure 15E-b] FIG. 1 shows the implementation of a U-PLEX assay on an assay system using the software described herein. [Figure 15(f)] FIG. 1 shows the implementation of a U-PLEX assay on an assay system using the software described herein. [Figure 15G-a] FIG. 1 shows the implementation of a U-PLEX assay on an assay system using the software described herein. [Figure 15G-b] FIG. 1 shows the implementation of a U-PLEX assay on an assay system using the software described herein. [Figure 15H-a] FIG. 1 shows the implementation of a U-PLEX assay on an assay system using the software described herein. [Figure 15H-b]FIG. 1 shows the implementation of a U-PLEX assay on an assay system using the software described herein. [Figure 16(a)] FIG. 1 shows the setup, optimization, and execution of an immunogenicity assay on the assay system. [Figure 16B] FIG. 1 shows the setup, optimization, and execution of an immunogenicity assay on the assay system. [Figure 16(c)] FIG. 1 shows the setup, optimization, and execution of an immunogenicity assay on the assay system. [Figure 16(d)] FIG. 1 shows the setup, optimization, and execution of an immunogenicity assay on the assay system. [Figure 17(a)] FIG. 1 shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(b)] FIG. 1 shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(c)] FIG. 1 shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(d)] FIG. 1 shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(E)-a] FIG. 1 shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(E)-b] FIG. 1 shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(F)-a] FIG. 1 shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(F)-b]FIG. 1 shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(G)-a] FIG. 1 shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(G)-b] FIG. 1 shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(H)-a] FIG. 1 shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(H)-b] FIG. 1 shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(i)] FIG. 1 shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 18(a)] FIG. 1 illustrates an assay system described herein and a consumable assay kit that can be used. [Figure 18(b)] FIG. 1 illustrates an assay system described herein and a consumable assay kit that can be used. [Figure 18(c)] FIG. 1 illustrates an assay system described herein and a consumable assay kit that can be used. [Figure 18(d)] FIG. 1 illustrates an assay system described herein and a consumable assay kit that can be used. [Figure 18(e)] FIG. 1 illustrates an assay system described herein and a consumable assay kit that can be used. [Figure 18(f)] FIG. 1 illustrates an assay system described herein and a consumable assay kit that can be used. [Figure 18(g)]FIG. 1 illustrates an assay system described herein and a consumable assay kit that can be used. [Figure 18(h)] FIG. 1 illustrates an assay system described herein and a consumable assay kit that can be used. [Figure 18(i)] FIG. 1 illustrates an assay system described herein and a consumable assay kit that can be used. [Figure 18(j)] FIG. 1 illustrates an assay system described herein and a consumable assay kit that can be used. [Figure 18(k)] FIG. 1 illustrates an assay system described herein and a consumable assay kit that can be used. [Figure 18(l)] FIG. 1 illustrates an assay system described herein and a consumable assay kit that can be used. [Figure 18(m)] FIG. 1 illustrates an assay system described herein and a consumable assay kit that can be used. [Figure 18(n)] FIG. 1 illustrates an assay system described herein and a consumable assay kit that can be used. [Figure 19(a)] FIG. 1 is a perspective view of a loading cart of the present invention designed for use with the assay system described herein. [Figure 19(b)] FIG. 1 is a perspective view of a loading cart of the present invention designed for use with the assay system described herein. [Figure 19(c)] FIG. 1 is a plan view of a loading cart showing a tray adapted to receive assay consumables. [Figure 19(d)] FIG. 1 is an exemplary plan view of a tray loaded with assay consumables. [Figure 19(e)] FIG. 1 is an exemplary plan view of a tray loaded with assay consumables. [Figure 19(f)] FIG. 1 is an exemplary plan view of a tray loaded with assay consumables. [Figure 19(g)] FIG. 1 is an exemplary plan view of a tray loaded with assay consumables. [Figure 19(h)]FIG. 1 is an exemplary plan view of a tray loaded with assay consumables. [Figure 19(i)] FIG. 13 shows the cooling compartment below the tray. [Figure 19(j)] FIG. 13 illustrates another embodiment of the loading cart of the present invention. [Figure 20(a)] FIG. 13 shows exemplary adjustments to dispense timing and ECL read patterns for an assay system of the present invention. [Figure 20(b)] FIG. 13 shows exemplary adjustments to dispense timing and ECL read patterns for an assay system of the present invention. [Figure 20(c)] FIG. 13 shows exemplary adjustments to dispense timing and ECL read patterns for an assay system of the present invention. [Figure 20(d)] FIG. 13 shows exemplary adjustments to dispense timing and ECL read patterns for an assay system of the present invention. [Figure 20(e)] FIG. 13 shows exemplary adjustments to dispense timing and ECL read patterns for an assay system of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0081] As used herein, figures with two suffixes separated by a hyphen that are presented in separate drawing sheet subsections, such as Figure 10V-a, Figure 10V-b, Figure 10V-c, and Figure 10V-d, are enlarged portions of a single drawing, such as Figure 10(v) or Figure 10(V). These enlarged figures are hereinafter referred to collectively and without the second suffix, such as Figure 10(v) or Figure 10V.

[0082] Unless otherwise specified herein, scientific and technical terms used in connection with the present invention shall have the meanings commonly understood by those skilled in the art. Furthermore, unless the context clearly dictates otherwise, singular terms shall include the plural and plural terms shall include the singular. The articles "a" and "an" are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, "an element" means one element or more than one element.

[0083] As used herein, the term "sample" is intended to mean a biological fluid, cell, tissue, organ, or combination or portion thereof that contains or potentially contains a biomarker of a disease of interest. For example, a sample can be a tissue section of a specimen obtained by biopsy, or cells placed in or adapted to tissue culture. A sample can also be a subcellular fraction or extract, or a crude or substantially pure nucleic acid molecule or protein preparation. In one embodiment, samples analyzed in the assays of the invention are blood, peripheral blood mononuclear cells (PBMCs), separated blood cells, serum, and plasma. Other suitable samples include biopsy tissue, intestinal mucosa, saliva, cerebrospinal fluid, and urine.

[0084] The assay consumables and systems used in the present invention include a variety of devices and configurations. In one embodiment, an assay system used in the present invention includes an assay reader capable of using the assay consumables and performing a biological assay. The assay consumables include an identifier (alternatively referred to as an identifier, consumable identifier, or assay consumable identifier throughout the specification), and the assay system, assay reader, or components thereof include an identifier controller that interacts with the identifier. As described below, the identifier is associated with information about the assay consumable (collectively referred to as "consumable data"), which may include, but is not limited to, how the consumable is manufactured and processed prior to use, and how the consumable is used in the assay system. Thus, an assay system is configured to use an assay consumable in performing an assay, the assay system including an identifier controller adapted to (i) read consumable data from an assay consumable identifier associated with the assay consumable, (ii) access the consumable data associated with the assay consumable that is indexed by the assay consumable identifier, and store the consumable data locally on the assay system or assay reader or remotely on a vendor computing system, (iii) erase the consumable data associated with the assay consumable identifier, and / or (iv) write the consumable data indexed to the consumable identifier to the assay system and / or a remote data table.

[0085] In a specific embodiment, the invention provides an assay system configured to use an assay consumable in performing an assay, the assay consumable comprising an assay consumable identifier as described herein, the assay system comprising (a) a storage medium comprising a consumable data repository, and (b) an identifier controller adapted to read information from the consumable identifier. In one embodiment, the system comprises a storage medium comprising a consumable data repository comprising local consumable data. The local consumable data stored by the assay system comprises consumable identification and / or configuration information, and one or more steps of an assay protocol that can be applied by the system in performing an assay using the consumable. For example, The assay consumable identifier includes information that can be used to identify a particular consumable, such as lot-specific information for a given lot of consumables and / or information that is specific to an individual consumable, and the corresponding local consumable data stored in the assay system includes information used to identify a consumable associated with the system, such as as a member of a given lot or as an individual consumable within a lot, which also includes information used by the system once the consumable is identified to perform an assay protocol using that consumable. Additionally, the consumable data (and / or local consumable data) may include one or more analytical tools that can be applied by the system to use the consumable and analyze and interpret generated data, system and / or consumable technical support information, or a combination thereof. Additionally, the system may be configured to receive updates to the consumable data repository from the remote storage medium, where those updates include additional consumable data, including, but not limited to, additional consumable identification and / or configuration information, assay protocol information, and one or more of the following: (x) one or more analytical tools that can be applied by the system to analyze the data and interpret results generated during and / or after performance of the assays, (y) assay system maintenance information, (z) system consumable promotional information, and (xx) system and / or consumable technical support information.

[0086] One embodiment of the use of identifiers / consumable data in the system is shown in Figures 1-4. Figure 1 shows how consumable data is generated, stored, and used by a manufacturer, distributor, or supplier (referred to herein as a "vendor"). First, the vendor generates a consumable and / or collection or lot of consumables (101), and for that consumable or lot of consumables, the consumable data is associated (step i) with a consumable identifier (103) generated and indexed to the consumable or lot of consumables using a consumable data (CD) creation system (102). The consumable data is generated by the consumable vendor before, during, and / or after the individual consumables and / or lots of consumables are made and / or distributed. The CD creation system generates a database of CD information for that consumable or lot, the CD database, in which the consumable data is stored. The CD database is sent to a CD server (104) that contains the master repository of all consumable data. Additionally, the CD Creation System stores information used to associate a given consumable identifier with the consumable data in the master repository. The CD Creation System and / or the CD Server may be located at a remote computing system, i.e., an assay system and / or a computing system remote from the customer, or at a customer, e.g., a site maintained by the vendor. Thus, as shown in Figure 1, the vendor generates consumable data for a consumable or lot (a) and associates that information with a consumable identifier (b) that indexes that consumable or lot. The CD System also generates a CD database (step ii), stores the consumable data in the CD database (step iii), and transmits the CD database to the CD Server (c), which contains the master repository of all consumable data (step iv).

[0087] FIG. 2 illustrates one method of distributing consumable data to customers (collectively referred to herein as "customers") or designated users of a customer. Upon receipt of an order from a customer, or once a consumable or lot has been manufactured (step i), the vendor generates, stores, and transmits a CD database to a CD server (201) (step ii). The CD database may include other fulfillment information, i.e., a summary of the components of an order for a given customer so that the system can verify that all components of the order have been supplied to the customer. The customer receives a consumable (202) including a consumable identifier (203) and contacts the consumable with an assay system (204) in preparation for performing an assay (step iii), which reads and / or accesses the data associated with the assay consumable identifier (203), which information is used by the system to identify the consumable (202) (step iv). The system generates, stores, and transmits a CD database that can be used for performing an assay using the given consumable (step iv). The system reviews the consumable data stored locally on the local storage media (referred to as "Local CD" in FIG. 2) to identify that consumable data stored on the media. If the storage media contains consumable data for that consumable or lot, the consumable can be used in the system (step v). If the storage media does not contain consumable data for that particular consumable or lot of consumables, the system can query the customer for that consumable data, and the customer can communicate with the vendor to receive the required consumable data, for example, via email, compact disc, memory card / memory stick, flash drive, web data storage service, etc. (step vi). The vendor sends the consumable data binary file (including, but not limited to, an encrypted XML file) to the customer, for example, as an email attachment to a customer email account, and the customer loads the file attachment into the assay system, and the system software stores the consumable data in the local system consumable data repository. The consumable / lot of consumables can then be used in the instrument (step vii).

[0088] In an alternative embodiment, the CD server can be connected to the system via a direct interface that can automatically obtain the consumable data from the CD server if the consumable data is not available locally on the system. In this embodiment, the vendor generates, stores, and transmits a CD database for the consumable order and / or consumable lot to the CD server as shown in FIG. 2 and described above. The customer then receives the consumable, order, and / or lot and contacts the system with a consumable identifier to enable the system to identify the consumable or lot. The system software queries the system consumable data repository for the consumable data associated with that consumable identifier, and if the consumable data is available locally on the system, the software adjusts the system based on the consumable data if necessary. If the consumable data is not present in the system consumable data repository, the system (i) prompts the customer to manually obtain the consumable data from the vendor, or (ii) automatically obtains the CD server's consumable data via a direct interface with the CD server and stores the information locally in the system consumable data repository. If the consumable data is available locally on the system, the software adjusts the system based on the consumable data, if necessary, to perform the assay. If the consumable data is available locally on the system, the consumable or lot can be used by the system to perform the assay and display the assay results to the customer. In a specific embodiment, the system software adjusts the output to the customer based on the consumable data.

[0089] Additionally, the CD Server can periodically send consumable data for new lots / types of consumables to the customer assay system via, for example, email, CD, memory card / memory stick, flash drive, and / or via a remote interface between the system and the CD Server. The storage medium includes a consumable data repository containing the consumable data, and the assay system is configured to receive updates to the repository from the remote storage medium, for example, via email, CD, memory card / memory stick, flash drive, and / or via a remote interface.

[0090] FIG. 3 illustrates the validation of consumable data by the system software, and the results of that procedure. Initially, a customer inserts a consumable (301) along with a consumable identifier (302) into the system (303) (or otherwise places the consumable identifier in contact with a controller on the system), and the system software identifies the consumable via the consumable identifier (302). The system attempts to associate that identifier with consumable data stored locally in the system repository. If the consumable data is verified and valid, the system processes the consumable and displays the results of that processing step to the customer. However, if the consumable data is invalid or cannot be verified, the consumable is processed by the system, but the results of the analysis are not displayed or shown until the consumable data is verified by the system software. Otherwise the customer will not be able to use it.

[0091] The present invention further provides a method of controlling customer access to an assay system and / or assay consumables by a vendor, the system including a system identifier, the method comprising: receiving the system identifier from a customer, the system identifier being transmitted to a vendor computing system; receiving, identifying the system identifier by vendor; and (i) allowing full access to the device and / or assay consumables used with the device; (ii) allowing partial access to the device and / or assay consumables used with the device; or (iii) Denying access to the equipment and / or assay consumables used with the equipment; The method includes performing an operation including:

[0092] The system identifier includes information that uniquely identifies the assay system, such as a serial number or other identification code that is generated and used by the vendor to identify the assay system. The system identifier is generated by the vendor during or after the manufacturing process and / or when the system is prepared for shipment or transfer to a customer.

[0093] In one embodiment, the step of enabling either full or partial access includes transmitting an access code from the vendor to the customer, thereby enabling access to the system. The access code may be a full access code or a partial access code that enables different features of the system. In one embodiment, the access code is a partial access code that allows the system to operate in a demonstration mode. The partial access code may be time limited. Alternatively, the access code may be a full access code that allows the system to be fully operational.

[0094] As shown in FIG. 4, the CD server (401) includes a master repository (402) that includes one or more directories of (i) consumable data, (ii) system data, and (iii) customer data. Additionally or alternatively, data included in one or more of the directories (i)-(iii) can be provided to the master repository by an interface between the CD server and one or more supplemental vendor directories. In one embodiment, the master repository includes (i) a master customer data directory (403), (ii) a master system identifier directory (404), and (iii) a master customer data directory (405). In a preferred embodiment, the customer data is provided to the CD server via an interface to a supplemental vendor-customer directory that maintains the customer data. The customer data can be stored in one or more supplemental vendor-customer directories, each of which is connected to the CD server via an interface. The master CD database includes multiple CD directories, each of which is generated for a consumable or a lot of consumables. The Master System Identifier Directory contains a unique system identifier for each system manufactured and / or distributed by the vendor, and a supplemental Vendor-Customer Directory that interfaces with the Master Customer Directory and / or CD Server contains information related to each customer of the vendor, such as contact information, billing information, pricing information, shipping information, order history, etc., for the customer and each of the customers' individual customers.

[0095] In a specific embodiment, when a system is manufactured and / or prepared for shipment, the vendor generates a system identifier for the system. The system identifier is stored in the master customer directory or is available through an interface between the supplemental vendor directory and the CD server. When a system is ordered by a customer, order information and customer information, such as the purchase order, related quotes, pricing, terms of sale or rental, related service contracts, etc., are stored in the master customer directory and / or in one or more supplemental vendor customer directories that interface with the CD server. In this regard, a unique system identifier for the system is associated with the customer who purchased the system in the master repository, as well as any information regarding the related purchase by that customer. Customer shipping information for the system is also available in the customer directory(ies), and once the system is shipped, the customer receives a shipping confirmation, a copy of which is also stored in the customer directory. Once the customer receives the system, and in the preferred embodiment, installation and training on the system is completed, if necessary, the system software connects to the CD server through a remote interface between the system and the CD server to enable interaction between the two. The system first connects to the CD server to confirm that system installation and training are complete and successful, and the CD server records the confirmation. Alternatively, if remote connections are not possible on the system, the customer can receive a confirmation code, system login, and / or email address from the system once the system is installed and training is complete, and the customer can log into the CD server via the confirmation code, system login, and / or email, thereby providing a customer login to the CD server that provides a separate vendor-customer interface without a direct connection between the system and the CD server. The separate vendor-customer interface may be a portal on a website hosted by the vendor that is accessible to the customer via a password, and / or the customer and the CD server can communicate via an email exchange server configured to send and receive email between the customer and the CD server (collectively referred to as an "indirect interface" between the customer and the CD server).Thus, the vendor can communicate with the customer via a direct system-CD interface (called a "direct interface") and / or via an indirect interface. As described above, the customer can then purchase the consumable, the system reads the consumable identifier, ensures that the consumable data is stored locally, receives the consumable data directly or indirectly from the CD server if necessary, and the system can then use the consumable or lot.

[0096] Once the customer and vendor have a means to communicate via a direct or indirect interface, the customer and vendor can interact in a variety of ways, and the communication between the parties can be more meaningful and productive because the vendor has the ability to track system and consumable purchases and / or customer-specific usage information used by the customer. For example, the customer can browse and / or purchase vendor products, get customer assistance, schedule service calls, etc., via a direct or indirect interface. Because the vendor can track customer activities and purchases very closely via the consumable identifier / CD server, the vendor can tailor its interactions with the customer based on that information. For example, because the vendor knows the customer's order history, the vendor can send the customer product promotional materials related to those products the customer has purchased / used in the past. Similarly, because the vendor tracks information related to the customer's system, the vendor can send the customer preventive maintenance tips and reminders, general or specific customer training and seminars based on the customer's specific needs (and informed by tracking that customer's consumable data), as well as system service, warranty repair information, maintenance contract information and reminders, and the like.

[0097] In one embodiment, the vendor tracks the usage of the consumables by the assay customers, and the consumable data stored in the assay system includes system-consumable usage information. To facilitate this, the assay system is configured to send system-consumable usage information directly or indirectly to the CD server. If the direct interface is enabled between the system and the CD server, the system-consumable usage information can be sent automatically. However, if the direct interface is not enabled, the system-consumable usage information can be provided indirectly by the customer to the CD server. In this embodiment, the system can periodically prompt the customer to provide system-consumable usage information to the vendor via the indirect interface. The vendor can maintain a directory of customer consumable information to track consumable usage, and information from the directory is used to send consumable data that may be relevant to the customer based on previous consumable and / or system usage via the direct or indirect interface. If the direct interface is enabled, the assay system can be configured to receive assay system maintenance and / or promotional information from the vendor computing system related to an individual customer's previous consumable and / or system usage.

[0098] The vendor may also track and / or communicate to the customer system maintenance information, such as, for example, the use of the monitored system and / or system components, service history, system troubleshooting information, results of diagnostics performed on the system, control chart generation, scheduled maintenance scheduling, warranty information regarding the system and / or system components, or a combination thereof. The system software may be programmed to monitor various components of the system and send monitoring reports to a remote computing system and / or a maintenance technician, either automatically or when prompted. If a direct interface is not enabled, the system may prompt the customer to send the monitoring reports to the CD Server via an indirect interface. Additionally or alternatively, such system monitoring reports may be accessed by a maintenance technician tasked with maintaining and / or servicing the system, either locally or remotely. In a specific embodiment where a direct interface is enabled, the CD Server monitors the use and / or warranty information of the system components and schedules scheduled system / component maintenance and / or upgrades by a maintenance technician based on standard system component life spans and / or warranty terms. Additionally, the CD Server can maintain a log of the service history of a given assay system and schedule service calls by a maintenance technician (this can be done using either the direct or indirect interface). Remote computing systems can also send individual assay system software updates via the direct or indirect interface.

[0099] Additionally, one or more of the following system components and / or operations may be controlled by the system software, including, but not limited to, expected motor position during normal use, position error per expected motor position, corrective action and / or attempted corrective action taken by the system in the event of a motor positioning error, and frequency of errors; usage of a component, e.g., the approximate time the component has been powered on in the system; in a preferred embodiment, the system also tracks the relative life of its components under normal use conditions; locking mechanism attempts, retries, and failures; barcode identifier controller attempts, retries, and failures; approximate temperature of one or more components of the system; error warnings; database performance and capacity; instrument hard disk capacity; software and firmware versions and patches; customer login / logout; system startup and shutdown; etc. In certain preferred embodiments involving systems designed to use assay consumables and perform electrochemiluminescence measurements, the system software may record the time and approximate temperature that the analyzer camera has been powered on, the use cycles of the latch within the system, barcode identifier controller attempts, retries, and failures, consumable lock and unlock events, ECL waveform voltage and integrated current, image processing analysis accuracy and failures, consumable type, kit, owner, consumable identifier (e.g., barcode), and a timestamp for each consumable run on the system. The system software may also be programmed to monitor the number of consumables, pumps, or combinations thereof. Additionally, the system software may monitor experiments performed on the system, such as when, by who, and what type(s) of consumables were used in the experiment. Such system usage monitoring information may be sent to the CD Server via direct and / or indirect interfaces to enable the vendor to schedule appropriate support, service, and / or maintenance for the system.

[0100] In another embodiment, the vendor can provide usage and / or purchasing assistance by tracking the usage of the assay system. For example, the vendor can track the usage and purchase history of consumables, and based on the consumable data for a given lot or consumable, the vendor can monitor the expiration date of a given lot or consumable and notify the customer of the approaching expiration date of the lot or consumable. Tracking the usage of the assay system / consumable type also allows the vendor to track the relative schedule / frequency of consumable usage and notify the customer that the customer's consumable supply needs to be replenished. If the direct interface is enabled, the system can also be configured to order / reorder consumables, and the system can further be configured to track and confirm consumable orders from the vendor. If the direct interface is not enabled, the system can monitor the usage and inventory of consumables and prompt the customer to replenish their supply of one or more consumables. (In this regard, the system can receive lot size information via the consumable identifier, and by monitoring the consumable usage, the system can prompt the customer when the available consumable supply of a given lot is reduced to a minimum level). Additionally, by tracking consumable usage, the vendor can send customers information regarding custom assay design services for specific custom consumable types based on the customer's order / consumable usage history. The direct or indirect interface can also provide customer training modules, consulting services, and / or live customer service assistance capabilities (i.e., live chat) to enhance the customer's experience (collectively referred to as system and / or consumable technical support information).

[0101] In another embodiment, tracking consumable / system usage allows the vendor to send promotional materials to the customer. For example, when new types or lots of consumables are being used by a given end customer, the vendor computing system sends consumable data to the customer regarding those new products. Such promotional materials may also relate to new assay systems that may be of interest to the customer based on that customer's previous usage. The remote computing system may also send references to the customer that may relate to one or more consumables / systems used by a given customer.

[0102] These and other specific examples of consumable data are described in more detail below.

[0103] A. Assay Systems, Consumables, and Methods of Use The assay systems contemplated by the present invention may be used to perform any type of diagnostic or analytical method known in the art, including, but not limited to, clinical chemistry assays (e.g., pH, ion, gas, and metabolite measurements), hematology measurements, nucleic acid amplification assays (e.g., polymerase chain reaction (PCR) and ligase chain reaction assays), immunoassays (e.g., direct immunoassays, sandwich immunoassays, and / or competitive immunoassays, and serological assays), oligonucleotide ligation assays, and nucleic acid hybridization assays. Nucleic acids, nucleotides, oligonucleotides, DNA, RNA, PNA, primers, probes, antibodies or fragments thereof, antigens, such as drugs or prodrugs, small molecules such as streptavidin, avidin, and biotin, may be used in such analytical methods, but are not limited to these. Any biological reagent that can be used in such a system.

[0104] These systems may be portable, e.g., handheld, and / or may be operated in a fixed laboratory or field environment, alone or in combination with one or more additional components, assay devices, or systems. These systems may be used in a variety of applications from field operations to laboratory environments in a wide variety of industries, including, but not limited to, medical, clinical, forensic, pharmaceutical, environmental, veterinary, biological, chemical, agricultural, waste management, hazardous chemical, drug testing, and defense applications, e.g., for detection of biological warfare agents. The assay systems, assay readers, and consumables used in the present invention may detect the analytes of interest in any suitable manner, including, but not limited to, optical, electromechanical, radio wave, electromagnetic, colorimetric, fluorimetric, chemiluminescent, electrochemiluminescent, radiochemical, nuclear magnetic resonance, enzymatic, fluorescent, particle count, and cell count based detection.

[0105] (i) Specific Embodiments of the Assay Consumables Assay consumables include devices in which one or more processes of an assay process are performed, and such devices may include one or more test sites in which an assay measurement is performed. In one embodiment, an assay consumable includes at least one assay test site for an assay. The test site may include multiple separate assay domains, at least two of which include reagents for measuring different analytes. Additionally, the consumable may include multiple test sites for multiple individual assays. Alternatively, an assay consumable may be a component that provides reagents or other assay components used by a system to perform an assay. For example, an assay consumable may be a container with one or more compartments for holding assay reagents. An assay consumable (or the test sites therein) may be disposable, or an assay consumable may be reusable. An assay consumable may be configured to perform one test or multiple tests (series or parallel).

[0106] Test site, as used herein, refers to an area of ​​a consumable that holds, contacts, and / or interrogates a sample. A test site may include multiple separate assay domains, with at least two such domains containing reagents for measuring different analytes. A consumable may include multiple test sites that can hold, contact, or otherwise interrogate separate amounts (aliquots) of the same sample and / or larger amounts of different samples. A sector of an assay consumable refers to a group of two or more test sites of the consumable. Each test site can be used to perform a single measurement or multiple measurements on a volume of sample (e.g., measurement of multiple different analytes in a multiplexed assay format). Depending on the specific requirements of an application, a consumable with multiple test sites can be configured to use all of its test sites in parallel, use its test sites at different times (e.g., allocate an unused test site to be used when a new sample is delivered to the assay system), or enable a combination of both modes of operation.

[0107] An assay consumable may be any structure useful in diagnostic applications, and the structure may be determined by the particular assay format or detection method employed by the device. Examples of assay consumables suitable for use with the present invention include, but are not limited to, test tubes, cuvettes, flow cells, assay cartridges and cassettes (which may include integrated fluidics for assay processing), multi-well plates, slides, assay chips, lateral flow devices (e.g., strip tests), flow-through devices (e.g., dot blots), pipette tips, solid supports for biological reagents, and the like. In certain embodiments, the test site of the assay consumable is defined by a compartment of the assay consumable, e.g., a well, chamber, channel, flow cell, etc. An assay consumable and / or test site is a single, non-transitory, or liquid-containing material used to perform an assay measurement according to one or more particular detection methodologies. Depending on the function of the consumable and the detection modality utilized by the assay system, examples of such components may include, but are not limited to, lateral flow matrices, filtration matrices, optical windows, sensors (e.g., electrochemical and optical sensors), solid supports for binding reactions (e.g., coated slides, chips, beads, pins, coated filtration or lateral flow matrices, tubes, etc.), reagents (in dry or liquid form), electrodes, analyte selection membranes, etc.

[0108] In one embodiment, the assay consumable may be a device that incorporates a conventional lateral flow test strip as the assay medium, such as, for example, an immunoassay test strip. In this example, the device is molded to include an identifier or the identifier is affixed to the device without any modification to the structure of the device and / or the assay medium. In one embodiment, the device is placed into an analysis system, i.e., an assay system, for analysis and before, during, or after the performance of an assay, and an identifier controller in, affixed to, or associated with the assay system reads the data contained in the identifier and uses that data in the assay or after the assay is completed by the system.

[0109] In another embodiment, the assay consumable and associated assay system or assay reader are capable of performing a multiplex assay. A multiplex assay is a type of assay in which multiple measurements are performed on a single sample, for example, by distributing the sample across multiple test sites and / or by performing multiple measurements on the amount of sample at each test site. Multiple measurements may include, but are not limited to, (i) multiple replicates of a measurement for an analyte, (ii) multiple measurements of a particular analyte (i.e., multiple non-identical measurements for the same analyte, e.g., measurements that differ in the format or identity of the assay reagents utilized), and / or (iii) measurements of multiple different analytes. In one specific embodiment, the assay consumable is configured to perform a multiplex measurement, including at least two assays for two different analytes, at one or more test sites.

[0110] The present invention is not limited to a particular technique for performing multiplexed measurements at a test site, and any of a number of techniques developed to perform multiplexed measurements can be utilized. Multiplexed measurements that can be used with the present invention include, but are not limited to, multiplexed measurements that (i) involve the use of multiple sensors, (ii) use discrete assay domains on a surface (e.g., an array) that can be distinguished based on their location on the surface, (iii) involve the use of reagents coated on particles that can be distinguished based on particle characteristics such as size, shape, color, etc., (iv) result in assay signals that can be distinguished based on optical properties (e.g., absorbance or emission spectra), (v) are based on temporal characteristics of the assay signals (e.g., time, frequency, or phase of the signal), and / or (vi) are based on some other assay feature. Thus, interpretation of multiplexed assay results may involve the use of multiplexing information, such as the identity of the assay performed at each test site, and, within a test site, any assay features (e.g., specific sensor identity, assay domain location and identity, etc.) that are used to distinguish the assays performed at the test sites and / or that are used to associate a particular assay identity with a corresponding assay signal.

[0111] In one embodiment, an assay test site comprises multiple separate assay domains, each domain containing one or more reagents for measuring a different analyte. Multiplexing information, including the location, identity, and composition of each assay domain, is used to identify the assay signal generated in each domain and link it to a determination of the presence or amount of the corresponding analyte (a process that may include application of additional consumable data, such as signal thresholds and / or calibration parameters). Such multiplexing information may be provided as consumable data and / or associated with a consumable identifier. can.

[0112] A test site can be configured to perform multiple multiplexed measurements (e.g., it may include multiple separate assay domains, each domain including reagents for measuring a different analyte). In one embodiment, an assay consumable may include multiple test sites. Information regarding the exact configuration of one or more test sites, assay domains, and / or one or more sectors of the consumable may be included in the information stored in the assay consumable identifier and / or provided as consumable data. This information may include not only multiplexing information (described above), including the number, identity, and differentiating characteristics of individual measurements within the test sites, assay domains, and / or sectors, but also the location and identity of the test sites, assay domains, and / or one or more sectors (e.g., the specific location, identity, and / or assay reagents of the assay domains within each test site). Additionally, the use of test sites, assay domains, and / or sectors in the assay consumable may also be recorded in the identifier to track the use of the consumable in the assay system. The identifier and / or consumable data may also include information regarding the assay format and specific processing steps used for the assay consumable or a test site, assay domain, and / or sector of the assay consumable. The identifier and / or consumable data may also include information regarding the analysis methodology that needs to be applied by the system once the assay is performed to analyze the output of the assays at a given test site, assay domain, and / or sector, and optionally provide a result that combines the output from multiple assays at a test site, assay domain, and / or sector.

[0113] The test sites can be configured in any suitable configuration depending on the geometry of the consumable and / or the type of assay to be performed with the consumable. In one embodiment, the test sites are configured as wells and / or chambers in the assay consumable. For example, the assay consumables of the present invention can be multi-well plates (e.g., 24-, 96-, 384-, or 1536-well plates), and the wells of the plate can further include a plurality of (e.g., 2 or more, 4 or more, 7 or more, 25 or more, 64 or more, 100 or more, etc.) distinct assay domains. Multi-domain multi-well plates adapted to perform assay measurements using electrode-induced luminescence measurements (e.g., electrochemiluminescence measurements) are described in U.S. Application Serial No. 10 / 238,391, filed September 10, 2002, entitled "Methods and Reader for Conducting Multiple Measurements on a Sample," which is incorporated herein by reference. The exact configuration of the domains, test sites, and / or sectors of the assay consumable, as well as the specific identity of each domain, test site, and / or sector and the reagents bound to that domain / test site / sector, may be included in the information stored in the assay consumable identifier and / or provided as consumable data. Additionally, use of a given domain, test site, and / or sector of the assay consumable may also be recorded in the identifier to track use of the consumable in the assay system.

[0114] Assay consumables can be used in multiple different assays, and this variety leads to a variety of suitable configurations of associated consumables. In one assay format, the same analyte is measured in different assay domains within a test site, where the different assay domains are designed to measure different properties or activities of the analyte. Information regarding the assay formats that can be used with an assay consumable, test site, and / or assay domain can also be stored in the assay consumable identifier and / or provided as consumable data. The identifier and / or consumable data may also include information regarding an analysis method that needs to be applied by the system once the assay is performed to analyze the output of an assay at a given test site and / or domain and compare that output to assays at separate test sites and / or domains.

[0115] An example of a multiplex assay consumable is described in US 2004 / 0022677, the disclosure of which is incorporated herein by reference in its entirety. Such an assay consumable includes one or more, and in one embodiment, multiple, test sites and / or assay domains for performing one or more assay measurements simultaneously or sequentially. For example, the test sites can be configured as wells and / or chambers. These test sites and / or assay domains include one or more electrodes for inducing luminescence from materials in the test sites and / or assay domains. The assay consumable may further include assay reagents in liquid or dried form, for example in the test sites, e.g., in the wells or chambers, of the consumable.

[0116] In addition to the test sites and assay domains, an assay consumable or multi-well assay plate may include several additional elements, such as, for example, a plate top, a plate bottom, wells, working electrodes, counter electrodes, reference electrodes, dielectric materials, electrical connections, and assay reagents. The wells of the plate may be defined by holes or openings in the plate top, or as depressions or indentations on the surface of the plate. The plate may have any number of wells of any size or shape arranged in any pattern or configuration, and may be constructed from a variety of different materials. Exemplary embodiments of consumables that can be used in the present invention include industry standard formats for the number, size, shape, and configuration of plates and wells, such as, for example, 96-, 384-, and 1536-well plates, where the wells are configured in a two-dimensional array. Other formats may include single well plates, 2-well plates, 6-well plates, 24-well plates, and 6144-well plates. Multi-well assay plates are well suited for applications where the plates can be used once or multiple times and are disposable. A variety of configurations for suitable assay plates can be used with the present invention, including, but not limited to, those shown in Figures 11A, 12A, 13A, 13B, 14A, 15, and 16A of U.S. Application No. 2004 / 0022677, each of which is incorporated herein by reference. As discussed above, the particular configuration and identity of the assay test sites, domains, and / or sectors of the assay consumable can be included in the information stored in the assay consumable identifier and / or can be provided as consumable data.

[0117] (ii) Specific Embodiments of Assay Reader The assay consumables can be used in an assay reader that can be used to induce and measure luminescence, e.g., electrode-induced luminescence or electrochemiluminescence, in an assay performed in or on the assay consumable, e.g., a multi-well assay plate. The assay reader can also induce and / or measure current and / or voltage, e.g., at an electrode. The assay reader may incorporate, for example, one or more photodetectors, a light-tight enclosure, mechanisms for transporting the assay plate into and out of the assay reader (and particularly into and out of the light-tight enclosure), mechanisms for aligning and orienting the assay plate with the photodetector(s) and / or electrical contacts, additional mechanisms for tracking and identifying the plate (e.g., a barcode identifier controller), mechanisms for making electrical connections to the plate, one or more sources of electrical energy for inducing luminescence, and appropriate devices, electronics, and / or software. The assay reader may also incorporate mechanisms (e.g., plate stackers and / or plate conveyors) for storing, stacking, moving, and / or dispensing one or more multi-well assay plates. The assay reader may be configured to measure light from a multi-well assay plate (i.e., a group of multiple adjacent assay domains in a plate) by measuring light sequentially from multiple sectors or regions of the plate, and / or from the entire plate substantially simultaneously or simultaneously. The assay reader may also incorporate additional microprocessors and computers to control certain functions within the system and to assist in the storage, analysis, and presentation of data. U.S. Application No. 2004 / 0022, incorporated herein by reference. A variety of suitable assay reader configurations can be used with the present invention, including, but not limited to, those shown in Figures 17-23 of '677.

[0118] In a specific embodiment, the assay reader is the device described and claimed in U.S. Application No. 14 / 147,216, published as U.S. 2014 / 0191109 and WO 2014 / 107576, the disclosures of which are incorporated herein by reference. Particular embodiments of the assay reader are shown in the figures of U.S. Application No. 14 / 147,216, certain views of which are reproduced herein. FIGS. 5(a)-5(b) show front and rear views, respectively, of the device 500 with a stylized cover, and FIGS. 5(c)-5(d) show corresponding front and rear views, respectively, of the device without the cover. As shown, for example, in FIG. 5(c), the device includes a light detection subsystem 510 and a plate handling subsystem 520. More detailed views are provided in FIGS. 6(a)-6(b). The plate handling subsystem 620 includes a light-tight enclosure 630 including a housing 631 having a housing top 632, a bottom 633, a front 634, and a rear 635. The housing also includes a number of alignment features, and the housing is adapted to receive a removable drawer. The removable drawer 640 is shown in FIG. 7 in a partially open or closed position. Referring to FIG. 6(a), the housing 632 also includes one or more plate entry (and exit) openings 636 and 637, respectively, through which plates are lowered (manually or mechanically) onto or removed from the plate translation stage. A sliding light-tight door (shown as 639 in FIG. 6(c)) is used to seal the plate entry openings 636, 637 from ambient light before performing luminescence measurements. Additionally, the housing top also includes an identifier controller to read and process data associated with identifiers on the plates. In one embodiment, the identifier controller is a barcode reader (638) mounted via a light-tight seal over an opening in the top of the housing, the barcode reader configured to read the consumable identifier (e.g., barcode) of a plate mounted in a plate translation stage within the housing. In a preferred embodiment, the consumable identifier (e.g., barcode) of a plate is read as the plate is lowered into the drawer.In alternative or additional embodiments, the identifier controller may be separate from the device.

[0119] In an additional specific embodiment, the assay reader is a MESO QcuickPlex SQ120 available from Meso Scale Discovery, Rockville, MD.

[0120] (iii) Specific Embodiments of the Assay System One embodiment of an assay system that can be used in the present invention is shown in U.S. Application No. 12 / 844,440, published as U.S. 2011 / 0143947, which is incorporated herein by reference. In particular, as shown in FIG. 8, the assay system may include the following components: (i) sample rack subassembly (810), (ii) light-tight enclosure (820), (iii) auxiliary plate subassembly (830), (iv) pipettor subassembly (840), (v) dispense tip storage / disposal compartment (850), (vi) liquid reagent subassembly (860), (vii) well wash subassembly (870), and (viii) power supply (880). The device is also attached to a computer through a user interface (not shown). The system uses array-based multiplex multiwell plate consumables and allows for fully automated random access analysis of samples. The device achieves enhanced sensitivity and high sample throughput. The device may be adapted for use with any of a variety of detection techniques, such as, for example, changes in optical absorption, luminescent or radioactive emissions, changes in light scattering, and / or changes in magnetic fields. In one embodiment, the device is configured to detect luminescent emissions, such as, for example, fluorescence, phosphorescence, chemiluminescence, and electrochemiluminescence (ECL). In certain embodiments, the device is configured to detect ECL. All biological reagents required for the assay are provided with the device, thus minimizing consumable and reagent requirements for the device. The device shown in Figure 8 further includes one or more consumable identifier controllers (not shown) that are integrated into the device housing and / or positioned externally to the device housing.

[0121] An additional embodiment of an assay system of the present invention is shown in Figure 9(a). The assay system (900) includes multiple subsystems positioned on a table or platform (901), each operatively connected to a robotic subsystem (902) configured to access and move one or more consumables, such as multi-well assay plates, from one subsystem of the assay system to another. The multiple subsystems include an assay reader (903), an assay consumable storage unit (904), a dispense subassembly (905) including at least one dispense probe (906) fixed to a dispense head gantry (907) that provides X, Y, and Z movement of the probe to and from a dispense tip washing station (908) and a plate washing subassembly (909), an orbital shaker subassembly (910), a liquid reagent subassembly (911), and an electronics subassembly including a computer (912). The computer also includes a user interface (not shown). The assay system may also include a multi-well plate preparation platform (913) positioned on the table (901) and configured to enable dispensing of liquids to and / or from one or more wells of a multi-well assay plate positioned on the preparation platform. Optionally, the platform (913) is positioned on a linear track that enables movement of the platform to and / or from the dispense subassembly (905) in a direction parallel to the plane of the table. Alternatively or in addition, one or more subcomponents of the platform and / or dispense subassembly are configured to move in the X-direction, the Y-direction, and / or the Z-direction relative to one another. The robotic subsystem is configured to move one or more plates to and / or from the plate preparation platform, the plate washing subassembly, the orbital shaking subassembly, the assay reader, and the consumable storage unit.As shown in Figures 9(b)-9(c), the assay system may further include an enclosure (914) that includes one or more environmental control units, such as, for example, thermoelectric cooling units (915(i) and 915(ii) respectively), disposed within the enclosure. In one embodiment, the enclosure is configured to encase the assay system to maintain an internal temperature within the enclosure at about 20-30°C.

[0122] The assay system shown in Figure 9(a) is configured to process multi-well assay plates that have been subjected to manual offline sample preparation steps using an automated sample preparation system or using an automated sample preparation system integrated with the assay system via an additional robotic subsystem. Additionally, reagents used in performing the assay in the assay plate can be provided in one or more additional assay plates, e.g., a reagent plate and / or a diluent plate, i.e., plates that contain the specific reagents used in performing the assay. In specific embodiments, samples can be added offline to the sample plate and the system uses one or more diluents and reagents that can be stored in a diluent plate and / or a reagent plate, respectively, and the assay can be performed in a test plate, i.e., a plate to which the reagents and / or reagents are added during one or more processing steps by the system.

[0123] In a specific embodiment, the system processes plates in batch mode, i.e., all wells of a plate are operated on or processed simultaneously by the system before moving to the next step and / or next plate. For example, the system may be configured to process a 96-well multiplate plate in batch mode. When configured to use multiwell plates, all 96 wells of the plate are exposed to each step in the assay system simultaneously before the system moves on to the next step and / or the next plate. Figure 9(d) illustrates the sequence of operation of the assay system operating in batch mode. In this example, the first system operation cycle (Cycle 1) includes the following steps: (a) one set of plates is moved to a storage unit of the assay system, the set including a sample plate, a diluent plate, and a test plate; (b) diluent and samples are removed from the diluent plate and sample plate, respectively, and added to the test plate; (c) the test plate is transferred to the orbital shaker subassembly, and the sample plate and diluent plate are returned to the storage unit. Cycle 1 is completed when the first test plate of the set completes the first incubation. The second system operation cycle (Cycle 2) includes the steps of (a) moving the test plate to the plate washing subsystem and washing the test plate, (b) moving the test plate and the detection antibody solution plate to the plate preparation platform, (c) adding detection antibody solution to the test plate, and (d) moving the test plate to the orbital shaker subassembly and returning the detection antibody solution plate to the storage unit. Cycle 2 is completed when the first test plate completes the second incubation. The third system operation cycle (Cycle 3) includes the steps of (a) moving the test plate to the plate washing subsystem and washing the test plate, (b) moving the test plate and the read buffer plate to the plate preparation platform, (c) adding read buffer to the test plate, (d) moving the test plate to the assay reader and returning the read buffer plate to the storage unit, and (e) reading a signal from the assay reader and moving the test plate from the assay reader to the storage unit. Throughout cycles 1-3, the assay system is configured to move the plate from one subsystem to another at most every 3 minutes (3 minutes / plate).

[0124] In one embodiment, the assay reader integrated with the assay system 900 is an assay reader as described herein, such as the apparatus 500 shown in Figures 5-7. In a specific embodiment, the assay reader is the apparatus described and claimed in U.S. Application No. 14 / 147,216, the disclosure of which is incorporated herein by reference. In an additional specific embodiment, the assay reader is a MESO QuickPlex SQ120 available from Meso Scale Discovery of Rockville, MD. Alternatively, the assay reader is a MESO SECTOR S600 available from Meso Scale Discovery of Rockville, MD.

[0125] The assay consumable storage unit (904) can be configured to store any type of consumable used in performing an assay on the assay reader. In a specific embodiment, the storage unit is a multi-well plate storage unit configured to store a plurality of multi-well assay plates. In one embodiment, the plate storage assembly is configured as a plurality of shelf subassemblies each comprising a shelf unit sized to accommodate a multi-well assay plate. The shelf subassembly includes a housing top, a housing rear, a left housing wall, and a right housing wall, as well as a plurality of storage units disposed within the housing, each storage unit including a plate entry opening. The shelf subassembly may include a MxN linear array of storage units, where M and N are integers, such as, for example, a 2x1, 2x2, 3x3, or 4x4 array. In one embodiment, the subassembly includes a 2x1 array of storage units. And, in a specific embodiment, the shelf subassembly is a 2x1 array of 20 storage units.

[0126] As described above, the dispense subassembly (alone or in combination with the platform) provides independent X, Y, and Z movement of the probe so that the probe can access sample plates, reagent plates, and / or test plates (as needed). The dispensing subassembly may also include appropriate pumps and valves to control the pipettors and / or probes (not shown). Pumps are used to transport fluids through the dispensing subassembly. One skilled in the art can select appropriate pumps for use with the device, including, but not limited to, diaphragm pumps, peristaltic pumps, and syringe (or piston) pumps. The pumps also include multi-port valves to allow the pumps to push and pull fluids from different fluid lines. Alternatively, multiple pumps can be used to independently control fluids in different fluid lines.

[0127] In one embodiment, the dispensing probe can use fixed or dispensing tips. In a specific embodiment, the dispensing probe uses fixed dispensing tips. Alternatively, if disposable tips are used, the dispensing tips can be stored in a dispensing tip storage / disposal compartment (not shown). The arm / track of the pipettor subassembly allows the probe access to the tip storage / disposal compartment for loading the tip on the dispensing probe and removing the tip after use. In addition to moving reagents and samples from one well to another, the fluid lines connected to the dispensing probe may be connected to working fluids or diluents such that the probe can be used to deliver these fluids / diluents to the wells. Optionally, the dispensing probe may include fluid sensing capabilities, for example using a capacitive sensor to detect when the probe contacts fluid in a tube or well. In a specific embodiment, the dispensing probe includes a multi-channel dispensing probe that allows for simultaneous fluid transfer to multiple wells of a multi-well plate. For example, the dispensing probe includes a 96-channel dispensing head that allows for simultaneous fluid transfer to a 96-well plate. In one embodiment, the dispensing head and corresponding fixed dispensing tips are available from Apricot Designs of Covina, Calif. Typically, when fixed dispensing tips are used, they are supplied by a supplier of the dispensing probe, such as Apricot Designs of Covina, Calif. When disposable dispensing tips are used, the tips can be stored and disposed of in a tip compartment that includes a housing for one or more separate drawers that can accommodate standard disposable tip boxes (available from Axygen, Qiagen, or Rainin) and a removable waste container for used dispensing tips. To remove a tip, the pipettor probe is translated horizontally to position the shaft within the slot and then translated vertically until the pipette tip is removed by the bracket. During operation, the particular slot to be used is selected using a set or random pattern such that used pipette tips are evenly distributed along the width of the waste container.The tip dimensions vary according to the size of the dispensing probe, the amount of sample / reagent to be dispensed, and / or the dimensions of the plate the tip is to be placed in. In one embodiment, the tip volume ranges from about 100 μL to 550 μL. In another embodiment, the tip volume ranges from about 100 μL to 250 μL.

[0128] The plate washing subassembly may be any suitable commercially available microtiter plate washing system, such as, for example, those available from BioTek Instruments, Inc. of Winooski, Vermont, including, but not limited to, the 405 Touch Washer, 405 LS Washer, Elc405x Select Deep Well Washer, or Elx50 Washer. Similarly, the robotics subsystem may be any suitable benchtop commercially available robotics system, such as, for example, those available from Precise Automation, Inc. of Fremont, California.

[0129] The liquid reagent subassembly includes a plurality of liquid reagent and waste compartments for use in one or more steps of an assay performed on the device. The reagent / waste compartments include a compartment body enclosing an internal volume, and a reagent or waste port for delivering reagents or accepting waste. The volume of a compartment of the subassembly is determined by the relative proportion of the compartment body volume occupied by the reagents and waste. is adjustable, e.g., so that it can be adjusted as reagents are consumed in an assay and returned to the compartment as waste. The total internal volume of the compartment body may be less than about 2 times, less than about 1.75 times, less than about 1.5 times, or less than about 1.25 times the amount of liquid stored in the body, e.g., the amount of reagent initially provided in the compartment, thus minimizing the space required for waste and reagent storage and allowing convenient one-step reagent refill and waste removal. In certain embodiments, the device has a reagent compartment slot configured to receive the compartment and optionally provide fluid connection to the waste and reagent ports via "push-fit" or "quick-fit" fittings.

[0130] Optionally, the reagent compartment and / or waste compartment are removable. In one embodiment, the reagent compartment and / or waste compartment are removable and the device further includes a sensor, such as an optical sensor, to monitor the liquid level(s) in the reagent compartment and / or waste compartment. Alternatively, the liquid reagent subassembly may include an electronic scale to monitor the weight of fluid in the reagent tank and waste tank for real-time tracking of reagent usage and availability. When the reagent compartment and / or waste compartment reaches a minimum or maximum capacity, as detected by the sensor or scale, the device alerts the user to remove the reagent compartment and / or waste compartment to refill and / or empty the contents. In one embodiment, the dispense probe motor is in communication with the sensor or scale, and when the reagent compartment and / or waste compartment reaches a minimum or maximum capacity, the dispense probe motor is disabled by the device. For example, the probe sensor relays information regarding the compartment's volume to the meter software, which then pauses additional dispense operations.

[0131] The reagent compartment and / or waste compartment may be provided as a collapsible bag located in the subassembly body. One of the reagent compartment and / or waste compartment may be provided as a collapsible bag and the other may be provided as the compartment body itself (i.e. the volume of the compartment body excluding the volume defined by any collapsible bag in the compartment body). In addition to the first reagent compartment and / or waste compartment, the reagent cartridge may further include one or more additional collapsible reagent compartments and / or waste compartments connected to one or more additional reagent and / or waste ports. Alternatively, one or the other of the reagent compartments and / or waste compartments may be constructed from hollow molded plastic. Additionally or alternatively, waste can be pumped to an external drain or container. In one embodiment, the liquid reagent subassembly also includes a reagent tank used during the performance of an assay on the device. In one specific embodiment, each reagent compartment is connected via a fluid line to a reagent tank that contains a large amount of reagent during an assay. The fluid lines to the pipettor subassembly lead directly from the reagent tank. In practice, reagents are stored in the reagent compartment and a predetermined amount of reagent is dispensed from the reagent compartment to the reagent tank. The device draws fluid from the reagent tank for use in the assay. The reagent compartment and the reagent tank can each be connected to an independent fluid sensor. The fluid sensor in the tank monitors the internal volume in the tank and if the internal volume decreases below a predetermined level, reagent is dispensed from the reagent compartment to the tank. Similarly, if the internal volume of the reagent compartment decreases below a predetermined level, the fluid center signals the operator to replace or refill the reagent container. The dual reagent compartment / tank assembly allows the device to continuously supply fluid to the assay as the assay is being performed by the device, since fluid is exchanged in the reagent compartment without interrupting the assay process by the instrument.

[0132] In one embodiment, the orbital vibration subassembly (910) is a A balanced assay consumable shaking apparatus as described and claimed in U.S. Ser. No. 62 / 143,557, filed Apr. 6, 2015, which is incorporated herein by reference. In particular, the orbital shaking apparatus includes (a) an orbital shaker assembly including a horizontal orbital platform, and (b) an assay consumable storage assembly positioned on the platform. The storage assembly includes (i) a shelf subassembly including a plurality of sets of vertically aligned storage units, each storage unit sized to accommodate a consumable and including a consumable locking mechanism, and (ii) a counterweight positioned within the storage assembly at a height corresponding to a center of mass of the storage assembly and the orbital platform. The orbital shaking apparatus further includes a rotation shaft extending vertically from the shaker assembly to the storage assembly, the counterweight being operatively connected to the rotation shaft.

[0133] The assay system shown in Figure 9 may include a table or platform, such as 901, or the system can be constructed and arranged on a laboratory benchtop. In the system shown in Figure 9(a), the assay system is positioned below a table top (901) and is positioned on a table that includes one or more shelving units (916 and 917, respectively) configured to house one or more elements or subsystems of the assay system. In embodiments of the system positioned on a laboratory benchtop, the various systems can be distributed across the benchtop in the same XY plane (not shown).

[0134] The assay system (900) shown in Figures 9(a)-9(d), including the orbital shaker (910), is described in U.S. Provisional Patent Application No. 62 / 311,752, filed March 22, 2016, and International Patent Application No. PCT / US 2016 / 026242, filed April 6, 2016, which are incorporated herein by reference in their entireties.

[0135] Additional embodiments of the assay system of the present invention are shown in FIG. 10 and its subsections. The assay system (1000) includes multiple subsystems positioned on a table (1001), each operatively connected to a robotic subsystem (1002) configured to access and move one or more consumables, e.g., a multi-well assay plate, from one subsystem of the assay system to another. The robotic subsystem of the instrument shown in FIG. 10 and its subsections includes one or more dispense subsystems (1021) each including one or more dispense tip head(s), e.g., a multi-channel dispense tip head, used to dispense / withdraw fluids into / from wells of a multi-well plate. The dispense subsystems are secured to a gantry (1022) within the robotic system that allows the dispense tip heads to move through the assay system in the X, Y, and Z directions. The multiple subsystems within the assay system include an assay reader (1003), an assay consumables storage unit (1004), a plate washing subassembly (1005), a plate shaking subassembly (1006) that includes one or more independent plate shaking devices (e.g., as described above with reference to FIG. 9, elements 910 except for the shaker 910 have dedicated assay consumables storage units and can shake and incubate several plates simultaneously), a liquid reagent subassembly (1007), a solid waste storage unit (1008) and a liquid waste storage unit (1020), as well as an electronics enclosure (1009) configured to house a system control computer, keyboard, display, wireless router, and power supply (not shown). Electronic components, designated elements (1010, 1011), are shown in FIG. 10(a) below the reader (1003) and can be positioned in the electronics enclosure (1009). The assay system may also include a platform (1012) positioned on the table (1001) and configured to enable dispensing of liquids into and / or from one or more wells of a multi-well assay plate positioned on the preparation platform.The robotic subsystem moves one or more plates to and from the platform, the plate washing subassembly, the shaking subassembly, the assay reader, and the consumable storage unit. The platform includes a consumable identifier controller (e.g., a barcode reader (1013)) configured to read assay consumable identifiers positioned on the bottom of a plate or tube mounted on a reagent rack or tube holder, e.g., a multi-well plate, and, optionally, a dispensing tip storage compartment (1014) configured to accommodate dispensing tip boxes of varying size tips (e.g., 1015 and 1016, 1000 μl and 350 μl tips, respectively), and one or more reagent troughs positioned on one or more sample / reagent tube carriers (1017) and one or more corresponding carriers (1018). Optionally, the system includes a second consumable identifier controller (1023) positioned above the platform and configured to read identifiers on the side of the plate(s) and / or reagent rack, and a third consumable identifier controller (not shown) configured to read identifiers on consumable boxes located outside of the system housing (not shown). In one embodiment, the third consumable identifier controller is remote from the assay system and is secured to the outer housing of the assay system or positioned on a front or side panel of the housing of the assay system and configured to allow a user to contact a consumable identifier, for example on a plate or kit, using the third consumable identifier controller before the consumable is used in the system. The assay system may further include one or more environmental control units, for example a thermoelectric cooling unit or TEC (1019) located within the assay system. Although a TEC is shown as the assay system (1000), any environmental control system, heat exchanger, or cooling device may be used.

[0136] Unlike the assay system shown in FIG. 9(a), the instrument shown in FIG. 10 and its subsections is configured to perform on-board all sample processing steps as well as all assay processing steps required in performing an assay. Additionally, the user interface of the assay system of FIG. 10 and its subsections is configured to display to the user step-by-step instructions for the appropriate sample / reagent preparation steps that must be performed manually before the system performs an assay. The sample / reagent preparation steps and individual assay steps performed by one or more subsystems of the assay system may vary from one assay protocol to another. Detailed examples of various assays performed by the assay system of FIG. 10 and its subsections are described below, including, but not limited to, cytokine assays, V-PLEX assays, U-PLEX assays, S-PLEX assays, pharmacokinetic (PK) assays, immunogenicity (IG) assays, and custom sandwich immunoassays (available from Meso Scale Discovery, Rockville, MD), as well as PK immunoassays, IG immunoassays, and custom sandwich immunoassays.

[0137] Another iteration of the assay system (1000) of the present invention is shown in Figure 10(c). Some of the components shown in Figures 10(a)-10(b) have been omitted for clarity. This iteration includes one or more capture trays (1024) positioned below the platform (1012) and above the table (1001) to capture and retain liquids that spill from the various reagents, diluents, and buffers during operation of the assay system (1000). The capture trays (1024) preferably have a flow path (1025) defined thereon to direct the flow of spilled liquid from the tray (1024) to the waste storage unit (1008). Preferably, the flow path includes a peripheral channel (1025b) for directing liquids away from the edges of the tray (1024) and an interior flow path (1025a) leading to the waste assembly (1008). 10(d), optionally, flow channels (1025) may have absorbent material disposed therein to absorb spilled liquid and / or wick the liquid to the waste assembly (1020). Alternatively, flow channels (1025) may be coated with a surfactant to reduce flow resistance.

[0138] Additionally, platform (1012) includes an additional raised platform (1026) designed to hold extra disposable tips or host additional components such as individual shakers (1006), thereby demonstrating the scalable nature of assay system (1000). A number of holes (1027) are provided on platform (1012) for accepting additional labware or other functional components.

[0139] In one embodiment, the assay reader used in assay system 1000 is an assay reader described herein, such as, for example, the apparatus 500 shown in Figures 5-7. In a specific embodiment, the assay reader is the apparatus described and claimed in U.S. Application No. 14 / 147,216, the disclosure of which is incorporated herein by reference. In an additional specific embodiment, the assay reader is a MESO QuickPlex SQ 120 available from Meso Scale Discovery of Rockville, Maryland. Alternatively, the assay reader is a MESO SECTOR S600 available from Meso Scale Discovery of Rockville, Maryland.

[0140] The assay consumable storage unit (1004) can be configured to store any type of consumable used in performing an assay on the assay reader. In a specific embodiment, the storage unit is a multi-well plate storage unit configured to store a plurality of multi-well assay plates. In one embodiment, the plate storage assembly is configured as a shelf subassembly including a plurality of shelf units, each sized to accommodate a multi-well assay plate. The shelf subassembly includes a housing including a housing top, a housing rear, left and right housing walls of the housing, and a plurality of storage units disposed therein, each storage unit including a plate entry opening. The shelf subassembly may include a MxN linear array of storage units, where M and N are integers, such as, for example, a 2x1, 2x2 array, 3x3, 4x4, 5x6, or 6x5 array. In one embodiment, the subassembly includes a 2x1 array of storage units. In a specific embodiment, the storage subassembly includes a 2x1 array of 20 storage units.

[0141] In the iteration of FIG. 10(c), the assay consumable storage unit (1004) is redesigned to have not only functional aspects but also decorative aspects. In this iteration, the assay consumable storage unit is a single integrated unit with several parallel shelf surfaces (1072) connected by several vertical supports (1074), as shown in FIG. 10(r). Each storage unit in the top row includes a raised corner (1076) sized and dimensioned to hold a reagent lid or loaded rack, as shown in FIG. 18 below and subdivisions thereof, when a technician or robotic system (1002) places an assay plate or rack thereon. As shown in FIG. 10(c), preferably, the bottom horizontal shelf of the assay consumable storage unit is cantilevered and bolted solely and securely to the platform (1012). The top assembly of the assay consumable storage unit uses multiple, preferably two or more, fixed to the bottom horizontal shelf, and alignment pins are used to maintain consistent positioning of the top assembly. Preferably, the alignment pins are located away from the X and / or Y centerlines to minimize improper alignment of the bottom horizontal shelf and the top assembly. Several thumb screws, preferably three or more, are used to secure the assay consumable storage unit together. Additionally, several Z adjustment screws, preferably at least three, are provided to level the assay consumable storage unit (1004) as needed.

[0142] An advantage of having the bottom horizontal shelf located separately from the upper assembly is the ease of removing the assay consumables storage unit 1004 for servicing and access to the components behind the unit 1004. Alignment pins and thumb screws further allow for easy and precise subsequent reattachment of the upper assembly to the bottom horizontal shelf.

[0143] The dispensing subassembly (1021) is supported on a gantry (1022) and is powered by one or more motors to provide independent X, Y, and Z motions to a probe, such as one or more pipette tips, allowing the probe to access a trough, tube, and / or plate (as required). The dispensing subassembly (1021) also includes appropriate pumps and valves to control the pipettors and / or probes, and optionally a dispensing tip cleaning subassembly (not shown). Pumps are used to transport fluids through the dispensing subassembly. Preferably, each pipette tip is independently controllable or independently disposable by control software, a controller, and motor(s). In other words, one or more pipette tips can dispense or draw up liquid independently of other pipette tips. Furthermore, the spacing between pipette tips can be varied by the control software and motors. These degrees of freedom allow the assay machine (1000) to perform a wide range of assays, calibrations, self-diagnostics, and the like. One skilled in the art will be able to select an appropriate pump for use with the device, including, but not limited to, diaphragm pumps, peristaltic pumps, and syringe (or piston) pumps. The pump also includes a multi-port valve to allow the pump to push and pull fluids from different fluid lines. Alternatively, multiple pumps can be used to independently control fluids in different fluid lines. In one specific embodiment, the dispensing subassembly includes an exhaust pipetter. Optionally, the dispensing probe may include a means for minimizing the external wetted surface of the probe, for example using an ultrasonic capacitance sensor or a pressure sensor, and a fluid sensing function for detecting when the probe contacts fluid in a tube or well as a means for detecting the presence of liquid in the vessel.

[0144] In a specific embodiment, the dispense probe includes a multi-channel dispense probe that allows fluid transfer to multiple wells of a multi-well plate either through all pipette tips or through a selected number of pipette tips that are less than all available pipette tips. For example, the dispense probe includes an 8-channel dispense head that allows simultaneous and independent fluid transfer to one or more channels into a multi-well plate or one or more tubes or troughs. Alternatively, the dispense probe may include a 12-channel dispense head, a 96-channel dispense head, or a 384-channel dispense head. In a specific embodiment, the dispense subassembly is supplied by Tecan Group LTD of Switzerland.

[0145] In one illustrative example, a capacitive sensor is designed between the pipette tips or between the pipettor and the dispense deck to detect contact of the disposable tip with the surface of liquid contained in a tube, plate, or rack found on the dispense deck. The dispense deck is preferably conductive, and the pipette tips / pipettors are also conductive so that a potential difference can be applied between them.

[0146] A common capacitor is a parallel plate capacitor consisting of two conductive plates electrically insulated from each other by a dielectric material. In a simple parallel plate capacitor, the capacitance is inversely proportional to the distance between the two plates. Quantitatively, the capacitance (C) in farads of two overlapping plates is expressed as: C=κε o (A / d), In the above formula, κ i is the dielectric constant of the material between the two plates (dimensionless), ε o is approximately 8.854x10 -12 F m -1 is an electrical constant, A is the area of ​​overlap between the two plates in meters, d is the distance between the two plates in meters.

[0147] For capacitive liquid level sensing, the capacitance of the system takes into account the multiple dielectrics in series between the pipette tip and the dispense deck. Quantitatively, the total capacitance (C) in Farads of two overlapping plates with multiple dielectric materials between them (e.g., air, liquid, plastic / glass container) is expressed as: 1 / C=Σ1 / C i In the above formula, the capacitance of each dielectric is C=κ i ε o (A / d i ) and in the above formula, κ i is the dielectric constant of the material between the two plates (dimensionless), ε o is approximately 8.854x10 -12 F m -1 is an electrical constant, A is the area of ​​overlap between the two plates in meters, d1 is the thickness of a given material between the two plates in meters.

[0148] In a system with multiple dielectrics, the capacitance change that occurs when the thickness of a single dielectric (e.g., air between the pipette tip and the liquid in a plate or rack) approaches zero produces a significant change in capacitance that allows the system to recognize that the pipette tip is in contact with the liquid.

[0149] The inventors have determined that the sensitivity of certain capacitive sensing systems used to detect liquids in conventional tubes and vials can be significantly increased by using conductive plates or racks made from plastics with conductive additives such as carbon, metal, or metal ions. Using a conductive rack, the liquid levels held in conventional tubes and vials contained therein can be determined using a capacitive sensor. Preferably, 500 μl tubes should be at least 50%, preferably at least 40% or 30%, and more preferably at least 10% full. 2 ml tubes should be at least 20%, preferably at least 15% or 10%, and more preferably at least 5% full. 4 mL vials with flat bottoms should be at least 25%, more preferably at least 12.5% ​​full. 4 mL vials with concave bottoms should be at least 10%, more preferably at least 5% full.

[0150] In one embodiment, the dispensing probe uses disposable dispensing tips that are stored in a dispensing tip storage compartment (1014, 1026). Disposable dispensing tips can be stored in one or more standard disposable tip boxes (e.g., 1015 and 1016 available from Tecan Group LTD, Switzerland) and used tips can be stored in a removable waste container for used dispensing tips (1008). Tip dimensions vary according to the dimensions of the dispensing probe, the amount of sample / reagent to be dispensed, and / or the dimensions of the plate in which the tip is placed. In one embodiment, the tip volume ranges from about 1000 μL to 50 μL. In another embodiment, the tip volume ranges from about 1000 μL to 350 μL.

[0151] As described above, the dispense subassembly (1021) provides independent X, Y, and Z motions to the probe or pipette tip so that the probe or pipette tip can access troughs, tubes, vials, racks, and / or plates. The inventors have invented a training plate designed to initialize the assay system (1000) prior to first use or periodically thereafter, so that the X, Y, Z, G (grip distance) and R (rotation) as well as the X, Y, and Z positions of the dispense subassembly (1021) and its pipette tip, the robotic system (1002) and its gripper pad (1031) can pinpoint with greater accuracy and repeatability.

[0152] As best shown in FIG. 10(e), a training or instruction plate (1035) is positioned on the platform (1012). Preferably, the training plate (1035) is a plate carrier having dimensions and sizes similar to industry standard assay plates (ANSI SLAS 1-2004) and designed to accept the assay plates. The training plate (1035) is designed to fit within a slot (1036), also known as a rear (1036). The training plate (1035) may be a solid rectangular prism, or is preferably hollow, having a fixed perimeter and an internal web member designed to provide rigidity and stiffness. The internal web member, which includes a curved member (1037) and a substantially linear element (1038), is provided for stiffness and stability. As shown, the curved member (1037) has opposing concave surfaces.

[0153] One or more reference points or pads (1040) are defined on the upper surface of the training plate (1035). During an initialization procedure for the assay system (1000), a probe such as a pipette tip (1042) connected to the robotic system (1002) or preferably to the pipette subsystem or pipettor (1021) is brought into close proximity to the reference pad (1040), or preferably within 0.1 mm of the reference pad (1040), to determine the vertical or Z reference point. Preferably, the probe (1042) does not contact the reference pad (1040) to ensure that the probe is not deformed or bent by contact. The capacitance sensor for the pipette subsystem (1021) described above can be used in the initialization process in conjunction with the conductive training plate (1035) to determine the Z reference point and Z maximum value of the lab equipment without touching the probe (1042) to the reference pad (1040).

[0154] Alternatively, the initialization process can be completed with a substrate thinner than about 0.1 mm moving back and forth between the probe (1042) and the reference pad (1040). Once the moving substrate is captured between the probe and the reference pad, a Z reference point is determined. In an additional alternative, a proximity sensor based on a magnetic field that changes as a function of the distance between the probe (1042) and the reference pad (1040) can be used. Exemplary magnetic proximity sensors include Hall effect sensors.

[0155] Yet another alternative is to use an optical distance sensor. Suitable optical distance sensors are commercially available from Keyence America, SensoPart, and Omega Engineering, among others. The optical sensor is attached to or replaces the probe (1042) and then used to measure the distance to the reference pad(s) (1040).

[0156] This Z reference point is selected to be at the center of a corner well in the XY plane of an industry standard ANSI SLAS 1-2004 96-well microplate (8 rows by 12 columns) and in the vertical Z direction at or near the top surface of the industry standard ANSI SLAS 1-2004 plate. Industry standard ANSI SLAS 1-2004 dimensions and tolerances are described below. More specifically, the Z reference point is used to calculate Z max or maximum height in the vertical direction for all labware. Advantageously, having an accurate Z max value for labware improves reliability of dispenses as well as placement and movement of labware.

[0157] The training plate (1035) may be reversible, i.e. the bottom surface has the same characteristics as the top surface. In yet another variation, in addition to the Z reference point(s), X and Y reference points are also determined. In this variation, the probe (1042) contacts at least two reference pads (1040) and Cartesian coordinates (x, y, z) are recorded for each reference pad.

[0158] The training plate (1035) can be used to initialize the position of the gripper pad (1031) or to align the gripper pad with the assay plate(s) on the platform (1012). Accurate and consistent alignment is preferred to achieve proper acquisition (retrieval) and placement (insertion) coordinates of the assay plate or any other plate, rack, trough, tube, etc. Gripping areas (1044) are provided on the long and short sides of the training plate (1035), as best shown in FIG. 10(f). During initialization or alignment, the training plate (1035) is aligned with the platform (1012) and the gripper pad is aligned with the platform (1012). Once positioned at the Z-height of the training plate (1035), the robotic system (1002) will position its gripper pads (1031) on either the short or long side of the training plate (1035). To pick up and move the training plate (1035), the gripper pads (1031) will be positioned within the gripping area (1044), which is an area defined by several raised tracks. As the gripper pads (1031) do this, not only the Z-height but also the relative distance between the pads (gripping distance), the location of the training plate in X,Y space, and the orientation (in degrees) of the gripper pads (rotational coordinates) are identified and recorded by the processor controlling the robotic system (1002). This alignment information is stored and used to command the robotic gripper pads (1031) to acquire and place lab equipment in the appropriate location.

[0159] As shown in FIG. 10(f), the perimeter of the first surface (1043) including the reference pad (1040) of the training plate (1035) is smaller than the perimeter of the opposing surface (1045) having the bead track (1041) surrounding the perimeter to provide a larger perimeter. When determining the Z reference point, the opposing surface (1045) having preferably a larger diameter and tighter tolerance is inserted into a nest on the platform (1012). This allows for a snug fit and more accurate and repeatable positioning of the reference pad (1040). When determining the position of the gripper pad (1031) of the robot arm (1002), the first surface (1043) having preferably a smaller perimeter is inserted into a nest on the platform (1012). This allows the gripper pad (1031) to lift the training plate (1035) without having to overcome any frictional forces caused by contact between the training plate and the nest.

[0160] The training plates (1035) can be individually machined, preferably by a computer numerically controlled (CNC) milling machine, to achieve tight tolerances. The training plates can be machined to a flatness within 5 thousandths of an inch, or 0.127 mm. If there are dimensional differences between different manufactured training plates, the differences or variations are ascertained by, for example, measuring the dimensions of the training plates with a calibrated coordinate measuring machine (CMM) and using the measured dimensions to adjust the training values ​​of the platform / assay machine (1000). The tolerances can be stored in an optional memory device and used to reconcile possible differences in measurements when different training plates are used to initialize and recalibrate one assay machine.

[0161] Preferably, the training plate (1035) is made from cast aluminum for its stiffness, strength, and light weight. A preferred cast aluminum is ATP5 (Aluminum Tooling Plate 5) or similar metal. For example, a suitable metal has a strength of about 2,400 to about 3,000 kg / m 3 The steel should have a density in the range of about 100 to about 200 HB, a hardness in the range of about 60 to about 80 HB, a tensile strength in the range of about 250 to about 300 MPa, and a yield strength in the range of about 100 to about 150 MPa. Other suitable steel materials may include, but are not limited to, stainless steel, brass, and rigid polymers such as polycarbonate and polystyrene.

[0162] The reference pads (1040) preferably have a diameter of about 1.46 mm ± 10% and the distance from the center of the reference pads (1040) to the side of the training plate (1035) is about 7 mm ± 10%. As shown in FIG. 10(e), the four reference pads (1040) correspond to the centers of the four corner wells of the 96-well microplate described above. Preferably, the training plates (1035) are anodized, more preferably gold anodized. Each training plate (1035) has a part number and revision number affixed thereto, preferably bordered, and a serial number affixed thereto.

[0163] Another embodiment of the training plate (1035) has a raised track bordering the gripping area (1044). 10(aa) and 10(b), which is substantially similar to that shown in FIG. 10(aa) and 10(f), except that the raised tracks are not included. Instead, the raised tracks are replaced with two rows of two depressions or divots (1044a) and (1044b). During initialization or alignment, a pair of small screws, for example size M1.5, are attached through the gripper pad (1031) of the robot arm (1002) such that the ends of the screws protrude through the gripper pad. When the gripper pad (1031) is brought into contact with either the short side or the long side of the training plate (1035), the ends of the screws align with either the divots (1044a) or (1044b) to train the position of the gripper arm (1031) relative to the training plate (1035). The upper pivot (1044a) is positioned so that the top of the gripper arm (1031) is flush with the top of the training plate (1035) and the lower pivot (1044b) is positioned so that the bottom of the gripper arm (1031) is aligned with the skirt of the training plate (1035) or aligned with the bead track (1041). Divots (1044a) and (1044b) are sized and dimensioned to receive the ends of screws.

[0164] Advantageously, the screws are conventional screws, selected to cooperate with this embodiment of the training plate (1035), which includes space for storing the screws and tools, such as an Allen wrench, for installing and removing the screws. A slot (1044c) is provided on one or more sides, preferably the short side, of the training plate (1035). The slot (1044c) has several holes (1044d), as shown in Fig. 10(aa) and Fig. 10(bb), each sized and dimensioned to receive and sink a single screw. Preferably, these holes (1044d) are threaded in the same way as the screws. The screw head is pressed into the slot (1044c). An elongated slot (1044e) is also provided for the tool, with a single hole (1044f) for the body of the tool, for example an Allen wrench, to be inserted into the body of the training plate (1035). One or more internal holes (1044g) can be provided to accommodate the length of a tool. The head of the tool can be pushed / inserted into the elongated slot (1044e) so that it does not protrude from the training plate.

[0165] In one embodiment, the training plate may have a bar code affixed to it with its serial number to allow automated access to the stored dimensional information for the training plate.

[0166] Plate washing subassemblies are available from, for example, BioTek, Winooski, Vermont. The robotic subsystem may be any suitable commercially available microtiter plate washing system, such as a plate washing subassembly including, but not limited to, the 405 Touch Washer, 405 LS Washer, Elc405x Select Deep Well Washer, or Elx50 Washer available from Instruments, Ic. Similarly, the robotic subsystem may be a suitable benchtop commercial robotic system, such as, for example, a system available from Tecan Group LTD, Switzerland.

[0167] In a specific embodiment, the plate shaking subassembly is a balanced assay consumable shaking device as described and claimed in U.S. Ser. No. 62 / 143,557, filed Apr. 6, 2015, the disclosure of which is incorporated herein by reference in its entirety and described herein with respect to FIG. 9(a). In particular, the shaking subassembly may include a 2x3 array, a 2x4 array, or a 2x6 array of 20 storage units. Preferably, the plate shaker (1006) is a separate thermoshaker having a heater to maintain an assay plate placed thereon at an elevated temperature. Such a thermoshaker is a BioShake 3000-T elm shaker from Q.Instruments of Jena, Germany. In one example, the plate shaker (1006) is adapted to operate at a temperature approximately 3° C. above the operating temperature of the assay system. These shakers can maintain a constant temperature, and a maximum of about 37° C., with a tolerance of about ±0.5° C. Samples, buffers, reagents, etc. contained in the wells of an assay plate can be mixed and incubated on these shakers.

[0168] The inventors have also discovered that during an assay run, the reagents contained in the trough (1018) as well as the sample / reagent mixture in the assay plate on the plate shaker (1006) during the incubation and mixing period undergo evaporation. Evaporation of the reagents in the trough (1018) represents a loss. On the other hand, evaporation from the assay plate on the plate shaker (1006) may cause changes in the concentration of the substances contained in the assay plate due to evaporation. According to one aspect of the invention, lids are designed for these containers.

[0169] As shown in FIG. 10(g), an exemplary trough lid (1028) is shown. The lid (1028) is shaped and sized to fit securely over the reagent trough (1018). The lid (1028) has a top (1029) and sidewalls sized and dimensioned to fit over the top of the trough (1018), with a pattern of cuts (1030) made in the top (1029), for example, by a laser cutter. The cuts (1030) are designed to allow the top (1029) to bend, as shown, and to allow the pipette subassembly or pipettor (1021) to insert a pipette tip into the reagent trough (1018) to retrieve a reagent. When the pipette tip is withdrawn, the cuts (1030) allow the top to return to its original configuration. Any pattern of cuts (1030) can be used, so long as the top portion (1029) bends to allow for the entry of the pipette tip and resumes substantially its original configuration when the pipette tip is withdrawn. An exemplary pattern of cuts (1030) is shown in Figure 10(h). However, the present invention is not limited to any particular cut pattern.

[0170] The lid (1028) limits exposure of the reagents contained in the trough (1018) to the interior space of the assay system (1000) to only the area of ​​the bonded cuts. Generally, the open trough may contain a buffer such as tripropylamine (TPA) that may evaporate and cause losses. Limiting exposure limits evaporation. To further limit exposure, a second top portion (1029'), e.g., having a different cut pattern in the opposite direction, may be attached to the top portion (10 The lid (1028) is placed on the top or bottom of the mold (29) to create a tortuous path for the evaporated gases to escape. The lid (1028) can be made from a relatively rigid or non-elastomeric material such as polyester, high density polyethylene (HDPE), or polycarbonate, and the flexibility of the top (1029) is provided by the cut pattern (1030). Alternatively, the lid (1028) can be made from an elastomeric material such as natural or synthetic rubber to improve flexibility, and optionally the cuts are made with a sharp cutting tool instead of a laser cutter to minimize lost material and bond areas of the cuts. Preferably, the lid (1028) is thermoformed or vacuum formed, and the cuts (1030) are punched out. Thermoforming is the process of heating a plastic sheet and forming its shape with air pressure against a mold, and vacuum forming is a similar process, but using a vacuum instead of pressure.

[0171] To minimize the possibility of the troughs (1018) being pull-out of the trough carrier shown without reference numbers in FIG. 10(a), elastomeric blocks can be inserted between the troughs. Such elastomeric blocks have a body with a protrusion on each side facing the adjacent trough. Each block then has two protrusions, preferably with different sizes and / or volumes depending on the amount of gripping desired. For example, the protrusions facing the end troughs should have a larger volume than the protrusions facing the central trough.

[0172] The plate lid (1032) is then removed after processing steps have been completed and the assay plate (1031) has been incubated and mixed on the shaker (1006) before the assay plate (1 The plate lid (1032) shown in FIG. 10(i) does not have a score pattern since it is mounted on the shaker (1006) (1007). As described above, the shaker (1006) may be heated to a suitable incubation temperature. The elevated temperature promotes evaporation, especially when exposed to ambient conditions inside the assay system (1000). The lid (1032) preferably includes a plurality of downwardly facing recesses (1034). Vapor evaporated from the sample / reagent mixture in the wells (1051) in the assay plate (1033) will preferably condense in the recesses (1034) and the condensate will drip back into the wells (1051). Preferably, one recess (1034) is positioned above each well (1051) of the assay plate (1033). For example, for a 96-well assay plate, 96 downwardly facing recesses are provided in the lid (1032).

[0173] As best shown in Figures 10(j)-10(k), the lid (1032) includes a skirt (1050) that depends from the top surface. When placed on top of a multi-well assay plate (1033), the perimeter of the top surface rides on the perimeter of the assay plate (1033), creating a contact line at (1052). The contact line (1052) provides a flow restriction or seal to restrict evaporated gases or to prevent evaporated gases from leaving the enclosure between the assay plate (1033) and the lid (1032). Preferably, the lid (1032) does not have structural ribs on its bottom surface to prevent contact at the contact line (1052).

[0174] Additionally, in the embodiment of the lid (1032) shown in Figures 10(i)-10(k), there are secondary contact lines (1053) between the bottom surface of the lid (1032) and the top surface of each well (1051). These secondary contact lines (1053) present another obstacle to prevent evaporated vapor from escaping. The effectiveness of the secondary contact lines (1053) for each well (1051) depends on the flatness of the lid (1032) and the flatness of the top surface of the assay plate (1033). Also, the depressions (1034) along the skirt (1050) help prevent the lid (1032) from shaking off the assay plate (1051) on the shaker (1006) during shaking and incubation. Additionally, the depressions (1034) act as condensation enhancers to promote condensation of evaporated vapor back into the wells (1051).

[0175] The plate lid is preferably made from polystyrene, polypropylene, or cyclic olefin copolymer (COC), or any other material commonly used in biological research.

[0176] To further minimize inconsistent evaporation and condensation, the lid (1032) is preferably made from a hydrophobic polymer or other hydrophobic material, and / or the bottom of the lid (1032) is coated with a hydrophobic coating or rendered hydrophobic.

[0177] The bottom surface of the lid (1032) can be made hydrophobic by micro-etching the surface to create micro-miniaturized air pockets. These micro-miniaturized pockets can create a rough micro-topography that acts as a buffer of air to prevent liquids from adhering to the surface. This is also known as the "lotus effect" after the hydrophobic nature of lotus leaves. This effect has also been observed in gecko skin. The rough micro-topography does not allow water to clump together and prevent wide dispersion. The clumped water will form larger droplets and fall away from the lid, thereby promoting condensation. The micro-etching can be achieved by a laser source known as TresClean (http: / / cordis.europa.eu / project / rcn / 200832_en.html). The hydrophobic surface also has antibacterial properties due to its ability to repel moisture.

[0178] Suitable hydrophobic polymers include poly(tetrafluorethene), polypropylene, polyamide, polyvinylidene, polyethylene. , polysiloxane, polyvinylidene fluoride, polyglactin, lyophilized dura, silicone, rubber, and / or mixtures thereof.

[0179] Suitable hydrophobic coatings include polyethylene, paraffin, oil, jelly, paste, grease, wax, polydimethylsiloxane, poly(tetrafluoroethene), polyvinylidene fluoride, tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer, fluorinated ethylene propylene, poly(perfluorooctylethylene acrylate) Suitable hydrophobic coatings include, but are not limited to, perfluorooctanoate, perfluorosulfonate, ammoniacal sodium lauryl sulfate, sodium laureth sulfate, alkylbenzenesulfonate, sulfated or sulfonated fatty substances, salts of alkylaryloxypolyalkoxy alcohol sulfates, alkylbenzenesulfonates, sodium dodecylbenzenesulfonate, fluorinated surfactants, sodium lauryl sulfate, sulfosuccinic acid mixtures, dioctyl sodium sulfosuccinate, sodium sulfosuccinate. The surfactants may include surfactants such as sodium sulfosuccinate, 2-ethylhexyl sulfate sodium, ethoxylated acetylenic alcohols, high ethylene oxide octylphenols, high ethylene oxide nonylphenols, high ethylene oxide linear and secondary alcohols, ethoxylated amines of any ethylene oxide length, ethoxylated sorbitan esters, random EO / PO polymers to butyl alcohol, water soluble block EO / PO copolymers, sodium lauryl ether sulfate, and / or mixtures thereof.

[0180] In a variation, the material of the top perimeter of plate (1033) that rests on the perimeter of assay plate (1051) forming contact line (1052) can be roughened, for example by a wire brush or similar device, to increase the tortuous path for gases and vapors, thereby minimizing the amount of vapor that escapes. The bottom surface of lid (1032) can be roughened to increase the hydrophobicity and exhibit the Cassie-Baxter behavior described above. It is known that microstructuring a surface amplifies the natural tendency of a surface, and in certain instances, the hydrophobicity of a surface can be further enhanced if the roughened surface is able to trap vapors (such as air or other gases) (Cassie-Baxter equation). It is also contemplated that the bottom surface of the lid (1032) can be microstructured using methods known in the art, including, but not limited to, micromachining, lithography (photolithography, soft lithography (nanoimprint lithography, capillary force lithography, micromolding in capillaries, microtransfer molding), electron beam lithography), and plasma etching, as well as using bath deposition, chemical vapor deposition, electrochemical deposition, layer-by-layer deposition via electrostatic assembly, colloidal assembly, sol-gel processing, nanosphere lithography, water droplet condensation induced patterning, and / or microablation to create patterns or textures on the surface. Hydrophobic materials, hydrophobic coatings, and hydrophobic surface treatments are disclosed in published International Patent Application No. WO2012 / 003111, which is incorporated herein by reference in its entirety.

[0181] Optionally, a gasket can be placed on the contact line (1052), preferably on the periphery of the lid (1032) adjacent the skirt (1050). One or more stacking features (1057) can be positioned on top of the lid (1032) around its periphery, allowing multiple lids (1032) to be stacked on top of each other without sliding off.

[0182] The liquid reagent subassembly (1007) includes a plurality of liquid reagent compartments and a waste The device includes a compartment for use in one or more steps of an assay performed in the device. The reagent / waste compartment includes a compartment body enclosing an internal volume, and a reagent or waste port for delivering reagents or receiving waste. The volume of the compartment of the subassembly is adjustable so that the relative proportions of the compartment body volume occupied by reagents and waste can be adjusted, for example, as reagents are consumed in the assay and returned to the compartment as waste. The total internal volume of the compartment body can be less than about 2 times, less than about 1.75 times, less than about 1.5 times, or less than about 1.25 times the amount of liquid stored in the body, for example, the amount of reagent initially provided in the compartment, thus minimizing the space required for waste and reagent storage and allowing convenient one-step reagent refill and waste removal. In certain embodiments, the device has a reagent compartment slot configured to receive the compartment and optionally provide a fluid connection to the waste and reagent ports via a "push-fit" or "quick-fit" fitting.

[0183] Optionally, the reagent compartment and / or the waste compartment are removable. In one embodiment, the reagent compartment and / or the waste compartment are removable and the device further includes a sensor, such as, for example, an optical sensor, to monitor the liquid level(s) in the reagent compartment and / or the waste compartment. Alternatively, the liquid reagent subassembly may include an electronic scale to monitor the weight of the fluid in the reagent tank and the waste tank for real-time tracking of reagent usage and availability. When the reagent compartment and / or the waste compartment reaches a minimum or maximum capacity, as detected by the sensor or scale, the device alerts the user to remove the reagent compartment and / or the waste compartment to refill and / or empty the contents. Other liquid level detectors can be used. Other exemplary liquid level detectors include multiple thermistors vertically positioned in each compartment, such as at the ¼ mark, ½ mark, ¾ mark, and full mark. Due to the different heat capacities of liquid and air / vapor, a thermistor submerged in liquid will produce a different electrical signal than one located in air or vapor. Another liquid level detector includes a capacitor with one conductive plate at the top of the liquid and the other conductive plate at the bottom of the compartment. The measurable capacitance of the liquid between the two conductive plates changes the distance between the two plates, which, as described above, indicates the amount of liquid contained in the compartment.

[0184] In one embodiment, the pumps or motors of the dispense subsystem (1021) are in communication with these sensors or scales, and the dispense probe motor is disabled by the device when the reagent and / or waste compartments reach minimum or maximum capacity, e.g., the probe sensors relay information regarding the compartment volumes to the meter software, which then pauses additional dispense operations.

[0185] The reagent compartment and / or waste compartment may be provided as a collapsible bag located in the subassembly body. One of the reagent compartment and / or waste compartment may be provided as a collapsible bag and the other may be provided as the compartment body itself (i.e., the volume of the compartment body excluding the volume defined by any collapsible bag within the compartment body). Alternatively, the reagent compartment and the waste compartment may be contained within the same container and separated by a flexible, movable, or elastic membrane or separator. In addition to the first reagent compartment and the waste compartment, the reagent cartridge may further include one or more additional collapsible reagent compartments and / or waste compartments connected to one or more additional reagent ports and / or waste ports. Alternatively, one or the other of the reagent compartments and / or waste compartments may be constructed from blow-molded plastic.

[0186] In accordance with another aspect of the present invention, the assay system (1000) can control the temperature inside when its panels or doors (1056) are closed. To illustrate the internal components, the assay system (1000) is shown in Figs. 10(a)-10(c) without the housing and doors, but includes a front door and / or front panel, generally designated as (1056). These doors and panels are closed before the assay system (1000) performs a run. When the system begins a run, it is preferred that the internal air temperature in the area above or near the platform where the assay steps are performed remains within a range of about 20°C to about 24°C, inclusive. Once the operating temperature is selected depending on the particular assay being performed, the selected temperature is preferably maintained within a range of ±1°C. The temperature control area may be defined from the front of the platform (1012) or consumable storage unit (1004) to about 6 inches forward of the rear of the deck or to the rear of the deck. The control area may extend from left to right of the platform (1012) or from position 26 to position 49 as shown in FIG. 10(u) to cover the length of all shakers (1006). The assay system (1000) also has temperature sensors located at several locations to monitor the temperature(s) inside the assay system. Temperature readings are monitored by the system software described herein and the user is notified if the operating temperature is outside of the operating range. The temperature of the liquid in a covered MSD plate placed on the plate shaker with the shaker temperature control turned off should rise by less than 2° C. above the ambient deck temperature over a two hour period.

[0187] The selected operating temperature is maintained despite heat generated by the plate shaker (1006), which may incubate the assay plate at the elevated temperatures described above, and the assay reader (1003), which includes electromechanical components and thermoelectric cooling for optical sensors such as heat-generating charge-coupled devices (CCDs) or complementary metal oxide semiconductor (CMOS) devices. The selected operating temperature is maintained by several TECs (1019), as best shown in FIG. 10(c). In this particular example, six TECs (1019) are used; however, any number can be deployed. Preferably, two TECs are centered on the reader (1003) to dissipate heat generated by the reader. The remaining TECs are used to control the selected operating temperature, and some of the remaining TECs may be centered on the optionally heated shaker (1006). Additionally, some of the cooling is directed to electronic devices (1010, 1011) or electronic devices housed in an electronic enclosure (1009) described below.

[0188] As shown in FIG. 10(m), which shows a cross-sectional side view of the assay system (1000), the TEC (1019) absorbs heat near its center, as indicated by arrows (1046), and produces cold air at the top and bottom, as indicated by arrows (1047). The cold air (1047) flows toward the front of the assay system (1000), cooling the enclosure, and is reversed by a closed door or panel (1056), returning as warm air (1046), which is absorbed by the TEC (1019). FIG. 10(n) shows a top view in which all six exemplary TECs (1019) are shown. The returning warm air is directed to a specific area proximate to the center of the TEC. The perspective view of FIG. 10(o) shows the flow paths of the warm and cold air baffles (1048) in more detail. Each baffle (1048) preferably surrounds one or more baffle TECs (1019) as shown and forces the cool air (1047) to flow upwards and downwards as described above. The baffles (1048) also direct the returning warm air to the side of the baffle where heat is exchanged with the TEC. Additional heat exchange occurs on the hot side of the TEC outside the enclosure of the assay machine (1000), where heat absorbed from the interior of the assay machine is exchanged with the atmosphere.

[0189] In addition, the shaker (1006) is configured to circulate air through the top of the shaker to improve convection heating. The fluid may be elevated above the platform (1002) to allow for flow underneath as well as above.

[0190] FIG. 10(p) illustrates cooling of electronic devices (1010, 1011) preferably housed within an electronic enclosure (1009). Cooling of the enclosure (1009) utilizes the chimney effect by taking cool air (1047) from the bottom, pulling the cool air upwards to cool the electronic devices (1010, 1011) and expelling the warm air (1046) to the outside of the assay machine (1000) through cooling channels (1049). Preferably, the cooling channels (1049) are positioned away from the main part of the assay machine (1000) and adjacent to the outer wall or skin of the system as shown for more effective heat removal. One or more fans are used to draw in cool air from the surroundings and push the air inside the electronic enclosure (1009) to cool the warm air and expel it through the chimney (1049).

[0191] Referring back to FIG. 10(l), at least one computer screen or tablet (1058) is attached to a glass surface (1060) of the assay system (1000). A pressure transducer, typically used in a touch screen, is attached or glued directly to the glass surface (1060) and relies on the glass surface (1060) of the assay system (1000) to transmit pressure applied by a user's fingertip to the transducer to generate a current signal to the tablet or computer CPU. Also relying on the same glass surface (1060) to generate sound waves is at least one sound exciter (1062). The sound exciter (1062) is also attached or glued to the glass surface (1060). The exciter (1062) vibrates the glass surface (1060) to produce sound. Both the touch screen and the sound exciter can be used in the graphic user interface (GUI) or user interface (UI) described herein.

[0192] A minimum distance between the exciter and the pressure transducer / touch screen is preferably established to minimize or eliminate interference caused by the exciter (1062) to the pressure transducer of the tablet (1058). Human audible frequencies range from about 20 Hz to about 20 kHz, while typical human speech occupies a significantly smaller range, e.g., from about 2048 Hz to about 8192 Hz (7th to 8th octaves). Preferably, the pressure transducers of the tablet (1058) are designed, selected, or adjusted such that they are not sensitive to the range of human speech, allowing visual and audio devices to share the same glass surface (1060).

[0193] Additionally, the glass surface (1060) or other surfaces of the assay system (1000) may include lighting, such as LED lighting or light strings. Preferably, the LED lighting is located on the door handle of the assay system, and may also be located on the top of the assay system. These lights illuminate different colors depending on the status of the immunoassay being run. In one example, the lights may communicate a satisfactory run by emitting a constant green or blue light, flashing or pulsing green or blue when the system is running, emitting yellow or red when an error is detected, and emitting white when the assay is completed. The same colors may also be displayed on the tablet (1058).

[0194] Another aspect of the assay system (1000) relates to how the panels and doors (1056), which can be heavy and bulky, are supported on the frame of the system. Referring to Figure 10(q), a flange system (1063) includes a main hanging part (1066) and a movable bracket (1064) movably mounted on a rail (1065) to allow the bracket (1064) to be adjusted up and down in the Z direction. The main hanging part (1066) is adapted on the bracket (1064) to be mounted to a support (1068). The door or panel (1056) has a pair of C-shaped openings (1067) corresponding to the vertical position of the door or panel (1056). Once the vertical position of the door or panel (1056) has been satisfactorily established, bolts are threaded into the openings (1069) to fix the vertical position.

[0195] The horizontal position (XY plane) of the door or panel (1056) can also be adjusted by the cam (1070). The cam (1070) may have any shape, including a circular protrusion eccentrically mounted to the bracket (1064). More specifically, the cam (1070) is mounted via a shaft spaced from the center of the circular protrusion. A nut, preferably polygonal or more preferably hexagonal, is attached to the protrusion with an eccentric shaft. Rotation of the nut will move the main hanging body (1066) horizontally in the XY plane. The horizontal movement of the main hanging body (1066) is limited by the shape of the opening (1069). In other words, the opening (1069) has a horizontal ellipse that gives the connecting bolt a small amount of movement inside the ellipse.

[0196] Thus, the flange system 1063 allows the door or flange 1056 to be adjusted in two directions to ensure that the assay system 1000 can be properly closed. The flange system 1063 can be used with any door or panel on the assay system.

[0197] Optionally, a video camera is positioned within the enclosure of the assay system (1000) to record the assay run and stream the video to a remote location where a user or technician can monitor the assay run without having to be present at the assay system. The video can also be saved and stored for future reference. The video camera can be mounted on the frame of the assay system (1000), as described below.

[0198] The assay system (1000) is designed to be stable, and as shown in FIG. 10(s), the table (1001) that supports the platform (1012), all permanent components, and lab equipment / consumables has a length (L) of 85 inches ± n%, a height (H) of about 28 inches ± n%, not including caster wheels, and a width (W) of 33 inches ± n%. When assembled to the table (1001), each caster wheel has a height of about 4.5 inches ± n%. The opening (1078) for the plate washer (1005) is about 5.5 inches ± n% x 10 inches ± n%. The opening (1080) for the solid waste storage unit is about 4.5 inches ± n% x 6 inches ± n%. The opening (1082) for the reader (1003) has a length (L direction) of about 16 inches ± n%. The tolerance n% is preferably 10%, more preferably 5%, and more preferably 2.5%.

[0199] Referring to FIG. 10(t), the frame (1084) has a height (H) of about 52 inches ± n%, a front overhang height (H front) of about 30 inches ± n%, a length (L) of about 84.5 inches ± n%, and a width at the top (W) of about 34.5 inches ± n%. The lower support has a long width (W2 bot) of about 33 inches ± n% and a short width (W1 bot) of about 18 inches ± n%. The tolerance n% is preferably 10%, more preferably 5%, and more preferably 2.5%.

[0200] The reader (1003) is advantageously positioned in the recessed opening (1082) and the plate washer (1005) is positioned in the recessed opening (1078) to provide clearance for the movement of the gripper pad (1031) and pipette system or pipettor (1021) of the robotic system (1002) and to free up space for lab equipment and consumables on the platform (1012). The reader (1003) is also positioned off-center, for example on the side of the table (1001), so that heat it generates is away from the center of the assay system and is more easily dissipated. The gripper pad ( Both the assay consumables storage unit (1004) is cantilevered on the front end of the platform (1012) and the shaker (1006) as described above is located towards the rear of the platform (1012) to free up space for lab equipment or consumables on the platform and allow a lab technician to load consumables from the front and gripper pads and pick and place consumables from the rear. The dimensions of the table (1001) and frame (1084) in combination with the locations / heights of the major components described herein provide stability and space savings for the assay system (1000).

[0201] A top view of the layout of labware for the assay system is shown in FIG. 10(u). The relative locations of the assay reader (1003), first consumable identifier controller 1013, such as the first barcode reader, and the assay consumable storage unit (1004) protruding on the platform (1012). Also shown in FIG. 10(u) are pipette tips (1015) and (1016), shaker (1006), tube carrier (1017), and trough (1018). As mentioned above, the platform (1012) includes a line of holes (1027) numbered 1 through 69 to facilitate referencing the location of the labware relative to the holes (1027). One or more grid location clips (1027a) are sized and dimensioned to fit into the holes (1027) on the platform (1012) to aid in positioning the labware.

[0202] Another configuration of the layout is shown in Figure 10(cc), where the first consumable identifier controller 1013 is located closer to the shaker 1006, with the pipette tips (1015) and (1016) omitted and the tip carrier (1026) shown below. An exemplary location for a second identifier controller (1023), such as a second barcode reader, is shown.

[0203] Exemplary electrical and electronic connections for the assay system (1000) are shown in Figures 10(v)-10(y). Figure 10(v) shows the power and internet connections. A power and Ethernet module (1085) is shown on the left and in association with a UPS (1086). The UPS (1086) provides emergency power to the assay system (1000) in the event of a power interruption. The UPS (1086) is connected to a reader (1003) and a processor (1087) for the assay system (1000) as well as a router (1088). The UPS (1086) is also connected to the washer (1005) and its pumps, and to the robotic system (1002). As mentioned above, each subsection of Figures 10(v)-10(y) depicted in dashed lines and individually labeled has been enlarged and shown on a separate drawing sheet.

[0204] FIG. 10(w) continues the wiring diagram of FIG. 10(v) and shows the electrical contacts on the right. FIG. 10(w) shows that the UPS is connected to another power supply (1089), which is a 300W AC and 24V DC unit. The power supply (1089) provides stepped down power at 5V DC at 24A to a DC power module. This 5V power module powers several sensors on either side, such as the waste pad sensor on its left side, the plate washer sensor, etc. On its right side, the power module powers a light panel and also powers a panel (1091) that illuminates the left and right doors (1092). The panel (1091) also provides power and signals to the exciter (1062), touch screen (1058), and barcode reader (1013).

[0205] FIG. 10(x) continues the diagram of FIG. 10(w) and shows a controller and power PCB (1093) that is connected to the six TECs (1019) and their associated sensors (1094). The controller and power PCB (1093) also provides power to the fans (1095) and the reader (1003). Supplying power.

[0206] FIG. 10(y) shows a deck control PCD (1096) that provides power to five shakers (1006), a barcode reader (1098), and a thermistor sensor (1099) used to monitor the temperature associated with the assay reader (1000).

[0207] FIG. 10(z) is a top view showing the plate carrier (1036) and tip carrier (1026).

[0208] In each of the assay systems shown in Figures 9-10, additional microprocessors and computers in the assay system can interact with the assay consumable identifiers by transferring data and commands to / from the identifiers to various microprocessors / controllers throughout the system to perform various operations of the components shown above in the assay system as described below.

[0209] The system can adjust assay parameters before starting the assay based on the consumable data stored in the identifier and / or provided as consumable data via a direct or indirect interface. The system then makes the appropriate electrical, fluidic, and / or optical connections to the consumable (utilizing electrical, fluidic, and / or optical connectors on the consumable and the system), uses the consumable, and performs the assay. The sample can be introduced into the consumable prior to inserting the consumable into the system. Alternatively, the sample is introduced by a component of the system after the consumable is inserted into the system. The assay may also include adding one or more assay reagents to the consumable, and instructions for adding the various assay reagents can be stored in the identifier and / or provided as consumable data, and the system adds those reagents to the consumable before or during the assay according to the instructions stored in the assay consumable identifier and / or provided as consumable data, as described further below.

[0210] (iv) Assay cartridge and cartridge reader Alternatively, the assay consumable is a cartridge, the consumable further comprising elements selected from one or more fluidic components, one or more detection components, one or more assay cells, reagents for performing the assay, working electrodes, counter electrodes, reference electrodes, dielectric materials, electrical connections, dry and / or liquid assay reagents, or combinations thereof. The cartridge may further comprise at least one assay cell comprising a plurality of separate assay test sites and / or domains, each of which comprises reagents for measuring a different analyte.

[0211] Examples of assay consumable cartridges that can be used in the present invention are described in US Application Publication No. 2004 / 0189311, the disclosure of which is incorporated herein by reference in its entirety. The assay consumables described therein are assay cartridges that incorporate one or more fluidic components, such as compartments, wells, chambers, fluid conduits, fluidic ports / vents, valves, and / or one or more detection components, such as electrodes, electrode contacts, sensors (e.g., electrochemical sensors, fluidic sensors, mass sensors, optical sensors, capacitive sensors, impedance sensors, optical waveguides, and the like), detection windows (e.g., windows configured to allow optical measurements on samples in the cartridge, such as measurements of absorbance, light scattering, light refraction, light reflection, fluorescence, phosphorescence, chemiluminescence, electrochemiluminescence, and the like). Such consumables also include reagents for performing the assay, such as binding reagents, detectable labels, sample processing reagents, wash solutions, buffers, and the like. The reagents may be present in liquid form, solid form, and / or may be immobilized on the surface of a solid support present in the cartridge. In this embodiment, the consumable includes all components necessary to perform the assay. Additionally, the assay consumables can receive consumables, e.g. It is used in conjunction with a consumable assay reader adapted to perform specific operations on the consumable, such as controlling bodily movements, providing power, or performing physical measurements on the cartridge.

[0212] More particularly, such assay consumable cartridges have one or more assay test sites (e.g., wells, compartments, chambers, conduits, flow cells, etc.) that may include one or more assay domains (e.g., discrete locations on the assay test site surface where an assay reaction occurs and / or an assay-dependent signal, such as an electrochemical or electrode-induced luminescence signal, is induced) for performing multiple assay measurements. In this embodiment, the assay domains are supported on assay electrodes (in one embodiment, an array of assay electrodes, e.g., a one-dimensional array of assay electrodes) to enable performance of an assay based on an electrochemical or electrode-induced luminescence measurement. The assay domains are optionally defined by a dielectric layer attached to the electrodes. Additionally, the assay consumables may have one or more attributes that make them suitable for use in "point-of-care" clinical measurements, e.g., small size, low cost, disposable, multiplexed detection, ease of use, etc.

[0213] The assay consumable cartridge may contain the electronic and / or active mechanical components necessary to perform the assay measurement, e.g., one or more electrical energy sources, ammeters, potentiometers, photodetectors, temperature monitors or controllers, pumps, valves, etc. Alternatively, some or all of the electronic and / or active mechanical components are located in a separate assay reader, which would also have the appropriate electrical, fluidic, and / or optical connections to the assay consumables to use the consumables and perform the assay. Using such an arrangement, the assay consumables can be designed to be low cost and disposable, while the assay reader (which retains the more expensive and complex components) can be reused.

[0214] In one embodiment, the cartridge-based biochemical detection system may include a system housing including a photodetector, the system housing adapted and configured to receive and position the assay consumables and / or the photodetector for processing. The system may further include support subsystems that may include one or more of a storage subsystem for storing assay reagents / consumables and / or waste, a sample acquisition / pretreatment / storage subsystem for handling samples, a fluid handling subsystem for handling reagents, samples, waste, etc., and for providing fluids to the detection chamber via the fluid inlet line, an electrical subsystem for electrically contacting electrical contacts of the cartridge and providing electrical energy to the electrodes, and a control subsystem for controlling and coordinating operation of the system and subsystems, and for acquiring, processing, and storing the optical detection signals. Information associated with the assay consumable identifier and / or provided as consumable data may include information used to control or regulate one or more of the assay system components prior to and / or during performance of an assay using the assay consumable.

[0215] Still further, an assay consumable may be a container that holds one or more assay reagents, including but not limited to one or more buffers, diluents, and / or reagents used by the assay system in performing an assay. An assay consumable identifier may be affixed to the container and / or may be affixed to the packaging of the container.

[0216] B. Assay Consumable Identifier In one embodiment, the assay consumable identifier includes memory for storing information relating to the consumable, its history, and / or its use. In one embodiment, the memory is non-volatile memory. Non-volatile memory is computer memory that can retain stored information without power. Examples of non-volatile memory that can be used in the consumable identifier include electronic non-volatile memory (e.g., read only memory and flash memory), magnetic memory (e.g., hard disk , floppy disk drives, and magnetic tape), optical memory (optical disk drives), and hybrids of these techniques (magneto-optical memories).

[0217] In one embodiment, the assay consumable identifier comprises an EPROM (Erasable PROM), a type of programmable read-only memory that can be erased by exposing it to ultraviolet light. Once erased, it can be reprogrammed with new or revised data. In another embodiment, the assay consumable identifier comprises an EEPROM (Electrically Erasable PROM), a type of non-volatile electronic memory that can be erased and programmed electrically without exposure to UV light. EEPROMs can be written or programmed multiple times and are selectively programmable (allowing the customer to change the value of a particular cell without erasing the programming of other cells). Thus, sections of data can be erased and replaced without having to modify or reinstall the rest of the chip's programming.

[0218] In another embodiment, the assay consumable identifier comprises flash memory, a particular type of EEPROM that is erased and programmed in large blocks. Although flash memory is technically a type of EEPROM, the term "EEPROM" is generally used to specifically refer to non-flash EEPROM that is erasable in small blocks, usually bytes. Because erase cycles are slow, the large block size used to erase flash memory gives it a significant speed advantage over conventional EEPROM when writing large amounts of data.

[0219] In another embodiment, the assay consumable identifier comprises a smart card, chip card, or integrated circuit card (ICC) (collectively referred to as "ICC"). These are small cards with embedded integrated circuits that can process and store data. There are two broad categories of ICCs: i) "memory cards" that contain a non-volatile memory storage component and optionally some special security logic, but no microprocessor, and ii) "microprocessor cards" that combine a non-volatile memory component with a microprocessor component to allow processing of information that is loaded into or read from the ICC. The ICC electronics are supported on a card that is typically made of a plastic such as PVC or ABS. The card may contain an embedded hologram to avoid counterfeiting. Contact ICCs have conductive contact pads. The compact pads on the ICC, when inserted into an assay reader, contact the electrical connectors of the identifier controller to allow transfer of information between the identifier controller and the ICC, for example, allowing the identifier controller to read, erase, or write information to the ICC.

[0220] Another way to transfer information is via RFID, or radio frequency identification, which is similar in theory to bar code identification. With RFID, electromagnetic or capacitive coupling in the RF portion of the electromagnetic spectrum is used to transmit signals. RFID systems consist of an antenna and transceiver that reads the radio frequencies and transfers the information to a processing unit, and a transponder, or tag, which is an integrated circuit that contains the RF circuitry and the information to be transmitted.

[0221] Identification can also be achieved by reading the consumable identifier (e.g., a barcode). One key difference between RFID and barcode technology is that RFID eliminates the need for line-of-sight reading that barcoding relies on. RFID scanning can also occur at greater distances than code scanning. High frequency RFID systems (850 MHz to 950 MHz, and 2.4 GHz to 2.5 GHz) offer transmission ranges of over 90 feet, although wavelengths in the 2.4 GHz range are absorbed by water (and the human body) and therefore have limitations.

[0222] In one embodiment, the non-volatile memory used in the present invention includes an EEPROM, a flash memory, an ICC, or a combination thereof. In one embodiment, the non-volatile memory is an EEPROM. In an alternative embodiment, the non-volatile memory is an RFID. In a specific embodiment, the non-volatile memory is a consumable identifier (e.g., a barcode), including but not limited to a one-dimensional or two-dimensional consumable identifier (e.g., a barcode), or a combination thereof.

[0223] In additional alternative embodiments, more than one non-volatile memory component can be used in the present invention. For example, a first assay consumable including a first identifier can be used in the assay system, and an additional assay consumable including an additional identifier can also be used in the assay system. Each identifier may include the same or different types of memory. However, for each different form of memory, there is a separate identifier controller. Certain consumable data can then be stored in one identifier, and other consumable data can be stored in additional identifiers of the same or different types. For example, one assay consumable used in the system may include an EEPROM or RFID as an identifier, while the system may be able to use additional assay consumables including, for example, a consumable identifier (e.g., a barcode) as an identifier. The assay system includes an identifier controller that can interface with the first identifier, i.e., the EEPROM or RFID, and the system further includes an additional controller that interfaces with the consumable identifier (e.g., a barcode).

[0224] The assay system of the present invention includes an identifier controller that controls the operation of the non-volatile memory and other components of the assay system. The identifier controller optionally includes, for example, an I 2 The non-volatile memory includes a microcontroller for interfacing with the non-volatile memory via a communications interface, which may incorporate conventional interface architectures and protocols, such as C, a two-line serial bus protocol, etc. The microcontroller addresses the non-volatile memory and performs write, read, and erase operations on the memory.

[0225] The consumable identifier may be located on the consumable, or the consumable identifier may be a separate component. In either case, the system can be designed to have a unique identifier for each consumable. Alternatively, the system can be configured such that one separate consumable identifier is used to hold information related to multiple consumables. In one example, each package of consumables has a package-specific identifier attached to (or alternatively provided with) the package that holds information related to the multiple consumables in the package. Optionally, each consumable also has an additional unique consumable-specific identifier attached to the consumable. This consumable-specific identifier is primarily used to uniquely identify the consumable and link the consumable to the package-specific identifier. In this embodiment, non-editable identifiers such as lot information content and / or consumable identifiers (e.g., barcodes) can be used.

[0226] The various components of the assay system may be housed together in a single unit or may be housed separately. For example, an assay system may include an assay reader and an identifier controller as separate units. The assay system provides communication between the assay reader and the identifier controller directly or alternatively indirectly (which may be wired or wireless communication) via additional components of the assay system. In alternative embodiments, the identifier controller is housed within the assay reader. In such embodiments, the assay reader may be configured such that insertion of a consumable into the assay reader during the performance of an assay also allows communication between the consumable identifier and the identifier controller (e.g., the port into which the consumable is inserted includes components for processing and / or reading the consumable and also includes components, such as electrical contacts or wireless transmitters, for communicating with the consumable identifier). In one example, when a consumable is loaded into the assay system, communication between the controller and the identifier is established. An electrical connection is made between the controller and the consumable identifier. The controller can then read, erase, and / or write the consumable data from / to the identifier. Alternatively, the assay reader may have separate ports for processing / reading the consumable and for communicating with the consumable identifier. The customer places the assay consumable or package in or adjacent to the controller port such that the controller is in electrical communication with the identifier so that the controller can read, erase, and / or write the consumable data.

[0227] In one embodiment, the identifier includes non-volatile memory including an RFID tag, a consumable identifier (e.g., a barcode), an EPROM, an EEPROM, or a combination thereof. Additionally, the identifier may include an EEPROM including a flash memory and an ICC. In a specific embodiment, the identifier is a consumable identifier (e.g., a one-dimensional or two-dimensional barcode).

[0228] C. Consumables Data The identifier is programmed, for example, during the manufacturing process or when the consumable is prepared for shipment. The identifier is associated with consumable data that can be used before, during, or after an assay or step of a multi-step assay to control the operation of an assay system, an assay reader, or a component of an assay system. Additionally or alternatively, some or all of the information required for use of a given consumable can be provided as consumable data. The term "consumable data" may include any information used to uniquely identify a particular assay or assay step, assay consumable, consumable domain(s), biological reagent or sample, or to distinguish a particular assay, assay step, assay consumable, consumable domain(s), biological reagent or sample from other assay consumables, consumable domains, biological reagents or samples. Consumable data may include consumable information, sample information, chain of custody information, consumable / test site information, assay process information, consumable security information, or a combination thereof. The consumable data may further include information related to one or more analytical tools that can be applied by the system to analyze data generated during and / or after the performance of an assay, assay system maintenance information, system consumable promotional information, and / or system and / or consumable technical support information.

[0229] Each type of consumable data is described in more detail below, and it should be understood that each type of consumable data can be associated with a consumable identifier and / or provided as consumable data.

[0230] (i) Consumable identification and composition information Consumable data may include consumable identification and configuration information, including, but not limited to, identification information, lot-specific analytical parameters, manufacturing process information, raw material information, expiration date, Material Safety Data Sheet (MSDS) information, product insert information (e.g., any information that may be contained in or described in the product insert information that may accompany the assay consumable, such as the assay type, how the assay is performed, instructions for use of the assay consumable, assay reagents, or both), threshold and / or calibration data for one or more reagents used in the assay consumable or in an assay or step of a multi-step assay, and the location of individual assay reagents and / or samples within one or more test sites of the assay consumable.

[0231] The consumable data may also include lot identification information, i.e., information used to identify a particular lot of assay consumables, including information that is unique to a given lot that can be used by the system to perform assays with consumables from that lot or to analyze assay results derived from consumables from that lot, as opposed to lot-specific analytical parameters. In the case of a well assay plate or cartridge, the lot-specific analytical parameters may include, but are not limited to, the following: (i) revision level, which determines the schema used to interpret the information; (ii) consumable type; (iii) date of manufacture; (iv) lot number; (v) expiration date; (vi) crosstalk correction matrix to account for chemical cross-reactivity; (vii) thresholds for the assays run on the consumable and their respective internal negative controls; (viii) ranges for the internal positive controls; (ix) ranges for each assay run on the cartridge for positive control samples; (x) software checksums to ensure data integrity; (xi) in-well (or in-test site) control tolerance ranges; (xii) assay name and / or identifier; (xiii) information regarding assay quality control, including negative and positive quality control materials used to verify the operation of the assay reader and consumable; (xiv) calibration information, such as a master calibration curve; and (xv) number and names of assay calibrators and / or assay calibrator tolerance ranges.

[0232] The consumable data may include sample information such as the location of the sample within at least one test site of the assay consumable, the assay result obtained on the assay consumable for the sample, and the identity of the sample that has been and / or will be the assay on the assay consumable.

[0233] Consumable data may also relate to chain of custody, such as information regarding the control, transfer, and / or analysis of samples and / or assay consumables. Chain of custody information may be selected from customer identification, sample identification, time and date stamps for the assay, location of the assay system in the laboratory during the assay, calibration and QC (quality control) status of the assay system during the assay, control and / or location information for the assay consumables before and after the performance of the assay, assay results for a given sample, and customer generated free text comments entered before, during, or after the assay is processed by the system. Additionally, chain of custody information may include time, date, manufacturing personnel, or processing parameters for one or more steps during the manufacture of the assay consumables, storage, location, and / or storage conditions for the assay consumables during steps following and / or during the manufacture of the assay consumables.

[0234] The consumable data may also include consumable / test site information, such as the type and structure of the consumable, the location and identity (e.g., structure, composition, order, concentration, and / or origin) of assay reagents included in the assay consumable, and the location and identity of the assay reagents in the assay test sites of the assay consumable. The consumable data may be used to distinguish between a first test site in the consumable and a different test site in the consumable. Additionally, the consumable data may include sample information including the location of the sample in at least one test site of the assay consumable, an assay result obtained with the assay consumable for the sample, the identity of the sample that has been assayed and / or will be assayed with the assay consumable, or a combination thereof. Additionally, the consumable data is consumable / test site information including the type and structure of the consumable, the location and identity of the assay reagents included with the assay consumable, the identity of the assay reagents in the assay test sites of the assay consumable, or a combination thereof.

[0235] In additional embodiments, the consumable / test site information may include information regarding assays previously performed by an assay reader or system at one or more test sites in the consumable, and information regarding assays to be performed by an assay reader at one or more test sites in the consumable. Thus, once an assay is performed by the system, the controller may be used to write the results of the assay to the identifier. Such information may include raw or analyzed data collected by the system during the assay (analyzed data is data that has been subjected to statistical analysis after collection, while raw data is data that has not been subjected to such statistical analysis), a list of test sites and / or domains in the assay consumable that were used during a given assay, information related to the assay consumable or test sites and / or domains in the assay consumable. The information may include, but is not limited to, a schedule of events to be performed during the assay, a list of those test sites and / or domains on the assay device that have not been assayed, assay or system errors that occurred during a given assay or assay step, or a combination thereof.

[0236] Additionally, the consumable data can be used as a security mechanism (referred to herein as "consumable security information"), for example, to verify that the correct assay consumable is being used in the system. The consumable data may include a digital signature to verify that the consumable was manufactured by an authorized vendor. In one embodiment, if an improper assay consumable is present in the system, for example, a counterfeit consumable or a consumable that is otherwise incompatible with the assay system, the controller disables the system, the assay reader, or a component thereof. Additionally or alternatively, the consumable data can be used to detect proper installation of the assay consumable in the system, for example, proper orientation of the assay consumable or a portion thereof in the assay system, such that the controller disables the system, the assay reader, or a component thereof until the assay is installed in the correct orientation. Additionally, the consumable data can also be used to detect defects in the assay consumable or assay test sites and / or domains, and the controller disables the system, the assay reader, or a component thereof accordingly. For example, depending on the nature of the defect in the assay consumable or domain, the controller may not allow the assay consumable to be used in its entirety or may instruct the assay reader not to allow the use of the test sites and / or domains or collections of test sites and / or domains of the assay consumable. In one embodiment, the assay reader may perform a diagnostic analysis on the assay consumable and / or the test sites and / or domains therein to identify defects therein, and the controller writes the results of the diagnostic analysis to the consumable's identifier. When the consumable is later used in a different assay reader, the results of this diagnostic analysis are read by the controller and used by the assay reader to adjust the use of the consumable or the test sites and / or domains therein accordingly. In additional embodiments, the assay consumable may undergo a quality control process during or after manufacture, and the results of the quality control analysis may be written to the identifier for later use and / or verification by the customer of the assay consumable in the assay reader.

[0237] Consumable data may also include authorization information for a consumable or its test site and / or domain or biological reagent, such as information regarding whether a particular customer has a valid license to use a particular consumable or biological reagent, such as whether the customer's license is for research purposes only, the number of times the particular customer is authorized to use a particular consumable or biological reagent in a particular assay, and any limitations on its use, if any. Such information may also include validation information regarding whether a particular consumable or biological reagent has been subject to a recall or is otherwise unsuitable or unauthorized for use. Recall information and optional last recall check date and / or timestamp may be written to the identifier and / or provided as consumable data.

[0238] The consumable data may further include information regarding the origin of the biological reagents used in the assay consumables, test sites and / or domains, including, for example, the identity of the sample from which it was derived or the number of generations it was removed from the original sample. For example, if the assay reagent used in the assay is an antibody, the consumable data may include the identity of the hybridoma from which the antibody was derived, such as, for example, the ATCC accession number of that hybridoma.

[0239] According to various embodiments, the biological samples or biological reagents provided in or with the consumables described above are licensed for use separately from the systems designed to act on the biological reagents. In various embodiments, the assay system, assay reader, or components thereof are coupled to a network that allows the system to communicate with biological reagents, consumables, or computer systems operated by or on behalf of customers, manufacturers, and / or licensors of the system over public and / or private networks. In various embodiments, a limited license can provide for use of the licensed biological reagents, consumables, or system for a particular biological analysis only with the licensed system. Thus, if a particular customer has a valid license, the system can authenticate the biological reagents, consumables, or system based on, for example, a digital signature included in an identifier associated with a particular consumable and / or provided as consumable data. In various embodiments, the identifier and / or consumable data can also be used to provide one-time use such that the biological reagent cannot be refilled for use with the same authentication.

[0240] In certain embodiments, when the identifier is read by a system, assay reader, or components thereof that have access to biological reagents, consumables, or public or private data networks operated by or on behalf of a customer, manufacturer, and / or licensor of the system, certain consumable data can be communicated to the assay system and read, written, or erased locally via the identifier / controller of the assay system. For example, additional consumable data such as lot specific information, expiration date, calibration data, consumable specific information, assay domain information, assay result information, consumable security information, or combinations thereof, can be stored locally on the identifier and are not otherwise available via a network connection of the assay system, whereas recall information and / or license information may be a subset of the consumable data available via a direct and / or indirect interface. In one embodiment, recall, license, and / or consumable security information can be available via a network connection on the assay system and / or stored in a storage medium as consumable data, while the remaining consumable data is stored locally on the identifier. An assay system or assay reader includes system hardware, system firmware, system data acquisition and control software, and method or consumable data. In various embodiments, the system hardware includes electronic control and data processing circuitry, such as a microprocessor or microcontroller, memory, and non-volatile storage. In various embodiments, the system hardware also includes physical devices for manipulating biological reagents, such as robotics and sample pumps. In various embodiments, the system firmware includes low-level computer readable instructions for performing basic operations in conjunction with the system hardware. In various embodiments, the system firmware includes microprocessor instructions for initializing operations on a microprocessor within the system hardware.

[0241] The system data acquisition and control software is high level software that interfaces with the system and controls the system hardware for more specific operations, such as, for example, operating a charge coupled device (CCD) to acquire visual luminescence information for a particular biological analysis. In various embodiments, the data acquisition and control software includes a state machine implemented in software that provides, for example, the following states: (i) idle, (ii) running, (iii) paused, and (iv) error. In various embodiments, when the state machine is in an idle state, it may receive instructions from a general purpose machine to perform a particular data acquisition or system control operation. In various embodiments, the general purpose computer opens a TCP / IP socket connection to the system, determines if the system is in an idle state, and then begins transmitting the instructions and / or parameters. In various embodiments, an encrypted TCP / IP connection is established, for example, using the SSH protocol. The instructions and / or parameters are ASCII encoded to define the behavior of the biological system. The method and / or consumable information may take the form of human readable consumable and / or method information stored in an identifier. In various embodiments, the consumable and / or method are stored in an ASCII text file. In various embodiments, a general purpose computer uses FTP protocol to transfer the ASCII text file to the system. In various other embodiments, the method and / or consumable are stored in the identifier and retrieved from the identifier. The method and / or consumable information may be stored in the identifier in an ASCII text file, although it will be understood that the information may be represented in other data formats without departing from the present teachings.

[0242] According to various embodiments, the consumable, macro, and / or method information includes parameters that can be used by the system data acquisition and control software to perform specific data acquisition and system control operations. In various embodiments, the method and / or consumable information includes sequences of operations to be performed by the system parameters or control parameters for use in connection with the data acquisition or control software.

[0243] (ii) Assay process information Additionally, consumable data may include assay process information regarding individual assay parameters that need to be applied by the system or assay reader during an assay. For example, such consumable data may include the order of steps for a given assay, the identities, concentrations, and / or amounts of assay reagents that need to be used or added during an assay or during a particular step of an assay, such as buffers, diluents, and / or calibrators that need to be used in the assay. Consumable data may also include the type or wavelength of light that needs to be applied and / or measured by the system or assay reader during an assay or a particular step of a multi-step assay, the temperature that needs to be applied by the system or assay reader during an assay, incubation times for an assay, and statistical or other analytical methods that need to be applied to raw data collected during an assay by the system or assay reader.

[0244] In one embodiment, one or more steps of an assay protocol can be tailored to an individual consumable or lot of consumable. One or more steps of the protocol may vary from one consumable lot to another and / or from one individual consumable within a given lot, and the consumable data stored in the system includes instructions to tailor those steps of the assay protocol. This type of consumable data can be used by the system to tailor one or more actions performed by the system before, during, and / or after the system performs an assay. Additionally, this type of consumable data can be optionally adjusted by a system user at the user's discretion. For example, a dilution step of an assay protocol can be adjusted to account for lot-to-lot or consumable-to-consumable differences. The amount of diluent added and / or the nature of the diluent can be modified based on such differences. Similarly, the amount of a given reagent that can be added during the performance of an assay, the incubation period and / or temperature of one or more steps of the assay may be due to lot-to-lot or consumable differences. Each of these are non-limiting examples of consumable data that can be stored in the system's storage medium.

[0245] Additionally, the consumable data may include information that directly or indirectly controls components of the assay system, such as, for example, one or more light detectors, a light-tight enclosure, mechanisms for transporting the assay consumables into and out of the assay reader, mechanisms for aligning and orienting the assay consumables with one or more light detector(s) and / or with electrical contacts of the assay reader, additional mechanisms and / or data storage media for tracking and / or identifying the assay consumables, one or more sources of electrical energy for inducing light emission, mechanisms for storing, stacking, moving and / or dispensing one or more consumables, mechanisms for measuring light from the consumables from multiple test sites on the consumables sequentially, substantially simultaneously or simultaneously during an assay, or combinations thereof.

[0246] The consumable data may also include assay process information (which may optionally be adjusted by a user) including assay parameters applied by the assay reader during the assay, the order of steps applied by the assay reader during the assay, the identity, concentration, and / or amount of assay reagents used or added during the assay, the type or wavelength of light applied and / or measured by the assay reader during the assay, the temperature applied by the assay reader during the assay, the incubation time for the assay, statistical or analytical methods applied by the assay reader to raw data collected during the assay, or a combination thereof. In a specific embodiment, the assay performed with the consumable is a multi-step assay, and the assay process information relates to a step or steps of the multi-step assay. In this embodiment, the consumable / test site information includes information about an assay previously performed by the assay reader on one or more test sites of the consumable, information about an assay performed by the assay reader or components thereof on one or more test sites in the consumable, or a combination thereof.

[0247] The consumable data may further include information about the consumable, test site, domain, sector, or biological reagent or sample, for example, as individual operations are performed on the consumable, test site, domain, sector, or biological reagent or sample during manufacture of the consumable, or while an assay or step is being performed on the consumable, test site, domain, sector, or biological reagent or sample. For example, if an assay consumable includes multiple assay test sites, domains, and / or sectors, the assay system may perform an assay or step of a multi-step assay at a single test site, domain, and / or sector of the assay consumable. Once the assay or assay step is completed by the assay system, the controller records the results of the assay in the identifier, for example, raw data or analyzed data generated during the assay or assay step, and / or the controller records which test sites, domains, and / or sectors of the assay consumable have been used during the assay or assay step, and / or which test sites, domains, and / or sectors of the assay consumable have not yet been used. The assay consumable can be stored for later use, and when the customer is ready to use another test site, domain, and / or sector of the assay consumable, the controller reads the consumable data stored in the assay consumable's identifier to identify which test sites, domains, and / or sectors have been used, have not yet been used, and / or the results of their assays. The controller can then instruct the assay system, assay reader, or components thereof to perform an assay or assay step on the unused test site, domain, and / or sector.

[0248] Additionally, a given assay protocol may require a collection of consumables of a particular type. Thus, if a customer inputs a particular type of assay consumable, such as a multi-well assay plate, for use with a particular assay protocol, one or more additional assay consumables may be required in the system to execute that assay protocol, such as, for example, one or more reagents may be required for use with the multi-well assay plate. Each of the required consumables may include a consumable identifier along with information regarding the consumable requirements for the assay protocol. When one of the required consumables is input into the assay system and the identifier controller interacts with the consumable identifier for that consumable, the system examines the components present in the system and compares the results to the consumable requirements associated with the consumable identifier and / or stored in the storage medium and / or provided as consumable data. If any of the required consumables are not present or are present in insufficient stock, the system will retrieve the consumables stored in the required consumable identifier. The system prompts the customer to enter additional required consumables for that assay protocol based on the information provided. If more than one assay consumable is used in the system, the meter correctly identifies the first assay consumable and any associated consumables based on the identifiers associated with each consumable and the associated consumable requirements. The system verifies that the assay consumable and associated consumables are loaded into the system before the sample is run. If only the first assay consumable is loaded into the system without the corresponding associated consumable, the system prompts the customer to load the associated consumable if the meter does not identify the associated consumable in the system within a predetermined period of time. If a mismatched assay consumable is loaded into the instrument, the system notifies the customer. If there is no matching set of assay consumables available (e.g., a multi-well assay plate and a given reagent for a particular assay), the system will not run the sample. The system checks the assay consumable expiration date before the start of the assay, and the system warns the customer and prevents the use of expired consumables. If the consumables have expired prior to sample aspiration, the system will not process the sample. When a partially used assay consumable is placed into a different instrument, consumable usage automatically begins with the next available unused well.

[0249] The identifier can also be used to track the time a given consumable has been in the assay system. Thus, when an assay consumable is inserted into or contacted with the assay system, a timer is started in the assay system and the start time is recorded in the identifier. When an assay is started by the system at the consumable or at a test site, domain, and / or sector within the consumable, the time is also recorded in the identifier. When the instrument, system, or a component thereof is stopped (e.g., by turning off the power), the timer is stopped and the time is recorded in the identifier. Thus, whenever the timer is stopped, the accumulated load time is recorded in the identifier.

[0250] (iii) Analysis tools In another embodiment, the consumable data further includes one or more analytical tools that can be applied by the system to analyze data generated during and / or after the performance of the assay. Moreover, such analytical tools may include instructions for the customer and / or the system to generate a particular output by the system software after the performance of the assay, such as, for example, a format for a data report and / or the results of the analysis tailored based on the consumable data. Alternatively or additionally, the analytical tools may further include one or more statistical algorithms that can be applied by the system to the data. For example, the consumable data may include a selection of one or more statistical algorithms that can be used to analyze data resulting from the use of a given consumable, and the customer can optionally select an appropriate algorithm for the desired data analysis. The consumable data may also include information that can be used by the customer to select an appropriate algorithm for their needs, such as, for example, technical notes or references related to the selection of the algorithm.

[0251] The analytical tools may vary from consumable lot to consumable lot and / or for individual consumables within a given lot. In this embodiment, the consumable data is used by the system to adjust analytical processing tools applied by the system software in performing the assay or after the assay is completed and results are generated and / or displayed. Such analytical processing tools include, but are not limited to, assay thresholds and / or calibration curves that can be applied to one or more steps of an assay protocol that can be modified based on differences in the consumable. In a specific embodiment, for a given consumable type and / or desired use, the consumable data may include project management tools to schedule the performance of one or more assays or steps thereof using a given consumable or collection of consumables in the system. Furthermore, such analytical processing tools can be optionally adjusted by the system user at the user's discretion. The analytical tools The rules can be sent to the customer via a direct interface between the system and the customer or via an indirect interface.

[0252] (iv) Assay system maintenance information The consumable data may further include system maintenance information for the customer, including, but not limited to, system monitoring reports, system component usage, inspection history, system troubleshooting information, results of diagnostics performed on the system, control chart generation, scheduled maintenance scheduling, warranty information regarding the system and / or components of the system, or combinations thereof. The system software may be programmed to monitor various components of the system and send monitoring reports to a remote computing system and / or a maintenance technician, either automatically or when prompted. If a direct interface is not enabled, the system may prompt the customer to send the monitoring reports to the CD Server via an indirect interface. Additionally or alternatively, such system monitoring reports may be accessed by a maintenance technician tasked with maintaining and / or inspecting the system, either locally or remotely. In this embodiment, the maintenance technician may communicate with the customer regarding instrument repair or assistance with the instrument via a direct or indirect interface. In certain embodiments where specific interfaces are enabled, the CD Server monitors system component usage and / or warranty information and schedules scheduled system / component maintenance and / or upgrades by a maintenance technician based on standard system component life spans and / or warranty terms. However, the system can be programmed to automatically monitor such information about the system, and if the direct interface is not enabled to allow a maintenance technician to access the system's status, the system can send the output of such monitoring activity to the CD Server via the indirect interface and periodically prompt the customer to determine if system service or maintenance is required. Additionally, the CD Server can maintain a log of the service history of a given assay system and schedule service calls by a maintenance technician (this can be done using either the direct or indirect interface).Additionally, the remote computing system can transmit individual assay system software upgrades via a direct or indirect interface.

[0253] (v) System - Consumables Promotion Information In another embodiment, the consumable data includes promotional materials, for example, when new types or lots of consumables become available, particularly those products that are traditionally used by a given customer. Such promotional materials may also relate to new assay systems, modifications to current systems, and / or optional installations or improvements to current systems, particularly those modifications, installations, or improvements to systems owned or operated by the customer, and / or those modifications, installations, or improvements that may be of interest to the customer based on that customer's previous use. This type of consumable data may also include references, brochures, product inserts, technical and application notes, technical presentations, conference information, and promotional seminars, particularly those that may relate to one or more consumables / systems used by a given customer. Such promotional information may be provided to the customer via a direct or indirect interface between the customer and the vendor.

[0254] (vi) Technical support information Consumable data may also assist customers in the use of the consumable or system, such as, for example, product insert and data sheet information, information relating to related products with which the consumable is intended to be used, instructions for use, training materials, tutorials, recommended use and / or storage information, data analysis templates, template reports, calibration curves, lot-specific QC data, validated quantitation limits, and troubleshooting methods and / or algorithms. In the case of consumables that include or are equipped with one or more additional consumables, such as, for example, reagents, the consumable data may also include reagent catalog numbers, reagent lot specific information, reagent manufacturing dates, reagent expiration dates, instructions for use, training materials, tutorials, recommended use and / or storage information, etc. Technical support information may also include receiving feedback or assistance via a direct or indirect interface with a technical support representative, such as, for example, customer training modules, consulting services, and / or live customer service assistance capabilities (i.e., live chat) to enhance the customer's experience. It is understood that technical support information may relate to the consumables, the system, or both.

[0255] In a specific embodiment, Table 1 includes a list of consumable data that may be associated with a consumable identifier and / or exchanged between the CD Server and the system via a direct or indirect interface. [Table 1] [Table 2]

[0256] D. Specific Implementations of Data Association Workflows A specific embodiment of a data association workflow, i.e., the process by which specific data is associated with and stored in a consumable identifier, is shown in Figure 11. In a first step of Figure 11, a vendor receives a request for a consumable, either from a sales order or from an internal request to replenish existing inventory. The vendor maintains a central database (1100) for various types of data, as described herein, which also includes one or more processors (1101) configured to process data queries, extract data from one or more databases or data tables in the central database, and generate, transmit, and / or store data sets in response to the data queries. An order (1102) has a unique identifier associated with it, such as an order number (1103), and the order number may be a unique identifier that is associated with the order (1102). The order number is stored in one or more vendor data tables, such as an order data table (1104). Each customer, whether external or internal, is also associated with a unique identifier, such as a customer number (1105), and each customer number is stored in a customer data table. The customer data table includes customer contact information, shipping address(es), etc. for one or more individuals or organizations associated with the customer. For example, if a customer is a business with many locations, the customer may be uniquely identified by a single customer number that is each associated with various locations of the business in the customer data table, or each location of the business may be uniquely identified by a single customer number. If a customer is internal, such as a department within a vendor's organization requesting replenishment of consumable inventory, the customer data table may also have one or more subdirectories or data tables for internal departments. Thus, the Customer Data Table contains a unique customer number for a customer (e.g., Customer X), the Order Data Table contains each unique order number (e.g., Order Y), and there is also a Customer-Order Association Data Table (1106) that stores the association between each customer and their orders (e.g., Customer X Order No. Y).

[0257] An order is received by a manufacturing engineer and a unique consumable identifier (e.g., a consumable identifier (e.g., barcode) as described above) is created for that particular consumable and the consumable identifier is stored in a consumable identifier data table (1107). Thus, in one embodiment, all data uniquely associated with that consumable is associated with the consumable identifier, which is stored in the consumable identifier data table. Alternatively, different types of data related to the product, such as quality related data or production related data, can be stored in individual data specific data tables, with each entry indexed by the consumable identifier. Thus, either all data uniquely associated with that consumable is stored in the consumable identifier data table, or the data is stored in a series of individual data specific data tables indexed by the consumable identifier, and when data is needed for that consumable, the consumable identifier is scanned via the consumable identifier controller and the data associated with that consumable is downloaded to the computing system requesting the data for that consumable. The system also includes a Customer Number-Order Number-Consumable Identifier Association Data Table (1108) whereby for each customer, order, and consumable, there is a unique association stored in the data table between Customer X, Order Number Y, and Consumable Identifier Z (Customer X-Order Number Y-Consumable Identifier Z). Additional unique identifiers may also be associated with the order, such as catalog number, sales representative number, order subcomponents, etc. Each association with an order number may be stored in one or more additional data tables in the system. Based on the type of consumable requested in the order, the technician queries one or more manufacturing data and / or order fulfillment data tables to identify the set of consumable data required to manufacture the consumable or fulfill the order (Consumable Specification Data Table (1109)). Data is associated with the consumable identifier, the consumable is manufactured or ordered, and an additional set of consumable data associated with the manufacture of the consumable or fulfillment of the order is associated with the consumable identifier. Consumable data associated with that consumable or lot so far in the manufacturing process is stored in the consumable identifier data table.The manufacturing process may also include a quality control system in which the product undergoes one or more quality control steps. Unique data from each quality control step performed on the consumable or lot is associated with the consumable identifier and the consumable identifier data table and / or the quality data specific data table are updated to include this data. The consumable or lot (1110) is then forwarded to a shipping department and shipping event-data is associated with the consumable identifier, e.g., packing date, shipping date, etc., and the consumable identifier data table and / or shipping specific data table are updated accordingly.

[0258] FIG. 11 and the accompanying description relate to consumables, consumable data, etc. It should be apparent that the same process can be used to associate data with an instrument, a kit containing multiple components, etc. For example, if a consumable is a kit containing multiple components, when the order is transferred to manufacturing and the manufacturing engineer queries the consumable specification data table for data regarding how the kit is to be manufactured, the consumable specification data table will provide a list of the components in the kit, with each component in the kit including a unique component identifier that is associated with the kit identifier in the system.

[0259] As described above with reference to FIG. 1, consumable (lot and / or instrument) data is generated by the vendor before, during, and / or after an individual consumable and / or lot of consumables is made and / or distributed. The CD creation system creates a database of CD information for that consumable or lot, i.e., a CD database in which the consumable data is stored. The CD database is sent to a CD server (104) that contains a master repository of all consumable data. Additionally, the CD creation system stores information used to associate a given consumable identifier with the consumable data in the master repository. The CD creation system and / or the CD server are located on a remote computing system, i.e., a computing system that is far away from the assay system and / or the customer, such as a site maintained by the vendor. In one embodiment, the remote computing system is a cloud-based computing system, such as a data hub or a system hosted by a third party (e.g., Amazon Web Services) but maintained by the vendor. The data hub may include any suitable data structure, for example, each customer may have a separate data structure on the data hub that is protected and distinct from the data structures of other customers on the data hub. As shown in FIG. 2, upon receipt of an order from a customer or when a consumable or lot is manufactured (step i), the vendor generates, stores, and transmits a CD database to a CD server (201) on the data hub (step ii). The CD database may include order fulfillment information, i.e., a summary of the components of a given customer's order, so that the system can verify that all components of the order have been supplied to the customer. The customer receives a consumable (202) including a consumable identifier (203) and contacts the consumable with an assay system (204) in preparation for performing an assay (step iii), which reads the information associated with the consumable identifier (203), which is used by the system to identify the consumable (202) (step iv).The system reviews the consumable data stored locally on the system on a local storage medium (referred to as "Local CD" in FIG. 2) to identify consumable data stored on the storage medium that can be used to perform an assay using a given consumable. If the storage medium contains consumable data for that consumable or lot, the consumable can be used in the system (step v). If the storage medium does not contain consumable data for that particular consumable or lot of consumable, the system can query the customer for the consumable data, and the customer can communicate with the vendor to receive the required consumable data, for example, via email, compact disc, memory card / stick, flash drive, web data storage service, etc. (step vi). The vendor sends the consumable data binary file (including, but not limited to, an encrypted XML file) to the customer, for example as an email attachment to the customer's email account, the customer loads the file attachment into the assay system, and the system software stores the consumable data in the local system consumable data repository. The consumable / consumable lot can then be used in the instrument (step vii).

[0260] In an alternative embodiment, the CD Server can be connected to the system through a direct interface where the consumable data can be obtained automatically from the CD Server if the consumable data is not available locally on the system. In this embodiment, as shown in FIG. 2 and described above, the vendor generates, stores, and transmits a CD database for consumable orders and / or consumable lots to the CD Server. The customer then receives the consumables, orders, and / or lots and updates the system. The system contacts the system with a consumable identifier to enable the system to identify the consumable or lot. The system software queries the system consumable data repository for consumable data associated with the consumable identifier, and if the consumable data is available locally on the system, the software adjusts the system based on the consumable data, if necessary. If the consumable data is not present in the system consumable data repository, the system (i) prompts the customer to manually obtain the consumable data from the vendor, or (ii) obtains the consumable data automatically from the CD server via a direct interface with the CD server and stores the information locally in the system consumable data repository. Once the consumable data is available locally on the system, the software adjusts the system based on the consumable data, if necessary, to perform the assay. Once the consumable data is available locally on the system, the consumable or lot can be used by the system to perform the assay and display the assay results to the customer. In a specific embodiment, the system software adjusts the output to the customer based on the consumable data.

[0261] As discussed above, consumable and / or instrument data can be sent to the data hub via the software to allow the vendor to collect data related to the customer, the instrument, the consumable, and / or the vendor. The software can be programmed on the instrument to collect this data automatically and / or the software may be an optional element selected by the customer at the time of installation of the instrument. In one embodiment, the following consumable data is collected by the instrument and sent to the data hub: unique consumable identifiers used on the instrument at the customer's location as well as the analysis layout for the experiment to be performed using one or more unique consumables. For instruments installed in a networked system, i.e., a computer network maintained by the customer to which two or more instruments are connected, the software can collect the following consumable data: consumable statistics, e.g., detection signal, CV, average, image center, etc.; control and calibrator performance, e.g., % recovery, detection signal data, etc.; identity of consumable identifiers uploaded on one or more instruments connected to the network; audit logs; and / or instrument logs.

[0262] In another embodiment, an exemplary system for coordinating communications between processors present in the assay system (1000) and computers located at a user's facility, also known as a Laboratory Information Management System (LIMS), is shown in Figure 11(b). The LIMS (1120) is linked to the various processors of the assay system (1100) through a Data Integration Agent (DIA) (1122). The DIA (1122) is preferably an API (Application Programming Interface) and is an interface between the LIMS (1120) and the Workbench software (1124), including a user interface (UI) and a database (DB) (1126).

[0263] To start an assay run, the LIMS (1120) sends a request (arrow 1) to the DIA (1122). The DIA (1122) then forwards and / or converts the request (arrow 1) to the DB (1126). The Workbench (1124), which is connected to the DB (1126), uses a UI to guide the user / lab technician through the protocol(s) of the assay. The assay system (1000) or another assay system (900) runs the immunoassay and reports the results to the DB (1126) as raw ECL data (arrow 3) and / or as ECL data with analysis (arrow 2) from the reader (1003). The DIA (1122) retrieves the ECL data from the DB (1126), converts the ECL data to XML (Extensible Markup Language) and sends it to the LIMS (1120) (arrow 5). The LIMS (1120) may send a query to the DIA (1122) over a connection (arrow 4) regarding the status of the assay run.

[0264] FIG. 11(c) shows the Workbench / UI (1124) and the assay system (100 1 shows the relationship of the Workbench / UI (1124) to other systems and processors in the labware (1002) and the labware (1030). The Workbench / UI (1124) is connected to components that have their own processors, such as the robotic system (1002) that includes the pipettor (1021) and gripper pad (1031). The Workbench / UI (1124) is also connected, either wired or preferably wirelessly through a router (1130), to the processors of the tablet (1058) that actually displays the UI, and the reader (1003). As mentioned above, the Workbench / UI (1124) is also connected to the LIMS (1120). A barcode scanner or consumer ID controller (1013) will read the consumable identifier (e.g., barcode) or unique ID from any labware or assay kit. As explained further below, the consumable identifier (e.g., barcode) or unique ID will inform the Workbench / UI of the type of labware or assay to be run from the kit. If any additional information or data is required, it can be downloaded from an external server or cloud (1130).

[0265] The software that runs the assay system (1000) has three main components: (i) a user interface (UI) that guides a user through the process of selecting, loading, and running the immunoassays described herein; (ii) an instrument control system that controls the functionality and operational and performance qualification of the robotic system (1002) as well as error reporting; (iii) A data service that stores ECL results and user priorities as described above in relation to FIG. 11(b).

[0266] Referring to Figure 11 (d), the Workbench / UI will send requests to the instrument control system which has three listening modules: (i) a system listener (1132), a command listener (1134), and an error command listener (1136). The system listener (1132) listens for requests during qualification of the assay system before and during routine maintenance, which will be described below in connection with the operational qualification and performance qualification system. The command listener (1134) listens for requests to instruct the robotic system, including the pipettor (1021) and the robotic gripper pad (1031), to perform steps of an immunoassay. The error response listener (1136) listens for error codes broadcast from various components of the assay system (1000).

[0267] Errors are classified into three types: (i) unrecoverable errors that result in data loss, such as communication errors with the reader (1003), (ii) unrecoverable errors that are detected by the software but do not require user intervention to recover, e.g., not a single sample is detected, and (iii) interactively recoverable errors, such as the door to the assay system (1000) was not properly closed. Preferably, the errors will return a flag in the results file and cause a visual or audio alert. In case of power loss, the instrument control part of the software will use a universal power supply (UPS) that must be stored in the instrument and will control the shut down of the instrument.

[0268] In accordance with another aspect of the invention, the UI portion of the software is built using plug-ins, also known as applications or applets. Once an assay system has been validated or qualified, an operator generally does not want to revalidate or optimize the system for software updates. Revalidation is necessary when components of a software system are interconnected. In other words, when one component relies on input or instructions from another component to function, then the components are interconnected. Thus, a feature of the present invention of the UI or Workbench is that its components are decoupled from each other. That is, each component may be a standalone piece of software. These standalone pieces require minimal instructions from a master organizer to run. Not so.

[0269] 11(e), a master organizer (labeled OSGI) (1140) is connected to the components of the UI platform. In this embodiment, the master organizer (1140) is shown as a bus or message bus and is connected to several components, such as a security / login / logoff component (1142), a UI (1144), an application framework (1146), and an event framework (1148). Other components, such as the instrument control components and data services mentioned above, can be connected to the master organizer (1140).

[0270] The master organizer (1140) acts like a traffic controller, sending start or stop requests to each component when it is necessary to operate or stop that component. Communication between components is carried through the master organizer bus, except that the master organizer (1140) may command the components to send information or data to each other. For example, in FIG. 11(e), the event framework (1148), which creates and maintains a log file of events during an assay run, may publish or notify the application network (1146) of important events, such as the reading of an assay plate, when commanded or requested by the master organizer (1140). Publication or notification would not occur without the master organizer (1140).

[0271] These communications between components do not create a level of connectivity that requires revalidation of the Workbench / UI platform if one component requires a software update. Instead, the master organizer (1140) may act as a conduit for passing data from one component to another.

[0272] An application may be created by an application implementation (1150) that obtains code from a storage medium, such as a base application (1152) that may reside in the application framework (1146). The base application (1152) stores code that can be accessed by the application implementation (1150) for use by the UI during an assay run. Applications created by the application implementation (1150) may be kept or deleted when the master organizer (1140) commands the stop framework (1142) to stop, as shown in FIG. 11(e). An application implementation (1150) that is shown to be external to the UI platform may be a separate software component connected to the master organizer bus.

[0273] Because of this decoupled architecture, if one component requires a software update, that one component needs to be recertified, but the entire software system does not need to be recertified.

[0274] In another embodiment, the other major components may have a similar architecture. For example, the instrument control component may have its own master organizer to control traffic between the internal components with processors, such as the robotic system (1002), pipettor (1021), robotic gripper (1031), plate washer (1005), tablet (1058), reader (1003), etc. Software updates to one of the internal components of the instrument control would not require revalidation of the instrument control and would not require revalidation of the software of the assay system (1000).

[0275] In addition, the main software components, i.e. workbench / UI, instrument control, and data services, are connected to the master organizer and use the same software architecture. Can be shared.

[0276] An example of the UI is shown below. [Table 3] The major components of the UI are shown in the left column, and the steps within each component are shown in the right column. The UI walks the user through these steps to perform an assay from start to finish.

[0277] Figures 12(a) to 12(l) show the Meso Scale model for Rockville, Maryland. Exemplary Software for Collecting, Deploying, and Locating Global Product Data (GPD) for Multiwell Assay Kits and Plates Available from Discovery FIG. 1 illustrates a software framework for assay systems, instruments, and additional assay consumables. Although the following description and accompanying figures relate specifically to plates and kits, it will be understood that the software framework and methods described herein are applicable beyond plates and kits to assay systems, instruments, and additional assay consumables.

[0278] The GPD is associated with a consumable identifier, such as a Global Product Identifier (GPI). The GPD is a flexible data container that contains a collection of consumable data as described herein, which may include the following non-limiting list of data for a given consumable, such as a plate, assay reagent container (reagent rack), or assay kit: Consumable physical properties, e.g. plate type, geometry, graphs, and other plate characteristics Image processing parameters Detection parameters Plate coating, assay allocation Partial plate information Recommended Reagent Layout Assay Protocol Assay workflow or script and associated instrument parameters with GPIs Test kit contents such as product inserts and reagents -Recommended analysis information such as curve fitting Recommended Reports Customer order information such as expiry dates and lot information for consumables

[0279] As shown in FIG. 12(a), a Data Deployable Bundle (DDB) is a container configured to organize and collect related consumable data, e.g., data related to individual consumables. DDBs are assembled by vendors and deployed into vendor software products. DDBs provide a framework for deploying new information or data to customers, e.g., software packages that run on customer assay systems. GPD is one example of a DDB. Some additional examples of DDBs include, but are not limited to, new assays, new plate types, new consumable types, etc. Different types of products, e.g., consumables and instruments or assay systems, are each associated with a different DDB. For example, an assay system includes a unique identifier as described above, which includes system identifier authentication, assay system information, and, e.g., System physical characteristics, e.g. system components, configuration, etc. Subsystem characteristics, configuration, etc. Associated consumable types The workflow used to guide users through the use of the system · May include other technical data related to the assay system, such as, but not limited to, customer order information, system manufacturing information, etc. associated with the DDB for that assay system.

[0280] Each DDB has a DDB identifier (UID), a version number, and a deployable bundle description file. The UID and version number together uniquely identify the DDB. The description file describes the DDB contents and instructions for processing the DDB, including a description of the steps required to integrate the DDB into a local assay system software package. The DDB provides a deployment framework for distributing GPDs. The data contained within the DDB may be in separate file structures or in one file structure. The format of the file may be XML, key-value pair. The DDB can be distributed through multiple forms, such as a vendor e-commerce site or as an email attachment.

[0281] As shown in FIG. 12(b), to install a DDB, the files are stored in a specified directory locally on the assay system. Using a plug-and-play framework, the local software system detects the bundle and processes it for incorporation into the software. The local software includes a registry, which is a directory that shows information about services and data available to the software. The DDB registers what data is available from itself with the registry, and the DDB instructs the local software how it should be processed. The DDB also includes a filtering processor that controls the data exposed in the registry and the characteristics of the exposed data to resolve or eliminate data conflicts that may occur from one DDB to another, for example, from one plate to another.

[0282] The DDB includes a unique DDB UID and version. As shown in FIG. 12(c), the DDB may include data that is persisted to a local data store, such as the DDB UID and version. When the DDB includes a large data set, the data is persisted to efficiently access the type of data required during system operation. The data is persisted by identifying one or more data types of the DDB and storing that data in a local database structured for the type(s) of data. In one embodiment, the entire contents of the DDB are persisted, i.e., reconstructed locally in a separate data set. In a specific embodiment, the DDB UID, version, plate static data (data about the plate type), and / or plate processing data (data used to process and / or run the plate) are persisted. In an additional specific embodiment, the DDB UID, version, and plate static data are persisted. During installation of the DDB, the software determines whether the DDB has data to persist and whether the data is already persisted by using the DDB UID and version. After persisting the DDB data that needs to be persisted to the data store, the DDB UID and version are saved to track what has been stored. This eliminates unnecessary data store operations in the same DDB by detecting that data has already been stored.

[0283] Generally, software understands and works with a particular version of a data format. The DDB framework supports different versions of data formats and different versions of software that work together for easier maintenance. FIG. 12(d) shows how different software versions of a DDB can coexist in the software. As shown in FIG. 12(d), the software is configured to update previous data format versions, and the software is backward compatible with older DDB versions. Similarly, the DDB may provide downgrades to previous data format versions. By providing downgrades, the DDB can be backward compatible with previous software versions. In this way, in the framework shown in FIG. 12(d), the DDB does not need to be re-released to work with new software versions, and one DDB can be created that works with multiple versions of software. DDB files are upgraded and / or downgraded as needed, one or more files are stored and / or persisted locally, and the DDB processor (factory) converts the raw class data into a data type or format that can be used by the software to perform an assay or assay step in the assay system.

[0284] As shown in FIG. 12(c), a typical DDB for a plate might contain the following consumable data: Plate static data contains data about the plate type. These are the characteristics associated with a physical plate, regardless of the type of instrument used to process it. Some example properties are as follows: Number of well columns / rows Number of spots per well Plate processing data includes data used to process / run a plate. Plate processing data is usually instrument specific. Some example characteristics are: ○Number of sectors / circuits o The detection parameters used to read the plate, e.g. camera binning, waveform, etc. ○ Image processing characteristics used to generate ECL results ○Plate type gain ○Spot Gain Optical crosstalk matrix The kit includes assay data and kit information. Some example data may be as follows: Assay spot allocation Assay Protocol Data analysis parameters ○Product insert · Lot contains specific data for the test kit or plate produced for the order.

[0285] Figure 12(f) shows an example of how a GPD DDB is deployed, and Figure 12(g) is an example diagram of the DDB xml and files in the GPD DDB. As shown in Figure 12(g), the DDB xml describes the data in the DDB and how to process it, the GPD is a container of data that references data by UID and version, and the GPI to GPD mapping provides indexing data for associated GPIs. Additionally, Figure 12(g) shows that other data can also be bundled inside the DDB.

[0286] FIG. 12(h) shows how the GPD data is located. The software includes a GPD service processor that interacts with the registry to locate the GPD data. Using the GPD, the software identifies the type of data and characteristics of the data required for a given consumable, and filters the registry for the required data. As described above, if the required data is included in the local registry, the GPD service queries the master repository for the required data and downloads the data locally. Most searches use the UID as the search criteria, which is available in the GPI to GPD mapping. The GPD factory takes the UID and retrieves the GPD data from the appropriate data store for the system software (in the example shown in FIG. 12(h), client 1 is, for example, the assay system software, and client 2 is, for example, an associated standalone software system that provides the user interface functionality of the client 1 software, for example, a remote laptop or desktop computer. Below are two possible options of how the search for data can occur: (a) The DDB registers all data it provides. The GPD service queries the registry for matches. Some aspects of this search approach include, but are not limited to, the following: · The registry contains many entries and all data can be accessed directly through the registry. · Searches may be slow depending on the registry implementation. (b) DDBs directly store selected subsets of data items, and can be used to organize data instead of directly exposing all available data. Registering Search Providers: The GPD service indirectly uses search providers in the DDB by going through a registry. Aspects of this search approach include, but are not limited to: · The DDB manages the data it provides, hiding or filtering details that it does not need to expose. Less information is published to the registry, making it smaller. This approach is suitable for factories and systems with limited resources.

[0287] These search options are not mutually exclusive: a GPD service implementation may support both, allowing each DDB to define what is exposed.

[0288] Figure 12(i) shows option (b) where the factory is responsible for accessing the final data. In this example, the assay system software interacts with the GPD service to access the data, and the GPD service uses a registry to look up the requested data, or a GPD factory that can provide the data. The GPD factory is registered as a provider of the data, and the GPD factory retrieves the data from a data store and returns it.

[0289] For example, a vendor produces a lot of consumables, such as plates, where each plate has a GPI. There is a DDB for that lot of consumables, which has a single UID and all GPIs in that lot, regardless of how large the lot is associated with that individual lot-specific UID. When a consumer purchases a plate that is an element of that lot, and the plate GPI is read by the assay system, the software identifies the type of data and characteristics of the data needed for that plate, and filters the registry for the needed data. As described above, if the needed data is not included in the local registry, the GPD service queries the master repository for the needed data and downloads that data locally. Using the GPI, the software queries the local and remote databases for the UID, and it installs the needed GPD locally, which can be used immediately to process that individual plate, or later if another plate from the same lot is processed by the system.

[0290] As shown in Figure 12(j)-Figure 12(l), the GPD goes through different stages in its life cycle from installation to erasure of data. These stages include, but are not limited to: All data for a DDB is collected and packaged into one DDB file for deployment. The DDB file is delivered to the software in the agreed directory. The DDB tells the software what needs to be done. The DDB controls how it needs to be processed. ·GPD data is extracted and stored in the software system according to instructions. The UID and version are used to track whether the GPD data has been processed before and can be omitted. Some GPD data is extracted to the file system if needed and the location of the data is stored in the database. The rest of the data is put into a database. Once the file has been processed, it no longer has data that is not already in the system and the file is moved from the extract directory to the archive / backup directory. · A software client uses the GPD service to retrieve GPD data. Using GPI to GPD mapping, the software can determine which GPD data should be used with a given plate. After reading, the software plate data storage contains a read-only copy of the data from the GPD about the plate, and the data generated from processing it.

[0291] Examples of interactions between GPD-DDB and GPI are described below.

[0292] The GPD may include a generic assay protocol, e.g., steps in an assay, preferably including all steps for several assays within one type of assay, e.g., immunoassays, including pharmacokinetic assays, immunogenicity assays, U-PLEX assays, V-PLEX assays, and other types of assays. A specific assay protocol for one type of assay may not require all of the steps in the generic assay protocol. Instead of preparing a unique assay protocol for each specific assay, the GPD of the present invention includes the generic assay protocol as well as an instrument parameter file associated with the GPIs of the specific assay.

[0293] As shown in FIG. 12(m), a protocol or script for a streptavidin plate, indirect assay is shown. This protocol or script includes several steps including, but not limited to, diluting samples for plates 1-5, blocking the plate, coating the plate, incubating the sample, preparing the first detection incubation, preparing the second detection incubation, and reading the assay plate. For another assay in this type of assay, the second detection step is not activated, as shown in FIG. 12(n). Another assay may not require a coating plate step, as shown in FIG. 12(o), and another assay in this type of assay does not require a coating plate step and the second detection step is not required, as shown in FIG. 12(p). The following table summarizes the assay protocols of FIG. 12(m)-FIG. 12(p). [Table 4] Assay 1: Custom assay, streptavidin plate, indirect assay Assay 2: Custom assay, streptavidin plate, direct assay Assay 3: Custom assay, uncoated plate, indirect assay, coating offline Assay 4: Custom assay, uncoated plate, direct assay, coating offline

[0294] In this embodiment, all steps of assay 1 are performed, so that this protocol serves as a general protocol for custom sandwich immunoassays, including pharmacokinetic assays. The general protocol is preferably part of the GPD. Attached to the GPD is an instrument parameter file associated with a GPI unique to assay 1. The instrument parameter file will include several flags or switches. Each flag or switch will be on ("1" or "true") or off ("0" or "false"). For assay 1, all flags in the instrument parameter file will be on. For assay 2, the flag associated with second detection will be off, while the remaining flags will be on. For assay 3, the flag associated with plate coating will be off, while the remaining flags will be on. For assay 4, the flag associated with plate coating and second detection will be off, while the remaining flags will be on.

[0295] The general protocol will be the same for all of these exemplary assays 1-4 and other compatible assays of this type, except for the instrument parameter files for assays 1-4, which are much smaller files in size than the general protocol. An exemplary instrument parameter file, which is a computer readable file in text format, is shown in Figure 12(q). Several flags are located at the bottom of this text file. Some of the flags are on or true, and some are off or false. Assays 1-4 include pharmacokinetic assays.

[0296] In this embodiment, before a particular assay is performed, the GPI of this particular assay, e.g., a consumable identifier (e.g., barcode) on the outer box of a kit containing labware and consumables for this particular assay, e.g., an assay kit available from Meso Scale Diagnostics, is read by a barcode reader or other processor. The GPI is mapped onto its associated GPI by the assay system's processor. The processor will then determine whether a generic protocol or script is included in the system's processor / memory and whether an instrument parameter file associated with the GPI is already stored in the system's memory. If not, the processor can download the generic protocol, which is preferably stored in binary format to minimize its size, and the instrument parameter file, which can be stored in text format from an external system or server or from the cloud.

[0297] Another table below shows another example of a general protocol or script for a bridging immunogenicity assay and a specific instrument parameter file associated with a GPI for an IG assay with acid treatment, and another specific instrument parameter file associated with a BPI for an IG assay without acid treatment. [Table 5]

[0298] The use of a general protocol for multiple assays along with individual instrument parameter files whose on / off flags are uniquely associated with the GPIs of a particular assay provides an improvement to immunoassays, and more particularly to immunoassays using ECL, and certain computer techniques used in conjunction with automated immunoassays.

[0299] The protocol or script embodiments shown in connection with Figures 12(m)-12(s) may represent best practices recommended to a user. The user interface may provide additional fine-tuning to the user / lab technician by allowing the user several options to turn on or off other features just prior to the start of an assay run. In the case of a sandwich immunoassay, such as Assays 1-4 described above, the user interface may allow one or more of the following non-limiting options to the user / lab technician: Assay type: direct or indirect Plate type Standard curve setup including number of points on the curve, dilution factors etc. Control setup including number of controls per plate and dilution factor per control Sample setup including the replicates of each unknown and their respective dilution factors Washing plate: Y / N Blocking: Y / N including blocking amount, incubation time, and subsequent washing plate Coating: Y / N including coating amount, online / offline incubation, incubation time, and subsequent washing plates (Y / N) Sample incubation including sample volume, online / offline incubation, incubation time, and subsequent wash plate (Y / N) For indirect assays: unlabeled / biotinylated detection species incubation: detection species amount, online / offline incubation, incubation time, subsequent washing plate (Y / N) STAG-labeled detection species incubation: detection species amount, online / offline incubation, incubation time, subsequent washing plate (Y / N) Read buffer incubation: On / Off, incubation time

[0300] For the Bridging Immunogenicity Assay, the following are some of the user-selectable options: Plate type Standard curve setup including number of points on the curve, dilution factors etc. Control setup including number of controls per plate and dilution factor per control Sample setup including the replicates of each unknown and their respective dilution factors Acid treatment (Y / N) including ratio of acid to diluted sample and incubation time Sample incubation time including mastermix to sample ratio · Pre-start cleaning delay (Y / N) -Shutdown (Y / N) including shutdown volume and subsequent wash plate (Y / N) Sample incubation on plates including sample volume, online / offline incubation, incubation time, followed by washing plate (Y / N) Read buffer incubation: On / Off, incubation time

[0301] One embodiment of the assay system shown in FIG. 10 and assays performed in its subsections are shown in FIGS. 13(a)-13(f). FIG. 13(a) shows a schematic representation of certain subsystems of an assay system (1300) involved in performing an assay positioned on a table or platform (1301), each subsystem operatively connected to a robotic subsystem (not shown). The subsystems include an assay reader (1302), an assay consumable storage unit (1303), a plate washing subassembly (1304), and a plate shaking subassembly (1305). The platform may include a consumable identifier controller (e.g., a barcode reader (1306)) configured to read assay consumable identifiers positioned on, for example, a multiwell plate, and, if necessary, a robotic subsystem (not shown). It includes a dispensing tip storage compartment (1307) configured to accommodate dispensing tip boxes of tips of varying sizes (e.g., 1308 and 1309, 1000 μl and 350 μl tips, respectively) and further including a dispensing tip disposal chute (1310) connected to a waste compartment (not shown), and one or more sample / reagent tube carriers (1311).

[0302] As shown in FIG. 13(b), when an assay consumable, such as a multi-well plate, is inserted into the assay system (1300), a barcode reader (1306) reads the consumable identifier (1313) on the consumable and downloads the available consumable data (1314) associated with that identifier (alternatively or in addition, the system can query a data hub for additional consumable data, as described above). A representative list of consumable data that may be associated with the identifier is shown in FIG. 13(b), including, but not limited to, a list of components, calibrator values, control values, recipient customer number, order number, catalog number, associated assay protocol for that consumable, and others. The assay protocol (1315) includes one or more steps to be performed by the user and / or by the components of the assay during the performance of the assay. For those steps to be performed by the user (1316), the software displays those steps to the user via a user interface of the assay system (1317). All of the manual steps can be displayed simultaneously in the user interface, or each manual step can be displayed individually in the user interface, with the software prompting the user to confirm completion of that step in the user interface before displaying the next manual step. Once a manual step is completed, the software proceeds to the next step in the assay protocol. Each step of the assay protocol that needs to be performed by the assay subsystem may include one or more substeps (1318 and 1319, respectively), and each substep may include one or more assay subsystem actions (e.g., 1320-1322, respectively). For example, if a step of the assay protocol is to incubate a test plate in the plate shaking subsystem, the step may include at least the following substeps: (a) moving the test plate to the plate shaking subsystem, and (b) starting the plate shaking subsystem for a specified duration.Each of these substeps requires the software to send one or more commands to the subsystem or its components that complete the required subsystem. For example, moving a test plate to the plate shaking subsystem requires the software to command one or more motors in the robotics subsystem to move to the test plate, retrieve the test plate, and move the test plate to a specified location in the plate shaking subsystem. Each of the subsystem operations is identified in the software's protocol script.

[0303] The assay system then needs to be prepared for running the assay before manual assay steps (if any) can be completed. For example, the software can instruct the assay reader to evaluate a demo multi-well assay plate to ensure proper performance of the assay reader. Wash buffers can be filled or refilled (manually) as needed, and waste containers or tanks can be emptied (manually) as needed. The software can also instruct the plate washing subsystem to run maintenance scripts and prepare the washing subsystem as needed. Additionally, the user can manually refill or replace the disposable tip box of the assay system. The user can also prepare the software for running the assay, either at a remote networked computer or directly on the assay system user interface. Consumables, e.g., kits, can be selected by the user at the user interface, and the number of samples to be run in the assay can be selected. The user can also review a list of consumables required for the assay (displayed by the software on the user interface) and select all consumables. It can be verified that the required consumables are available. The user can then submit the defined experiment to the system software for initiation and completion. As described above, the software prompts the user to complete manual steps as necessary and follow any software prompts to prepare the system for assay performance. The user initiates the assay run in the user interface, the system is locked, and the software script for the protocol is initiated.

[0304] In one embodiment of a V-PLEX assay, e.g., a cytokine assay, performed in the assay system of FIG. 13(b), the following manual steps are required, with the software displaying each step in a user interface and optionally requesting the user via the user interface to confirm that each step is completed: a) Unpack the consumables kit; b) Thaw the reagents according to the consumables' instructions; c) Dilute the ECL reading buffer 2X using deionized water; d) dilute the wash buffer to 1X using deionized water; e) Reconstitute the lyophilized calibrators by adding 1000 μL of Diluent A and mix the wells by vortexing; f) Reconstitute the lyophilized controls by adding 250 μL of Diluent A to the vial and mix the wells by vortexing.

[0305] A calibrator is a sample with known concentration of an analyte relevant to the assay that is used to determine and apply a fit curve to unknown samples. Calibrators are generally provided at high concentrations and diluted to prepare lower concentration solutions. Usually up to eight (8) points are used to prepare a fit curve. A control is also a sample with known concentration of an analyte relevant to the assay that is used to determine system performance and whether the assay is functioning correctly. Either calibrators or controls are used in immunoassays, and in some assays both calibrators and controls are used.

[0306] The appropriate consumables and reagents are loaded into the assay system as shown in FIG. 13(c). Briefly, the disposable dispense tips are loaded onto the platform, the empty dilution plate, the empty test plate, and the preloaded sample plate are loaded onto the platform, the troughs are filled with ECL read buffer and sample diluent and loaded onto the trough carriers of the platform, and the reagent racks carry empty antibody mixing tubes, control vials, calibrator vials, detection antibody tubes, and antibody diluent tubes. The software can display the subsystem layout shown in FIG. 13(c) in the user interface and highlight each subsystem to assist in the proper placement of each consumable or reagent in the subsystem. Once the loading steps are completed, the software prompts the user to close the door to the assay system, the software locks the door to the system, and initiates a loading verification script configured to verify that each consumable and reagent is properly loaded into the instrument in the correct position and orientation. If any consumable or reagent is improperly loaded, the system door will unlock and the software will display a warning on the user interface and instruct the user to manually adjust the improperly loaded consumable or reagent.

[0307] For example, a protocol for the performance of a V-PLEX assay, such as a cytokine assay, on the assay system is shown in Figure 13(d). As described above with respect to Figure 13(b), each step of the protocol corresponds to one or more sub-steps and subsystem operations, and the software includes the requisite scripts and sub-scripts required to instruct the system to perform each step, sub-step, and operation required to complete the assay. The order of steps and timing of events in the assay protocol are shown in Figure 13. The process is shown in FIG. 13(e) and a summary of the steps is shown in FIG. 13(f).

[0308] FIG. 14(a)-FIG. 14(i) show the performance of a V-PLEX assay in the assay system shown in FIG. 14. V-PLEX assays are commercially available from Meso Scale Discovery, LLC (Rockville, MD). Similar to FIG. 13(a), FIG. 14(a) shows the layout of various subsystems of the assay system. FIG. 14(b) shows the configuration of the plate storage subassembly for the performance of one or more V-PLEX assays in the assay system, and similarly FIG. 14(c) shows the orientation of the reagent tubes and troughs in the tube carrier (panel (i)), trough carrier (panel (ii)), and reagent rack (panel (iii)). FIG. 14(d)-FIG. 14(i) show various assay protocols for V-PLEX kits, and as mentioned above, the protocols that need to be used with a given item number or catalog number are the consumable data associated with the consumable identifiers of the kits and kit subcomponents. Figure 14(j) and Figure 14(k) show two example timing sequences or scripts for the V-PLEX protocol. Figure 14(l) shows the sequence shown in Figure 14(d). 1 shows the updated protocol for V-PLEX.

[0309] The assay systems and software described herein can be configured to perform a number of different types of assays, and based on the type of assay and protocol, the user interface is configured to display step-by-step instructions to the user for proper preparation of samples and / or reagents for use with the assay system. For example, in addition to the V-PLEX assays described in detail above, the assay systems and software can be used to perform assays in a variety of different assay formats, including those available from Mesologic Scientists (of Rockville, MD). Scale The assay system is also configured to perform U-PLEX and S-PLEX assays (available from Discovery). Both U-PLEX and S-PLEX assays require a specific number of preparation steps and optional optimization steps, and the software is configured to display a personalized step-by-step protocol to the user for those preparation and optimization steps. For example, a U-PLEX protocol requires one or more reagents to be prepared according to a specific reagent preparation protocol, and those steps are displayed to the user via the user interface prior to performing the assay on the assay system. Figures 15(a)-15(b) show assay protocols performed on the assay system for a single plate U-PLEX assay, and Figures 15(c)-15(f) show assay protocols performed on the assay system for a multi-plate U-PLEX assay. Figures 15(a)-15(h) show two exemplary timing sequences or scripts for the U-PLEX protocol. In addition to the specific assay protocols identified herein above, the assay system can be configured to perform the following types of assays, and the software is configured to guide the user through the sample / reagent preparation steps via the user interface: Pharmacokinetic assays, preparation, optimization, and assay execution Immunogenicity assays, preparation, optimization, and assay execution Custom Sandwich Immunoassays: Preparation, Optimization, and Assay Execution Reaction rate measurement Assay Development Panels Antibody screening Calibration curve titration Manually reading prepared consumable test plates Plate incubation -IQ / OQ / PQ (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ))

[0310] The U-PLEX and V-PLEX assays, when automated to run on an assay system such as assay system (1000) or (900), may comprise the following steps. Automated Assay Sequencing 1. Check plate inventory 2. Prepare the washer 3. Binding the antibody to the U-PLEX linker 4. Incubate the capture antibody with the linker 5. Add stop solution to the bound antibody-linker solution 6. Incuba...

Claims

1. 1. A holder for an assay reagent, comprising: at least two regions configured to receive at least one or two reagent containers; and at least one or two holes or windows configured to view at least one or two consumable identifiers located at the bottom of the reagent container.

2. 2. The holder of claim 1, wherein the at least two regions are of at least two different sizes for receiving the at least two reagent containers of different sizes.

3. 2. The holder of claim 1, wherein the at least two regions and the at least two holes or windows are circular, and the at least two holes or windows have a smaller diameter than the at least two regions.

4. 2. The holder of claim 1, wherein the at least two regions and the at least two holes or windows are linear, and the diameter of the holes or windows is smaller than the diameter of the at least two regions.

5. The holder of claim 1 comprising a frame, at least one optional insert, and at least one optional mask.

6. The holder of claim 5 , wherein the mask is attached to the top of the frame.

7. 7. A holder according to claim 5 or 6, wherein the insert is positioned within the frame and below the mask.

8. A holder according to any one of claims 5 to 7, wherein the at least two holes are holes in the frame.

9. A holder according to any of claims 5 to 8, wherein said at least two regions comprise cylindrical holes in said frame or said optional insert, or both.

10. A holder according to any one of claims 5 to 9, wherein the at least two regions comprise holes in the mask.

11. A holder according to any one of claims 5 to 10, wherein said at least two holes are clear plastic coated holes in said frame.

12. The holder of any one of claims 5 to 11, wherein the footprint dimensions of the vessel conform to ANSI-SLAS dimensions for multi-well plates.

13. The holder according to any one of claims 5 to 12, wherein the height of the holder complies with the ANSI-SLAS height for multi-well plates.

14. A holder according to any one of claims 9 to 13, wherein the insert is a foam and is inserted into at least a cylindrical hole in the frame for padding the at least two reagent containers.

15. The insert is positioned between a reagent container of the at least one or two reagent containers and a region of the at least two regions that is larger than the reagent container. A holder according to any one of claims 5 to 13.

16. A holder according to any one of claims 9 to 13, wherein the insert is a foam, defines the cylindrical cavity of the assay reagent container and fills the frame.

17. A holder according to any of claims 5 to 16, wherein the mask defines a plurality of regions, the number of mask regions being the same as or less than the number of regions of the container, frame or insert.

18. A holder according to any one of claims 5 to 17, wherein the mask limits the number of assay vessels that can be received by the assay reagent vessel.

19. A holder according to any of claims 5 to 18, wherein the mask comprises labels for the at least one or two reagent containers.

20. A holder according to any preceding claim, comprising an assay consumable identifier affixed thereto.

21. 21. The holder of claim 20, wherein the assay consumable identifier is located on the bottom, side, or top of the container.

22. A holder according to any preceding claim, further comprising an additional reagent container.

23. The holder of claim 22 , wherein the reagent container comprises an assay reagent.

24. 24. The holder of claim 23, wherein the assay reagents are reagents for a V-PLEX assay, a U-PLEX assay, an immunogenicity (IG) assay, a pharmacokinetic (PK) assay, or a custom assay.

25. The holder of any of claims 19 to 24, wherein the label defines assay reagents for a V-PLEX assay, a U-PLEX assay, an immunogenicity (IG) assay, a pharmacokinetic (PK) assay, or a custom assay.

26. A holder according to any of claims 5 to 25, wherein the at least one or two reagent vessels or the frame are made from conductive plastic.

27. A holder according to any preceding claim, further comprising a lid.

28. 28. The holder of claim 27, wherein the lid is completely or substantially transparent.

29. 28. A holder according to any preceding claim, wherein the at least one or two reagent containers comprise an assay consumable identifier located at a bottom thereof and visible from the bottom of the container.

30. A holder according to any preceding claim, wherein the at least two regions are configured to receive the at least one tube and the at least one vial.

31. (a) a frame having a bottom and sides, the bottom being generally rectangular in shape and having dimensions conforming to ANSI-SLAS standards and defining the holder hole or window; (b) an insert that fits within the frame having an insert hole sized to hold a tube or vial and positioned to align the tube or vial with a hole or window in the holder; (c) a mask positioned over the insert, the mask holes being aligned with the insert holes to allow insertion of a tube or vial into the insert, the mask also providing identification information for the tube or vial; 5. The holder of claim 1, further comprising: (d) optionally a lid for enclosing said vial in said holder.

32. 30. The holder of claim 20, 21, or 29, wherein the consumable identifier is a two-dimensional barcode.

33. 33. The holder of claim 32, wherein the two-dimensional barcode is printed on a plastic puck that is inserted into a recess in the bottom of the tube or vial.

34. 33. The holder of claim 32, wherein the two-dimensional barcode is printed on a foil disc that is heat sealed to a recess in the bottom of the tube or vial.

35. The at least one tube or the at least one vial contains the following assay reagents: (i) calibration materials; (ii) a control material; (iii) a capture reagent; (iv) a detection reagent; (v) a diluent, or 31. A holder according to any of claims 30, comprising (vi) a tube or vial having one or more of the linker reagents.

36. An assay kit comprising a holder according to any one of claims 1 to 35 in a cardboard container.

37. 37. The kit of claim 36, further comprising an assay consumable identifier on the cardboard container.

38. 38. The kit of claim 36 or 37, further comprising at least one assay consumable plate in said cardboard container.

39. 40. The kit of claim 38, wherein the assay consumable plate is a multi-well assay plate.

40. 40. The kit of claim 38 or 39, wherein the assay consumable plate comprises an assay consumable identifier.

41. The kit of any of claims 36 to 40, further comprising at least one trough or tube or both.

42. a lid configured to cover a top surface of a multiwell plate, the lid comprising a skirt depending from a top portion of the lid, the skirt adapted to fit around a perimeter of the top surface of the multiwell plate, the top surface of the plate sized and dimensioned to contact the perimeter of the multiwell plate; a lid having a plurality of recesses extending from the top of the lid toward the multiwell plate; 。

43. 43. The lid of claim 42, wherein the plurality of recesses correspond to the plurality of wells of the multiwell plate.

44. 44. The lid of claim 43, wherein the plurality of recesses are configured to extend into the plurality of wells.

45. 44. The lid of claim 43, wherein the top surface of the lid is adapted to contact an upper lip of at least one of the plurality of wells.

46. A lid according to any one of claims 42 to 45 which is not made from a compliant plastic or elastomeric material.

47. A lid according to any one of claims 42 to 46 made from hard plastic.

48. 48. The lid of claim 47 made from polystyrene.

49. a lid configured to cover a top surface of a multiwell plate, the lid comprising a skirt depending from a top portion of the lid, the skirt adapted to fit around a perimeter of the top surface of the multiwell plate, the top surface of the plate sized and dimensioned to contact the parameters of the multiwell plate; A lid, said lid being optionally hydrophobic.

50. 50. The lid of claim 49, wherein the lid is made from a hydrophobic polymer.

51. 50. The lid of claim 49, wherein a bottom surface of the top portion of the lid is rendered hydrophobic.

52. 52. The lid of claim 51, wherein said bottom surface is microetched to create a rough surface for trapping air, such that said bottom surface exhibits Cassie-Baxter behavior as a barrier to moisture.

53. 50. The lid of claim 49, wherein the bottom surface is coated with a hydrophobic coating.

54. 50. The lid of claim 49, wherein the bottom surface is coated with a surfactant.

55. 50. The lid of claim 49, further comprising a plurality of recesses extending from the top of the lid toward the multiwell plate.

56. 56. The lid of claim 55, wherein the plurality of recesses correspond to the plurality of wells of the multiwell plate.

57. 57. The lid of claim 56, wherein the plurality of recesses are configured to extend into the plurality of wells.

58. A lid according to any one of claims 49 to 57 which is not made from a compliant plastic or elastomeric material.

59. A lid according to any one of claims 49 to 58 made from rigid plastic.

60. 60. The lid of claim 59 made from polystyrene.

61. A lid configured to be attached to a reagent container and adapted for a probe to enter and exit the lid, the lid having an upper surface, the upper surface having a pattern of cuts separating the upper surface into segments, the segments bending downwardly when the probe enters the reagent container and returning to their original orientation when the probe exits the lid.

62. 62. The lid of claim 61, wherein the probe comprises at least one pipette tip.

63. 63. The lid of claim 61 or 62, wherein the pattern of cuts comprises at least one curvilinear line.

64. 63. The lid of claim 61 or 62, wherein the pattern of cuts comprises at least one serpentine line.

65. 63. The lid of claim 61 or 62, wherein the pattern of cuts comprises at least one substantially circular line.

66. 63. The lid of claim 61 or 62, wherein the pattern of cuts comprises parallel straight lines.

67. The lid of any one of claims 61 to 66, wherein the lid is made from a non-elastomeric material.

68. The lid of any one of claims 61 to 66, wherein the lid is made from an elastomeric material.

69. A lid according to any one of claims 61 to 68 for covering a reagent trough.

70. A loading cart adapted for use with an assay system, said loading cart comprising a computer screen and a movable body comprising at least one shelf and a support for said computer screen; the shelf comprises at least one tray, a plurality of slots defined in the tray, the slots sized and dimensioned to receive a plurality of consumables for performing an assay; A loading cart, wherein the computer screen is adapted to display a user interface illustrating a first arrangement of the plurality of containers of consumables on the at least one tray.

71. 71. The loading cart of claim 70, wherein the computer screen is a tablet computer screen.

72. 71. The loading cart of claim 70, wherein the computer screen is connected to a personal computer or laptop computer.

73. A loading cart according to any of claims 70 to 72, wherein the computer screen is controlled by a processor on the assay machine.

74. 74. The loading cart of claim 73, wherein the computer screen is connected to the processor on the assay machine by a WiFi or Bluetooth connection.

75. 71. The loading cart of claim 70, wherein the plurality of slots are defined in an upper surface of the at least one tray.

76. 76. The loading cart of claim 75, wherein a plurality of slots are also defined in a bottom surface of the at least one tray.

77. 77. The loading cart of any of claims 70, 75, or 76, wherein the plurality of slots comprises different sized slots adapted to receive the plurality of consumables of different sizes.

78. 71. The loading cart of claim 70, wherein the support for the computer screen is an adjustable support.

79. 79. The loading cart of claim 78, wherein the adjustable support is rotatable about a substantially vertical axis.

80. 80. The loading cart of claim 79, wherein the adjustable support is further tiltable about an axis substantially perpendicular to the vertical axis.

81. 71. The loading cart of claim 70, wherein said at least one shelf is an upper shelf.

82. 82. The loading cart of claim 81, further comprising a bottom shelf.

83. 82. The loading cart of claim 81, further comprising a center shelf.

84. 71. The loading cart of claim 70, further comprising a compartment beneath said at least one tray, said compartment adapted to store a coolant.

85. 85. The loading cart of claim 84, wherein the compartment includes a drain.

86. 85. The loading cart of claim 84, wherein the bottom surface of the compartment is concave.

87. A loading cart according to any of claims 70 to 86, wherein the movable body is supported by at least one caster wheel.

88. 88. The loading cart of claim 87, wherein the at least one caster wheel is a hubless caster wheel.

89. The loading cart of any of claims 70-88, wherein the plurality of consumables comprises at least one multi-well plate.

90. 90. The loading cart of claim 89, wherein said at least one multi-well plate comprises at least one assay plate or at least one dilution plate.

91. 91. The loading cart of any of claims 70 to 90, wherein the plurality of consumables comprises at least one container of a reagent.

92. The loading cart of any of claims 70-91, wherein the plurality of consumables comprises at least one tube.

93. The loading cart of any of claims 70-91, wherein the plurality of consumables comprises at least one trough.

94. A loading cart according to any of claims 70 to 93, wherein the tray is configured as shown in Figure 19.

95. A loading cart according to any of claims 70 to 94, comprising a mobile computer display associated with the computer screen.

96. 1. An assay preparation system for preparing assay components, comprising: (a) an assay system having a processor with information about the components required to perform an assay run; (b) a loading cart comprising a shelf for assembling components used in the assay and a support for holding a mobile computing device; (c) a mobile computing device including a computer screen; An assay preparation system including networking capabilities for the mobile computing device to access the information on the processor, and a graphical user interface for presenting the information to a user on a computer screen and guiding the placement of assay components on the loading cart.

97. 1. An assay preparation system for preparing assay components, comprising: (a) an assay system having a processor with information about the components required to perform an assay run; (b) a loading cart comprising a shelf for assembling components used in the assay and a support for holding a mobile computing device; (c) a mobile computing device including a computer screen; said mobile computing device including networking capabilities for accessing said information on said processor, and a graphical user interface for presenting said information to a user on a computer screen and guiding placement of assay components on said loading cart; An assay preparation system, wherein the loading cart is a loading cart according to any one of claims 70 to 95.

98. The preparation system of claim 97, wherein the loading cart further comprises a consumable identifier reader, and the graphical user interface is configured to use the reader when placing assay components on the cart, accept identifier information provided by the user, use the information to verify the validity of the components, and transfer the identification information to the processor.

99. 96. A method of instructing a user to load consumables onto an assay system comprising using the loading cart of any of claims 70-95.

100. 100. The method of claim 99, comprising arranging a plurality of consumables at the loading station according to a first arrangement displayed by a user interface on the screen.

101. 1. A method for loading consumables for performing an assay into an assay system, comprising: a. receiving a plurality of consumable items; b. placing the plurality of consumables at an intermediate consumable loading station according to a first configuration displayed by a user interface on a screen positioned at the intermediate consumable loading station; c. moving said intermediate consumable loading station to said assay system; Top and and d. transferring said plurality of consumables to said assay system according to a second configuration, said first configuration being substantially the same as said second configuration.

102. 102. The method of claim 101, wherein the intermediate consumable loading station comprises a mobile cart.

103. 103. The method of claim 102, wherein the screen is a computer screen.

104. 104. The method of claim 103, wherein the computer screen is movably mounted to the cart.

105. 105. The method of claim 104, wherein the computer screen is rotatable about a substantially vertical axis.

106. 106. The method of claim 105, wherein the computer screen is further tiltable about the vertical axis.

107. 107. The method of any of claims 101 to 106, further comprising the step of cooling at least one consumable of the plurality of consumables.

108. 103. The method of claim 102, wherein step (b) comprises placing the plurality of consumables within a plurality of slots defined in an upper surface of the movable cart.

109. The method of any of claims 101 to 108, wherein the plurality of consumables comprises at least one multi-well plate or at least one container of reagent.

110. A method according to any of claims 102 to 109, wherein the mobile cart is the loading cart of any of claims 70 to 95.

111. a plate sized and dimensioned to match the sizes and dimensions of an ANSI-SLAS format assay plate, the plate comprising a rectangular perimeter and at least one support member connecting a first side of said rectangular perimeter to a second side of said rectangular perimeter, at least one reference pad located on a first major surface of said plate and corresponding to the location of at least one well of said ANSI-SLAS format assay plate; A plate, the location of said at least one reference pad in one dimension of a three-dimensional coordinate system being measurable by a probe of an assay system when said plate is positioned in a plate carrier of said assay system.

112. 112. The plate of claim 111, wherein the probe measures a capacitance between the probe and the at least one reference pad.

113. 113. The plate of claim 112, wherein the plate is electrically conductive.

114. 112. The plate of claim 111, wherein said ANSI-SLAS format assay plate is an 8x12 multiwell plate, and said at least one reference pad corresponds to a corner well on said ANSI-SLAS format assay plate.

115. At least two oriented lateral surfaces of the plate connecting the two major surfaces of the plate.

112. The plate of claim 111, further comprising mating gripping areas, the gripping areas adapted to be gripped by a gripper arm of a robotic system.

116. 116. A plate as claimed in claim 111 or 115, wherein the rectangular perimeter adjacent the first major surface is smaller than the rectangular perimeter adjacent the second major surface, and the first major surface and the second major surface are substantially parallel.

117. A plate according to any one of claims 111 to 116, wherein the plate is made from cast aluminium.

118. A plate according to any one of claims 111 to 116, wherein the plate is machined from cast aluminium.

119. 116. The plate of claim 115, wherein the at least two opposing regions are bordered by raised tracks.

120. 116. The plate of claim 115, wherein the at least two opposing regions comprise at least one pair of divots sized and dimensioned to receive a corresponding pair of protrusions on the gripper arms.

121. 121. The plate of claim 120, wherein the pair of protrusions comprise terminal ends of removable screws on the gripper arms.

122. 121. The plate of claim 120, wherein the at least one pair of divots comprises an upper pair and a lower pair.

123. 123. The plate of claim 122, wherein when the gripper arms grip the upper pair, the upper surfaces of the gripper arms are substantially flush with the first major surface of the plate.

124. 124. The plate of claim 123, wherein when the gripper arms grip the lower pair, a bottom surface of the gripper arms is substantially flush with a surface opposite the first major surface of the plate.

125. A method of training or teaching a robotic gripper or pipettor comprising using the plate of any of claims 111 to 124.

126. 1. A method for training or instructing a robotic gripper, comprising: commanding the robotic gripper arm to move to a specific location in X-space, Y-space, and Z-space corresponding to an area on the plate; commanding the robotic gripper arm to rotate to a specific location corresponding to an area on the plate; commanding the robotic gripper arm to open or close its gripper to a particular width or length corresponding to an area on the plate; using the specific location of the gripper arm relative to the plate to estimate a fixed location throughout the automated setup; and using the particular location of the gripper arm relative to the plate to calculate a robot training position for said location and other associated pieces of laboratory equipment.

127. Steps below: commanding an automated dispense arm to move to a specific location in X-space, Y-space, and Z-space corresponding to an area on the plate; using the specific location of the automated dispense arm relative to the plate to estimate a fixed location throughout the automated setup; and using the particular location of the automated dispensing arm relative to the plate to calculate robotic training positions for said location and other associated pieces of laboratory equipment.

128. 1. A method for training a robotically controlled probe of an assay system, comprising: positioning a plate sized and dimensioned to match the size and dimensions of an ANSI-SLAS format assay plate in a plate carrier within the assay system, the position of the plate being known in a three-dimensional coordinate system; moving the robotically controlled probe towards reference pads on the plate, the reference pads corresponding to wells of the ANSI-SLAS plate; obtaining a first location of the reference pad using a capacitance between the probe and the reference pad in the three-dimensional coordinate system; assigning the first location as one dimension in the three-dimensional coordinate system for the robotically controlled probe.

129. The method of claim 128, wherein the plate is any of the plates of claims 111 to 118.

130. an assay consumable storage unit adapted to be mounted to a platform of an assay system comprising a base and a shelf assembly having a plurality of sets of vertically aligned storage units, each storage unit sized and dimensioned to receive a consumable for said performance of an assay by said assay system; the shelf assembly comprising a plurality of horizontal members connected by a plurality of upstanding vertical supports; An assay consumable storage unit, wherein the base is cantilevered to the platform and the shelf assembly is removably attached to the base by at least two locating pins and by at least one threaded connector having a finger-actuable head.

131. 131. The apparatus of claim 130, wherein the shelf assembly comprises an M x N linear array of vertically aligned sets of storage units, where M and N are integers.

132. The upper horizontal member is ANSI 131. The apparatus of claim 130, comprising alignment features for a container bottom that is SLAS compliant.

133. The upper horizontal member is ANSI 133. Apparatus according to any of claims 130 to 132, comprising alignment features for a lid of an assay reagent holder which is larger than a SLAS compliant container bottom.

134. 134. The apparatus of claim 133, wherein the assay reagent holder is an assay reagent holder according to any one of claims 1 to 35.

135. 1. An assay system comprising a housing, the housing comprising a continuous glass member, a touch screen for a computer display formed by a first portion of the continuous glass member and an array of pressure transducers, and a sound emitter formed by a second portion of the continuous glass member and at least one sound exciter.

136. an automated assay system adapted to receive consumables in said performing of an assay, said assay system comprising a robotically controlled pipetter and a robotically controlled gripper arm, an assay reader, a plate washer, and at least one optional heatable shaker, at least one heat exchanger, and at least one processor adapted to execute at least one instruction to minimize potential errors in loading said consumables and in running said assay; the consumables comprising at least one assay test plate, at least one dilution plate, at least one set of pipette tips, at least one sample plate, and a plurality of containers containing at least one of a calibrator, a diluent, and an antibody; The at least one instruction comprises: instructions for a user interface that directs a user to load the consumable into the assay system; commands to the robotic gripper arm to place a lid on the at least one assay test plate when the at least one assay test plate is placed on the shaker; instructions to the at least one heat exchanger to maintain a selected temperature within the assay system; and instructions for performing the assay for the at least one assay test plate, the at least one assay plate comprising a plurality of assay test plates, each assay test plate being completed substantially simultaneously.

137. 137. The automated assay system of claim 136, wherein the instructions to the user interface include instructions to load a consumable from a kit.

138. 137. The automated assay system of claim 136, wherein the instructions to the user interface include instructions to load a consumable into an intermediate consumable loading station.

139. 139. The automated assay system of claim 138, wherein the intermediate consumable loading station comprises a movable cart.

140. 139. The automated assay system of any of claims 136-138, wherein the at least one instruction further comprises instructions for the robotically controlled pipettor to use a training plate and obtain a vertical position thereof.

141. 141. The automated assay system of claim 140, wherein the instructions to the robotically controlled pipettor further comprise instructions to obtain its horizontal position.

142. 142. The method of claim 136, wherein the at least one instruction further comprises an instruction for the robotically controlled gripper arm to use a training plate and obtain its vertical position. The automated assay system according to any one of claims 1 to 4.

143. 143. The automated assay system of claim 142, wherein the instructions to the robotically controlled pipettor further comprise instructions to obtain at least one position in a horizontal plane.

144. 144. The automated assay system of any of claims 136-143, wherein the at least one instruction further comprises instructions for performing a qualification procedure.

145. 145. The automated assay system of any of claims 136-144, wherein the assay reader is an ECL reader.

146. The qualification procedure is as follows: (i) validating said ECL reader; (ii) verifying the aspiration function of the plate washer; (iii) verifying the dispensing functionality of the plate washer; (iv) verifying the dispensing functionality of the pipettor.

147. said validating said ECL reader comprising: (a) reading the electronic plate with the ECL reader to verify the flow of the current through the ECL reader; (b) reading a blank assay test plate with said ECL reader to ascertain background electronic noise; (c) reading an assay test plate, wherein wells in said plate are filled with free tag buffer to verify that said ECL reader reads said expected counts.

148. 148. The automated assay system of any of claims 136-147, wherein the at least one processor executes at least two instructions.

149. 149. The automated assay system of any of claims 136-148, wherein the at least one processor executes at least three instructions.

150. 150. The automated assay system of any of claims 136-149, wherein the at least one processor executes at least four instructions.

151. The automated assay system of claim 139, wherein the movable cart is the loading cart of any of claims 70-95.

152. 1. A method for operating an automated assay system to minimize potential errors in loading consumables for an assay and running said assay, comprising: the assay system comprising a robotically controlled pipetter and a robotically controlled gripper arm, an assay reader, a plate washer, and at least one shaker and incubator, at least one heat exchanger, and at least one processor; the assay system is adapted to receive consumables, the consumables including at least one assay test plate, at least one dilution plate, at least one set of pipette tips, at least one sample plate, and a plurality of containers including at least one of calibrators, controls, diluents, antibodies, reagents, and buffers; The method comprises the steps of: instructing a user interface to guide a user to load the consumable into the assay system; commanding the robotic gripper arm to place a lid on the at least one assay test plate when the at least one assay test plate is placed on the shaker and the incubator; directing the at least one heat exchanger to maintain a selected temperature within the assay system; and instructing the at least one processor to perform the assay for the at least one assay test plate, wherein the at least one assay plate includes a plurality of assay test plates, each assay test plate being completed substantially simultaneously.

153. 153. The method of claim 152, wherein the assay reader is an ECL reader.

154. 154. The method of claim 152 or 153, wherein the instructions to the user interface include instructions to load a consumable from a kit.

155. The method of any of claims 152 to 154, wherein the instructions to the user interface include instructions to load a consumable into an intermediate consumable loading station.

156. The method of any of claims 152-155, wherein the intermediate consumable loading station comprises a movable cart.

157. 157. The method of any of claims 152-156, wherein the at least one instruction further comprises instructions for the robotically controlled pipetter to use a training plate and obtain a vertical value thereof.

158. The method of any of claims 152 to 157, wherein the instructions to the robotically controlled pipettor further include instructions to obtain its horizontal position.

159. A method according to any of claims 152 to 158, wherein the at least one instruction further comprises instructions to the robotically controlled gripper arm to use a training plate and obtain its vertical position.

160. 160. The method of claim 159, wherein the instructions to the robotically controlled pipettor further include instructions to obtain at least one position in a horizontal plane.

161. The method of any of claims 152 to 160, wherein the at least one instruction further comprises instructions for performing a qualification procedure.

162. The method of any of claims 152-161, wherein the assay reader is an ECL reader.

163. The qualification procedure is as follows: (i) validating said ECL reader; (ii) verifying the aspiration function of the plate washer; (iii) verifying the dispensing functionality of the plate washer; (iv) verifying the dispensing function of the pipettor.

164. said validating said ECL reader comprising: (a) reading the electronic plate with the ECL reader to verify the flow of the current through the ECL reader; (b) reading a blank assay test plate with said ECL reader to ascertain background electronic noise; (c) reading an assay test plate, wherein wells in said plate are filled with free tag buffer to verify that said ECL reader reads said expected counts.

165. The method of any of claims 152 to 164, wherein the at least one processor executes at least two instructions.

166. 166. The method of claim 165, wherein the at least one processor executes at least three instructions.

167. 167. The method of claim 166, wherein the at least one processor executes at least four instructions.

168. A method according to any of claims 154 to 167, wherein the mobile cart is a loading cart as defined in any of claims 70 to 95.

169. 1. An automated assay system configured to use an assay consumable in said performing an assay, said assay system comprising at least one processor and at least one storage medium; the storage medium storing instructions for performing the assay by the processor; The instructions are divided into a plurality of components, the plurality of components comprising: A security component; A user interface component; an instrument control component; a data services component; Each component operates substantially independently of the others and has substantially no interaction with each other; An automated assay system, wherein the components are connected to a master organizer, which instructs each component when to operate.

170. 170. The assay system of claim 169, wherein the system comprises multiple components and an update to one component does not require revalidation of all of the components.

171. 171. The assay system of claim 169 or 170, wherein the master organizer acts as a conduit for passing information between the plurality of components.

172. The method according to any one of claims 169 to 171, wherein at least one of the components is further divided into subcomponents, each of which operates substantially independently of the others and has substantially no interaction with each other, and a submaster organizer is connected to the subcomponents, the submaster organizer instructing each of the subcomponents when to operate. The assay system described.

173. 173. The assay system of claim 172, wherein an update to one subcomponent does not require revalidation of all of the subcomponents.

174. 1. An assay system configured to use an assay consumable in the performance of a first assay, the first assay comprising a unique assay identifier, the assay system comprising: a reader adapted to read the unique assay identifier; a processor having access to a general protocol file and an instrument parameter file; the generic protocol file includes a generic assay protocol including assay steps that are applicable to a plurality of assays, including the first assay; the instrument parameter file includes a number of flags that are either on or off; The assay system, wherein the processor turns on or off the testing steps of the general assay protocol according to the flag to perform the first assay.

175. 175. The assay system of claim 174, wherein said general assay protocol includes a calibration step for a V-PLEX assay.

176. 175. The assay system of claim 174, wherein said general assay protocol includes a calibration step for a U-PLEX assay.

177. 175. The assay system of claim 174, wherein the general assay protocol includes a testing step for an immunogenicity assay.

178. 175. The assay system of claim 174, wherein the general assay protocol includes a testing step for a pharmacokinetic assay.

179. The assay system of claim 174, wherein the general assay protocol includes a testing step for a custom sandwich assay.

180. 1. An automated assay system configured to minimize user, instrument, and assay method variability, comprising: Measures to minimize user error in system load; and A means for minimizing user error when selecting an automated workflow; and A means for minimizing sample dilution errors; a means for minimizing system plate handling errors; Measures to minimize system dispensing errors; A means for minimizing temperature fluctuations; a means for minimizing evaporation or condensation in the assay consumable; means for controlling the shaking frequency of at least one shaker; and a means for minimizing the complexity of maintenance procedures.

181. 1. An automated assay system configured to minimize user, instrument, and assay method variability, said system comprising a robotic gripper arm and a robotic pipetter; performing a sample dilution step; Selecting and executing the correct assay workflow for a given assay; controlling an air cooling processing system, thereby maintaining a defined temperature in an assay workflow area of ​​said system with defined tolerances; Maintaining consistent timing between runs, plates, and wells; and allowing a user to execute different assay workflows without having to reconfigure or revalidate the workflow software.

182. 182. An assay system according to claim 180 or 181, comprising the assay system according to any one of claims 135-151, 169-179 and 218-229.

183. A system according to any one of claims 180 to 182, comprising the loading cart according to any one of claims 70 to 95.

184. 184. An assay system according to any one of claims 180 to 183, comprising the device according to any one of claims 130 to 134.

185. 185. An assay system according to any one of claims 180 to 184, comprising the cooling air handling system of any one of Figures 10(l) to 10(p).

186. 186. An assay system according to any one of claims 180 to 185, comprising the assay system of any one of Figures 10(a) to 10(d), 10(l) or 10(s).

187. 187. An assay system according to any one of claims 180 to 186, comprising the assay reagent holder of any one of claims 1 to 35.

188. 188. An assay system according to any one of claims 180 to 187, comprising the kit according to any one of claims 36 to 41.

189. 189. An assay system according to any one of claims 180 to 188, comprising the lid according to any one of claims 42 to 60.

190. 190. An assay system according to any one of claims 180 to 189, comprising the lid according to any one of claims 61 to 69.

191. 240. An assay system according to any one of claims 180 to 190, comprising the computer readable medium of claim 238 or 239.

192. An automated assay system comprising a robotic gripper arm and a robotic pipetter, and at least the following additional components: (a) a plate carrier; (b) a tip box carrier; (c) five optional heatable shakers; (d) an air cooling handling system; (e) an assay consumable storage unit for assay reagents; (f) an assay consumable storage unit for ready-to-use tips; (g) an assay consumable storage unit for spare tips; (h) an assay consumable storage unit for plates; (i) an assay consumable storage unit for tubes and troughs; 10(a), 10(b), 10(c), 10(l), 10(n) or 10(o), and component (d) is located on the back panel of the instrument substantially as shown in FIG. 10(l), 10(m), or 10(n).

193. 200. The assay system of claim 192, further comprising a plate washer located below said platform or said table, said platform or said table having an opening for accessing said plate washer.

194. 194. The assay system of claim 192 or 193, comprising both a platform and a table, the platform being attached to and supported by the table.

195. 195. The assay system of any one of claims 192 to 194, further comprising an assay reader.

196. 200. The assay system of claim 195, wherein the assay reader is located below the platform or table.

197. 197. The assay system of any of claims 192-196, wherein the platform or table has an opening for disposing of waste.

198. 200. The assay system of claim 197, further comprising a solid waste chute extending from, through and below said waste opening.

199. 200. The assay system of any of claims 192-198, further comprising at least one waste container located below said platform or said table.

200. 200. The assay system of any of claims 192-199, further comprising a laptop computer for controlling said robotic gripper, said robotic pipetter, and said components (c) and (d).

201. 201. The assay system of any of claims 192-200, wherein the components are positioned relative to one another substantially as shown in Figures 10(c), 10(l) and 10(n).

202. 202. The assay system of any of claims 192-201, further comprising a container below the plate washer for wash buffer and liquid waste.

203. The assay system of any of claims 192-202, further comprising one or a combination of the wiring diagrams of Figures 10(v)-10(y).

204. The assay system of any of claims 192-203, wherein the components are positioned relative to each other as shown in one or a combination of Figures 10(a)-10(d), 10(l)-10(p), 10(s) and 10(u).

205. The assay system of any of claims 192-204, wherein the components have dimensions within 10% of the dimensions shown in any of the figures.

206. 206. The assay system of any of claims 192-205, further comprising a universal power supply (UPS) below said platform or said deck.

207. 20. The components below the platform or deck are divided into compartments as shown in Figure 10(a), 10(b) or 10(c). The assay system according to any one of 2 to 206.

208. An automated method of performing an assay comprising any of the sequences and timings of Figure 9d, Figures 12(m)-12(p), Figures 12(r)-12(s), Figures 13(d)-13(f), Figures 14(d), Figures 14(f)-14(l), Figures 15(b), Figures 15(d)-15(h), Figures 16(b), Figures 17(b), and Figures 17(d)-17(h).

209. 1. An automated assay system comprising: (a) a single robotically controlled 8-channel pipettor; (b) a single robotically controlled assay plate gripper arm; (c) a single 96 channel assay plate washer; and (d) a single plate reader; and (e) one or more plate shakers having a total capacity of at least five plate shaking stations; (f) a processor adapted to execute an assay process for analyzing a plurality of samples in a 96-well plate, the processor comprising the following operations: (i) a blocking step comprising adding a blocking buffer with said pipettor, incubating for a blocking period (b), and washing with said plate washer; (ii) a sample binding step comprising adding one of the samples using the pipettor while shaking at one of the plate shaking stations and washing using the plate washer, and incubating for a sample incubation period (s); (iii) a detector binding step, comprising adding detection reagent using the pipettor while shaking at one of the plate shaking stations and washing using the plate washer, and incubating for a detector incubation period (d); (iv) adding read buffer using the pipettor; (v) measuring an assay signal with the reader for each well of the plate; Up to five plates can be processed in a run. 13(d)-(f), 14(d), 14(f)-(l), 15(b), 15(d)-(h), 16(b), 17(b), 17(d)-(h), an automated assay system, wherein the steps are performed as shown in Figures 9(d), 12(m)-12(p), 12(r)-12(s), 13(d)-13(f), 14(d), 14(f)-(l), 15(b), 15(d)-15(h), 16(b), 17(b), 17(d)-17(h).

210. The process comprises the steps of: (vi) using said pipettor to dilute a calibrator stock solution to form a plurality of calibration standards, said standards being included in said plurality of samples; (vii) using said pipettor to pre-dilute one or more of said samples prior to addition of said samples to said wells of said plate; (viii) using the pipettor to combine multiple detection reagent components to form the detection reagent.

211. 211. The system of claim 209 or 210, wherein the steps are carried out under temperature control capable of maintaining a temperature of 20-24°C ± 1°C.

212. The system of any one of claims 209 to 211, wherein the measurement is an ECL measurement.

213. The system of any one of claims 209 to 212, wherein the measurement is a multiplex measurement.

214. 1. An automated assay system comprising: (a) a processing deck for holding assay components providing a generally rectangular surface with a front end, a first lateral end, a second lateral end, and a rear edge; (i) an assay consumable hotel generally centered and cantilevered on the front end of the deck having a plurality of consumable slots sized to hold consumables meeting the ANSI-SLAS specifications for width and length of a 96-well assay plate; (ii) a plurality of pipette tip locations for holding pipette tip containers located on a first side of the deck; (iii) a plurality of plate shaker locations located along the trailing edge of the deck; and (iv) a set of processing locations located approximately at the center of the deck between the hotel and a shaker configured to hold consumables having dimensions conforming to ANSI-SLAS; (v) the deck having a barcode scanner located on the first side of the deck rearward of the pipette tip location, the barcode scanner having a scanning surface large enough to scan the bottom surface of a consumable having dimensions conforming to ANSI-SLAS; (b) a plate washer located below the deck and accessible through an opening in the deck between the pipette location and the assay plate processing location; (c) a gantry located above said deck that movably supports a robotic plate gripper such that said gripper can be moved to access locations (i) to (v) and that movably supports a robotic 8 channel pipetter such that said pipetter can access locations (ii) and (iv); (d) an assay reader positioned adjacent the first side of the deck on a platform that is at a lower vertical height than the deck, the highest point on the reader being lower than the lowest point to which the robotic grabber can travel; and (e) an enclosure surrounding components (a)-(d), having a temperature controller for maintaining said components under temperature control, and having a door providing a user with access to said front of said deck and said consumable hotel located thereon.

215. The system of claim 214, further comprising the apparatus of any of claims 130 to 134.

216. 1. An automated assay system comprising: (a) a single robotically controlled 8-channel pipettor; (b) a single robotically controlled assay plate gripper arm; (c) a single 96 channel pre-assay plate washer; and (d) a single plate reader; and (d) one or more plate shakers having a total capacity of at least five plate shaking stations; (e) a processor adapted to execute an assay process for analyzing a plurality of samples in a 96-well plate, the processor comprising: (i) a blocking step comprising adding a blocking buffer using said pipettor, incubating for a blocking period (b), and (c) washing using said plate washer; (ii) a sample binding step comprising adding one of said samples using said pipettor while shaking at one of said plate shaking stations and washing using said plate washer, and incubating for a sample incubation period (s); (iii) a detector binding step including adding detection reagent using the pipettor while shaking at one of the plate shaking stations and washing using the plate washer, and incubating for a detector incubation period (d); (iv) adding a read buffer with said pipettor; (v) a processor for measuring an assay signal using the reader for each well of the plate; An automated assay system that can run up to five plates.

217. The system of claim 216, further comprising the apparatus of any of claims 130 to 134.

218. 1. An assay system configured to use an assay consumable in performing an assay, the assay consumable comprising an assay consumable identifier comprising an assay consumable identifier comprising a data deployable bundle (DBB) for the assay consumable; (a) a storage medium including a consumable data repository and a data registry comprising local consumable data; (b) a consumable identifier controller adapted to read and install said DDB on said storage medium; (c) a consumable data service processor adapted to use the assay consumables and to query the data registry and one or more remote consumable data databases to identify and download consumable data required for the performance of an assay by the assay system.

219. The assay system of claim 218, further configured to cause the consumable identifier to persist one or more data files of the DDB to the storage medium.

220. 220. The assay system of claim 219, wherein the one or more data files comprise a DDB unique identifier, a DDB version, consumable static information, consumable processing information, and combinations thereof.

221. 220. The assay system of claim 219, wherein the one or more data files comprise a DDB unique identifier, a DDB version, and consumable static information.

222. 222. The assay system of claim 220 or 221, wherein the consumable static information comprises consumable type information.

223. 223. The assay system of claim 222, wherein the consumable is a multi-well assay plate, and the consumable type information comprises the number of columns of wells, the number of rows of wells, the number of binding domains per well, and combinations thereof.

224. The assay system of claim 220, wherein the consumable is a multi-well assay plate and the consumable processing information includes data used by the assay system in performing an assay using the plate and / or in processing assay data resulting from performing an assay using the plate.

225. The assay system of claim 224, wherein the consumable processing information comprises the number of sectors per plate, the number of circuits per plate, detection parameters used by the assay system to read the plate, image processing characteristics used to produce ECL results, plate type gain, binding domain gain, optical crosstalk matrix, and combinations thereof.

226. The assay consumable is a kit comprising a multi-well assay plate and one or more reagents used in the performance of an assay using the plate, and the DDB includes assay binding domain information, assay protocols, data analysis parameters, product inserts, and the like.

221. The assay system of claim 220, comprising:

227. 227. The assay system of any of claims 218 to 226, wherein the assay system comprises a DDB version compatibility processor configured to downgrade and / or upgrade incompatible DDB software.

228. The assay system of any of claims 218 to 227, further comprising a DDB factory adapted to convert raw classification data into assay system configuration data suitable for use by the assay system in performing the assay.

229. The DDB includes data description information and data processing information.

229. The assay system of any of claims 218 to 228, comprising an xml file.

230. A Data Deployable Bundle (DDB) including one or more data files comprising consumable data relating to an assay consumable and use of the assay consumable in an assay system, the one or more data files including a DDB unique identifier, a DDB version, a DDB A data deployable bundle including xml files, consumable static information, consumable processing information, and combinations thereof.

231. The one or more data files include a DDB unique identifier, a DDB version, a DDB xml file, and consumable static information.

232. 232. The DDB of claim 230 or 231, wherein the consumable static information comprises consumable type information.

233. 233. The DDB of claim 232, wherein the consumable is a multi-well assay plate, and the consumable type information comprises the number of columns of wells, the number of rows of wells, the number of binding domains per well, and combinations thereof.

234. The DDB of claim 230, wherein the consumable is a multi-well assay plate and the consumable processing information comprises data used by the assay system in performing an assay using the plate and / or in processing assay data resulting from performing an assay using the plate.

235. The DDB of claim 230, 232, or 234, wherein the consumable processing information comprises the number of sectors per plate, the number of circuits per plate, detection parameters used by the assay system to read the plate, image processing characteristics used to produce ECL results, plate type gain, binding domain gain, optical crosstalk matrix, and combinations thereof.

236. The DDB of any of claims 230-235, wherein the assay consumable is a kit comprising a multi-well assay plate and one or more reagents used in the performance of an assay using the plate, and the DDB comprises assay binding domain information, assay protocols, data analysis parameters, product inserts, and combinations thereof.

237. The DDB A DDB according to any one of claims 230 to 236, wherein the xml file contains data description information and data processing information.

238. 14. A computer readable medium having stored thereon a computer program which, when executed by a computer system operatively connected to an assay system, causes the assay system to perform a method of performing an assay on the assay system, the assay system being configured to use an assay consumable in the performing of the assay, the assay consumable comprising an assay consumable identifier comprising the DDB of claim 13, the assay system comprising: (a) a storage medium including a consumable data repository with local consumable data and a data registry; (b) a consumable identifier controller adapted to read and install said DDB on said storage medium; (c) a consumable data services processor adapted to query the data registry and one or more remote consumable databases to identify and download consumable data needed for the performance of an assay by the assay system using the assay consumable; The method further comprising: (a) reading the DDB from the consumable identifier; (b) storing the DDB in the consumable data repository; (c) identifying consumable data from said consumable data repository and, optionally, downloading consumable data from one or more remote consumable data databases; (d) adjusting one or more actions performed by the system before, during, and / or after the performance of the assay based on the consumable data; (e) using the assay consumable and performing the assay on the assay system.

239. 239. The computer readable medium of claim 238, wherein the method further comprises the step of persisting one or more data files of the DDB to the storage medium.

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