Consumables 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 of related applications This international patent application, filed on July 22, 2016, with application number PCT / US2016 / 043755, is for "Integrated Consumable Data". We claim priority from an international patent application titled "Management System and Platform."

[0002] References are also made to concurrently pending U.S. applications No. 12 / 844,345, filed on 27 July 2010, U.S. provisional patent application No. 61 / 400,411, filed on 27 July 2010, and No. 61 / 462,024, filed on 27 January 2011. Furthermore, references are made to U.S. applications No. 13 / 191,000, filed on 26 July 2011, now U.S. Patent No. 8,770,471, U.S. applications No. 14 / 719,818, filed on 22 May 2015, and the U.S. provisional patent application entitled "Integrated Consumable Data Management System and Platform" with application number 62 / 195,956, filed on 23 July 2015. The overall contents of each of these applications are incorporated herein by reference.

[0003] Technical field This instruction relates to methods, devices, and systems for associating consumable data with assay consumables used in biological assays. It also relates to consumables (e.g., kits and reagent containers), software, data-expandable bundles, computer-readable media, loading carts, instruments, systems, and methods for performing automated biological assays. [Background technology]

[0004] Numerous methods and systems have been developed for conducting assays. These methods and systems are essential in a wide range 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, reagents and consumables are typically coded and labeled by the manufacturer for tracking purposes. Furthermore, understanding the analytical results of any given assay requires tracking countless analytical parameters, often necessitating input from various parallel tracking systems supplied by the manufacturer, the customer, or both. [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] The automation of immunoassays presents a series of challenges. Repeatability and / or reproducibility remain goals 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 specifically, electrochemiluminescence (ECL) immunoassays. The automated assay system of the present invention can perform assay runs with reproducible results. Human or machine stochastic errors that may occur during the preparation for assay runs (e.g., dilution of samples or calibrators), loading of assay consumables onto the instrument, and during assay runs have been identified and minimized. Other aspects include consumables, instruments, loading carts, software, data-expandable bundles, and computers for performing biological assays. Including a reader-readable medium and method.

[0007] Variables that have been minimized in different aspects of the present invention include one or more of the following: Variations in sample concentration between wells in a multi-well assay tray caused by evaporation of liquid during incubation are minimized. The position and location of the gripper pads of the robotic system, as well as pipettes for specific assay systems, are trained by precision training plates. Heat exchangers are provided to maintain the selected operating temperature of the assay system. Identical assay runs are completed within a substantially expected period to ensure reproducibility. Consumables for specific assays are provided in kits to ensure that the appropriate consumables and their quantities are available for the assay run. Loading of consumables into the assay system is standardized to minimize errors. Specialized assay consumable storage units on the assay instrument (e.g., plate hotels, plate carriers, spare pipette tip container carriers, trough carriers) minimize loading errors and assay execution errors. For example, the configuration and position of the plate hotel minimize loading errors for user safety considerations, ergonomic considerations, or consumable handling considerations. The user interface guides the user in loading consumables and selecting the assay protocol to be executed. The loading cart functions as an intermediate consumable loading station to assist the user in properly loading consumables into the assay system. The operational performance 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 special plate reader is configured to read assay plates in an order that minimizes the difference in the timing of additional reading buffers relative to the time it takes to read signals from one well to another, even within a single plate. Various background signal noises in the ECL reader are measured and offset from the actual ECL readings. The metering, dispensing, and / or aspirating capabilities of the pipette and plate washer are calibrated.

[0008] Other improvements include, but are not limited to, a software architecture that minimizes the need for software revalidation when the software system receives software updates, and the creation of generic protocols applicable to multiple assays paired with assay-specific instrument parameter files that allow for the customization of protocols to specific assays by turning certain components of the generic protocol on or off. Specialized lids are provided to minimize the loss of reagents from the container due to evaporation while maintaining the pipette's ability to access the reagents.

[0009] One embodiment of the present invention is an assay system configured to use assay consumables in the conduct of an assay, wherein the assay consumables include an assay consumable identifier that includes an assay consumable identifier that includes a data expandable bundle (DDB) for the assay consumables, and the assay system is (a) A storage medium including a consumables data repository that includes consumables local data and a data registry, (b) A consumable identifier controller adapted to read the DDB and install it into the storage medium, (c) A consumable data service processor adapted to query the data registry and one or more remote consumable data databases to identify and download consumable data required for performing an assay using an assay system that uses the assay consumables, Includes.

[0010] Additional embodiments of the present invention include assay consumables and assay consumables in assay systems. A data-extractable bundle (DDB) containing one or more data files containing consumable data related to the use of consumables, the one or more data files containing 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 that stores a computer program thereon causing the assay system to perform a method of performing an assay against the assay system when run by a computer system connected to the assay system, wherein the assay system is configured to use assay consumables in performing the assay, the assay consumables include assay consumable identifiers, including DDBs as described herein, and the assay system (a) A storage medium including a consumables data repository that includes local consumables data and a data registry, (b) A consumable identifier controller adapted to read the DDB and install it into the storage medium, (c) A consumable data service processor adapted to query the data registry and one or more remote consumable data databases to identify and download consumable data required for performing an assay using an assay system that uses the assay consumables, Includes, The method is, (a) The step of reading the DDB from the consumable identifier, (b) The step of storing the DDB in the consumables data repository, (c) The steps of identifying consumable data from the consumable data repository and optionally downloading consumable data from one or more remote consumable data databases, (d) A step of coordinating one or more actions performed by the system before, during, and / or after the assay based on the consumable data, (e) The step of performing the assay using the assay consumables and the assay system; 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 at least two different sizes for receiving at least two reagent containers of different sizes. The at least two regions and the at least two holes or windows may be circular, the at least two holes or windows may have a smaller diameter than the at least two regions, or the at least two regions and the at least two holes or windows may be linear, 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 can be attached to the top of the frame, and the insert may be positioned within the frame and below the mask. The two regions of the holder may include the cylindrical holes of 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 holes coated with transparent plastic within the frame.

[0014] The installation area dimensions of the holder preferably conform to the ANSI - SLAS dimensions of a multi - well plate. Also, the height of the holder may conform to the ANSI - SLAS height of the multi - well plate. It may be suitable.

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

[0016] The mask may define a plurality of mask regions, the number of mask regions may be the same as or less than the number of regions of the container, the frame, or the insert, and the mask may limit the number of assay containers that can be received 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 the bottom, side, or top surface of the container. Also, the holder may include one additional reagent container. The additional reagent container contains an assay reagent. The assay reagent may be a reagent 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 an assay reagent 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 the frame may be made of a conductive plastic. The holder may have a lid. The lid may be complete or substantially so. The reagent container may include an assay consumable identifier located at the bottom of the container that is visible from the bottom of the container. 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 a side, the bottom being generally rectangular in shape and having dimensions compliant with ANSI-SLAS standards, the frame defining holes or windows of the holder; (b) an insert sized to hold a tube or vial and disposed within the frame to align the tube or vial with the holes or windows of the holder, the insert having insert holes; (c) a mask located above the insert, the mask holes being aligned with the insert holes to allow insertion of a tube or vial into the insert of the tube or vial, the mask providing identification information about the tube or the vial; and (d) optionally, a lid for enclosing the vial within the holder.

[0020] The consumable identifier may be, but is not limited to, a two-dimensional barcode or a one-dimensional barcode. The two-dimensional or one-dimensional barcode may be printed on a plastic pack inserted into a recess at the bottom of the tube or vial, or on a foil disc that is heat-sealed to the recess at the bottom of the tube or vial.

[0021] The assay tube or vial comprises one or more tubes or vials containing 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 assay kits comprising any of the above-described holders in a cardboard container. Preferably, the kit has an assay consumable identifier on the cardboard container. The kit also has at least one assay consumable plate in the cardboard container. The assay consumable plate may be a multiwell 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 the upper surface of a multiwell plate, including a skirt, depending on the top of the lid, wherein the skirt is adapted to fit around the outer circumference of the upper surface of the multiwell plate, the upper surface of the plate is made to be the size and dimensions that contact the outer circumference of the multiwell plate, and the lid may have a plurality of recesses extending from the top of the lid toward the multiwell plate. The plurality of recesses correspond to a plurality of wells of the multiwell plate and are configured to extend into the plurality of wells. The upper surface of the lid is adapted to contact the 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, wherein the skirt is adapted to fit around the outer circumference of the top surface of the multiwell plate, and the top surface of the plate is made to be sized and dimensions to contact the outer circumference 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 micro-etched to create a rough surface for trapping 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 may also have multiple recesses extending from the top of the lid toward the multiwell plate. These recesses correspond to the multiple wells of the multiwell plate, and the recesses are configured to extend into the multiple wells.

[0026] The lids covering the multiwell plates are preferably not made from adaptive plastic or elastomer materials. These lids are preferably made from rigid plastic, and more preferably from polystyrene.

[0027] The present invention also relates to another lid, which is attached to a reagent container and adapted to allow a probe to enter and exit, and includes a top surface, the top surface including a pattern of cuts that divide the top surface into segments, the segments of which bend downward when the probe enters the reagent container and return 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 curved line, at least one meandering line, at least one substantially circular line, or parallel straight lines. The lid may be made from a non-elastomer material or from an elastomer material. The lid can 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 comprising a computer screen and a movable body comprising at least one shelf and a support for the computer screen, the shelf comprising at least one tray, the tray having a plurality of slots defined therein, the slots being made to a size and dimensions to receive a plurality of consumables for performing the assay. The computer screen is adapted to display a user interface showing a first arrangement of a plurality of containers of consumables on at least one tray.

[0030] The computer screen may be a tablet computer screen, or it 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 via a WiFi or Bluetooth connection. In one embodiment, a mobile computer device is associated with the computer screen.

[0031] Multiple slots on the loading cart can be defined on the top or both sides of at least one tray; that is, the tray can be reversed. The slots may be of different sizes, adapted to accommodate multiple 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. At least one shelf is an upper shelf. The cart may also have a bottom shelf and / or a middle shelf. The cart may have a compartment below at least one tray or upper tray, which is adapted for storing coolant. The compartment may also have a drain, and the bottom of the compartment may be concave. The movable body of the cart must be supported by at least one caster wheel, which may be a hubless caster wheel.

[0033] The loading cart may perforate at least one multiwell plate or other consumables, and at least one multiwell plate may contain at least one assay plate or at least one dilution plate. The consumables may contain at least one container of reagents. The consumables may contain at least one tube or at least one trough. Examples of trays are shown in Figures 19(a) to 19(j).

[0034] The present invention also relates to an assay preparation system for preparing assay components, the preparation system being: (a) an assay system having a processor that includes information about the components required to perform an assay run, (b) A loading cart including shelves for assembling components used in the assay, and supports for holding mobile computing devices, (c) Mobile computing devices including computer screens and Includes, The mobile computing device includes networking capabilities for accessing the information via the processor, and a graphical user interface for presenting the information to the user on a computer screen and guiding the placement of assay components in a loading cart.

[0035] The loading cart may be one of the loading carts described above and / or below. The loading cart may also include a consumable identifier reader, and the graphical user interface is configured to use the reader when placing assay components on the cart, to receive identifier information provided by the user, to use that information to verify the validity of the components, and to transfer the identifier information to the processor.

[0036] The present invention also relates to a method for instructing a user to load consumables into an assay system, including using the loading cart described above and / or below. The method may include 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, a. Steps to accept multiple consumables, b. The step of placing multiple consumables in 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. The step of moving the intermediate consumable loading station to the assay system, d. A step of transferring multiple consumables to the assay system according to the second configuration, The first configuration is substantially the same as the second configuration, and the transport step and This also relates to methods for loading consumables for performing an assay into the assay system, including those mentioned above.

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

[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 made to 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, wherein at least one reference pad is located on a first major surface of the plate and corresponds to the location of at least one well of an ANSI-SLAS format assay plate, and the location of at least one reference pad in one dimension of a three-dimensional coordinate system is measurable by a probe of the assay system when the plate is positioned on the plate carrier of the assay system.

[0041] The probe can measure the capacitance between the probe and at least one reference pad. The plate is preferably conductive. The ANSI-SLAS format assay plate is an 8x12 multiwell plate, and 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 regions located on the side connecting the two main surfaces of the plate, the gripping regions being adapted to be gripped by the gripper arm of the robotic system. The rectangular perimeter adjacent to the first main surface is smaller than the rectangular perimeter adjacent to the second main surface, and the first and second main surfaces are substantially parallel.

[0043] In one embodiment, at least two opposing gripping regions are in contact with a raised track. In another embodiment, the at least two opposing gripping regions include at least one pair of divots made to be sized and dimensional to receive a corresponding pair of projections on the gripper arm. The pair of projections may include the ends of a removable screw attached to the gripper arm. The at least one pair of divots may include an upper pair and a lower pair. When the gripper arm grips the upper pair, the top surface of the gripper arm is substantially coplanar with the first main surface of the plate. When the gripper arm grips the lower pair, the bottom surface of the gripper arm is substantially coplanar with the surface opposite the first main surface of the plate.

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

[0045] An additional embodiment relates to a plate for instructing or training an automated instrument, wherein the plate is made to be sized and dimensional to match the size and dimensions of an assay plate in ANSI-SLAS format, and includes a rectangular perimeter and at least one support member connecting the first side of the rectangular perimeter to the second side of the perimeter, and at least one reference pad positioned on the first main surface of the plate. Place it in a location corresponding to at least one well of an ANSI-SLAS format assay plate, The location of at least one reference pad in one dimension of a three-dimensional coordinate system can be measured by the assay system's probe when the plate is positioned on the plate carrier of the assay system.

[0046] An additional embodiment relates to a method for training or instructing a robotic gripper or pipette, which involves using the plate described above. The method for training or instructing a robotic gripper using the plate described above involves the following steps: The steps include: instructing the robotic gripper arm to move to a specific location in the X, Y, and Z space corresponding to a region on the plate; The steps include: instructing the robotic gripper arm to rotate to a specific location corresponding to an area on the plate; The steps include commanding the robotic gripper arm to open or close the gripper to a specific width or length corresponding to a region on the plate, A step of using a specific location of the gripper arm relative to the plate to estimate the fixed location throughout the automated setup, To calculate the robot training position of the location and other related parts of the experimental equipment, the steps include using a specific location of the gripper arm relative to the plate and It includes at least one of the following.

[0047] The method for training or instructing an automated dispensing arm using the plates described above is as follows: The steps include instructing the automated dispensing arm to move to a specific location in X-space, Y-space, and Z-space corresponding to a region on the plate, A step of using the specific location of the automatic dispensing arm relative to the plate to estimate the fixed location throughout the entire automatic setup, The steps include using the specific location of the automatic dispensing arm relative to the plate in order to calculate the robot training position of the location and other related parts of the experimental equipment, and It includes at least one of the following.

[0048] Another aspect of the present invention is, A positioning step of positioning a plate, which is made to the size and dimensions of an ANSI-SLAS format assay plate, in a plate carrier inside the assay system, wherein the position of the plate is known in a three-dimensional coordinate system. A step of moving a robot-controlled probe toward a reference pad on the plate, wherein the reference pad corresponds to a well of the ANSI-SLAS plate, A step of obtaining a first location of the reference pad using the capacitance between the probe in the three-dimensional coordinate system and the reference pad, The steps of assigning the first location as one dimension in the three-dimensional coordinate system for a robot-controlled probe, and The present invention relates to a method for training a robot-controlled probe of an assay system, which includes at least one of the following:

[0049] Furthermore, aspects of the present invention relate to an assay consumable storage unit adapted to be mounted on a platform of an assay system, which includes a shelf assembly having a base and multiple sets of vertically aligned storage units, each storage unit being made to the size and dimensions to receive consumables for the assay system to perform assays. The shelf assembly includes multiple horizontal members connected by multiple upright vertical supports. The base is cantilevered to the platform, and the shelf assembly is removably attached to the base by at least two positioning pins and at least one screw-type connector having a finger-operable head.

[0050] A shelf assembly may include a linear array of MxN of vertically aligned storage units, where M and N are integers. The upper horizontal member of the shelf assembly may include alignment features for container bottoms conforming to ANSI SLAS. The upper horizontal member may also include alignment features for assay reagent holder lids that are larger than the container bottoms conforming to ANSI SLAS.

[0051] An additional embodiment relates to an assay system. The assay system includes an assay system configured to use assay consumables in the performance of an assay, wherein the assay consumables include an assay consumable identifier associated with a data expandable bundle (DDB) for the assay consumables, and the assay system (a) A storage medium including a consumables data repository and a data registry containing local consumables data, (b) A consumable identifier controller adapted to read the DDB and install it into the storage medium, (c) A consumable data service processor adapted to query the data registry and at least one remote consumable data database in order to use the assay consumables and to identify and download the consumable data required for performing the assay by the assay system. Includes.

[0052] The additional assay includes an assay system including a housing, the housing including a continuous glass member, a touchscreen for a computer screen 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 present invention further includes an automated assay system adapted to receive consumables in the performance of an assay, the automated assay system including a robot-controlled pipette and robot-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 consumables and in the performance of an 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 multiple containers containing at least one of a calibrator, diluent, and antibody. At least one instruction is: Instructions for the user interface that guide the user in loading consumables into the assay system, A command to the robotic gripper arm to place a lid on at least one assay test plate when at least one assay test plate is placed on the shaker, A command to at least one heat exchanger to maintain a selected temperature within the assay system, An instruction to perform an assay for at least one assay test plate, wherein at least one assay plate comprises multiple assay test plates, and each assay test plate is completed substantially in the same time period. It includes at least one of the following.

[0054] Commands to the user interface in this automated assay system may further include commands to load consumables from the kit and / or commands to load consumables into an intermediate consumable loading station, which may include a movable cart. Commands may further include commands to obtain the vertical position of a robot-controlled pipette using a training plate, which may include commands to obtain its horizontal position. Commands may further include commands to obtain the vertical position of a robot-controlled gripper arm using a training plate, which may include commands to obtain its horizontal position.

[0055] At least one instruction further includes instructions that perform a qualification procedure. The qualification procedure consists of the following steps: (i) A step of confirming that the assay reader is preferably an ECL reader, (ii) A step to confirm the suction function of the plate washing machine, (iii) A step to verify the weighing and dispensing function of the plate washing machine, (iv) Steps to confirm the metering and dispensing function of the pipette and It includes at least one of the following.

[0056] The validation of the ECL reader involves the following steps: (a) A step of reading the electronic plate using the ECL reader in order to confirm the flow of current in the ECL reader, (b) A step of reading an empty assay test plate using an ECL reader to check for background electrical noise, (c) A step of reading an assay test plate, wherein the wells in the plate are filled with free tag buffer to ensure that the ECL reader reads the expected count. It includes at least one of the following.

[0057] 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 present invention relates to a method for loading consumables for an assay and operating an automated assay system to minimize potential errors when performing the assay. The assay system includes a robot-controlled pipette and robot-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, which 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 multiple containers containing at least one of a calibrator, control, diluent, antibody, reagent, and buffer. The method is as follows: A step of instructing the user interface to guide the user in loading consumables into the assay system, When at least one assay test plate is placed in the shaker and incubator, the robotic gripper arm is instructed to place a lid on at least one assay test plate. The steps include instructing at least one heat exchanger to maintain a selected temperature within the assay system, To run the assay for at least one assay test plate, The step of instructing at least one processor, wherein at least one assay plate includes multiple assay test plates, and each assay test plate is completed substantially in a synchronous period. It includes at least one of the following.

[0059] Commands to the user interface in this method may further include commands to load consumables from the kit and / or commands to load consumables into an intermediate consumable loading station, which may include a movable cart. Commands may further include commands to obtain the vertical position of a robot-controlled pipette using a training plate, which may include commands to obtain its horizontal position. Commands may further include commands to obtain the vertical position of a robot-controlled gripper arm using a training plate, which may include commands to obtain its horizontal position.

[0060] At least one instruction further includes instructions that perform a qualification procedure. The qualification procedure consists of the following steps: (i) A step of confirming that the assay reader is preferably an ECL reader, (ii) A step to confirm the suction function of the plate washing machine, (iii) A step to verify the weighing and dispensing function of the plate washing machine, (iv) Steps to confirm the metering and dispensing function of the pipette and It includes at least one of the following.

[0061] Validation of the ECL reader involves the following steps: (a) A step of reading the electronic plate using the ECL reader in order to confirm the flow of current in the ECL reader, (b) A step of reading an empty assay test plate using an ECL reader to check for background electrical noise, (c) A step of reading an assay test plate, wherein the wells in the plate are filled with free tag buffer to ensure that the ECL reader reads the expected count. It includes at least one of the following.

[0062] 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 assay consumables in the performance of an assay, the assay system comprising at least one processor and at least one storage medium. The storage medium stores the instructions for the processor to perform the assay. The instruction is divided into multiple components, and these multiple components are, Security components and User interface components, Instrument control components and, Data service components and, Includes, Each component operates substantially independently of the others and has substantially no interaction with one another. The component is connected to a master organizer, which commands each component when to operate.

[0064] This automated assay system includes multiple components, and updating one component does not require revalidation of all components. The master organizer includes multiple components. It functions as a route for passing information between components. At least one of these components is further divided into subcomponents, each operating substantially independently of and substantially interacting with the others, with a submaster organizer connected to the subcomponents, which instructs each subcomponent on when to act. Preferably, an update to one subcomponent, preferably a software update, does not require the revalidation of all subcomponents.

[0065] The present invention further relates to an assay system configured to use assay consumables in the performance of a first assay, wherein the first assay includes a unique assay identifier, and the assay system is A reader adapted to read a unique assay identifier, A processor that accesses general protocol files and instrument parameter files, Includes, The general protocol file includes a validation step applicable to multiple assays, including the first assay. The instrument parameter file contains multiple flags that are either on or off. The processor turns on or off the validation steps of the general assay protocol according to the flag in order to perform the first assay.

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

[0067] The additional assay system relates to an automated assay system configured to minimize variations in user, instrument, and assay method, wherein the system is: Measures to minimize user errors during system loading, Means to minimize user error when selecting automated workflows, Means to minimize sample dilution errors, Measures to minimize errors in handling system plates, Measures to minimize system dispensing errors, Means to minimize temperature fluctuations, Means for minimizing evaporation or condensation in assay consumables, Means for controlling the shaking frequency of at least one shaker, Means to minimize the complexity of maintenance procedures and It includes at least one of the following.

[0068] In an additional embodiment, the automated assay system is configured to minimize variations in user, instrument, and assay method, and the system includes a robotic gripper arm and a robotic pipette. Perform the sample dilution step, Selecting and executing the correct assay workflow for a given assay, Controlling the air cooling system to maintain a defined temperature within the system's assay workflow area within defined tolerances, Maintaining consistent timing between runs, plates, and wells, To enable users to run different assay workflows without having to reconfigure or re-verify the workflow software. This also includes software and instrument components for at least one of the following.

[0069] Additional embodiments include a robotic gripper arm and a robotic pipette, and include the following additional components: (a) a plate carrier, (b) a tip box carrier, (c) five optional heatable shakers, (d) an air cooling processing 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, and (i) an assay consumable storage unit for tubes and troughs. (j) a platform or table, or both, including a position for fixing the product storage unit, and components (a) to (c) and (e) to (h) located in the system on the platform or table in substantially the same position relative to each other as shown in Figures 10(a), 10(b), 10(c), 10(l), 10(n), or 10(o), and component (d) located substantially on the back panel of the instrument as shown in Figures 10(l), 10(m), or 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 access to the plate washer. The platform can be mounted on 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 waste disposal, 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 to control the robotic gripper, the robotic pipette, and components (c) and (d). The assay system may also include containers for washing buffer and liquid waste below the plate washer.

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

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

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

[0075] In additional embodiments, the present invention is (a) A single robot-controlled 8-channel pipette, (b) A single robot-controlled assay plate gripper arm, (c) A single 96-channel assay plate washer, (d) A single plate reader and (e) One or more plate shakers having a total capacity of at least five plate shaking locations, (f) A processor adapted to perform an assay process for analyzing multiple samples in a 96-well plate, wherein the process performs the following operations, i.e. (i) A blocking step including adding block buffer with a pipette, incubation during the blocking period (b), and washing using a plate washer, (ii) A sample binding step including shaking in one of the plate shaking locations, washing using a plate washing machine, adding one of the samples using a pipette, and incubation during a sample incubation period (s), (iii) A detector coupling step which includes shaking the plate in one of the plate shaking locations, washing the plate using a plate washer, adding the detection reagent using a pipette, and incubation during the detector incubation period (d), (iv) Addition of reading buffer using a pipette, (v) Measurement of assay signal using a reading device, A processor and run in each well of the plate. Includes, Up to 5 plates can be processed in a single run. The steps are performed as shown in Figures 9(d), 12(m) to 12(p), 12(r) to 12(s), 13(d) to 13(f), 14(d), 14(f) to 14(l), 15(b), 15(d) to 15(h), 16(b), 17(b), and 17(d) to 17(h). Regarding automated assay systems.

[0076] The process of this system consists of the following steps: (vi) Diluting a calibrator storage solution using a pipette to form a plurality of calibration standards, wherein the calibration standards are included in the plurality of samples, such as the samples to be tested, and are accessible for controlling a software automated assay system or stored in memory, etc. (vii) Using a pipette, pre-dilute one or more samples before adding them to the wells of the sample plate, (viii) The step of using a pipette to combine multiple detection reagent components to form a detection reagent. It may further include one or more of the following.

[0077] The step is preferably carried out under temperature control that allows for the maintenance of 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 are available. (a) A processing deck for holding assay components having a front edge, a first side edge, a second side edge, and a rear edge on a substantially rectangular surface, (i) A cantilevered assay consumable hotel positioned approximately in the center of the front end of a deck having multiple consumable slots sized to hold consumables that meet the ANSI-SLAS specifications for the width and length of a 96-well assay plate, (ii) Multiple pipette tip locations for holding pipette tip containers located on the first side of the deck, (iii) Multiple plate shaker locations located along the rear edge of the deck, (iv) A set of processing areas located approximately in the center of the deck between the hotel and a shaker configured to hold consumables having dimensions compliant with ANSI-SLAS, (v) A barcode scanner located on the first side of the deck behind the pipette tip location, having a scanning surface large enough to scan the bottom surface of a consumable having dimensions compliant with ANSI-SLAS; The deck that supports this, (b) A plate washer located below the deck and accessible through an opening in the deck between the pipetting area and the assay plate processing area, (c) A gantry located above the deck that provides movable support for a robotic plate gripper so that the gripper can move to access locations (i) to (v), and provides movable support for a robotic 8-channel pipette so that the pipette can access locations (ii) and (iv), (d) Assay reading device located next to the first side of the deck on a platform at a vertical height lower than the deck, wherein the highest point on the reading device is lower than the lowest point to which the robot grabber can move, (e) An enclosure surrounding components (a) to (d) having a temperature controller for maintaining the components under temperature control and a door that provides the user with access to the front of the deck and the consumable hotel located above it, This relates to automated assay systems, including those mentioned above.

[0079] Additional aspects include: (a) A single robot-controlled 8-channel pipette, (b) A single robot-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 locations, (e) A processor adapted to perform an assay process for analyzing multiple samples in a 96-well plate, wherein the following operations are performed: (i) a blocking step including adding block buffer using a pipette, incubation during the blocking period (b), and (c) washing using a plate washer, (ii) A sample binding step including adding one of the samples using a pipette while shaking in one of the plate shaking locations and washing with a plate washer, and incubation during a sample incubation period (s), (iii) A detector coupling step which includes shaking the plate in one of the plate shaking locations, washing with a plate washer, adding detection reagent using a pipette, and incubation during the detector incubation period (d), (iv) Addition of a reading buffer with a pipette, (v) Measurement of assay signal using a reading device and The processor that runs in each well of the plate Includes, Up to 5 plates can be processed in a run. Regarding automated assay systems. [Brief explanation of the drawing]

[0080] [Figure 1] This diagram shows the generation and storage of consumables data, as well as consumables data provided by consumables manufacturers. [Figure 2] This diagram shows the distribution of consumables data to customers who inquire about it. [Figure 3] This figure shows the use of consumable data to verify the permitted use of consumables in the assay system. [Figure 4] This diagram shows the interface between the master repository on the CD server, its contents, and / or additional vendor directories. [Figure 5(a)] This figure shows the assay reading device described herein. [Figure 5(b)] This figure shows the assay reading device described herein. [Figure 5(c)] This figure shows the assay reading device described herein. [Figure 5(d)] This figure shows the assay reading device described herein. [Figure 6(a)] This is an alternative diagram of the assay reader described herein. [Figure 6(b)] This is an alternative diagram of the assay reader described herein. [Figure 6(c)] This is an alternative diagram of the assay reader described herein. [Figure 7] This is an additional diagram of the assay reader described herein. [Figure 8] This figure shows the assay system described herein. [Figure 9(a)]This figure shows an assay system and the various subsystems included in that system. In particular, the system includes multiple subsystems positioned on a table or platform, and each subsystem is operablely connected to a robotic subsystem configured to access one or more consumables, such as multiwell assay plates, and to move from one subsystem to another within the assay system. [Figure 9(b)] This figure shows an assay system and the various subsystems included in that system. [Figure 9(c)] This figure shows an assay system and the various subsystems included in that system. [Figure 9(d)] This shows the scheduling of operations performed on the system during the assay. [Figure 10(a)] This figure shows one embodiment of an assay system and various subsystems within the system. The assay system shown in Figures 10(a) and 10(b) is configured to perform all assay processing steps, as well as all sample preparation steps, onboard, and the assay system is connected to a user interface configured to display step-by-step instructions to the user for appropriate sample / reagent preparation steps that need to be performed manually before the system performs the assay. [Figure 10(b)] This figure shows one embodiment of an assay system and various subsystems within the system. [Figure 10(c)] This figure shows another replication of the assay system shown in Figures 10(a) to 10(d). [Figure 10(d)] This diagram shows the top surface of the table supporting the assay system equipment. [Figure 10(e)] This is a perspective view of the training plate. [Figure 10(f)] This is a perspective view of the training plate. [Figure 10(g)] This is a perspective view showing the tip of a pipette entering the lid of a reagent trough. [Figure 10(h)]Figure 10(g) is a top view of the various cut patterns of the lid. [Figure 10(i)] This is a perspective view of the lid and assay plate. [Figure 10(j)] Figure 10(i) is a cross-sectional view of the lid and assay plate. [Figure 10(k)] This figure shows an enlarged portion of Figure 10(j). [Figure 10(l)] Figures 10(a) to 10(c) show a front view of the assay system with the internal door closed. [Figure 10 (m)] This diagram shows the cooling pattern within the assay system. [Figure 10(n)] This diagram shows the cooling pattern within the assay system. [Figure 10(o)] This diagram shows the cooling pattern within the assay system. [Figure 10(p)] This diagram shows the cooling pattern of an electronic enclosure. [Figure 10(q)] This figure shows an adjustable hinge for a door in an assay system with two degrees of freedom. [Figure 10(r)] This is a top perspective view of the assay consumables storage unit. [Figure 10(s)] This diagram shows the dimensions of the assay system frame. [Figure 10(t)] This diagram shows the dimensions of the assay system frame. [Figure 10(u)] This is a plan view of the platform. [Figure 10V] This is a diagram showing a portion of the wiring diagram for the assay system (1000). [Figure 10V-a] This is an enlarged view of Figure 10V. [Figure 10V-b] This is an enlarged view of Figure 10V. [Figure 10V-c] This is an enlarged view of Figure 10V. [Figure 10V-d] This is an enlarged view of Figure 10V. [Figure 10W] This is a diagram showing a portion of the wiring diagram for the assay system (1000). [Figure 10W-a]This is an enlarged view of Figure 10W. [Figure 10W-b] This is an enlarged view of Figure 10W. [Figure 10W-c] This is an enlarged view of Figure 10W. [Figure 10W-d] This is an enlarged view of Figure 10W. [Figure 10W-e] This is an enlarged view of Figure 10W. [Figure 10W-f] This is an enlarged view of Figure 10W. [Figure 10W-g] This is an enlarged view of Figure 10W. [Figure 10W-h] This is an enlarged view of Figure 10W. [Figure 10X] This is a diagram showing a portion of the wiring diagram for the assay system (1000). [Figure 10X-a] This is an enlarged view of Figure 10X. [Figure 10X-b] This is an enlarged view of Figure 10X. [Figure 10X-c] This is an enlarged view of Figure 10X. [Figure 10X-d] This is an enlarged view of Figure 10X. [Figure 10X-e] This is an enlarged view of Figure 10X. [Figure 10Y] This is a diagram showing a portion of the wiring diagram for the assay system (1000). [Figure 10Y-a] This is an enlarged portion of Figure 10Y. [Figure 10Y-b] This is an enlarged portion of Figure 10Y. [Figure 10Y-c] This is an enlarged portion of Figure 10Y. [Figure 10Y-d] This is an enlarged portion of Figure 10Y. [Figure 10(z)] This is a top view showing the plate carrier (1036) and the end carrier (1026). [Figure 10(aa)] Figure 10(f) is a top perspective view of another embodiment of the training plate shown. [Figure 10(bb)] This is a bottom perspective view of the embodiment shown in Figure 10(aa). [Figure 10 (cc)] This is another top view of the platform shown in Figure 10(u). [Figure 11a] This figure shows a data association workflow, a specific embodiment of the process by which specific data is associated with consumable identifiers. [Figure 11(b)] This diagram shows the interaction between the assay system's computer system and the customer's computer system. [Figure 11(c)] This is a diagram showing the components of the assay system's computer system. [Figure 11(d)] This is a flowchart for the instrument control section of the software. [Figure 11E] This figure shows an example of a software architecture. [Figure 12(a)] This figure shows one embodiment of a software architecture for deploying and using Data Expandable Bundles (DDBs). [Figure 12(b)] This figure shows one embodiment of a software architecture for deploying and using Data Expandable Bundles (DDBs). [Figure 12(c)] This figure shows one embodiment of a software architecture for deploying and using Data Expandable Bundles (DDBs). [Figure 12(d)] This figure shows one embodiment of a software architecture for deploying and using Data Expandable Bundles (DDBs). [Figure 12(e)] This figure shows one embodiment of a software architecture for deploying and using Data Expandable Bundles (DDBs). [Figure 12(f)] This figure shows one embodiment of a software architecture for deploying and using Data Expandable Bundles (DDBs). [Figure 12(g)] This figure shows one embodiment of a software architecture for deploying and using Data Expandable Bundles (DDBs). [Figure 12(h)] This figure shows one embodiment of a software architecture for deploying and using Data Expandable Bundles (DDBs). [Figure 12(i)]This figure shows one embodiment of a software architecture for deploying and using Data Expandable Bundles (DDBs). [Figure 12(j)] This figure shows one embodiment of a software architecture for deploying and using Data Expandable Bundles (DDBs). [Figure 12(k)] This figure shows one embodiment of a software architecture for deploying and using Data Expandable Bundles (DDBs). [Figure 12(l)] This figure shows one embodiment of a software architecture for deploying and using Data Expandable Bundles (DDBs). [Figure 12M-a] This figure shows a script illustrating an example of a general protocol. [Figure 12M-b] This figure shows a script illustrating an example of a general protocol. [Figure 12N-a] Figure 12M shows the script with selected steps of the protocol that have been turned off. [Figure 12N-b] Figure 12M shows the script with selected steps of the protocol that have been turned off. [Figure 12O-a] Figure 12M shows the script with selected steps of the protocol that have been turned off. [Figure 12O-b] Figure 12M shows the script with selected steps of the protocol that have been turned off. [Figure 12P] Figure 12M shows the script with selected steps of the protocol that have been turned off. [Figure 12Q-a] This figure shows an example instrument parameter file that indicates the on / off status of a specific step in the protocol. [Figure 12Q-b] This figure shows an example instrument parameter file that indicates the on / off status of a specific step in the protocol. [Figure 12R-a] This figure shows another example of a general protocol. [Figure 12R-b] This figure shows another example of a general protocol. [Figure 12S-a] This diagram shows a typical script with specific steps turned off. [Figure 12S-b] This diagram shows a typical script with specific steps turned off. [Figure 13(a)] This figure shows one embodiment of the use of data-extractable bundles and consumables / system data for operating an assay system during assay execution. [Figure 13(b)] This figure shows one embodiment of the use of data-extractable bundles and consumables / system data for operating an assay system during assay execution. [Figure 13C] This figure shows one embodiment of the use of data-extractable bundles and consumables / system data for operating an assay system during assay execution. [Figure 13D-a] This figure shows one embodiment of the use of data-extractable bundles and consumables / system data for operating an assay system during assay execution. [Figure 13D-b] This figure shows one embodiment of the use of data-extractable bundles and consumables / system data for operating an assay system during assay execution. [Figure 13E-a] This figure shows one embodiment of the use of data-extractable bundles and consumables / system data for operating an assay system during assay execution. [Figure 13E-b] This figure shows one embodiment of the use of data-extractable bundles and consumables / system data for operating an assay system during assay execution. [Figure 13(f)] This figure shows one embodiment of the use of data-extractable bundles and consumables / system data for operating an assay system during assay execution. [Figure 14(a)] This figure shows the performance of the V-PLEX assay using the assay system described herein. [Figure 14(b)]This figure shows the performance of the V-PLEX assay using the assay system described herein. [Figure 14(c)] This figure shows the performance of the V-PLEX assay using the assay system described herein. [Figure 14(d)] This figure shows the performance of the V-PLEX assay using the assay system described herein. [Figure 14(e)] This figure shows the performance of the V-PLEX assay using the assay system described herein. [Figure 14(f)] This figure shows the performance of the V-PLEX assay using the assay system described herein. [Figure 14(g)] This figure shows the performance of the V-PLEX assay using the assay system described herein. [Figure 14(h)] This figure shows the performance of the V-PLEX assay using the assay system described herein. [Figure 14(i)] This figure shows the performance of the V-PLEX assay using the assay system described herein. [Figure 14J-a] This figure shows the performance of the V-PLEX assay using the assay system described herein. [Figure 14J-b] This figure shows the performance of the V-PLEX assay using the assay system described herein. [Figure 14K-a] This figure shows the performance of the V-PLEX assay using the assay system described herein. [Figure 14K-b] This figure shows the performance of the V-PLEX assay using the assay system described herein. [Figure 14(l)] This figure shows the performance of the V-PLEX assay using the assay system described herein. [Figure 15A] This figure shows the performance of the U-PLEX assay using the assay system with the software described herein. [Figure 15B] This figure shows the performance of the U-PLEX assay using the assay system with the software described herein. [Figure 15C-a] This figure shows the performance of the U-PLEX assay using the assay system with the software described herein. [Figure 15C-b] This figure shows the performance of the U-PLEX assay using the assay system with the software described herein. [Figure 15D-a] This figure shows the performance of the U-PLEX assay using the assay system with the software described herein. [Figure 15D-b] This figure shows the performance of the U-PLEX assay using the assay system with the software described herein. [Figure 15E-a] This figure shows the performance of the U-PLEX assay using the assay system with the software described herein. [Figure 15E-b] This figure shows the performance of the U-PLEX assay using the assay system with the software described herein. [Figure 15(f)] This figure shows the performance of the U-PLEX assay using the assay system with the software described herein. [Figure 15G-a] This figure shows the performance of the U-PLEX assay using the assay system with the software described herein. [Figure 15G-b] This figure shows the performance of the U-PLEX assay using the assay system with the software described herein. [Figure 15H-a] This figure shows the performance of the U-PLEX assay using the assay system with the software described herein. [Figure 15H-b]This figure shows the performance of the U-PLEX assay using the assay system with the software described herein. [Figure 16(a)] This figure shows the preparation, optimization, and execution of an immunogenicity assay in an assay system. [Figure 16B] This figure shows the preparation, optimization, and execution of an immunogenicity assay in an assay system. [Figure 16(c)] This figure shows the preparation, optimization, and execution of an immunogenicity assay in an assay system. [Figure 16(d)] This figure shows the preparation, optimization, and execution of an immunogenicity assay in an assay system. [Figure 17(a)] This figure shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(b)] This figure shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(c)] This figure shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(d)] This figure shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(E)-a] This figure shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(E)-b] This figure shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(F)-a] This figure shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(F)-b]This figure shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(G)-a] This figure shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(G)-b] This figure shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(H)-a] This figure shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(H)-b] This figure shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 17(i)] This figure shows the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 18(a)] This figure shows the assay system and available consumable assay kits described herein. [Figure 18(b)] This figure shows the assay system and available consumable assay kits described herein. [Figure 18(c)] This figure shows the assay system and available consumable assay kits described herein. [Figure 18(d)] This figure shows the assay system and available consumable assay kits described herein. [Figure 18(e)] This figure shows the assay system and available consumable assay kits described herein. [Figure 18(f)] This figure shows the assay system and available consumable assay kits described herein. [Figure 18(g)]This figure shows the assay system and available consumable assay kits described herein. [Figure 18(h)] This figure shows the assay system and available consumable assay kits described herein. [Figure 18(i)] This figure shows the assay system and available consumable assay kits described herein. [Figure 18(j)] This figure shows the assay system and available consumable assay kits described herein. [Figure 18(k)] This figure shows the assay system and available consumable assay kits described herein. [Figure 18(l)] This figure shows the assay system and available consumable assay kits described herein. [Figure 18(m)] This figure shows the assay system and available consumable assay kits described herein. [Figure 18(n)] This figure shows the assay system and available consumable assay kits described herein. [Figure 19(a)] This is a perspective view of the loading cart of the present invention, designed for use with the assay system described herein. [Figure 19(b)] This is a perspective view of the loading cart of the present invention, designed for use with the assay system described herein. [Figure 19(c)] This is a plan view of a loading cart showing trays adapted to accept assay consumables. [Figure 19(d)] This is an illustrative plan view of a tray loaded with assay consumables. [Figure 19(e)] This is an illustrative plan view of a tray loaded with assay consumables. [Figure 19(f)] This is an illustrative plan view of a tray loaded with assay consumables. [Figure 19(g)] This is an illustrative plan view of a tray loaded with assay consumables. [Figure 19(h)]This is an illustrative plan view of a tray loaded with assay consumables. [Figure 19(i)] This diagram shows the cooling compartment located beneath the tray. [Figure 19(j)] This figure shows another embodiment of the loading cart of the present invention. [Figure 20(a)] This figure shows exemplary adjustments to the dispensing timing and ECL reading pattern for the assay system of the present invention. [Figure 20(b)] This figure shows exemplary adjustments to the dispensing timing and ECL reading pattern for the assay system of the present invention. [Figure 20(c)] This figure shows exemplary adjustments to the dispensing timing and ECL reading pattern for the assay system of the present invention. [Figure 20(d)] This figure shows exemplary adjustments to the dispensing timing and ECL reading pattern for the assay system of the present invention. [Figure 20(e)] This figure shows exemplary adjustments to the dispensing timing and ECL reading pattern for the assay system of the present invention. [Modes for carrying out the invention]

[0081] As used herein, figures presented in subsections of separate drawing sheets, such as Figure 10V-a, Figure 10V-b, Figure 10V-c, and Figure 10V-d, and having two suffixes separated by a hyphen, are enlargements of a single drawing, such as Figure 10(v) or Figure 10(V). These enlargements are referred to collectively below herein, 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 meanings generally understood by those skilled in the art. Furthermore, unless the context clearly indicates otherwise, singular terms shall include plural terms, and plural terms shall include singular terms. The articles “one” and “a” refer herein to one or more (i.e., at least one) grammatical objects of the article. For example, “element” means one or more elements.

[0083] As used herein, the term “sample” is intended to mean a biological fluid, cell, tissue, organ, or combination or part thereof that contains, or potentially contains, a biological indicator of the disease in question. For example, a sample may be a tissue section of a specimen obtained by biopsy, or cells placed in or adapted for tissue culture. A sample may further be a subcellular fraction or extract, or crude or substantially pure nucleic acid molecules or protein modifiers. In one embodiment, samples analyzed in the assay of the present invention are blood, peripheral blood mononuclear cells (PBMCs), isolated hematopoietic 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, the assay system used in the present invention includes an assay reader capable of using assay consumables to perform a biological assay. The assay consumables include an identifier (referred to, instead, as identifiers, consumable identifiers, or assay consumable identifiers throughout the specification), and the assay system, assay reader, or its components include an identifier controller that interacts with the identifiers. As described below, the identifiers are associated with information about the assay consumables (collectively referred to as “consumable data”), which may include, but is not limited to, how the consumables are manufactured and processed before use, and how the consumables are used in the assay system. Accordingly, the assay system is configured to use assay consumables in the execution of the assay, and the assay system includes an identifier controller adapted to (i) read consumable data from an assay consumable identifier associated with the assay consumable, (ii) access consumable data associated with the assay consumable indexed by the assay consumable identifier, and store the consumable data locally in the assay system or assay reader, or remotely in a vendor computing system, (iii) erase the consumable data associated with the assay consumable identifier, and / or (iv) write the consumable data indexed by the consumable identifier to the assay system and / or a remote data table.

[0085] In specific embodiments, the present invention provides an assay system configured to use assay consumables in the conduct of an assay, wherein the assay consumables include assay consumable identifiers as described herein, and the assay system includes (a) a storage medium containing a consumable data repository, and (b) an identifier controller adapted to read information from the consumable identifiers. In one embodiment, the system includes a storage medium containing a consumable data repository containing local consumable data. The local consumable data stored by the assay system includes consumable identification and / or configuration information, and one or more steps of an assay protocol that can be applied by the system in the conduct of an assay using the consumables. For example, a 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 specific to individual consumables, and the corresponding local consumable data stored in the assay system includes information used to identify consumables associated with the system, for example, as components of a given lot or as individual consumables within a lot, and it also includes information used by the system when a consumable is identified to use that consumable and perform an assay protocol. Furthermore, the consumable data (and / or local consumable data) may include one or more analytical tools that the system can apply to analyze and interpret the generated data, system and / or consumable technical support information, or a combination thereof, using that consumable. Furthermore, the system may be configured to receive updates to the consumables data repository from a remote storage medium, and these updates may include, but are not limited to, additional consumables data, including, additional consumables identification and / or configuration information, assay protocol information, and one or more of the following: (x) one or more analytical tools that the system can apply to analyze data and interpret the results generated during and / or after the assay, (y) assay system maintenance information, (z) system consumables promotional information, and (xx) system and / or consumables technical support information.

[0086] One embodiment of the use of identifier / consumable data in the system is shown in Figures 1 to 4. Figure 1 shows how consumable data is generated, stored, and used by a manufacturer, distributor, or supplier (hereinafter referred to as the “vendor”). First, the vendor generates a set or lot of consumables and / or consumables (101), and for that consumable or lot of consumables, consumable data is generated using a consumable data (CD) creation system (102) and associated with a consumable identifier (103) indexed to the consumable or lot of consumables (step i). Consumable data is generated by the consumable vendor before, during, and / or after 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, i.e., a CD database, in which the consumable data is stored. The CD database is transmitted to a CD server (104) which contains a master repository of all consumable data. Furthermore, the CD creation system stores information used to associate a given consumable identifier with consumable data in the master repository. The CD creation system and / or CD server are located at the customer's location, such as a remote computing system, i.e., an assay system and / or a computing system located away from the customer, or 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) to which that consumable or lot is indexed. 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 a CD server (c) containing the master repository of all consumable data (step iv).

[0087] Figure 2 illustrates one method for distributing consumable data to a customer or a designated user of a customer (collectively referred to herein as “customer”). 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) (step ii). The CD database may include other performance 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 the consumable (202) containing a consumable identifier (203) and brings the consumable into contact with an assay system (204) in preparation for performing the assay (step iii), and the system reads and / or accesses data associated with the assay consumable identifier (203), which is used by the system to identify the consumable (202) (step iv). The system stores the information that can be used for performing assays using the given consumable. To identify the consumable data stored on the medium, the system reviews the consumable data stored locally on the local storage medium (referred to as the "local CD" in Figure 2). If the storage medium contains consumable data for that consumable or lot, the consumable is available for use 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 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 to the customer, for example, as an email attachment to the customer's email account (including, but not limited to, an encrypted XML file), 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 consumable is then available for use in the instrument (step vii).

[0088] In an alternative embodiment, the CD server can connect to the system via a direct interface that allows it to automatically retrieve consumable data from the CD server if the consumable data is not locally available on the system. In this embodiment, the vendor generates, stores, and sends a CD database for consumable orders and / or lots of consumables, as shown in Figure 2 and described above. The customer then receives the consumables, orders, and / or lots and contacts the system with the consumable identifier so that the system can identify the consumables or lots. The system software queries the system consumable data repository for the consumable data associated with that consumable identifier, and if the consumable data is locally available on the system, the software adjusts the system based on the consumable data as necessary. If the consumable data is not present in the system consumable data repository, the system (i) prompts the customer to manually retrieve the consumable data from the vendor, or (ii) automatically retrieves the consumable data from the CD server via a direct interface with the CD server and stores the information locally in the system consumable data repository. If consumable data is available locally in the system, the software adjusts the system based on the consumable data as needed and performs the assay. If consumable data is available locally in the system, the consumable or lot can be used in 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] Furthermore, the CD server can periodically transmit consumable data for new lots / types of consumables to the customer assay system, for example, via email, CD, memory card / memory stick, flash drive, and / or via a remote interface between the system and the CD server. The storage medium contains a consumable data repository containing the consumable data, and the assay system is configured to receive updates to the repository from a remote storage medium, for example, via email, CD, memory card / memory stick, flash drive, and / or via a remote interface.

[0090] Figure 3 shows the verification of consumable data by system software and the results of the procedure. First, the customer inserts the consumable (301) along with the consumable identifier (302) into the system (303) (or otherwise contacts the consumable identifier 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 the 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 its analysis are not displayed until the consumable data is verified by the system software, or Customer service is unavailable in all other cases.

[0091] Furthermore, the present invention provides a method for controlling customer access by a vendor to an assay system and / or assay consumables, wherein the system includes a system identifier, the method involves receiving the system identifier from the customer, the system identifier being transmitted to and received by a vendor computing system, and identifying the system identifier by vendor, and (i) To enable full access to the apparatus and / or assay consumables used in the apparatus, (ii) To enable partial access to the apparatus and / or assay consumables used in the apparatus, (iii) Denying access to the apparatus and / or assay consumables used with the apparatus This includes performing operations that involve

[0092] The system identifier includes information that uniquely identifies the assay system, such as a serial number or other identification codes 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 being prepared for shipment or transfer to the customer.

[0093] In one embodiment, the step of enabling either full or partial access includes sending an access code from the vendor to the customer, thereby enabling access to the system. The access code may be a full or partial access code that enables different functions of the system. In one embodiment, the access code is a partial access code that allows the system to operate in 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 Figure 4, the CD server (401) includes a master repository (402) containing one or more directories of (i) consumable data, (ii) system data, and (iii) customer data. Furthermore, or alternatively, data contained in one or more directories (i) to (iii) can be supplied to the master repository via 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, customer data is supplied to the CD server via an interface to supplemental vendor customer directories that maintain customer data. Customer data can be stored in one or more supplemental vendor-customer directories, each connected to the CD server via an interface. The master CD database includes multiple CD directories, each generated for a consumable or lot of consumables. The master system identifier directory contains a unique system identifier for each system manufactured and / or distributed by the vendor. The supplemental vendor-customer directory, which interfaces with the master customer directory and / or CD server, contains information related to each of the vendor's customers, such as customer and contact information for individual customers, invoice creation information, pricing information, shipping information, and order history.

[0095] In a specific embodiment, when the system is manufactured and / or prepared for shipment, the vendor generates a system identifier for the system. The system identifier is a master copy. The system identifier is stored in the system identifier directory or can be obtained through the 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 purchase orders, relevant quotes, pricing, terms of sale or lease, and relevant service agreements, 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, the unique system identifier for the system is associated not only with any relevant purchase information by that customer but also with the customer who purchased the system from the master repository. Also, shipping information for the system to the customer is available in the customer directory(s), and when 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 a preferred embodiment, has completed installation and training on the system, the system software may, if necessary, connect to the CD server via 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 this confirmation. Alternatively, if remote connection is not possible on the system, the customer receives a verification code, system login, and / or email address from the system once the system is installed and training is complete, and the customer logs into the CD server via that verification code, system login, and / or email, thereby providing a customer login to the CD server which 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, accessible to the customer via a password, and / or the customer and the CD server may communicate via an email exchange server configured to send and receive email between the customer and the CD server (collectively referred to as the “indirect interface” between the customer and the CD server).Therefore, the vendor can communicate with the customer via a direct system-CD interface (referred to as the "direct interface") and / or via an indirect interface. As described above, the customer can then purchase consumables, the system reads the consumable identifier, verifies that the consumable data is stored locally, and receives the consumable data directly or indirectly from the CD server if necessary, and the system can then use that consumable or lot.

[0096] When customers and vendors have means of communicating via direct or indirect interfaces, they can interact in various ways, and communication between parties can become 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, customers can browse and / or purchase vendor products, receive customer assistance, schedule service calls, etc., via direct or indirect interfaces. Because vendors can track customer activity and purchases very closely via consumable identifiers / CD servers, they can tailor their interactions with customers based on that information. For example, because vendors know the customer's order history, they can send the customer promotional materials related to those products the customer has purchased / used in the past. Similarly, as vendors track information related to a customer's system, they can send customers preventative 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 information on system services, warranty repairs, maintenance contract information, and reminders.

[0097] In one embodiment, the vendor tracks the use of consumables by the assay customer, and the consumable data stored in the assay system includes system-consumable usage information. Tracking of consumable usage To facilitate this, the assay system is configured to send system-consumable usage information directly or indirectly to the CD server. When 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 to the CD server by the customer. 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 that 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. When 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 the individual customer's previous consumable and / or system usage.

[0098] Furthermore, the vendor may track and / or communicate to the customer system maintenance information, such as the use of monitoring systems and / or system components, inspection history, system troubleshooting information, results of diagnostics performed on the system, control diagram creation, periodic maintenance scheduling, warranty information regarding the system and / or system components, or combinations thereof. System software can be programmed to monitor various components of the system and, automatically or when prompted, send monitoring reports to remote computing systems and / or maintenance technicians. If the direct interface is not enabled, the system may prompt the customer to send monitoring reports to the CD server via the indirect interface. Alternatively, such system monitoring reports can be accessed by maintenance technicians responsible for on-site or remote maintenance and / or inspection of the system. In specific embodiments where the direct interface is enabled, the CD server monitors the use and / or warranty information of system components and schedules periodic system / component maintenance and / or upgrades by maintenance technicians based on the lifespan and / or warranty conditions of standard system components. Furthermore, the CD server manages a log of the inspection history of a given assay system and can schedule service calls by maintenance technicians (this can be done using either a direct or indirect interface). The remote computing system can also send individual assay system software updates via a direct or indirect interface.

[0099] Furthermore, one or more of the following system components and / or operations may be controlled by system software, including, but not limited to, the expected motor position during normal use, position errors for each expected motor position, corrective actions taken by the system in the event of a motor positioning error, attempted corrective actions, and error frequency, and the usage of the component, such as the approximate amount of time the component was powered on by the system. In a preferred embodiment, the system also tracks the relative lifespan of its component under normal operating conditions, lock mechanism attempts, retries, and failures, barcode identifier controller attempts, retries, and failures, the 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, including a system designed to perform electrochemiluminescence measurements using assay consumables, the system software records the time the analyzer camera was powered on and its approximate temperature, the latch usage cycle within the system, attempts, retries, and failures of the barcode identifier controller, consumable lock and unlock events, ECL waveform voltage and integrated current, accuracy and failure of image processing analysis, consumable type, kit, owner, consumable identifier (e.g., barcode), and timestamps per consumable run within the system. The system can also be programmed to monitor a lamp, or a combination thereof. Furthermore, the system software can monitor experiments conducted on the system, such as when, by whom, and what type of consumables(s) were used in the experiment. This system usage monitoring information can be sent to the CD server via direct and / or indirect interfaces so that the vendor can schedule appropriate support, inspection, and / or maintenance for the system.

[0100] In another embodiment, the vendor can provide support for use and / or purchase by tracking the use of assay systems. For example, the vendor can track the use and purchase history of consumables, and based on the consumable data of 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 use of assay system / consumable types also allows the vendor to track the relative schedule / frequency of consumable use and notify the customer when their 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 consumable orders and confirm them with the vendor. If the direct interface is not enabled, the system can monitor consumable use and inventory and prompt the customer to replenish the supply of one or more consumables. (In this regard, by receiving lot size information via consumable identifiers and monitoring consumable usage, the system can prompt the customer when the available consumable supply of a given lot has decreased to a minimum level.) Furthermore, by tracking consumable usage, vendors can send customers information about custom assay design services for specific custom consumable types based on their order / consumable usage history. Direct or indirect interfaces can also provide customer training modules, consulting services, and / or live customer service support capabilities (i.e., live chat) to facilitate the customer experience (collectively referred to as system and / or consumable technical support information).

[0101] In another embodiment, tracking consumable / system usage allows a vendor to send promotional materials to customers. For example, when a new type or lot of consumables is conventionally 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 their previous use. The remote computing system may also send the customer references that may relate to one or more consumables / systems used by the given customer.

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

[0103] A. Assay system, consumables, and method of use The assay systems intended by the present invention are used to carry out any type of diagnostic or analytical method known in this technology. Such analytical methods include, but are not limited to, clinical chemical assays (e.g., measurement of pH, ions, gases, and metabolites), hematological 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 tests), oligonucleotide ligation assays, and nucleic acid hybridization assays. Such analytical methods include, but are not limited to, nucleic acids, nucleotides, oligonucleotides, DNA, RNA, PNA, primers, probes, antibodies, or fragments thereof, antigens, drugs or prodrugs, and small molecules such as streptavidin, avidin, and biotin. Any biological reagents that may potentially be used can be used in the system.

[0104] These systems may be portable, such as handheld devices, and / or operated alone or in combination with one or more additional components, assay devices, or systems in a fixed laboratory or field environment. These systems can be used in a wide variety of applications, from field work to laboratory environments, in a diverse range of industries, including but not limited to medical, clinical, forensic, pharmaceutical, environmental, veterinary, biological, chemical, agricultural, waste management, hazardous chemicals, and drug testing, as well as in defensive applications, such as for the detection of biological weapons. The assay systems, assay readers, and consumables used in this invention can detect the target specimen by any suitable method, including but not limited to optical, electromechanical, radio wave, electromagnetic, colorimetric, fluorescence, chemiluminescence, electrochemiluminescence, radiochemistry, nuclear magnetic resonance, enzyme, fluorescence, particle count, and cell count-based detection.

[0105] (i) Specific embodiments of assay consumables Assay consumables include a device on which one or more processes of an assay process are performed, and such device may include one or more test sites on which assay measurements are performed. In one embodiment, an assay consumable includes at least one assay test site for an assay. A test site may include at least two of several distinct assay domains, domains containing reagents for measuring different specimens. Furthermore, a consumable may include multiple test sites for several individual assays. Alternatively, an assay consumable may be a component that provides reagents, or other assay components used by the system to perform the assay. For example, an assay consumable may be a container having one or more compartments for holding assay reagents. Assay consumables (or test sites within them) may be disposable, or assay consumables may be reusable. Assay consumables can be configured to perform one or more tests (sequentially or in parallel).

[0106] A test site, as used herein, refers to an area of ​​a consumable that holds, contacts, and / or examines a sample. A test site may include multiple distinct assay domains, at least two of which contain reagents for measuring different specimens. A consumable may include multiple test sites that can hold, contact, or otherwise examine distinct quantities (aliquots) of the same sample and / or large quantities 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 or multiple measurements on a sample volume (e.g., measurement of multiple different specimens in a multiplexed assay format). Depending on the specific requirements of the application, a consumable with multiple test sites may be configured to use all of its test sites in parallel, use its test sites at different times (e.g., assigning unused test sites to be used when a new sample is delivered to the assay system), or enable a combination of both operating modes.

[0107] Assay consumables may be any structure useful for diagnostic purposes, and their structure can be determined by the specific assay format or detection method used 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 contain integrated fluids for assay processing), multiwell plates, slides, assay tips, lateral flow devices (e.g., strip tests), inflow devices (e.g., dot blots), pipette tips, solid support structures for biological reagents, etc. In certain embodiments, the test site of the assay consumable is defined by a compartment of the assay consumable, such as a well, chamber, channel, or flow cell. The assay consumable and / or test site is used to perform assay measurements according to one or more specific detection methodologies. The above components may be included. Depending on the function of the consumables and the detection modality used by the assay system, examples of such components may include, but are not limited to, a lateral flow matrix, a filtration matrix, an optical window, sensors (e.g., electrochemical sensors and optical sensors), solid support for binding reactions (e.g., coated slides, tips, beads, pins, coated filtration matrices or lateral flow matrices, tubes, etc.), reagents (in dry or liquid form), electrodes, sample selection membranes, etc.

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

[0109] In another embodiment, assay consumables and associated assay systems or assay readers can perform multiple assays. A multiple 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 with respect to the volume of the sample at individual test sites. Multiple measurements may include, but are not limited to, (i) multiple reproductions of measurements for a sample, (ii) multiple measurements for a particular sample (i.e., multiple non-identical measurements for the same sample, e.g., measurements that differ in format or identity of the assay reagents used), and / or (iii) measurements for multiple different samples. In one specific embodiment, assay consumables are configured to perform multiple measurements, including at least two assays for two different samples, at one or more test sites.

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

[0111] In one embodiment, the assay test site includes a plurality of distinct 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 signals generated at each domain and tie them to the determination of the presence or amount of the corresponding analyte (a process that may include the application of additional consumable data such as signal thresholds and / or calibration parameters). Such multiplexing information can be provided as consumable data and / or associated with a consumable identifier can be

[0112] A test site can be configured to perform multiple multiplexed measurements (for example, it may contain multiple distinct assay domains, each domain containing reagents for measuring different samples). In one embodiment, an assay consumable may contain 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 the multiplexing information (as described above), including the number, identity, and differentiating features of individual measurements within the test site, assay domain, and / or sector, but also the location and identity of the test site, assay domain, and / or one or more sectors (for example, the specific location, identity, and / or assay reagent of the assay domain within each test site). Furthermore, 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. Additionally, identifiers and / or consumable data may include information about assay consumables or the assay format and specific processing steps used for the test sites, assay domains, and / or sectors of the assay consumables. Identifiers and / or consumable data may also include information about analytical methods that need to be applied by the system when the assay is performed to analyze the assay output at a given test site, assay domain, and / or sector, and optionally to provide results that combine the outputs from multiple assays at the test site, assay domain, and / or sector.

[0113] The test site can be configured in any suitable configuration depending on the geometry of the consumable and / or the type of assay performed using the consumable. In one embodiment, the test site is configured as wells and / or chambers in an assay consumable. For example, the assay consumable of the present invention may be a multi-well plate (e.g., a 24-, 96-, 384-, or 1536-well plate), and the wells of the plate may 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.) separate assay domains. A multi-domain multi-well plate adapted to perform assay measurements using electrode-induced luminescence measurements (e.g., electrochemiluminescence measurements) is described in U.S. Application No. 10 / 238,391, filed September 10, 2002, titled "Methods and Reader for Conducting Multiple Measurements on a Sample," which is incorporated herein by reference. Not only the specific identity of each domain, test site, and / or sector, and the reagents coupled to that domain / test site / sector, but also the exact configuration of the domains, test sites, and / or sectors of the assay consumable can be included in the information stored in the assay consumable identifier and / or provided as consumable data. Further, the use of a given domain, test site, and / or sector of the assay consumable can also be recorded in the identifier to track the use of the consumable in the assay system.

[0114] Assay consumables can be used in multiple different assays, and this versatility leads to various appropriate configurations of associated consumables. In a single assay format, the same sample is measured in different assay domains within a test site, and the different assay domains are designed to measure different characteristics or activities of the sample. Information about the assay formats that can be used with assay consumables, test sites, and / or assay domains 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 about the analytical methods that the system needs to apply when an assay is performed to analyze the assay output at a given test site and / or domain and compare that output to assays at different test sites and / or domains.

[0115] An example of a multiple assay consumable is described in U.S. Patent No. 2004 / 0022677, the disclosure of which is incorporated herein by reference in whole. Such assay consumables include 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 may be configured as wells and / or chambers. These test sites and / or assay domains include one or more electrodes for inducing luminescence from the material of the test sites and / or assay domains. The assay consumables may further include assay reagents in liquid or dry form in the test sites, such as wells or chambers.

[0116] In addition to the test site and assay domain, assay consumables or multiwell assay plates may include several additional elements, such as the top of the plate, the bottom of the plate, the wells, the working electrode, the counter electrode, the reference electrode, the dielectric material, the electrical connections, and the assay reagents. The wells of the plate can be defined by holes or openings in the top of the plate, or as depressions or depressions 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 made of 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 96-, 384-, and 1536-well plates, where the wells are arranged 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. Multiwell assay plates are suitable for applications where the plate is disposable, either for single use or multiple uses. Various configurations for a suitable assay plate can be used in the present invention, including, but not limited to, the configurations shown in Figures 11A, 12A, 13A, 13B, 14A, 15, and 16A of U.S. Patent Application No. 2004 / 0022677, each of which is incorporated herein by reference. As stated above, the specific configuration and identity of the assay test sites, domains, and / or sectors of the assay consumable may be included in the information stored in the assay consumable identifier and / or provided as consumable data.

[0117] (ii) Specific Embodiments of Assay Readers Assay consumables can be used in an assay reader that can be used to induce and measure luminescence, such as electrode-induced luminescence or electrochemiluminescence, in an assay performed in or on an assay consumable, such as a multiwell assay plate. The assay reader can also induce and / or measure current and / or voltage at electrodes, for example. The assay reader may incorporate, for example, one or more photodetectors, a light-shielding enclosure, a mechanism for transferring the assay plate into and out of the assay reader (and especially into and out of the light-shielding enclosure), a mechanism for aligning and oriented 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), a mechanism for making electrical connections to the plate, one or more electrical energy sources for inducing luminescence, and appropriate devices, electronics, and / or software. The assay reader may also incorporate mechanisms for storing, stacking, moving, and / or distributing one or more multiwell assay plates (e.g., plate stackers and / or plate conveyors). The assay reader can be configured to measure light from a multiwell assay plate (i.e., a group of multiple adjacent assay domains within a plate) and / or from the entire plate substantially simultaneously or concurrently by measuring light sequentially from multiple sectors or regions of the plate. The assay reader may also incorporate additional microprocessors and computers to control specific functions within the system and to assist in data storage, analysis, and presentation. (U.S. Patent Application No. 2004 / 0022, incorporated herein by reference) A variety of suitable assay reading device configurations, including but not limited to those shown in Figures 17-23 of No. 677, can be used in the present invention.

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

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

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

[0121] An additional embodiment of the assay system of the present invention is shown in Figure 9(a). The assay system (900) includes a plurality of subsystems positioned on a table or platform (901), each subsystem being operablely connected to a robot subsystem (902) configured to access one or more consumables, such as multiwell assay plates, and to move from one subsystem of the assay system to another. The plurality of subsystems include an assay reader (903), an assay consumable storage unit (904), a dispensing subassembly (905) including at least one dispensing probe (906) fixed to a dispensing head gantry (907) that provides X, Y, and Z motion of the probe to and from the dispensing tip washing station (908) and plate washing subassembly (909), an orbital oscillation subassembly (910), a liquid reagent subassembly (911), and an electronic subassembly including a computer (912). The computer also includes a user interface (not shown). The assay system may also include a multiwell plate preparation platform (913) positioned on a table (901) and configured to allow dispensing of liquid into and / or from one or more wells of a multiwell assay plate positioned on a preparation platform. Optionally, the platform (913) is positioned on a linear track that allows movement of the platform to and / or from the dispensing subassembly (905) in a direction parallel to the plane of the table. Alternatively, or further, one or more subcomponents of the platform and / or the dispensing subassembly are configured to move relative to each other in the X, Y, and / or Z directions. The robotic subsystem is configured to move one or more plates to and from the plate preparation platform, plate washing subassembly, orbital shaking subassembly, assay reader, and consumable storage unit.As shown in Figures 9(b) to 9(c), the assay system may further include an enclosure (914) containing one or more environmental control units, such as thermoelectric cooling units (915(i) and 915(ii) respectively), which are placed inside the enclosure. In one embodiment, the enclosure is configured to house the assay system in order to maintain the internal temperature inside the enclosure at approximately 20-30°C.

[0122] The assay system shown in Figure 9(a) is configured to process multiwell assay plates that have undergone manual offline sample preparation steps, using an automated sample preparation system or an automated sample preparation system integrated with the assay system via an additional robotic subsystem. Furthermore, the reagents used to perform the assay on the assay plate can be provided in one or more additional assay plates, such as a reagent plate and / or dilution plate, i.e., plates containing the specific reagents used to perform the assay. In a specific embodiment, the sample can be added offline to the sample plate, the system can use one or more diluents and reagents which can be stored in a diluent plate and / or reagent plate, respectively, and the assay can be performed on a test plate, i.e., a plate to which reagents and / or reagents are added during one or more processing steps by the system.

[0123] In specific embodiments, the system processes plates in batch mode. That is, all wells of a plate are operated by the system or processed simultaneously by the system before moving to the next step and / or the next plate. For example, the system processes 96 wells... When configured to use thiwell plates, all 96 wells of the plate are simultaneously exposed to each step in the assay system before the system moves to the next step and / or to the next plate. Figure 9(d) shows the sequence of operations 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 the storage unit of the assay system, the set includes a sample plate, a diluent plate, and a test plate; (b) the diluent and sample are removed from the diluent plate and sample plate, respectively, and added to the test plate; and (c) the test plate is moved to the orbital shaking 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 has completed its 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 detection antibody solution plate to the plate preparation platform, (c) adding the detection antibody solution to the test plate, and (d) moving the test plate to the orbital shaking 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 read buffer plate to the plate preparation platform, (c) adding the 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 the 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 plates from one subsystem to another at intervals of up to 3 minutes (3 minutes / plate).

[0124] In one embodiment, the assay reader integrated with the assay system 900 is an assay reader described herein, such as the apparatus 500 shown in Figures 5 to 7. In a specific embodiment, the assay reader is the apparatus described and claimed in U.S. Patent 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, Rockville, Maryland. Alternatively, the assay reader is a MESO SECTOR S600, also available from Meso Scale Discovery, Rockville, Maryland.

[0125] The assay consumable storage unit (904) can be configured to store any type of consumable used in performing assays on the assay reader. In a specific embodiment, the storage unit is a multiwell plate storage unit configured to store multiple multiwell assay plates. In one embodiment, the plate storage assembly is configured as multiple shelf subassemblies, each having a shelf unit made to accommodate a multiwell assay plate. The shelf subassembly includes the top of the housing, the rear of the housing, the left housing wall, and the right housing wall, as well as multiple storage units placed inside the housing, each storage unit including a plate entry opening. The shelf subassembly may include an MxN linear array of storage units, where M and N are integers such as 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 dispensing subassembly (either alone or in combination with the platform) provides independent X, Y, and Z movements of the probe so that the probe can access sample plates, reagent plates, and / or test plates (if necessary). The dispensing subassembly may also include a suitable pump and valve for controlling the pipette and / or probe (not shown). The pump is used to transport fluid by the dispensing subassembly. Those skilled in the art can select a suitable pump for use in the apparatus, including but not limited to diaphragm pumps, peristaltic pumps, and syringe (or piston) pumps. The pump may also include a multiport valve to allow the pump to push and pull fluid from different fluid lines. Alternatively, multiple pumps can be used to independently control fluid in different fluid lines.

[0127] In one embodiment, the dispensing probe can use a fixed or disposable dispensing tip. In a specific embodiment, the dispensing probe uses a fixed dispensing tip. If disposable tips are used instead, they can be stored in a dispensing tip storage / disposal compartment (not shown). An arm / track of the pipette subassembly allows the probe to access the tip storage / disposal compartment for loading and removing tips after use. In addition to moving reagents and samples from one well to another, a fluid line connected to the dispensing probe may be connected to a working fluid or diluent so 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 volume sensor to detect when the probe is in contact with the fluid in the tube or well. In a specific embodiment, the dispensing probe includes a multi-channel dispensing probe that enables simultaneous fluid transfer to multiple wells of a multi-well plate. For example, the dispensing probe includes a 96-channel dispensing head that enables simultaneous fluid transfer to a 96-well plate. In one embodiment, the dispensing head and the corresponding fixed dispensing tip are available from Apricot Designs in Covina, California. Generally, when fixed dispensing tips are used, they are supplied by dispensing probe suppliers, such as Apricot Designs in Covina, California. 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 individual drawers capable of accommodating a standard disposable tip box (available from Axygen, Qiagen, or Rainin) and a removable waste container for used dispensing tips. To remove the tip, the pipette probe is translated horizontally to position the shaft in the slot, and then translated vertically until the pipette tip is removed by the bracket. During operation, the specific slots used are selected using a pattern or random pattern set so that the used pipette tips are evenly distributed along the width of the waste container.The tip dimensions vary according to the dimensions of the dispensing probe, the volume of sample / reagent being metered and dispensed, and / or the dimensions of the plate in which the tip is placed. In one embodiment, the tip volume ranges from approximately 100 μL to 550 μL. In another embodiment, the tip volume ranges from approximately 100 μL to 250 μL.

[0128] The plate washing subassembly may be any suitable commercially available microtiter plate washing system, such as a plate washing subassembly available from BioTek Instruments, Inc. in Winuski, Vermont, including, but not limited to, the 405 Touch Washer, 405 LS Washer, Elc405x Select Deep Well Washer, or Elx50 Washer. Similarly, the robot subsystem may be any suitable commercially available desktop robotic system, such as a system available from Precise Automation, Inc. in Fremont, California.

[0129] A liquid reagent subassembly includes multiple liquid reagent and waste compartments for use in one or more steps of an assay performed in the instrument. Each reagent / waste compartment includes a compartment body that encloses an internal volume, and a reagent or waste port for delivering reagents or receiving waste. The volume of the compartments in the subassembly is the relative ratio of the volume of the compartment body occupied by the reagents and waste. However, it is adjustable to allow for adjustments as, for example, reagents are consumed in the assay and returned to the compartment as waste. The total internal volume of the compartment body may be less than about twice, less than 1.75 times, less than 1.5 times, or less than 1.25 times the amount of liquid stored in the body, such as the amount of reagent initially supplied to the compartment, thus minimizing the space required for waste and reagent storage and enabling convenient one-step reagent replenishment and waste removal. In certain embodiments, the device has a reagent compartment slot configured to receive the compartment and provide fluid connections to waste and reagent ports via optionally "push-in" or "quick-release" 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 sensors, such as optical sensors, 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 the fluid in the reagent tank and waste tank for real-time tracking of reagent use 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 warns the user to remove the reagent compartment and / or waste compartment to replenish and / or empty its contents. In one embodiment, the motor of the dispensing probe is in communication with the sensor or scale, and when the reagent compartment and / or waste compartment reaches a minimum or maximum capacity, the dispensing probe motor is deactivated by the device. For example, the probe sensor relays information about the compartment's capacity to instrument software, which then pauses any further dispensing operations.

[0131] The reagent compartments and / or waste compartments may be provided as foldable bags located within the subassembly body. One of the reagent compartments and / or waste compartments may be provided as a foldable bag, and the other as the compartment body itself (i.e., the capacity of the compartment body excluding the capacity defined by any foldable bags within the compartment body). In addition to the first reagent compartments and / or waste compartments, the reagent cartridge may further include one or more additional foldable 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. Furthermore or alternatively, waste can be pumped into an external drain pipe or container. In one embodiment, the liquid reagent subassembly also includes a reagent tank used during the execution of assays in the instrument. In one specific embodiment, each reagent compartment is connected via a fluid line to a reagent tank that contains a large quantity of reagents during the assay. The fluid line to the pipette subassembly runs directly from the reagent tank. In practice, reagents are stored in a reagent compartment, and predetermined amounts of reagent are metered and dispensed from the reagent compartment to the reagent tank. The instrument draws fluid from the reagent tank for use in the assay. Both the reagent compartment and the reagent tank can be connected to independent fluid sensors. A fluid sensor in the tank monitors the internal volume, and if the internal volume falls below a predetermined level, reagent is metered and dispensed from the reagent compartment to the tank. Similarly, if the internal volume of the reagent compartment falls below a predetermined level, the fluid sensor signals the operator to replace or replenish the reagent container. Since fluid is exchanged in the reagent compartment without interrupting the instrument's assay processing, the dual reagent compartment / tank assembly ensures that the instrument continuously supplies fluid to the assay as the assay is performed by the instrument.

[0132] In one embodiment, the orbital shaking subassembly (910) is the balanced assay consumable shaking device described and claimed in U.S. Patent Application No. 62 / 143,557, filed Apr. 6, 2015, the disclosure of which is incorporated herein by reference in its entirety. In particular, the orbital shaking device 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 contain a consumable and including a consumable locking mechanism, and (ii) a counterweight positioned within the storage assembly at a height corresponding to the center of mass of the storage assembly and the orbital platform. The orbital shaking device further includes a rotating shaft extending vertically from the shaker assembly to the storage assembly, and the counterweight is operably connected to the rotating shaft.

[0133] The assay system shown in FIG. 9 may include a table or platform such as 901, or the system can be constructed and configured on a laboratory benchtop. In the system shown in FIG. 9(a), the assay system is positioned below the tabletop (901) and is positioned on a table including one or more shelf 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, various systems can be distributed across the benchtop in the same X-Y plane (not shown).

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

[0135] Additional embodiments of the assay system of the present invention are shown in Figure 10 and its subdivisions. The assay system (1000) comprises a plurality of subsystems positioned on a table (1001), each subsystem being operably connected to a robot subsystem (1002) configured to access one or more consumables, such as multiwell assay plates, and to move from one subsystem to another in the assay system. The robot subsystems of the instrument shown in Figure 10 and its subdivisions each comprise one or more dispensing subsystems (1021) each containing one or more dispensing tip heads, such as multichannel dispensing tip heads, used to meter / dispense / draw fluid into / from the wells of a multiwell plate, for example. The dispensing subsystems are fixed to a gantry (1022) in the robot system, which allows the dispensing tip heads to move through the assay system in the X, Y, and Z directions. Multiple subsystems within the assay system include an assay reader (1003), an assay consumable storage unit (1004), a plate washing subassembly (1005), a plate shaking subassembly (1006) including one or more independent plate shaking devices (for example, as described above with reference to Figure 9, element 910 excluding the shaker 910 has a dedicated assay consumable storage unit 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 electronic enclosure (1009) configured to house a system control computer, keyboard, display, wireless router, and power supply (not shown). The electronic components are indicated as elements (1010, 1011) and are located below the reader (1003), as shown in Figure 10(a), and can be positioned in the electronic enclosure (1009). The assay system may also include a platform (1012) positioned on a table (1001) and configured to allow dispensing of liquid into and from one or more wells of a multiwell assay plate positioned on a preparation platform.The robot subsystem moves one or more plates to / from the platform, plate washing subassembly, shaking subassembly, assay reader, and consumable storage unit. The system is configured as follows: The platform includes a consumable identifier controller (e.g., a barcode reader (1013)) configured to read assay consumable identifiers positioned on a multiwell plate, for example, positioned at the bottom of a plate or tube placed on a reagent rack or tube holder; a dispensing tip storage compartment (1014) configured to accommodate dispensing tip boxes of varying sizes (e.g., 1015 and 1016, 1000 μl and 350 μl tips, respectively) as needed; 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 a plate(s) and / or reagent rack; and a third consumable identifier controller (not shown) configured to read identifiers on a consumable box located outside the system housing (not shown). In one embodiment, the third consumable identifier controller is separate from the assay system and fixed to the outer housing of the assay system, or positioned on the front panel or side panel of the housing of the assay system, and is configured to allow the user to access the 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, such as a thermoelectric cooling unit, i.e., a TEC (1019), placed within the assay system. Although the TEC is indicated as assay system (1000), any environmental control system, heat exchanger, or cooling device can be used.

[0136] Unlike the assay system shown in Figure 9(a), the instruments shown in Figure 10 and its subcategories are configured to perform all sample preparation steps onboard, as well as all assay processing steps required for performing the assay. Furthermore, the user interface of the assay systems in Figure 10 and its subcategories is configured to display step-by-step instructions to the user for the appropriate sample / reagent preparation steps that need to be performed manually before the system performs the assay. The sample / reagent preparation steps and individual assay steps performed by one or more subsystems of the assay system may differ from one assay protocol to another. Detailed examples of the diverse assays performed by the assay systems in Figure 10 and its subcategories, 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, Maryland), are described below.

[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) to 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 hold liquids spilled from various reagents, diluents, and buffers during the operation of the assay system (1000). The capture trays (1024) preferably have a defined channel (1025) thereon to direct the flow of spilled liquids from the trays (1024) to a waste storage unit (1008). Preferably, the channel includes a peripheral channel (1025b) for guiding liquid away from the edge of the tray (1024) and an internal channel (1025a) leading to the waste assembly (1008). As best shown in Figure 10(d), optionally, the channel (1025) may contain a hygroscopic material to absorb spilled liquid and / or transport the liquid to the waste assembly (1020) by capillary action. Alternatively, the channel (1025) may be coated with a surfactant to reduce flow resistance.

[0138] Furthermore, the 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 expandable nature of the assay system (1000). Multiple holes (1027) are provided on the platform (1012) to accommodate additional laboratory equipment or other functional components.

[0139] In one embodiment, the assay reader used in assay system 1000 is an assay reader described herein, such as the apparatus 500 shown in Figures 5 to 7. In a specific embodiment, the assay reader is the apparatus described and claimed in U.S. Patent 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, Rockville, Maryland. Alternatively, the assay reader is a MESO SECTOR S600, also available from Meso Scale Discovery, Rockville, Maryland.

[0140] The assay consumable storage unit (1004) can be configured to store any type of consumable used in performing assays on the assay reader. In a specific embodiment, the storage unit is a multiwell plate storage unit configured to store multiple multiwell assay plates. In one embodiment, the plate storage assembly is configured as a shelf subassembly, which includes multiple shelf units, each made to accommodate a multiwell assay plate. The shelf subassembly includes a housing, a housing rear, left and right housing walls of the housing, and a housing containing multiple storage units placed inside the housing, each storage unit including a plate entry opening. The shelf subassembly may include an MxN linear array of storage units, where M and N are integers such as 2x1, 2x2, 3x3, 4x4, 5x6, or 6x5 arrays. 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 Figure 10(c), the assay consumable storage unit (1004) is redesigned to have not only a functional aspect but also a decorative aspect. In this iteration, the assay consumable storage unit is a single, integrated unit having several parallel shelf surfaces (1072) connected by several vertical supports (1074), as shown in Figure 10(r). Each storage unit in the upper row includes a raised corner (1076) made to the size and dimensions to hold reagent lids or equipped racks as shown in Figure 18 and its subsections below, when an engineer or robotic system (1002) places assay plates or racks on it. Preferably, as shown in Figure 10(c), the bottom horizontal shelf of the assay consumable storage unit is cantilevered and securely bolted alone to the platform (1012). The upper assembly of the assay consumable storage unit uses multiple, preferably two or more, upper assemblies and is fixed to the bottom horizontal shelf, with alignment pins used to maintain consistent positioning of the upper assembly. Preferably, the alignment pins are positioned away from the X and / or Y centerlines to minimize incorrect alignment of the bottom horizontal shelf and upper assembly. Several thumb screws, preferably three or more, are used to secure the assay consumable storage unit together. In addition, several Z-axis adjustment screws, preferably at least three, are provided to level the assay consumable storage unit (1004) as needed.

[0142] The advantage of having the bottom horizontal shelf installed separately from the upper assembly is the ease with which the assay consumable storage unit (1004) can be removed for repair, inspection, and access to its components from behind. Alignment pins and thumb screws further enable ease and accurate subsequent reinstallation of the upper assembly onto the bottom horizontal shelf.

[0143] The dispensing subassembly (1021) is supported on a gantry (1022) and powered by one or more motors to give independent X, Y, and Z motion to probes, such as one or more pipette tips, so that the probes can access troughs, tubes, and / or plates (if necessary). The dispensing subassembly (1021) also includes appropriate pumps and valves for controlling the pipettes and / or probes, and optionally a dispensing tip cleaning subassembly (not shown). The pump is used to transport fluid through the dispensing subassembly. Preferably, each pipette tip is independently controllable or independently disposable by control software, a controller, and motors(s). In other words, one or more pipette tips can meter and 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-diagnoses, etc. Those skilled in the art will be able to select a suitable pump for use in the apparatus, including, but not limited to, diaphragm pumps, peristaltic pumps, and syringe (or piston) pumps. The pumps also include multiport valves to allow the pumps to push and pull fluid from different fluid lines. Alternatively, multiple pumps can be used to independently control fluid in different fluid lines. In one specific embodiment, the dispensing subassembly includes an exhaust pipette. Optionally, the dispensing probe may include a fluid sensing function to detect when the probe comes into contact with fluid in a tube or well, as a means of minimizing the external wetted surface of the probe and a means of detecting the presence of liquid in a container, for example, using an ultrasonic volume sensor or pressure sensor.

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

[0145] In one exemplary example, a volume sensor is designed between pipette tips or between a pipette and a dispensing deck to detect contact between a disposable tip and the surface of a liquid contained in a tube, plate, or rack found on the dispensing deck. The dispensing deck is preferably conductive, and the pipette tip / pipette is 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 simplified parallel-plate capacitor, the capacitance is inversely proportional to the distance between the two plates. Quantitatively, the capacitance (C) in farads of the two overlapping plates is expressed as follows: C=κε o (A / d) In the above equation κ i This is the dielectric constant of the material between the two plates (dimensionless), ε o It is approximately 8.854 x 10 -12 F·m -1 The electrical constant is, A is the overlapping area between the two plates in meters. d is the distance between the two plates in meters.

[0147] For capacitance level sensing, the capacitance of the system takes into account 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 (e.g., air, liquid, plastic / glass container) between them is expressed as follows, 1 / C = Σ1 / C i , where the capacitance of each dielectric is C = κ i ε o (A / d i ) and is calculated individually, where in the above equation κ i is the dielectric constant of the material between the two plates (dimensionless), ε o is the electric constant of approximately 8.854x10 -12 F·m -1 , A is the overlapping area 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 as the thickness of a single dielectric (e.g., air between the pipette tip and the plate or the liquid in the rack) approaches zero causes a significant change in capacitance, enabling the system to recognize that the pipette tip is in contact with the liquid.

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

[0150] In one embodiment, the dispensing probe uses disposable dispensing tips stored in dispensing tip storage compartments (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 in 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 volume of sample / reagent to be metered and dispensed, and / or the dimensions of the plate in which the tip is placed. In one embodiment, tip volumes range from approximately 1000 μL to 50 μL. In another embodiment, tip volumes range from approximately 1000 μL to 350 μL.

[0151] As described above, the dispensing subassembly (1021) provides the probe or pipette tip with independent X, Y, and Z movements 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) before first use or periodically thereafter, thereby enabling the X, Y, Z, G (grip distance) and R (rotation) as well as the X, Y, and Z positions of the dispensing subassembly (1021) and its pipette tip, the robotic system (1002) and its gripper pad (1031) to be accurately indicated with greater precision and repeatability.

[0152] As best shown in Figure 10(e), the training plate or instruction plate (1035) is positioned on the platform (1012). Preferably, the training plate (1035) has dimensions and size similar to an industry standard assay plate (ANSI SLAS 1-2004) and is designed to accept the assay plate. It is designed to fit into an elongated hole (1036), also known as the rear (1036). The training plate (1035) may be a three-dimensional right-angle prism, or preferably hollow, and has a fixed periphery as well as an internal web member designed to provide rigidity and stiffness. An internal web member, including a curved member (1037) and substantially linear elements (1038), is provided for rigidity 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 the initialization procedure for the assay system (1000), a probe such as a pipette tip (1042) connected to a robotic system (1002) or preferably a pipette subsystem i.e., a pipette (1021) is brought close to the reference pad (1040), or preferably within 0.1 mm of the reference pad (1040), to determine the vertical i.e., the Z reference point. Preferably, the probe (1042) does not come into contact with 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 with the conductive training plate (1035) to determine the Z reference point and Z maximum value of the laboratory equipment without the probe (1042) coming into contact with the reference pad (1040).

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

[0155] Another alternative involves the use of optical distance sensors. Suitable optical distance sensors are commercially available from companies such as Keyence America, SensoPart, and Omega Engineering. The optical sensor is attached to or replaces the probe (1042) and is then used to measure the distance to a reference pad (or more) (1040).

[0156] This Z reference point is selected to be at the center of the corner wells in the XY plane of a 96-well microplate (8 rows x 12 columns) conforming to the industry standard ANSI SLAS 1-2004, and to be located on or near the top surface of the plate in the vertical Z direction. The dimensions and tolerances of the industry standard ANSI SLAS 1-2004 are described below. More specifically, the Z reference point is used to calculate the maximum Z value or highest height in the vertical direction for all laboratory equipment. Advantageously, having an accurate maximum Z value for laboratory equipment improves the reliability of dispensing and the setup and movement of the equipment.

[0157] The training plate (1035) may be reversible; that is, the bottom surface has the same characteristics as the top surface. In yet another variant, in addition to the Z reference point(s), X and Y reference points are also determined. In this variant, 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 to the assay plate(s) on the platform (1012). Accurate and consistent alignment is preferred to achieve proper acquisition (retrieval) and installation (insertion) coordinates of the assay plate or any other plate, rack, trough, tube, etc. The gripping areas (1044) are provided on the long and short sides of the training plate (1035), as best shown in Figure 10(f). During initialization or alignment, the training plate (1035) is positioned on the platform (1012). With the positioning enabled, the robot system (1002) positions its gripper pad (1031) on either the short or long side of the training plate (1035). In order to pick up and move the training plate (1035), the gripper pad (1031) will be positioned within the gripping area (1044), which is an area defined by several raised tracks. In this way, the gripper pad (1031) is identified and recorded not only by its Z height, but also by the processor controlling the robot system (1002), the relative distance between the pads (gripping distance), the location of the training plate in X and Y space, and the orientation (rotation coordinates) of the gripper pad (in degrees). This alignment information is stored and used to instruct the robot gripper pad (1031) to acquire the experimental equipment and place it in the appropriate location.

[0159] As shown in Figure 10(f), the outer circumference of the first surface (1043) of the training plate (1035), including the reference pad (1040), is smaller than the outer circumference of the opposing surface (1045), which has a bead track (1041) surrounding the periphery to provide a larger outer circumference. When determining the Z reference point, the opposing surface (1045), which preferably has a larger diameter and tighter tolerances, is inserted into the nest on the platform (1012). This allows for a sliding fit of the reference pad (1040) and more accurate and repeatable positioning. When determining the position of the gripper pad (1031) of the robot arm (1002), the first surface (1043), which preferably has a smaller periphery, is inserted into the 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 numerical control (CNC) milling machine, to achieve tight tolerances. The training plates can be machined to a flatness within a range of 1 / 5000th of an inch, or 0.127 mm. If there are dimensional differences between different training plates manufactured, these differences or variations can be verified, for example, by 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 are stored in any memory device and used to harmonize 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 rigidity, strength, and light weight. Preferred cast aluminum is ATP5 (Aluminum Tooling Plate 5) or a similar metal. For example, a suitable metal has a weight of approximately 2,400 to 3,000 kg / m 3 It must have a density in the range of approximately 60 to 80 HB, a tensile strength in the range of approximately 250 to 300 MPa, and a yield strength in the range of approximately 100 to 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 pad (1040) preferably has a diameter of about 1.46 mm ± 10%, and the distance from the center of the reference pad (1040) to the side of the training plate (1035) is about 7 mm ± 10%. As shown in Figure 10(e), the four reference pads (1040) coincide with the centers of the wells at the four corners of the 96-well microplate described above. Preferably, the training plate (1035) is 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 in contact with the gripping area (1044) Figure 10(bb) is substantially similar to those shown in Figures 10(aa) and 10(f), except that the raised track is not shown. Instead, the raised track is replaced by two rows of two depressions or divots (1044a) and (1044b). During initialization or alignment, a pair of small screws, such as size M1.5, is mounted through the gripper pad (1031) of the robot arm (1002) so that the ends of the screws protrude through the gripper pad. When the gripper pad (1031) is brought into contact with either the short or long side of the training plate (1035), the ends of the screws are aligned with either the divot (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 coplanar with the top of the training plate (035), 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 with the bead track (1041). The divots (1044a) and (1044b) are made to the size and dimensions to receive the end of a screw.

[0164] Advantageously, the screws are conventional screws, selected to work in conjunction with this embodiment of the training plate (1035), which includes space for storing screws and tools such as Allen wrenches for installing and removing screws. Slots (1044c) are provided on one or more sides of the training plate (1035), preferably on the shorter sides. The slots (1044c) have several holes (1044d) as shown in Figures 10(aa) and 10(bb), each made to the size and dimensions to receive and sink a single screw. Preferably, these holes (1044d) are threaded as well as the screws. The screw heads are pressed into the slots (1044c). Additionally, elongated slots (1044e) are provided for tools, and there is a single hole (1044f) for the body of a tool, such as an Allen wrench, to be inserted into the body of the training plate (1035). One or more internal holes (1044g) may be provided to accommodate the length of the tool. The head of the tool can be pushed / inserted into an elongated hole (1044e) to prevent it from protruding from the training plate.

[0165] In one embodiment, the training plate may have a barcode with its serial number affixed to it in order to enable automatic access to the dimensional information stored for the training plate.

[0166] Plate washing subassemblies are, for example, at BioTek in Winuski, Vermont. This could be any suitable commercial microtiter plate washing system, 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 robot subsystem could be any suitable desktop commercial robot system, such as a system available from Tecan Group LTD in Switzerland.

[0167] In specific embodiments, the plate shaking subassembly is an equilibrium assay consumable shaking device described and claimed in U.S. Patent No. 62 / 143,557, filed April 6, 2015, the disclosure of which is incorporated herein by reference as a whole and is illustrated herein by reference to Figure 9(a). In particular, the shaking subassembly may include a 2x3, 2x4, or 2x6 array of 20 storage units. Preferably, the plate shaker (1006) is an individual thermoshaker having a heater to maintain the assay plate placed thereon at a rising temperature. Such a thermoshaker is the BioShake 3000-T elm shaker from Q. Instruments of Jena, Germany. In one example, the plate shaker (1006) is set to a temperature about 3°C ​​higher than the operating temperature of the assay system. It can maintain a temperature of approximately ±0.5°C and up to approximately 37°C. Samples, buffers, reagents, etc., contained in the wells of assay plates can be mixed and incubated on these shakers.

[0168] Furthermore, the inventors have found that during assay runs, the reagents contained in the trough (1018), as well as the sample / reagent mixture on the assay plate on the plate shaker (1006), experience 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) can cause a change in the concentration of the substances contained in the assay plate due to evaporation. According to one aspect of the present invention, lids are designed for these containers.

[0169] An exemplary trough lid (1028) is shown as shown in Figure 10(g). The lid (1028) is made to be shaped and sized to fit securely onto the reagent trough (1018). The lid (1028) has a top (1029) and side walls made to be sized and sized to fit onto the top of the trough (1018), and a pattern of notches (1030) is created on the top (1029), for example by a laser cutter. The notches (1030) are designed so that the top (1029) can be bent, as shown, and so that a pipette subassembly or pipetter (1021) can insert the pipette tip into the reagent trough (1018) to collect the reagent. When the pipette tip is withdrawn, the notches (1030) allow the top to return to its original configuration. Any pattern of the notch (1030) can be used, as long as the upper part (1029) is bent to allow the pipette tip to enter and substantially restores its original configuration when the pipette tip is withdrawn. Exemplary patterns of the notch (1030) are shown in Figure 10(h). However, the present invention is not limited to any particular notch pattern.

[0170] The lid (1028) restricts the exposure of reagents contained in the trough (1018) to the internal space of the assay system (1000) to only the region bounded by the slit. Generally, an open trough may contain buffers such as tripropylamine (TPA), which may evaporate and result in loss. Restricting exposure restricts evaporation. To further restrict exposure, a second top (1029') with a different slit pattern facing the opposite direction may be added to the top (10 The lid (1028) is installed on the upper or lower part of 29) to create a winding path for evaporated gas to leak out. The lid (1028) can be made from a relatively rigid or non-elastomer material such as polyester, high-density polyethylene (HDPE), or polycarbonate, and the flexibility of the upper part (1029) is given by the cut pattern (1030). Alternatively, the lid (1028) can be made from an elastomer material such as natural rubber or synthetic rubber to improve flexibility, and optionally the cuts are made using a sharp cutting tool instead of a laser cutter to minimize material loss and the bonding area of ​​the cuts. Preferably, the lid (1028) is thermoformed or vacuum formed, and the cuts (1030) are punched out. Thermoforming is a process in which a plastic sheet is heated and its shape is formed by air pressure against a mold, while vacuum forming is a similar process, but vacuum is used instead of pressure.

[0171] To minimize the possibility that the trough (1018) is a pullout of the trough carrier shown in Figure 10(a) without a reference number, an elastomer block can be inserted between the troughs. Such an elastomer block has a body with projections on each side facing the adjacent trough. Each block then has two projections, preferably the projections having different sizes and / or volumes depending on the desired amount of gripping. For example, the projection facing the end troughs needs to have a larger volume than the projection facing the center trough.

[0172] The plate lid (1032) is used after the processing step is completed, the assay plate (1031) has been incubated and mixed on the shaker (1006), and then the assay plate (1 Since it is installed in (031), the plate lid (1032) shown in Figure 10(i) does not have a cut pattern. As described above, the shaker (1006) may be heated to a suitable incubation temperature. The heating promotes evaporation, especially when exposed to the ambient conditions inside the assay system (1000). The lid (1032) preferably includes a plurality of downward-facing depressions (1034). Vapors evaporated from the sample / reagent mixture in the wells (1051) in the assay plate (1033) will preferably condense in the depressions (1034), and the condensate will drip back into the wells (1051). Preferably, one depression (1034) is positioned above each well (1051) of the assay plate (1033). For example, in the case of a 96-well assay plate, 96 downward-facing depressions are provided in the lid (1032).

[0173] As best shown in Figures 10(j) to 10(k), the lid (1032) includes a skirt (1050) that rests on the top surface. When placed on top of a multiwell assay plate (1033), the outer circumference of the top surface rests on the outer circumference of the assay plate (1033), creating a contact line at (1052). The contact line (1052) provides flow restriction or a seal to limit evaporated gas or prevent evaporated gas 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] Furthermore, in the embodiments of the lid (1032) shown in Figures 10(i) to 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) provide another barrier to prevent evaporated vapor from leaking out. The effect 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 indentations (1034) along the skirt (1050) help prevent the lid (1032) from shaking the assay plate (1051) off the shaker (1006) during the shaking and incubation period. In addition, the indentations (1034) also function as a condensation enhancer to promote the condensation of evaporated vapor returning 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] Furthermore, to minimize inconsistent evaporation and condensation, the lid (1032) is preferably made of a hydrophobic polymer or other hydrophobic material, and / or the bottom of the lid (1032) is coated with or made hydrophobic with a hydrophobic coating.

[0177] The bottom surface of the lid (1032) can be made hydrophobic by micro-etching the surface to create miniature air pockets. These miniature pockets can produce a coarse microtopography, which acts as an air buffer preventing liquid from adhering to the surface. This is also known as the "lotus effect," after the hydrophobic properties of lotus leaves. This effect has also been observed on gecko skin. The coarse microtopography prevents water from coagulating with each other and preventing broad dispersion. Coagulated water would form larger droplets, fall away from the lid, and thereby promote condensation. Micro-etching can be achieved using a laser source known as TresClean (http: / / cordis.europa.eu / project / rcn / 200832_en.html). Furthermore, the hydrophobic surface also possesses antibacterial properties due to its ability to repel moisture.

[0178] Suitable hydrophobic polymers include poly(tetrafluoroethene), polypropylene, polyamide, polyvinylidene, and polyethylene. This includes, but is not limited to, polysiloxanes, polyvinylidene fluoride, polyglutinin, lyophilized hard film, silicones, rubbers, and / or mixtures thereof.

[0179] Furthermore, suitable hydrophobic coatings include polyethylene, paraffin, oil, jelly, paste, grease, wax, polydimethylsiloxane, poly(tetrafluoroethene), polyvinylidene fluoride, tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer, fluorinated ethylene propylene, and poly(perfluorooctylethylene acrylate). Suitable hydrophobic coatings include, but are not limited to, acrylates, polyphosphazenes, polysiloxanes, silica, carbon black, alumina, titania, hydrated silanes, silicones, and / or mixtures thereof. Also suitable hydrophobic coatings include perfluorooctanoates, perfluorosulfons, sodium ammonia lauryl sulfate, sodium laureth sulfate, alkylbenzene sulfons, sulfated or sulfonated fatty acids, salts of alkylallyloxypolyalkoxy sulfate alcohols, alkylbenzene sulfons, sodium dodecylbenzenesulfonate, fluorinated surfactants, sodium lauryl sulfate, sulfosuccinate mixtures, sodium dioctyl sulfosuccinate, and sodium sulfosuccinates. The surfactant may include, for example, sulfosuccinate, sodium 2-ethylhexyl sulfate, ethoxylated acetylene alcohol, high ethylene oxide octylphenol, high ethylene oxide nonylphenol, high ethylene oxide linear alcohols and secondary alcohols, ethoxylated amines of any ethylene oxide length, ethoxylated sorbitan esters, random EO / PO polymers for butyl alcohol, water-soluble block EO / PO copolymers, sodium lauryl ether sulfate, and / or mixtures thereof.

[0180] In the modified configuration, the upper outer periphery of the plate (1033) that rests on the outer periphery of the assay plate (1051) forming the contact line (1052) can be roughened, for example, with a wire brush or similar instrument, to increase the winding paths for gases and vapors, thereby minimizing the amount of vapor leakage. The bottom surface of the lid (1032) can be roughened to increase the aforementioned hydrophobicity and exhibit Cassi-Baxter behavior. It is known that microstructuring a surface amplifies its natural tendencies, and in certain cases, the hydrophobicity of a surface can be further enhanced if the roughened surface can trap vapors (e.g., air or other gases) (Casssi-Baxter equation). It is also intended that the bottom surface of the lid (1032) may be microstructured using methods known in the art, including but not limited to micromachining, lithography (photolithography, soft lithography (nanoimprint lithography, capillary lithography, micro-shaping in capillaries, microtransfer shaping), electron beam lithography), and plasma etching, as well as creating patterns or textures on the surface using chemical bath deposition, chemical vapor deposition, electrochemical deposition, layer deposition via electrostatic assembly, colloid assembly, sol-gel method, nanosphere lithography, water droplet condensation-induced pattern formation, and / or microablation. Hydrophobic materials, hydrophobic coatings, and hydrophobic surface treatments are disclosed in published international patent application WO2012 / 003111, which is incorporated herein by reference in its entirety.

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

[0182] The liquid reagent subassembly (1007) has multiple liquid reagent compartments and waste The device includes compartments for use in one or more steps of an assay performed by the apparatus. The reagent / waste compartment includes a compartment body that encloses an internal volume, and a reagent or waste port for delivering reagents or receiving waste. The volume of the compartment in the subassembly is adjustable so that the relative ratio of the volume of the compartment body 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 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, such as the amount of reagent initially supplied to the compartment, thus minimizing the space required for storing waste and reagents and enabling convenient one-step reagent replenishment and waste removal. In certain embodiments, the device has a reagent compartment slot configured to receive the compartment and provide fluid connections to the waste port and reagent port via optionally "push-in" or "quick-release" fittings.

[0183] 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 sensors, such as optical sensors, 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 the fluid in the reagent tank and waste tank for real-time tracking of reagent use 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 warns the user to remove the reagent compartment and / or waste compartment to replenish and / or empty its contents. Other liquid level detectors are available. Other exemplary liquid level detectors include multiple thermistors vertically positioned within each compartment, for example, at 1 / 4 mark, 1 / 2 mark, 3 / 4 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, indicating the amount of liquid contained in the compartment, as described above.

[0184] In one embodiment, the pump or motor of the dispensing subsystem (1021) communicates with these sensors or scales, and when the reagent compartment and / or waste compartment reach a minimum or maximum capacity, the dispensing probe motor is deactivated by the device. For example, the probe sensor relays information about the compartment capacity to the instrument software, which then pauses any further dispensing operations.

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

[0186] According to another aspect of the present invention, the assay system (1000) can control the temperature internally, when its panel or door (1056) is closed. To illustrate the internal components, the assay system (1000) is shown in Figures 10(a)–10(c) without the housing and door, but includes a front door and / or front panel, which is shown collectively as (1056). These doors and panels are closed before the assay system (1000) runs. Once the system starts running, it is preferable that the internal air temperature in the area above or near the platform on which the assay steps are performed remains comprehensively within the range of about 20°C to about 24°C. Once the operating temperature is selected according to the specific 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 on the platform (1012) or from position 26 to position 49 as shown in Figure 10(u) to cover the entire length of the shaker (1006). The assay system (1000) also has temperature sensors located at several locations to monitor the temperature(s) inside the assay system. The temperature readings are monitored by the system software described herein, and the user is notified if the operating temperature is outside the operating range. With the shaker temperature control turned off, the temperature of the liquid in the covered MSD plate placed on top of the plate shaker 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 the heat generated by the plate shaker (1006), which may incubate the assay plate with the aforementioned heating, and the assay reader (1003), which includes electromechanical components for optical sensors such as heat-generating charge-coupled devices (CCDs) or complementary metal-oxide-semiconductor (CMOS) devices, and a thermoelectric cooling device. The selected operating temperature is maintained by several TECs (1019), as best shown in Figure 10(c). In this particular example, six TECs (1019) are used. However, any number can be deployed. Preferably, two TECs are concentrated on the reader (1003) to dissipate the heat generated by the reader. The remaining TECs are used to control the selected operating temperature, and some of the remaining TECs may optionally be concentrated on a heated shaker (1006). Furthermore, some of the cooling applies to electronic devices (1010, 1011) or electronic devices housed in electronic enclosures (1009) as described below.

[0188] As shown in Figure 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 arrow (1046) and generates cold air at the top and bottom as indicated by arrow (1047). The cold air (1047) flows toward the front of the assay system (1000), cooling the enclosure, and is reversed by the closed door or panel (1056) and returns as warm air (1046), with the heat absorbed by the TEC (1019). Figure 10(n) shows a plan view showing all six exemplary TECs (1019). The returning warm air is directed to a specific area close to the center of the TEC. A perspective view Figure 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, forcing the cold air (1047) to flow upward and downward as described above. The baffles (1048) also direct the returning warm air to the sides of the baffles where heat is exchanged by the TECs. Additional heat exchange occurs on the hot sides of the TECs outside the enclosure of the assay machine (1000), where heat absorbed from inside the assay machine is exchanged with the atmosphere.

[0189] Furthermore, the shaker (1006) is designed to improve convective heating by allowing air to flow over the top of the shaker. It may be raised above the platform (1002) to allow flow not only upwards but also downwards.

[0190] Figure 10(p) shows the cooling of electronic devices (1010, 1011) preferably housed in an electronic enclosure (1009). Cooling of the enclosure (1009) utilizes the chimney effect by drawing in cold air (1047) from the bottom and drawing the cold air upward to cool the electronic devices (1010, 1011), and discharging warm air (1046) to the outside of the assay machine (1000) through a cooling channel (1049). Preferably, the cooling channel (1049) is 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 ambient cold air, push the air within the electronic enclosure (1009) to cool the warmed air, and discharge it through the chimney (1049).

[0191] Referring again to Figure 10(l), at least one computer screen or tablet (1058) is mounted on the glass surface (1060) of the assay system (1000). A pressure transducer, commonly used in touchscreens, is directly mounted or bonded to the glass surface (1060) and relies on the glass surface (1060) of the assay system (1000) to transmit pressure applied by the user's fingertip to the transducer, generating an electrical signal to the tablet or computer's CPU. At least one sound exciter (1062) also relies on the same glass surface (1060) to generate sound waves. The sound exciter (1062) is also mounted or bonded to the glass surface (1060). The exciter (1062) vibrates the glass surface (1060) to produce sound. Both the touchscreen and the sound exciter can be used in the graphic user interface (GUI) or user interface (UI) described herein.

[0192] To minimize or eliminate interference caused by the exciter (1062) to the pressure transducer of the tablet (1058), a minimum distance is preferably established between the exciter and the pressure transducer / touchscreen. While the human audible frequency range is approximately 20 Hz to 20 kHz, typical human speech occupies a significantly smaller range, such as approximately 2048 Hz to 8192 Hz (7th to 8th octaves). Preferably, the pressure transducers of the tablet (1058) are designed, selected, or adjusted so that they do not respond to the range of human speech, thereby allowing the visual and auditory devices to share the same glass surface (1060).

[0193] Furthermore, 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 in different colors depending on the status of the immunoassay being performed. In one example, the lighting may emit a constant green or blue light, flash or pulse green or blue while the system is running, emit yellow or red when an error is detected, and emit white when the assay is complete to indicate a satisfactory run. The same colors may also be displayed on a tablet (1058).

[0194] Another aspect of the assay system (1000) relates to how panels and doors (1056), which may be heavy and bulky, are supported on the system's frame. Referring to Figure 10(q), a flange system (1063) including a main hanging section (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 section (1066) is sized to be mounted on a support (1068) on the bracket (1064). It has a pair of corresponding C-shaped openings (1067). Once the vertical position of the door or panel (1056) is established to a satisfactory degree, bolts are screwed into the openings ((1069)) to fix the vertical position.

[0195] Furthermore, the horizontal position (XY plane) of the door or panel (1056) can also be adjusted by a cam (1070). The cam (1070) may have any shape, including a circular projection eccentrically mounted on a bracket (1064). More specifically, the cam (1070) is mounted via an axis spaced apart from the center of the circular projection. Preferably a polygonal or more preferably hexagonal nut is attached to the projection on the eccentric axis. Rotation of the nut will move the main hanging body (1066) horizontally on 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 a small amount of movement to the connecting bolt inside the ellipse.

[0196] Therefore, 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 and 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 the assay run can be monitored without the need for a user or technician 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 Figure 10(s), the platform (1012), all permanent components, and the table (1001) supporting the laboratory equipment / consumables have a length (L) of 85 inches ± n%, a height (H) of approximately 28 inches ± n%, and a width (W) of 33 inches ± n%, excluding the caster wheels. When assembled to the table (1001), each caster wheel has a height of approximately 4.5 inches ± n%. The opening (1078) for the plate washer (1005) is approximately 5.5 inches ± n% x 10 inches ± n%. The opening (1080) for the solid waste storage unit is approximately 4.5 inches ± n% x 6 inches ± n%. The opening (1082) for the reader (1003) has a length (L) of approximately 16 inches ± n%. The tolerance n% is preferably 10%, more preferably 5%, and more preferably 2.5%.

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

[0200] The reader (1003) is advantageously positioned within a recessed opening (1082), and the plate washer (1005) is positioned within a recessed opening (1078), providing clearance for the movement of the gripper pad (1031) and pipette system or pipette (1021) of the robotic system (1002), and leaving space on the platform (1012) for laboratory equipment and consumables. Furthermore, the reader (1003) is positioned off-center, for example, on the side of the table (1001), so that the heat it generates is away from the center of the assay system and dissipates more easily. (Gripper pad ( Both the apparatus (1031) and the pipette system or pipetta (1021) share the same gantry (1022) to save space. The assay consumable storage unit (1004) is cantilevered to the front end of the platform (1012), and the shaker (1006), as described above, is positioned toward the rear of the platform (1012) to leave space on the platform for laboratory equipment or consumables, allowing laboratory technicians to load consumables from the front and gripper pads and to retrieve and install consumables from the rear. The dimensions of the table (1001) and frame (1084), as well as the location / height combinations of the main components described herein, provide stability and space savings to the assay system (1000).

[0201] A top view of the layout of the laboratory equipment for the assay system is shown in Figure 10(u). For example, the relative locations of the assay reader (1003), such as the first barcode reader and the assay consumable storage unit (1004) protruding from the platform (1012), and the first consumable identifier controller 1013. Also shown in Figure 10(u) are pipette tips (1015) and (1016), a shaker (1006), a tube carrier (1017), and a trough (1018). As described above, the platform (1012) includes a line of holes (1027) numbered from 1 to 69 to facilitate the reference of the location of the laboratory equipment relative to the holes (1027). One or more grid position clips (1027a) are made to the size and dimensions to fit into the holes (1027) on the platform (1012) to assist in the positioning of the laboratory equipment.

[0202] Another configuration of the layout is shown in Figure 10(cc). The first consumable identifier controller 1013 is located closer to the shaker 1006, the pipette tips (1015) and (1016) are omitted, and the tip carrier (1026) is shown below. An exemplary location of 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) to 10(y). Figure 10(v) shows the power and internet connections. The power and Ethernet module (1085) is shown on the left and in relation to the UPS (1086). The UPS (1086) provides emergency power to the assay system (1000) in the event of a power outage. The UPS (1086) is connected not only to the router (1088) but also to the reader (1003) and the processor (1087) for the assay system (1000). The UPS (1086) is also connected to the washing machine (1005) and its pump, as well as to the robotic system (1002). As described above, each subdivision of Figures 10(v) to 10(y), drawn with dashed lines and individually labeled, is shown enlarged on individual drawing sheets.

[0204] Figure 10(w) continues the wiring diagram of Figure 10(v), showing the electrical contacts on the right. Figure 10(w) shows the UPS connected to another power supply (1089), which is a 300W AC and 24V DC unit. Power supply (1089) supplies step-down power to a DC power module at 24A 5V DC. This 5V power module powers several sensors on both sides, including the waste plate sensor on its left, the plate washing machine sensor, etc. To its right, the power module powers the lighting panel, which powers the panel (1091) that illuminates the left and right doors (1092). Panel (1091) also supplies power and signals to the exciter (1062), touchscreen (1058), and barcode reader (1013).

[0205] Figure 10(x) continues the diagram from Figure 10(w), showing the control unit and power PCB (1093) connected to six TECs (1019) and their associated sensors (1094). The control unit and power PCB (1093) also powers the fan (1095) and the reader (1003). To supply power.

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

[0207] Figure 10(z) is a plan view showing the plate carrier (1036) and the end carrier (1026).

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

[0209] The system can adjust assay parameters before starting the assay based on consumable data stored in the identifier and / or provided as consumable data via a direct or indirect interface. The system then makes appropriate electrical, fluid, and / or optical connections to the consumable (using electrical, fluid, 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 before inserting it into the system. Alternatively, the sample is introduced by system components after the consumable has been inserted into the system. The assay may also involve adding one or more assay reagents to the consumable, and instructions for adding these various assay reagents can be stored in the identifier and / or provided as consumable data. The system adds these 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 further described below.

[0210] (iv) Assay cartridge and cartridge reader Instead, assay consumables are cartridges, which further include elements selected from one or more fluid components, one or more detection components, one or more assay cells, reagents for performing the assay, a working electrode, a counter electrode, a reference electrode, a dielectric material, electrical connections, dry assay reagents and / or liquid assay reagents, or a combination thereof. A cartridge may further include at least one assay cell containing multiple distinct assay sites and / or domains, each of which contains reagents for measuring different specimens.

[0211] Examples of assay consumable cartridges usable in the present invention are described in U.S. Patent Application No. 2004 / 0189311, the disclosure of which is incorporated herein by reference in whole. The assay consumables described therein are assay cartridges incorporating one or more fluid components, such as compartments, wells, chambers, fluid conduits, fluid ports / vents, valves, etc., and / or one or more detection components, such as electrodes, electrode contacts, sensors (e.g., electrochemical sensors, fluid sensors, mass sensors, optical sensors, capacitive sensors, impedance sensors, optical waveguides, etc.), and detection windows (e.g., windows configured to enable optical measurements of a sample in the cartridge, such as measurements of absorbance, light scattering, light refraction, light reflection, fluorescence, phosphorescence, chemiluminescence, electrochemiluminescence, etc.). The consumables also include reagents for performing the assay, such as binding reagents, detectable labels, sample preparation reagents, washing solutions, and buffers. The reagents may exist in liquid form, solid form, and / or immobilized on the surface of a solid-phase support present in the cartridge. In this embodiment, the consumables include all components necessary to perform the assay. Furthermore, assay consumables receive the consumables, for example, in It is used in conjunction with a consumable assay reader adapted to perform specific operations on consumables, such as controlling body movement, supplying power, or performing physical measurements on cartridges.

[0212] More specifically, the assay consumable cartridge has one or more assay sites (e.g., wells, compartments, chambers, conduits, flow cells, etc.) which may include one or more assay domains (e.g., separate locations on the assay site surface where assay reactions occur and / or assay-dependent signals such as electrochemical signals or electrode-induced luminescence signals are 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, such as a one-dimensional array of assay electrodes) to enable the performance of assays based on electrochemical measurements or electrode-induced luminescence measurements. The assay domains are optionally defined by a dielectric layer attached to the electrodes. Furthermore, the assay consumables may have one or more attributes that make them suitable for use in "point-of-care" clinical measurements, such as being small, low-cost, disposable, multiple detection, and easy to use.

[0213] Assay consumable cartridges may contain, for example, one or more electrical energy sources, ammeters, potentiometers, photodetectors, temperature monitors or controllers, pumps, valves, and other electronic and / or active mechanical components necessary to perform the assay measurement. Alternatively, some or all of the electronic and / or active mechanical components may be located in a separate assay reader. The assay reader would also use the consumables and have appropriate electrical, fluid, and / or optical connections to the assay consumables to perform the assay. Using such an arrangement, the assay consumables can be designed to be low-cost and disposable. On the other hand, the assay reader (which holds more expensive and complex components) can be reused.

[0214] In one embodiment, a cartridge-based biochemical detection system may include a system housing containing a photodetector, which is adapted and configured to receive and position assay consumables and / or the photodetector for processing. The system may further include a support subsystem which may include one or more of the following: 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 supplying fluid to the detection chamber via a fluid inlet line; an electrical subsystem for electrically contacting the electrical contacts of the cartridge and supplying electrical energy to the electrodes; and a control subsystem for controlling and adjusting the operation of the system and subsystems, and for acquiring, processing, and storing the photodetection signal. Information provided as and / or consumable data associated with an assay consumable identifier may include information used to control or adjust one or more assay system components before and / or during the execution of an assay using the assay consumable.

[0215] Furthermore, assay consumables may include, but are not limited to, one or more buffers, diluents, and / or reagents used by the assay system in performing the assay, and / or containers that hold one or more assay reagents. Assay consumable identifiers may be affixed to the containers and / or to the container packaging.

[0216] B. Assay consumable identifier In one embodiment, the assay consumable identifier includes a 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) and magnetic memory (e.g., hard disks). This includes, but is not limited to, floppy disk drives and magnetic tapes, optical memory (optical disk drives), and hybrids of these methods (magneto-optical memory).

[0217] In one embodiment, the assay consumable identifier includes an EPROM (Erasable PROM), a type of programmable read-only memory that can be erased by exposure to ultraviolet light. Once erased, it can be reprogrammed with new or modified data. In another embodiment, the assay consumable identifier includes an EEPROM (Electrically Erasable PROM), a type of non-volatile electronic memory that can be electrically erased and programmed without exposure to UV light. The EEPROM can be written to or programmed multiple times and can be selectively programmed (the customer can modify the value of a specific 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 includes flash memory, i.e., a specific type of EEPROM that is erased and programmed in large blocks. While 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 the erase cycle is slow, the large block size used for erasing flash memory gives it considerable speed compared to conventional EEPROM when writing large amounts of data.

[0219] In another embodiment, the assay consumable identifier includes 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 do not include a microprocessor but include non-volatile memory storage components and optionally some special security logic; and ii) "microprocessor cards" that combine non-volatile memory components with microprocessor components to enable processing of information read into or read from the ICC. The ICC electronic components are supported by cards that are typically made of plastic such as PVC or ABS. The cards may include embedded holograms to prevent counterfeiting. Contact ICCs have conductive contact pads. The compact pads on the ICC, when inserted into the assay reader, contact the electrical connector of the identifier controller, enabling the 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 method of transferring information is via RFID, or Radio Frequency Identification, which is theoretically similar to barcode identification. RFID utilizes electromagnetic or electrostatic coupling in the RF portion of the electromagnetic spectrum to transmit signals. An RFID system consists of an antenna and transceiver that reads radio frequencies and transmits information to a processing unit, as well as a transponder, or tag, which is an integrated circuit containing the RF network and the information to be transmitted.

[0221] Furthermore, identification can be achieved by reading consumable identifiers (e.g., barcodes). One key difference between RFID and barcode technology is that RFID eliminates the need for line-of-sight reading, on which barcoding relies. Also, RFID scanning can be performed over greater distances than code scanning. While wavelengths in the 2.4 GHz range are absorbed by water (the human body) and therefore have limitations, high-frequency RFID systems (850 MHz to 950 MHz, and 2.4 GHz to 2.5 GHz) offer a transmission range of over 90 feet.

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

[0223] In additional alternative embodiments, two or more non-volatile memory components can be used in the present invention. For example, a first assay consumable containing a first identifier can be used in the assay system, and additional assay consumables containing additional identifiers can also be used in the assay system. Each identifier may contain the same or different types of memory. However, for each different form of memory, there is a separate identifier controller. Certain consumable data can be stored in one identifier, and other consumable data can be stored in additional identifiers of the same or different types. For example, a system may use additional assay consumables that contain, for example, a consumable identifier (e.g., a barcode) as the identifier, while one assay consumable used in the system may contain an EEPROM or RFID as the 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 is optionally, for example, I 2 The system includes a microcontroller to interface with non-volatile memory via a communication interface that may incorporate conventional interface architectures and protocols such as the C, 2-line serial bus protocol. 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 itself, or it 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 so that one separate consumable identifier is used to hold information relating to multiple consumables. For example, each package of consumables has a package-specific identifier attached to (or supplied with) the package that holds information relating to multiple consumables within the package. Optionally, each consumable also has an additional unique consumable-specific identifier attached to it. This consumable-specific identifier is primarily used to uniquely identify the consumable and link it 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 an assay system can be housed together in a single unit or 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 indirectly (which may be wired or wireless) through additional components of the assay system. In an alternative embodiment, the identifier controller is housed within the assay reader. In such an embodiment, the assay reader may be configured to allow the insertion of a consumable into the assay reader during the assay to also enable communication between the consumable identifier and the identifier controller (for example, the port into which the consumable is inserted includes components for processing and / or reading the consumable, and also includes components for communicating with the consumable identifier, such as electrical contacts or a wireless transmitter). In one example, when a consumable is loaded into the assay system, the controller and the identifier communicate An electrical connection is made between them. The controller can then read, erase, and / or write consumable data from / to an identifier. Alternatively, the assay reader may have separate ports for processing / reading consumables and for communicating with consumable identifiers. The customer places the assay consumable or package in or near the controller port so that the controller can electrically connect to the identifier and the controller can read, erase, and / or write consumable data.

[0227] In one embodiment, the identifier includes non-volatile memory, such as an RFID tag, a consumable identifier (e.g., a barcode), an EPROM, an EEPROM, or a combination thereof. Furthermore, the identifier may include flash memory and an EEPROM containing 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 Identifiers are programmed, for example, during the manufacturing process or when consumables are prepared for shipment. Identifiers are associated with consumable data that can be used before, during, or after a step in an assay or multi-step assay to control the operation of an assay system, assay reader, or components of an assay system. Furthermore, or alternatively, some or all of the information required for the 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, analytical process control information, consumable / test site information, assay process information, consumable security information, or a combination thereof. Consumable data may further include information related to one or more analytical tools that the system can apply to analyze data generated during and / or after the assay, assay system maintenance information, system consumable sales promotion 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 is associated with a consumable identifier and / or can be provided as consumable data.

[0230] (i) Consumables identification and configuration information Consumable data may include, but is not limited to, identification information, lot-specific analytical parameters, manufacturing process information, raw material information, expiration date, chemical safety data sheet (MSDS) information, product insert information (e.g., any information that may be included in or described in product insert information that may accompany assay consumables, such as assay type, how the assay is performed, instructions for use of assay consumables, assay reagents, or both), threshold and / or calibration data for one or more reagents used in the 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, as well as consumable identification and configuration information.

[0231] Furthermore, the consumable data may also include lot identification information, i.e., information unique to a given lot that can be used by the system to perform an assay using consumables from that lot or to analyze assay results drawn from consumables from that lot, distinct from lot-specific analytical parameters, and used to identify a specific lot of assay consumables. In one embodiment, the assay consumables are multi-layered. If the product is a well assay plate or cartridge, lot-specific analytical parameters may include, but are not limited to, (i) revision level which determines the schema used to interpret the information, (ii) consumable type, (iii) manufacturing date, (iv) lot number, (v) expiration date, (vi) crosstalk correction matrix to account for chemical cross-reactivity, (vii) thresholds for assays performed on the consumable and their respective internal negative controls, (viii) range for internal positive controls, (ix) range for each assay performed on the cartridge for positive control samples, (x) software checksum to ensure data integrity, (xi) in-well (or in-test site) control tolerance, (xii) assay name and / or identifier, (xiii) assay quality control information including negative and positive quality control materials used to verify the operation of the assay reader and consumable, (xiv) calibration information such as master calibration curves, and (xv) number and names of assay calibrators and / or assay calibrator tolerances.

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

[0233] Furthermore, consumable data may relate to the management of the analytical process, such as information regarding the control, transfer, and / or analysis of samples and / or assay consumables. Analytical process management information can be selected from customer identification, sample identification, timestamps and date stamps for assays, location of the assay system in the laboratory between assays, calibration and QC (quality control) status of the assay system between assays, management information and / or location information for assay consumables before and after the assay is performed, assay results for a given sample, and free-text comments created by the customer before, during, or after the assay is processed by the system. In addition, analytical process management information may include time, date, manufacturing personnel, or processing parameters for one or more steps during the manufacturing of assay consumables, and storage, location, and / or storage conditions for assay consumables following and / or during the manufacturing steps.

[0234] Furthermore, consumable data may include consumable / test site information, such as the type and structure of the consumable, the location and identity of the assay reagent contained in the assay consumable (e.g., structure, composition, sequence, concentration, and / or origin), and the location and identity of the assay reagent within the assay test site of the assay consumable. Consumable data can be used to distinguish the first test site within the consumable from other test sites within the consumable. In addition, consumable data may include sample information, including the location of the sample within at least one test site of the assay consumable, assay results obtained with the assay consumable for the sample, the identity of the sample assayed and / or assayed with the assay consumable, or a combination thereof. Furthermore, consumable data is consumable / test site information, including the type and structure of the consumable, the location and identity of the assay reagent contained with the assay consumable, the identity of the assay reagent within the assay test site of the assay consumable, or a combination thereof.

[0235] In additional embodiments, the consumable / test site information may include information about assays previously performed by the assay reader or system on one or more test sites of the consumable, and information about assays performed by the assay reader on one or more test sites in the consumable. Thus, once the assay is performed by the system, the controller can use it to write the assay results to an identifier. Such information may include raw or analyzed data collected by the system during the assay (analyzed data is data that has undergone statistical analysis after collection, and raw data is data that has not undergone such statistical analysis), a list of test sites and / or domains in the assay consumable used during a given assay, and information regarding the assay consumable or test sites and / or domains in the assay consumable. This includes, but is not limited to, the schedule of events to be carried out, a list of test sites and / or domains of assay devices that have not been assayed, and assay errors or system errors, or combinations thereof, that occurred during a given assay or assay step.

[0236] Furthermore, consumable data can be used as a security mechanism (referred to herein as “Consumable Security Information”) to verify, for example, that the correct assay consumables are being used in the system. Consumable data may include a digital signature to prove that the consumables were manufactured by a designated vendor. In one embodiment, if an inappropriate assay consumable is present in the system, such as a counterfeit consumable or a consumable that is otherwise incompatible with the assay system, the controller disables the system, the assay reader, or its components. Alternatively, consumable data can be used to detect the proper placement of assay consumables in the system, such as the correct orientation of the assay consumable or a part thereof in the assay system, so that the controller disables the system, the assay reader, or its components until the assay is installed in the correct orientation. Furthermore, consumable data can also be used to detect defects in assay consumables or assay test sites and / or domains, so that the controller disables the system, the assay reader, or its components accordingly. For example, depending on the nature of the defect in the assay consumable or domain, the controller may not permit the use of the assay consumable as a whole, or may instruct the assay reader not to permit the use of the test sites and / or domains or sets 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 within it to identify defects therein, and the controller writes the results of the diagnostic analysis to the consumable's identifier. If the consumable is later used with 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 within it accordingly. In an additional embodiment, the assay consumable may undergo a quality control process during or after manufacturing, and the results of the quality control analysis may be written to the identifier by the customer of the assay consumable in the assay reader for later use and / or verification.

[0237] Furthermore, consumable data may include authorization information for consumables or their test sites and / or domains or biological reagents, such as whether the customer's license is for research purposes only, the number of times a particular customer is permitted to use a particular consumable or biological reagent in a particular assay, and any restrictions on such use, to determine whether the customer has a valid license to use a particular consumable or biological reagent. Such information may also include validation information regarding whether a particular consumable or biological reagent has been recalled, or otherwise become 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] Consumable data may further include information about the origin of assay consumables, test sites and / or domains, such as the identification of the original sample from which it was drawn or the number of generations from which it was removed. For example, if the assay reagent used in the assay is an antibody, the consumable data may include identification of the hybridoma from which the antibody was drawn, such as the ATCC acceptance number of that hybridoma.

[0239] According to various embodiments, biological samples or biological reagents provided in or with the aforementioned consumables are permitted to be used separately from systems designed to act on biological reagents. It can be received. In various embodiments, the assay system, assay reader, or its components are connected to a network that allows the system to communicate with a computer system operated by or on behalf of the customer, manufacturer, and / or licensor of the biological reagents, consumables, or system via public and / or private networks. In various embodiments, a limited license may provide the use of a licensed biological reagent, consumable, or system for a specific biological analysis only with the licensed system. Thus, if a particular customer has a valid license, the system may authenticate the biological reagent, consumable, or system based on a digital signature contained in an identifier provided as associated with a specific consumable and / or as consumable data. In various embodiments, the identifier and / or consumable data may also be used to provide a one-time use so that the biological reagent cannot be replenished for use with the same authentication.

[0240] In certain embodiments, when an identifier is read by a system, assay reader, or its components that have access to a public or private data network operated by or on behalf of a biological reagent, consumable, or system customer, manufacturer, and / or licensor, specific consumable data can be transmitted to the assay system and read, written, or erased locally via the assay system's identifier / controller. For example, additional consumable data such as lot-specific information, expiration dates, calibration data, consumable-specific information, assay domain information, assay result information, consumable security information, or a combination thereof may be stored locally in the identifier and not available via the assay system's network connection, whereas recall information and / or license information may be a subset of consumable data available via direct and / or indirect interfaces. In one embodiment, recall, license, and / or consumable security information may be available via the network connection on the assay system and / or stored on a storage medium as consumable data, while the remaining consumable data is stored locally in 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 an electronic control and data processing network such as a microprocessor or microcontroller, memory, and non-volatile storage devices. In various embodiments, the system hardware also includes physical devices for operating 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 in the microprocessor within the system hardware.

[0241] System data acquisition and control software is high-level software that interfaces with the system and controls system hardware for more specific operations, such as operating a charge-coupled device (CCD) to acquire visual luminescence information related to a particular biological analysis. In various embodiments, the data acquisition and control software includes a state machine implemented with 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, the state machine may receive instructions from a general-purpose computer to perform a specific data acquisition operation or system control operation. In various embodiments, the general-purpose computer opens a TCP / IP socket connection to the system, determines whether the system is in an idle state, and then begins transmitting 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 information may take the form of human-readable consumables and / or method information. In various embodiments, consumables and / or methods are stored in the form of ASCII text files. In various embodiments, a general-purpose computer uses the FTP protocol to transfer ASCII text files to the system. In various other embodiments, methods and / or consumables are stored in an identifier and read from the identifier. While method and / or consumable information can be stored in an identifier in the form of ASCII text files, it is understood that the information can be represented in other data formats without deviating from this teaching.

[0242] In various embodiments, the consumables, macros, and / or method information includes parameters that can be used by system data acquisition and control software to perform specific data acquisition and system control operations. In various embodiments, the method and / or consumables information includes a sequence of operations performed by system parameters or control parameters for use associated with data acquisition or control software.

[0243] (ii) Assay process information Furthermore, consumable data may include assay process information relating to individual assay parameters that need to be applied by the system or assay reader during the assay. For example, such consumable data may include the sequence of steps for a given assay, such as the identity, concentration, and / or quantity of assay reagents that need to be used or added during the assay or at specific steps of the assay, such as buffers, diluents, and / or calibrators. 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 a specific step of an assay or multi-step assay, the temperature that needs to be applied by the system or assay reader during the assay, the incubation time for the assay, and statistical methods or other analytical methods that need to be applied to the raw data collected during the assay by the system or assay reader.

[0244] In one embodiment, one or more steps of an assay protocol can be adjusted to individual consumables or lots of consumables. One or more steps of the protocol may differ from consumable lot to consumable lot and / or from consumable to individual consumable within a given lot, and the consumable data stored in the system includes instructions to adjust those steps of the assay protocol. This type of consumable data can be used by the system to adjust one or more actions performed by the system before, during, and / or after the system performs an assay. Furthermore, this type of consumable data can be optionally adjusted by the system user at the user's discretion. For example, the 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 properties of the diluent can be modified based on such differences. Similarly, the amount of a given reagent that can be added during the assay, the incubation period and / or temperature of one or more steps of the assay may be due to lot-to-lot or consumable-to-consumable differences. Each of these is an unrestricted example of consumable data that can be stored in the system's storage medium.

[0245] Furthermore, the consumable data includes information that directly or indirectly controls components of the assay system, such as one or more photodetectors, light-shielding enclosures, mechanisms for transferring assay consumables into and out of the assay reader, mechanisms for aligning and oriented assay consumables with one or more photodetectors and / or electrical contacts of the assay reader, additional mechanisms and / or data storage media for tracking and / or identifying assay consumables, one or more electrical energy sources for inducing luminescence, mechanisms for storing, stacking, moving and / or distributing one or more consumables, mechanisms for measuring light from multiple test sites of consumables sequentially, substantially simultaneously, or simultaneously during an assay, or combinations thereof.

[0246] Furthermore, the consumable data may also include assay process information, including assay parameters applied by the assay reader during the assay, the sequence of steps applied by the assay reader during the assay, the identity, concentration, and / or quantity 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, the statistical or analytical method applied by the assay reader to the raw data collected during the assay, or a combination thereof (such assay process information can be optionally adjusted by the user). In one specific embodiment, the assay performed using the consumable is a multi-step assay, and the assay process information relates to one or more steps of the multi-step assay. In this embodiment, the consumable / test site information includes information about assays previously performed by the assay reader on one or more test sites of the consumable, information about assays performed by the assay reader or its components on one or more test sites in the consumable, or a combination thereof.

[0247] For example, during the manufacture of a consumable, test site, domain, sector, or biological reagent, or while an assay or step is being performed on a consumable, test site, domain, sector, or biological reagent or sample, individual operations are performed on that consumable, test site, domain, sector, or biological reagent or sample, so consumable data may further include information about the consumable, test site, domain, sector, or biological reagent or sample. For example, if an assay consumable contains multiple assay test sites, domains, and / or sectors, the assay system can perform the assay or a step of a multi-step assay on 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 an identifier, such as raw data or analysis data generated during the assay or assay step, and / or the controller records which test sites, domains, and / or sectors of the assay consumable were 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. Assay consumables 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 identifier to identify which test sites, domains, and / or sectors have been used, which have not yet been used, and / or the results of those assays. The controller can then instruct the assay system, assay reader, or its components to perform the assay or assay step on the unused test sites, domains, and / or sectors.

[0248] Furthermore, a given assay protocol may require a specific set of consumables. Therefore, when a customer inputs a specific 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 run that assay protocol, for example, one or more reagents may be required for use with that multi-well assay plate. Each required consumable 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 a 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 check the required consumable identifier stored in the system. Based on the information provided, the system prompts the customer to input any additional consumables required for the assay protocol. If two or more assay consumables are used in the system, the instrument correctly identifies the first assay consumable and any associated consumables based on the identifier and associated consumable requirements for each consumable. 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 a corresponding associated consumable, the system prompts the customer to load the associated consumable if the instrument does not identify the associated consumable in the system within a given period. If mismatched assay consumables are loaded into the instrument, the system notifies the customer. If there is no available matching set of assay consumables (e.g., a multiwell assay plate and given reagents for a particular assay), the system will not run the sample. The system checks the expiration date of assay consumables before starting the assay, and the system warns the customer to prevent the use of expired consumables. If a consumable has expired before sample aspiration, the system will not process the sample. If partially used assay consumables are installed in a different instrument, use of the consumables will automatically begin in the next available unused well.

[0249] Furthermore, the identifier can be used to track the time a given consumable is present in the assay system. Therefore, when an assay consumable is inserted into or comes into contact with the assay system, the timer is started in the assay system, and the start time is recorded in the identifier. When the assay is started by the system at the consumable, or at the test site, domain, and / or sector within the consumable, the time is also recorded in the identifier. Whenever an instrument, system, or its components are shut down (e.g., by turning off the power), the timer is stopped, and that time is recorded in the identifier. Therefore, whenever the timer is stopped, the accumulated onboard 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 assay is performed. Furthermore, such analytical tools may include instructions to the customer and / or the system to generate specific outputs by the system software after the assay is performed, such as a format for data reports and / or analysis results tailored based on the consumable data. Alternatively or further, 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 algorithm appropriate for the desired data analysis. The consumable data may also include information that the customer can use to select an algorithm appropriate for their needs, such as technical notes or references relating to the selection of algorithms.

[0251] The analysis tools may differ for each consumable lot and / or for each individual consumable within a given lot. In this embodiment, consumable data is used by the system to adjust the analysis processing tools applied by the system software during or after the assay, and the results are generated and / or displayed. Such analysis 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 the differences in consumables. In a specific embodiment, for a given consumable type and / or desired use, the consumable data may include a project management tool that schedules the execution of one or more assays or steps thereof using a given set of consumables in the system. Furthermore, such analysis processing tools can be adjusted by the system user at the user's discretion and at their discretion. The message can be sent to the customer via a direct or indirect interface between the system and the customer.

[0252] (iv) Assay system maintenance information Consumable data may include, but is not limited to, system monitoring reports, system component usage, inspection history, system troubleshooting information, results of diagnostics performed on the system, control diagram creation, periodic maintenance scheduling, warranty information regarding the system and / or system components, or combinations thereof, and may further include system maintenance information for the customer. The system software can monitor various components of the system and be programmed to send monitoring reports automatically or when prompted to remotely compute systems and / or maintenance technicians. If the direct interface is not enabled, the system may prompt the customer to send monitoring reports to the CD server via the indirect interface. Alternatively, such system monitoring reports may be accessible to maintenance technicians responsible for on-site or remote maintenance and / or inspection tasks of the system. In this embodiment, maintenance technicians can communicate with the customer regarding instrument repair or instrument-based assistance via the direct or indirect interface. In specific embodiments where a particular interface is enabled, the CD server monitors system component usage and / or warranty information and schedules periodic system / component maintenance and / or upgrades by maintenance technicians based on the standard system component lifespan 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 maintenance technicians to access the system status, the system can send the output of such monitoring activities to the CD server via the indirect interface and periodically prompt the customer to determine whether system service or maintenance is required. Furthermore, the CD server can maintain a log of the inspection history of a given assay system and schedule service calls by maintenance technicians (this can be done using either the direct or indirect interface).Furthermore, the remote computing system can transmit individual assay system software upgrades via a direct or indirect interface.

[0253] (v) System - Consumables Sales Promotion Information In another embodiment, consumable data includes promotional materials, for example, when a new type or lot of consumables becomes available, particularly those products conventionally used by a given customer. Such promotional materials also relate to new assay systems, modifications to existing systems, and / or optional modifications or improvements to existing systems, particularly those relating to systems owned or operated by the customer, and / or those modifications, modifications, or improvements that may be of interest to the customer based on the 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 relating to one or more consumables / systems used by a given customer. Such promotional information can be provided to the customer through a direct or indirect interface between the customer and the vendor.

[0254] (vi) Technical support information Furthermore, consumable data can assist customers in using consumables or systems, such as product insert and datasheet information, information related to related products intended to be used with the consumable, user manuals, training materials, tutorials, recommended use and / or storage information, data analysis templates, template reports, calibration curves, lot-specific QC data, verified quantitative limits, and troubleshooting methods and / or algorithms. This may also include technical support information. For example, in the case of consumables that include or are equipped with one or more additional consumables such as reagents, the consumable data may also include reagent catalog number, reagent lot-specific information, reagent manufacturing date, reagent expiration date, instructions for use, training materials, tutorials, recommended use and / or storage information, etc. Technical support information may also include receiving feedback or assistance through a direct or indirect interface with a technical support representative, such as customer training modules, consulting services, and / or live customer service support capabilities (i.e., live chat) to facilitate the customer experience. It is understood that technical support information may relate to consumables, systems, or both.

[0255] In a specific embodiment, Table 1 includes a list of consumable data that can 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 Figure 11 shows a specific embodiment of a data association workflow, i.e., a process in which specific data is associated with a consumable identifier and stored in the consumable identifier. In the first step of Figure 11, the 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, and the central database 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, generate, transmit, and / or store data sets in response to data queries. An order (1102) has a unique identifier associated with it, for example, an order number (1103), and its order number The customer number is stored in one or more vendor data tables, such as the order data table (1104). Each customer, whether external or internal, is associated with a unique identifier, such as a customer number (1105), and each customer number is stored in the customer data table. The customer data table contains customer contact information, shipping addresses, etc., for one or more individuals or organizations associated with that customer. For example, if the customer is a company with many locations, each customer can be uniquely identified by a single customer number associated with the company's various locations in the customer data table, or each location of the company can be uniquely identified by a single customer number. If the customer is internal, for example, a department within a vendor's organization requesting replenishment of consumable inventory, the customer data table may have one or more subdirectories or data tables for the internal department. Therefore, the customer data table contains a unique customer number for each customer (e.g., customer X), the order data table contains a unique order number for each customer (e.g., order Y), and there is also a customer-order association data table (1106) that stores the association between each customer and their order (e.g., customer X order number Y).

[0257] An order is received by a manufacturing technician, a unique consumable identifier (e.g., a consumable identifier, e.g., a barcode) is created for that particular consumable, and the consumable identifier is stored in the consumable identifier data table (1107). Thus, in one embodiment, all data uniquely associated with that consumable is associated with the consumable identifier and is stored in the consumable identifier data table. Alternatively, different types of data related to the product, such as quality-related data or manufacturing-related data, can be stored in individual data-specific data tables, each entry being 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 set 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 a computing system requesting data about that consumable. The system also includes a customer number-order number-consumable identifier association data table (1108), which provides 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) for each customer, order, and consumable. Additional unique identifiers, such as catalog number, salesperson number, and order subcomponent, can also be associated with an order. Each association with an order number can be stored in one or more additional data tables of the system. Based on the type of consumable requested in an order, the technician queries one or more manufacturing data and / or order processing data tables to identify the set of consumable data required for the manufacture of the consumable or the acceptance of the order (consumable designation data table (1109)). The data is associated with a consumable identifier, and when a consumable is manufactured or accepted for order, an additional set of consumable data associated with the manufacture of that consumable or the acceptance of the order is associated with the consumable identifier. Consumable data associated with that consumable or lot up to that point in the manufacturing process is stored in the consumable identifier data table.Furthermore, the manufacturing process may also include a quality control system in which the product undergoes one or more quality control steps. Unique data derived from each quality control step performed on a consumable or lot is associated with a consumable identifier, and the consumable identifier data table and / or quality data-specific data table are updated to include this data. The consumable or lot (1110) is then transferred to the shipping department, and shipping event data is associated with a consumable identifier, such as packing date, shipping date, etc., and the consumable identifier data table and / or shipping-specific data table are updated accordingly.

[0258] Figure 11 and the attached explanation relate to consumables, consumable data, etc., but the same as outlined in Figure 11 The process must clearly be usable to associate data with instruments, kits containing multiple components, etc. For example, if a consumable is a kit containing multiple components, when an order is forwarded to manufacturing and a manufacturing technician queries the consumable specification data table for data on how the kit is manufactured, the consumable specification data table provides a list of the kit's components, and each component of the kit contains a unique component identifier associated with the system's kit identifier.

[0259] As described above with reference to Figure 1, consumable (lot and / or instrument) data is generated by the vendor before, during, and after the production and / or distribution of individual consumables and / or lots of consumables. The CD creation system creates a database of CD information for the consumable or lot, i.e., a CD database in which the consumable data is stored. The CD database is transmitted to a CD server (104) which contains a master repository of all consumable data. Furthermore, 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 CD server are located in a remote computing system, i.e., an assay system and / or a computing system located far from the customer, such as a site maintained by the customer or, for example, 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 contain any appropriate data structures, for example, each customer may have a distinct data structure on the data hub that is protected from and clearly different from the data structures of other customers on the data hub. As shown in Figure 2, when an order is placed with a customer, or when consumables or lots are 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 contain order processing 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 the consumables (202) with a consumable identifier (203) and brings the consumables into contact with the assay system (204) in preparation for performing the assay (step iii), and the system reads the information associated with the consumable identifier (203), which the system uses to identify the consumables (202) (step iv).The system examines consumable data stored locally on the system on a local storage medium (referred to as the "local CD" in Figure 2) to identify the consumable data stored on a storage medium that can be used to perform an assay with a given consumable. If the storage medium contains the consumable data for that consumable or lot, the consumable is available for use with the system (step v). If the storage medium does not contain the consumable data for that particular consumable or lot of that consumable, the system can query the customer for the consumable data, and the customer can communicate with the vendor to receive the necessary consumable data, for example, via email, compact disk, 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's email account, for example, as an email attachment, 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 consumables / lots of consumables are then available for use in the instrument (step vii).

[0260] In an alternative embodiment, the CD server can connect to the system via a direct interface that allows it to automatically obtain consumable data from the CD server if the consumable data is not locally available on the system. In this embodiment, as shown in Figure 2 and described above, the vendor generates, stores, and sends a CD database for consumable orders and / or lots of consumables to the CD server. The customer then receives the consumables, orders, and / or lots, and The system is brought into contact with a consumable identifier so that the system can identify a 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) automatically obtains the consumable data from the CD server 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 and performs 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 the assay results are displayed to the customer. In a specific embodiment, the system software adjusts the output to the customer based on the consumable data.

[0261] As described above, consumable and / or instrument data can be transmitted to a data hub via software so that the vendor can collect data related to the customer, instrument, consumables, and / or vendor. The software can be programmed on the instrument to automatically collect this data, and / or the software may be an optional element selected by the customer when the instrument is installed. In one embodiment, the instrument collects and transmits to the data hub not only the analysis layout for experiments performed using one or more specific consumables, but also specific consumable identifiers used on the instrument at the customer's location. In the case of a networked system, i.e., an instrument installed on a computer network maintained by the customer to which two or more instruments are connected, the software can collect the following consumable data, i.e., consumable statistics such as detection signal, CV, mean, image center, etc., control and calibrator performance such as % recovery, detection signal data, etc., identity of consumable identifiers uploaded by one or more instruments connected to the network, audit logs, and / or instrument logs.

[0262] In another embodiment, an exemplary system for coordinating communication between a processor present in an assay system (1000) and a computer located at the user's facility, also known as a laboratory information management system (LIMS), is shown in Figure 11(b). The LIMS (1120) is linked to various processors in 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 Workbench software (1124), such as a user interface (UI) and a database (DB) (1126).

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

[0264] Figure 11(c) shows Workbench / UI(1124) and assay system(100 The relationship with other systems and processors in 0) is shown. The Workbench / UI (1124) is connected to components having their own processors, such as a robotic system (1002) including a pipette (1021) and a 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) and reader (1003) that actually display the UI. As described above, the Workbench / UI (1124) is also connected to the LIMS (1120). A barcode scanner or consumer ID controller (1013) will read a consumable identifier (e.g., a barcode) or unique ID from any laboratory equipment or assay kit. As will be further described below, the consumable identifier (e.g., a barcode) or unique ID will inform the Workbench / UI of the type of laboratory equipment or the assay to be performed from the kit. If any additional information or data is needed, it can be downloaded from an external server or cloud (1130).

[0265] The software that runs the assay system (1000) consists of three main components. (i) A user interface (UI) that guides the user through the process of selecting, loading, and running the immunoassays described herein, (ii) An instrument control system that controls not only the reported errors but also the functions of the robot system (1002), as well as operational performance qualification and performance qualification, (iii) A data service that stores the ECL results and user priorities as described above in relation to Figure 11(b).

[0266] Referring to Figure 11(d), the Workbench / UI will send requests to an instrument control system having 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 the qualification of the assay system before and between routine maintenance, as described below in relation to operational performance qualification and performance qualification systems. The command listener (1134) listens for requests to instruct the robotic system, including the pipette (1021) and robotic gripper pad (1031), to perform steps of the immunoassay. The error reaction listener (1136) listens for error codes sent simultaneously 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) absent-recoverable errors that are detected by the software but do not require user intervention to recover, such as the failure to detect a single sample; and (iii) interactive recoverable errors, such as the door to the assay system (1000) not being properly closed. Preferably, the error will return a flag in the results file and generate a visual or audible alert. In the case of power loss, the instrument control portion of the software will use a universal power supply (UPS) that needs to be stored in the instrument to control the instrument's shutdown.

[0268] In another aspect of the present invention, the UI portion of the software is constructed using a plug-in, also known as an application or applet. Once an assay system is validated or qualified, operators generally do not want to re-validate or optimize the system for software updates. Re-validation is necessary when the components of a software system are interconnected. In other words, components are interconnected when one component depends on input or instructions from another component to function. Thus, a feature of the present invention of the UI or Workbench is that its components are decoupled from one another. That is, each component may be a standalone part of the software. These standalone parts require only minimal instructions from the master organizer to execute. Do not.

[0269] Referring to Figure 11(e), the master organizer (1140) (labeled OSGI) 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 the security / login / logoff component (1142), the UI (1144), the application framework (1146), and the event framework (1148). Other components such as the aforementioned instrument control components and data services can be connected to the master organizer (1140).

[0270] The master organizer (1140) operates similarly to 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 transmitted through the master organizer bus, except that the master organizer (1140) may command components to send information or data to each other. For example, in Figure 11(e), the event framework (1148), which creates and maintains an event log file during assay runs, may issue or notify the application network (1146) of important events, such as assay plate readings, when commanded or requested by the master organizer (1140). Such issuance or notification would not occur without the master organizer (1140).

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

[0272] Applications can be created by application implementations (1150) that obtain 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 application implementations (1150) used by the UI during assay runs. Applications created by application implementations (1150) may be retained or deleted when the master organizer (1140) instructs the stop framework (1142) to stop, as shown in Figure 11(e). Application implementations (1150) indicated as being outside the UI platform may be other software components connected to the master organizer bus.

[0273] Due to this decoupled architecture, if one component requires a software update, that component needs to be re-certified, but the entire software system does not need to be re-certified.

[0274] In another embodiment, other key components may have a similar architecture. For example, an instrument control component may have its own master organizer to control traffic between internal components having processors, such as a robot system (1002), a pipette (1021), a robotic gripper (1031), a plate washer (1005), a tablet (1058), and a reader (1003). A software update to one of the internal components of the instrument control would not require revalidation of the instrument control, nor would it require revalidation of the software of the assay system (1000).

[0275] Furthermore, the main software components, namely the workbench / UI, instrument control, and data services, are connected to the master organizer and share the same software architecture. It can be shared.

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

[0277] Figures 12(a) to 12(l) show the Meso Scale in Rockville, Maryland. Exemplary software for collecting, deploying, and locating global product data (GPD) for multiwell assay kits and plates available from Discovery. The software framework is shown below. While the following description and accompanying diagrams relate specifically to plates and kits, it should 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] A GPD is associated with a consumable identifier, such as a Global Product Identifier (GPI). A GPD is a flexible data container containing a collection of consumable data as described herein, which may include the following unrestricted list of data for a given consumable, such as a plate, assay reagent container (reagent rack), or assay kit. • For example, consumable physical properties such as plate type, geometry, graph, etc. Image processing parameters • Detection parameters • Plate coating, assay assignment • Partial plate information Recommended reagent layout • Assay protocol • Assay workflow or script, and instrument parameters associated with GPI. • Product inserts, reagents, and other contents of test kits • Recommended analysis information such as fit curves Recommended Report • Customer order information such as the expiration date of consumables and lot information for consumables.

[0279] As shown in Figure 12(a), a Data Expandable Bundle (DDB) is a container configured to organize and collect relevant consumable data, such as 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, such as a software package that runs on a customer assay system. A GPD is an example of a DDB. Additional examples of DDBs include, but are not limited to, novel assays, novel plate types, novel consumable types, etc. Different types of products, such as consumables and instruments or assay systems, are associated with different DDBs. For example, an assay system includes a unique identifier, as described above, which includes system identifier authentication, assay system information, and, for example, • System physical characteristics such as system components and configuration. • Subsystem characteristics, configuration, etc. • Associated consumable type • Workflow used to guide users through the use of the system This may include, but is not limited to, other technical data related to the assay system, such as customer order information including system manufacturing information, and is associated with the DDB for that assay system.

[0280] Each DDB has a DDB identifier (UID), a version number, and an expandable bundle description file. Both the UID and version number uniquely identify the DDB. The description file describes instructions for processing the DDB, including the DDB contents and a description of the steps required to integrate the DDB into the 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 a single file structure. The file format may be XML, key-value pairs, etc. The DDB can be distributed in multiple forms, such as vendor e-commerce sites or email attachments.

[0281] As shown in Figure 12(b), to install the DDB, the files are stored in a locally designated directory on the assay system. Using a plug-and-play framework, the local software system discovers the bundle and processes it for integration into the software. The local software includes a registry, which is a directory that shows information about the services and data available to the software. The DDB uses the registry to register what data is available from it, and the DDB instructs the local software on 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 in order to resolve or eliminate data conflicts that may occur between one DDB and another, for example, between one plate and another.

[0282] A DDB includes a unique DDB UID and version. As shown in Figure 12(c), a DDB may contain data that persists to a local data store, such as the DDB UID and version. If a DDB contains a large dataset, the data is persisted to efficiently access the types of data required during system operation. Data is persisted by identifying one or more data types in the DDB and storing that data in a local database structured for the data type(s). In one embodiment, the entire contents of the DDB are persisted, i.e., reconstructed locally in separate datasets. 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 DDB installation, 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 requires persistence to the data store, the DDB UID and version are saved to track that they are being stored. This eliminates unnecessary data store operations within the same DDB by detecting that the data is already stored.

[0283] Generally, software understands and interacts with specific versions of a data format. The DDB framework supports different versions of data formats and different versions of software that work together for easier maintenance. Figure 12(d) illustrates how different software versions of a DDB can coexist within the software. As shown in Figure 12(d), the software is configured to update previous data format versions, and the software is backward compatible with older DDB versions. Similarly, a 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, the framework shown in Figure 12(d) allows for the creation of a single DDB that works with multiple versions of the software, without the DDB needing to be re-released to interact with new software versions. DDB files are upgraded and / or downgraded as needed, one or more files are stored locally and / or persisted, and the DDB processor (factory) converts the raw class data into a data type or format that can be used by the software to execute an assay or assay step in the assay system.

[0284] As shown in Figure 12(c), a typical DDB for plates may include the following consumable data: • Plate static data includes data about the plate type. These are characteristics associated with the physical plate, regardless of the type of instrument used to process it. The characteristics of some examples are as follows: ○ Number of columns / rows in the well ○ Number of spots per well • Plate processing data includes data used to process / execute plates. Plate processing data is typically instrument-specific. Some examples of its characteristics are as follows: ○ Sectors / Number of circuits ○ For example, detection parameters used to read plates such as camera binning and waveforms. ○Image processing characteristics used to produce 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 ○Analysis Protocol ○Data analysis parameters ○Product insert • The lot number contains data specific to the test kit or plate created for the order.

[0285] Figure 12(f) shows an example of how a GPD DDB is deployed, and Figure 12(g) shows an example of a DDB XML and files within a GPD DDB. As shown in Figure 12(g), the DDB XML describes the data within the DDB and how it is processed, the GPD is a data container that references the data by UID and version, and the GPI-to-GPD mapping provides indexed data to the associated GPI. Furthermore, Figure 12(g) shows that other data can also be bundled within the DDB.

[0286] Figure 12(h) illustrates how GPD data is located. The software includes a GPD service processor that interacts with the registry to locate GPD data. Using GPD, the software identifies the type and characteristics of the data required for a given consumable and filters the registry for the required data. As mentioned above, if the required data is included in the local registry, the GPD service queries the master repository for the required data and downloads it locally. Most searches use UIDs as the search criterion, which can be obtained from GPI through 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 Figure 12(h), client 1 is, for example, assay system software, and client 2 is, for example, a remote laptop or desktop computer, an associated standalone software system that provides the user interface functionality for client 1's software). Below are two possible options for how data retrieval may occur. (a) The DDB registers all the data it provides. The GPD service searches the registry for matches. Some aspects of this search method 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) DDB directly registers a selected subset of data items. Also, DDB can be used to place data instead of directly exposing all available data. Register the search provider. The GPD service indirectly uses the DDB search provider by passing it through the registry. This search method includes, but is not limited to, the following: • A DDB manages the data it provides and hides or filters out details that it does not need to expose. • Fewer pieces of information are published to the registry, making the registry smaller. This method is suitable for systems with limited factory and resource resources.

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

[0288] Figure 12(i) shows option (b) in which 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 data provider, and the GPD factory retrieves the data from the data store and returns it.

[0289] For example, a vendor manufactures a lot of consumables, such as plates, where each plate has a GPI. There is a Data Database (DDB) for that lot of consumables, and this DDB has a single UID and all the GPIs within that lot, regardless of how large the lot is associated with its individual lot-specific UIDs. 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 and characteristics of the data required for that plate and filters the registry for the required data. As described above, if the required data is not included in the local registry, the GPD service queries the master repository for the required data and downloads it locally. Using the GPI, the software queries the local and remote databases for its UID and installs the required 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 Figures 12(j) to 12(l), the GPD goes through different stages of its lifecycle, from data installation to erasure. These stages include, but are not limited to, the following: All data for the DDB is collected and packaged into a single DDB file for deployment. • The DDB file is delivered to the software in the agreed-upon directory. The DDB instructs the software on what needs to be done. The DDB controls how that 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 as needed, and the data location is stored in a database. The remaining data will be placed in the database. Once the file is processed, it will no longer contain any data that is no longer on the system, and the file will be moved from the extraction directory to the archive / backup directory. • The 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 includes a read-only copy of the data from the GPD for the plate, and the data generated from processing it.

[0291] An example of the interaction between GPD-DDB and GPI is described below.

[0292] The GPD may include a general assay protocol, such as steps in an assay, preferably including all steps for several assays within one type of assay, including immunoassays such as 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 steps in the general assay protocol. Instead of preparing a unique assay protocol for each specific assay, the GPD of the present invention includes not only an instrument parameter file associated with the GPI of a specific assay, but also a general assay protocol.

[0293] As shown in Figure 12(m), a streptavidin plate protocol or script, an indirect assay, is shown. This protocol or script includes, but is not limited to, several steps: diluting samples for plates 1-5, blocking plates, coating plates, incubating samples, preparing the first detection incubation, preparing the second detection incubation, and reading assay plates. In another assay of this type, as shown in Figure 12(n), the second detection step is not activated. Another assay may not require a coated plate step, as shown in Figure 12(o), and another assay of this type may not require a coated plate step and the second detection step is not required, as shown in Figure 12(p). The following table summarizes the assay protocols in Figures 12(m) to 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, since all steps of Assay 1 are performed, this protocol functions 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 unique GPI for Assay 1. The instrument parameter file will contain 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 the 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 flags associated with plate coating and the second detection will be off, while the remaining flags will be on.

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

[0296] In this embodiment, before a particular assay is performed, the GPI for that particular assay, such as a consumable identifier (e.g., a barcode) on the outer packaging of a kit containing the laboratory equipment and consumables for that particular assay, such as an assay kit available from Meso Scale Diagnostics, is read by a barcode reader or other processor. The GPI is mapped to its associated GPD by the assay system's processor. The processor will then determine whether a general protocol or script is contained in the system's processor / memory and whether the instrument parameter file associated with the GPI is already stored in the system's memory. If not, the processor can download the general 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] The following table shows another example of a general protocol or script for bridging immunogenicity assays, a specific instrument parameter file associated with GPI for IG assays with acid treatment, and another specific instrument parameter file associated with BPI for IG assays without acid treatment. [Table 5]

[0298] Using a general protocol for multiple assays, along with individual instrument parameter files where on / off flags are uniquely associated with the GPI of a particular assay, brings improvements to immunoassays, and more specifically, immunoassays using ECL, and certain computer technologies used with automated immunoassays.

[0299] The embodiments of the protocol or script shown in association with Figures 12(m) to 12(s) may represent best practices recommended to the user. The user interface may provide additional fine-tuning to the user / laboratory technician by allowing the user to use several options to turn other features on or off immediately before starting the assay run. For sandwich immunoassays such as Assays 1-4 described above, the user interface may allow the user / laboratory technician one or more of the following non-restrictive options: • Assay type: Direct or indirect • Plate type • Standard curve setup including the number of points on the curve, dilution coefficient, etc. • Control setup including the number of controls per plate and the dilution factor for each control. • Sample setup including each unknown replication number and its respective dilution factor • Washing plate: Y / N • Blocking: Y / N including blocking amount, incubation time, and subsequent washing of plates. • Coating: Y / N including coating amount, online / offline incubation, incubation time, and subsequent washing of plates (Y / N) Sample incubation including sample volume, online / offline incubation, incubation time, and subsequent plate washing (Y / N). • For indirect assays: Unlabeled / biotinized sample incubation: Sample quantity, online / offline incubation, incubation time, and subsequent plate washing (Y / N) • STAG-labeled species incubation: Species count, online / offline incubation, incubation time, and subsequent plate washing (Y / N) • Read buffer incubation: On / Off, incubation time

[0300] For bridging immunogenicity assays, the following are some of the user-selectable options: • Plate type • Standard curve setup including the number of points on the curve, dilution coefficient, etc. • Control setup including the number of controls per plate and the dilution factor for each control. • Sample setup including each unknown replication number and its respective dilution factor • Acid treatment (Y / N), including the ratio of acid to diluted sample and incubation time. • Sample incubation time including the ratio of master mix to sample • Pre-start cleaning delay (Y / N) • Shutdown amount and subsequent cleaning plate (Y / N) including shutoff (Y / N) • Sample volume, online / offline incubation, incubation time, and subsequent sample incubation on plates including washed plates (Y / N) • Read buffer incubation: On / Off, incubation time

[0301] One embodiment of the assay system and its sub-components, as shown in Figure 10, is shown in Figures 13(a) to 13(f). Figure 13(a) shows a schematic representation of a specific subsystem of the assay system (1300) involved in carrying out the assay positioned on a table or platform (1301), each subsystem being operationally connected to a robot 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 includes a consumable identifier controller (e.g., a barcode reader (1306)) configured to read assay consumable identifiers positioned on, for example, a multiwell plate, as needed. The system includes a dispensing tip storage compartment (1307) configured to accommodate dispensing tip boxes of varying sizes (e.g., 1308 and 1309, 1000 μl and 350 μl tips, respectively), and further includes 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 Figure 13(b), when an assay consumable, such as a multiwell 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 further, the system may query the data hub for additional consumable data, as described above). A typical list of consumable data that can be associated with an identifier, including but not limited to lists of components, calibrator values, control values, recipient customer numbers, order numbers, catalog numbers, and the relevant assay protocol for that consumable, is shown in Figure 13(b). The assay protocol (1315) includes one or more steps performed by the user and / or by components of the assay during the execution of the assay. For those steps performed by the user (1316), the software displays those steps to the user via the user interface of the assay system (1317). All manual steps can be displayed simultaneously in the user interface, or each manual step can be displayed individually in the user interface, and the software prompts the user to confirm completion of the 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 operations (e.g., 1320-1322, respectively). For example, if a step in the assay protocol is to incubate a test plate in the plate shaking subsystem, that step may include at least the following substeps: (a) a substep to move the test plate to the plate shaking subsystem, and (b) a substep to start the plate shaking subsystem for a specified duration.Each of these substeps requires the software to send one or more commands to a subsystem or its components to complete the required subsystem. For example, moving a test plate to the plate oscillation subsystem requires the software to instruct one or more motors of the robot subsystem to move to the test plate, retrieve the test plate, and move the test plate to a specified position in the plate oscillation subsystem. Each subsystem operation is identified in the software's protocol script.

[0303] The assay system must then be prepared for assay execution before manual assay steps (if any) can be completed. For example, the software can instruct the assay reader to evaluate a demo multiwell assay plate to ensure proper performance of the assay reader. Wash buffer can be filled or replenished (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. Furthermore, the user can manually replenish or replace the disposable tip boxes of the assay system. The user can also prepare the software for assay execution either remotely on a networked computer or directly on the assay system user interface. For example, consumables such as kits can be selected by the user on the user interface, and the number of samples to be performed in the assay can be selected. The user can also review the list of consumables required for the assay (displayed on the user interface by the software) and all The system can verify that the necessary consumables are available. The user can then submit the experiment defined in the system software for start and completion. As described above, the software prompts the user to follow any software prompts to complete manual steps as needed and prepare the system for performing the assay. The user starts the assay run in the user interface, the system locks, and the software script for the protocol starts.

[0304] In one embodiment of the V-PLEX assay, such as the assay system shown in Figure 13(b), the following manual steps are required. The software displays each step in the user interface and optionally prompts the user to confirm that each step has been completed via the user interface. a) Unpack the consumables kit. b) Thaw the reagents according to the instructions for the consumables. c) Dilute the ECL reading buffer to 2X using deionized water. d) Use deionized water and dilute the washing buffer to 1X. e) Reconstitute the lyophilized calibrator by adding 1000 μL of dilution A, and mix the wells by vortexing. f) Reconstitute the lyophilized control by adding 250 μL of dilution A to the vial, and mix the wells by vortexing.

[0305] A calibrator is a sample with a known concentration of the assay-related sample used to determine a fit curve and apply it to an unknown sample. Calibrators are generally supplied at high concentrations and diluted to prepare lower-concentration solutions. Typically, up to eight (8) points are used to prepare a fit curve. A control is also a sample with a known concentration of the assay-related sample used to determine system performance and whether the assay is functioning correctly. Either a calibrator or a control is used in an immunoassay, and in some assays, both a calibrator and a control are used.

[0306] As shown in Figure 13(c), the appropriate consumables and reagents are loaded into the assay system. In short, disposable dispensing tips are loaded onto the platform, empty dilution plates, empty test plates, and pre-loaded sample plates are loaded onto the platform, the trough is filled with ECL reading buffer and sample diluent and loaded onto the trough carrier on the platform, and the reagent rack holds empty antibody mixing tubes, control vials, calibrator vials, detection antibody tubes, and antibody diluent tubes. The software displays the subsystem layout shown in Figure 13(c) in the user interface and can highlight each subsystem to assist in the proper placement of each consumable or reagent in the subsystem. Once the loading step is complete, the software prompts the user to close the door to the assay system, and the software locks the door to the system and starts a loading confirmation 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, the software will display a warning on the user interface, and the user will be instructed to manually adjust the improperly loaded consumable or reagent.

[0307] For example, a protocol for performing a V-PLEX assay for cytokines, etc., on an assay system is shown in Figure 13(d). As described above with respect to Figure 13(b), each step of the protocol corresponds to the operation of one or more substeps and subsystems, and the software includes essential scripts and subscripts required to instruct the system to perform each step, substep, and operation necessary to complete the assay. The order of steps and timing of events in the assay protocol are shown in Figure 13. (e) is shown, and a summary of the steps is shown in Figure 13(f).

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

[0309] The assay systems and software described herein can be configured to perform multiple 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 the proper preparation of samples and / or reagents for use with the assay system. For example, in addition to the V-PLEX assay described in detail above, the assay systems and software can be used in Meso (Rockville, Maryland). Scale The system is also configured to perform U-PLEX and S-PLEX assays (available from Discovery). Both U-PLEX and S-PLEX assays require a certain number of preparation steps and optional optimization steps, and the software is configured to display personalized step-by-step protocols to the user for those preparation and optimization steps. For example, the U-PLEX protocol requires that one or more reagents be prepared according to a specific reagent preparation protocol, and those steps are displayed to the user via the user interface before the assay is performed on the assay system. Figures 15(a) to 15(b) show the assay protocols performed on the assay system for a single-plate U-PLEX assay, and Figures 15(c) to 15(f) show the assay protocols performed on the assay system for a multi-plate U-PLEX assay. Figures 15(a) to 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 immunoassay: preparation, optimiz...

Claims

1. An automated assay system, (a) A processing deck for holding assay components, having a surface with a front end, a first side end, a second side end, and a rear end edge, (i) an assay consumable storage unit, which is cantilevered and positioned near the center of the front end of the processing deck, having multiple consumable slots made to hold assay consumables, (ii) A plurality of pipette tip locations for holding pipette tip containers located on the first side of the processing deck, (iii) A plurality of plate shaker locations located along the rear edge of the processing deck, (iv) A set of processing locations located approximately in the center of the processing deck between the assay consumable storage unit and the plate shaker location, and configured to hold the assay consumables, (v) A barcode scanner located at the first side end of the processing deck behind the plurality of pipette tip locations, the processing deck having the barcode scanner having a scanning surface large enough to scan the bottom surface of the assay consumables, (b) A plate washer located below the processing deck and accessible through the opening in the processing deck between the plurality of pipette tip locations and the processing locations, (c) A gantry located above the processing deck that provides movable support for a robotic plate gripper, allowing the robotic plate gripper to access (i) to (v), and provides movable support for a robotic 8-channel pipette, allowing the robotic 8-channel pipette to access (ii) and (iv), (d) An assay reader located at the first side end of the processing deck and installed on a platform having a lower vertical height than the processing deck, An automated assay system comprising: (e) an enclosure surrounding (a) to (d) having a temperature controller for temperature control and a door that allows user access to the front end of the processing deck and the assay consumable storage unit.

2. The automated assay system according to claim 1, wherein the assay consumable storage unit is configured as a shelf assembly and adapted to be mounted on the processing deck, and the plurality of consumable slots are configured as a plurality of sets of vertically aligned storage units.

3. The automated assay system according to claim 2, wherein the assay consumable is a multiwell plate, and each of the vertically aligned storage units is made to be of a size and dimensions that can receive the multiwell plate.

4. The automated assay system according to claim 3, wherein the shelf assembly comprises a plurality of horizontal members and a plurality of upright vertical supports.

5. The automated assay system according to claim 4, wherein the assay consumable storage unit is fixed to the processing deck, and the shelf assembly is detachably attached to the processing deck by at least one screw connector having at least two positioning pins and a finger-operable head.

6. The automated assay system according to claim 5, wherein the shelf assembly comprises a set of storage units arranged vertically in a linear arrangement of M x N, where M and N are integers.

7. The automated assay system according to claim 5, wherein the upper horizontal member has a function for aligning the bottom of the container.

8. The automated assay system according to claim 7, wherein the upper horizontal member is larger than the bottom of the container and has a function for aligning the lid of the assay reagent holder.

9. The automated assay system according to claim 1, wherein the assay reader and the plate washer are positioned to provide clearance for the operation of the robotic plate gripper and the robotic 8-channel pipette.

10. An automated assay system, (a) A processing deck for holding assay components, having a surface with a front end, a first side end, a second side end, and a rear end edge, (i) an assay consumable storage unit cantilevered over the front end of the processing deck, (ii) A plurality of pipette tip locations for holding pipette tip containers located on the first side of the processing deck, (iii) A plurality of plate shaker locations located along the rear edge of the processing deck, (iv) A set of processing areas located approximately in the center of the processing deck between the assay consumable storage unit and the plate shaker area, (v) The processing deck having a barcode scanner located at the first side end of the processing deck behind the plurality of pipette tip locations, (b) A plate washer located below the processing deck and accessible through the opening in the processing deck between the plurality of pipette tip locations and the processing locations, (c) A gantry located above the processing deck that movably supports the robot plate gripper and movably supports the robot 8-channel pipette, (d) An assay reader located at the first side end of the processing deck and installed on a platform having a lower vertical height than the processing deck, (e) An automated assay system comprising an enclosure surrounding (a) to (d), with a temperature controller for temperature control.

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