Consumables data integrated management system and platform

Abstract

To solve the problem that automation of immunoassays presents a series of challenges such as repeatability and / or reproducibility which remains goals for all automated assay systems.SOLUTION: The present invention relates to a method, a device, and a system for associating consumable data with assay consumables used in biological assays. Provided is an assay system and associated consumable, where the assay system adjusts one or more steps of an assay protocol based on consumable data specific to the consumable. Various types of the consumable data and a method of using such data in execution of assays by the assay system are described. The present invention also relates to a consumable (for example, a kit and a reagent container), software, a data deployable bundle, a computer readable medium, a loading cart, a measuring instrument, a system, and a method for performing automated biological assays.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This international patent application claims priority to U.S. provisional patent application entitled "Integrated Consumable Data Management System and Platform," filed July 23, 2015, with application serial number 62 / 195,956.

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

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

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

[0005] Automating 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 particularly electrochemiluminescence (ECL) immunoassays. The automated assay system of the present invention is capable of performing assay runs with reproducible results. Random human or machine errors that may occur during preparation for an assay run (e.g., diluting samples or calibrators), loading assay consumables onto the instrument, and the assay run have been identified and minimized. Other aspects include consumables, instruments, loading carts, software, data-deployable bundles, computer-readable media, and methods for performing biological assays.

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

[0008] Other improvements include, but are not limited to, software architectures that minimize 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 turn on or off specific components of the generic protocol to customize the protocol to a specific assay.Specialized lids are provided to minimize loss of reagents from containers due to evaporation while maintaining the ability of pipettors to access the reagents.

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

[0010] An additional embodiment of the present invention is a Data Deployable Bundle (DDB) that includes one or more data files containing consumable data related to an assay consumable and the use of the assay consumable in an assay system, the one or more data files including a DDB unique identifier, a DDB Includes version, DDB xml file, consumable static information, consumable processing information, and combinations thereof.

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

[0012] Another embodiment relates to a holder for assay reagents, the holder including 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 on the bottom of the reagent containers. The regions may be at least two different sizes to receive at least two assay containers of different sizes. The regions and holes or windows may be circular, with the holes or windows having a smaller diameter than the regions, or the regions and holes or windows may be rectilinear, with the holes or windows having a smaller diameter than the regions.

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

[0014] The footprint dimensions of the vessel preferably conform to the ANSI-SLAS dimensions of the multiwell plate, and the height of the vessel may also conform to the ANSI-SLAS height of the multiwell plate.

[0015] In one embodiment, the insert is a foam and is inserted into at least two cylindrical holes in the frame for packing the at least two reagent containers. The insert may be positioned between the vessel and an area larger than the reagent vessel. The insert may define a cylindrical hole in the assay reagent vessel and fills the frame.

[0016] The mask may define multiple regions, the number of mask regions may be the same as or less than the number of regions on the container, frame, or insert, and the mask may limit the number of assay containers that can be accommodated by the assay reagent container. Preferably, the mask includes labels for the reagents.

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

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

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

[0020] The consumable identifier may be a two-dimensional or one-dimensional barcode that can be printed on a plastic pack that is inserted into a recess in the bottom of the tube or vial, or printed on a foil disc that is heat sealed to the recess in the bottom of the tube or vial.

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

[0022] The present invention also relates to an assay kit comprising any of the assay containers described above 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 multi-well plate and may have an assay consumable identifier. The kit may also have at least one trough or tube or both.

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

[0024] The lid may not be made from a compliant plastic or elastomeric material, or may be made from a hard plastic or polystyrene.

[0025] The present invention also relates to a lid configured to cover the top surface of a multiwell plate, including a skirt corresponding to the top of the lid, the skirt adapted to fit around the periphery of the top surface of the multiwell plate, and the top surface of the plate sized and dimensioned to contact the periphery of the multiwell plate. The lid is optionally hydrophobic. The lid may be made from a hydrophobic polymer, or the bottom surface of the top of the lid can be made hydrophobic. The bottom surface can be microetched to create a rough surface to trap air, so that the bottom surface exhibits Cassie-Baxter behavior as a barrier to moisture.

[0026] Alternatively, the bottom surface can be coated with a hydrophobic coating or a surfactant. The lid can also have a plurality of recesses extending from the top of the lid toward the multiwell plate, the plurality of recesses corresponding to the plurality of wells of the multiwell plate, and configured to extend into the plurality of wells.

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

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

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

[0030] The computer screen may be the screen of a tablet computer or may be connected to a personal computer or laptop computer. The computer screen may be controlled by a processor on the assay machine. The computer screen may be connected to the processor on the assay machine by a WiFi or Bluetooth connection.

[0031] The slots on the loading cart can be defined on the top or both sides of at least one tray, i.e., the tray can be reversible. The slots can be of different sizes adapted to receive 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 may be an upper shelf. Also, the cart may have a bottom shelf. The cart may have a shelf and / or a central shelf. The cart may have a compartment below at least one tray or upper tray, the compartment adapted to store coolant. The compartment may also have a drainage opening, and the bottom surface 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 pierce a plurality of consumables, such as at least one multiwell plate, which may include at least one assay plate or at least one dilution plate. The plurality of consumables may include at least one container of a reagent. The plurality of consumables may include at least one tube or at least one trough. An example of a tray is shown in FIG. 19.

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

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

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

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

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

[0039] The present invention also relates to a plate sized and dimensioned to match the size and dimensions of an ANSI-SLAS format assay plate, comprising a rectangular perimeter and at least one support member connecting a first side of the rectangular perimeter to a second side of the perimeter, at least one reference pad located on a first major surface of the plate and corresponding to the location of at least one well in the ANSI-SLAS format assay plate, the location of the at least one reference pad in one dimension of a three-dimensional coordinate system being measurable by a probe of an assay system when the plate is positioned in a plate carrier of the assay system.

[0040] The probe can measure 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 the at least one reference pad corresponds to a corner well on the ANSI-SLAS format assay plate.

[0041] The plate may also have at least two opposing gripping areas located on sides connecting the two major surfaces of the plate, the gripping areas adapted to be gripped by a gripper arm of a robotic system, the rectangular perimeter adjacent the first major surface being smaller than the rectangular perimeter adjacent the second major surface, and the first and second major surfaces being substantially parallel.

[0042] The plates are preferably made from and / or machined from cast aluminum.

[0043] An additional aspect relates to a plate for teaching or training an automated instrument, the plate being sized and dimensioned to match the size and dimensions of an ANSI-SLAS format assay plate, the plate including a rectangular perimeter and at least one support member connecting a first side of the rectangular perimeter to a second side of the perimeter, at least one reference pad located on a first major surface of the plate and corresponding to the location of at least one well of the ANSI-SLAS format assay plate; The location of the at least one reference pad in one dimension of a three-dimensional coordinate system is measurable by a probe of an assay system when the plate is positioned in a plate carrier of the assay system.

[0044] An additional aspect relates to a method of training or teaching a robotic gripper or pipettor that includes using the plate described above.

[0045] Also related to an aspect of the present invention is an assay consumable storage unit adapted to be attached to a platform of an assay system including a shelf assembly having a base and a plurality of sets of vertically aligned storage units, each storage unit sized and dimensioned to receive a consumable for performance of an assay by the assay system; The shelving assembly includes a plurality of horizontal members connected by a plurality of upstanding vertical supports; The base is cantilevered to the platform and the shelf assembly is removably attached to the base by at least two locating pins and by at least one threaded connector having a finger-actuable head.

[0046] An additional aspect relates to an assay system configured to use an assay consumable in performing an assay, the assay consumable including an assay consumable identifier associated with a data deployable bundle (DDB) for the assay consumable, the assay system comprising: (a) a storage medium including a consumable data repository and a data registry containing local consumable data; (b) a consumable identifier controller adapted to read and install the DDB on the storage medium; (c) a consumable data service processor adapted to query the data registry and at least one remote consumable data database to use the assay consumables and to identify and download consumable data needed for performance of an assay by the assay system; Includes.

[0047] Additional assays include an assay system including a housing, the housing comprising a continuous glass member, a touch screen 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.

[0048] An additional assay includes an automated assay system adapted to receive consumables in performing an assay, the assay system including a robotically controlled pipettor and a robotically controlled gripper arm, an assay reader, a plate washer, and at least one optional heatable shaker, at least one heat exchanger, and at least one processor adapted to execute at least one instruction to minimize potential errors in loading the consumables and in performing the assay; the consumables include at least one assay test plate, at least one dilution plate, at least one set of pipette tips, at least one sample plate, and a plurality of containers containing at least one of a calibrator, a diluent, and an antibody; At least one instruction must be instructions to a user interface that guides a user to load the consumable into the assay system; instructing the robotic gripper arm to place a lid on the at least one assay test plate when the at least one assay test plate is placed on the shaker; commanding at least one heat exchanger to maintain a selected temperature within the assay system; instructions for performing an assay for at least one assay test plate, the at least one assay plate including a plurality of assay test plates, each assay test plate being completed substantially contemporaneously; Contains at least one of the following:

[0049] An additional aspect relates to a method for operating an automated assay system to minimize potential errors in loading consumables for an assay and running the assay, the assay system includes a robotically controlled pipettor and a robotically controlled gripper arm, an assay reader, a plate washer, and at least one shaker and incubator, at least one heat exchanger, and at least one processor; the assay system is configured to receive consumables, the consumables including at least one assay test plate, at least one dilution plate, at least one set of pipette tips, at least one sample plate, and a plurality of containers containing at least one of calibrators, controls, diluents, antibodies, reagents, and buffers; The method comprises the following steps: instructing a user interface to guide a user to load a consumable into the assay system; commanding a robotic gripper arm to place a lid on the at least one assay test plate when the at least one assay test plate is placed in the shaker and incubator; directing at least one heat exchanger to maintain a selected temperature within the assay system; instructing at least one processor to run an assay for at least one assay test plate, the at least one assay plate including a plurality of assay test plates, each assay test plate being completed in a substantially synchronous time period; Contains at least one of the following:

[0050] The present invention also relates to an automated assay system configured to use assay consumables in performing an assay, the assay system including at least one processor and at least one storage medium; the storage medium stores instructions for performing the assay by the processor; The instructions are divided into a plurality of components, the plurality of components comprising: a security component; a user interface component; an instrument control component; a data service component; Including, Each component operates substantially independently of the others and has substantially no interaction with each other; The components are connected to a master organizer, which tells each component when to operate.

[0051] The present invention further relates to an assay system configured to use an assay consumable in performing a first assay, the first assay including a unique assay identifier, the assay system comprising: a reader adapted to read the unique assay identifier; a processor that accesses a general protocol file and an instrument parameter file; Including, the general protocol file includes assay steps that are applicable to multiple assays, including the first assay; The instrument parameter file contains a number of flags that are either on or off, The processor turns on or off the testing steps of the general assay protocol according to the flag to perform the second assay.

[0052] An additional assay system relates to an automated assay system configured to minimize user, instrument, and assay method variability, the system comprising: Measures to minimize user error in system load; and Measures for minimizing user error when selecting an automated workflow; and a means for minimizing sample dilution errors; a means for minimizing system plate handling errors; Measures to minimize system dispensing errors; means for minimizing temperature fluctuations; a means for minimizing evaporation or condensation within the assay consumable; means for controlling the shaking frequency of the at least one shaker; Measures to minimize the complexity of maintenance procedures and Contains at least one of the following:

[0053] In an additional aspect, the automated assay system is configured to minimize user, instrument, and assay method variability, the system comprising a robotic gripper arm and a robotic pipettor; performing a sample dilution step; Selecting and running the correct assay workflow for a given assay; controlling an air cooling processing system, thereby maintaining a defined temperature in the assay workflow area of ​​the system within defined tolerances; Maintaining consistent timing between runs, plates, and wells; Allowing users to run different assay workflows without having to reconfigure or revalidate the workflow software; The present invention also includes software and instrument components for at least one of the following:

[0054] Additional embodiments include a robotic gripper arm and robotic pipettor, and the following additional components: (a) a plate carrier; (b) a tip box carrier; (c) five optional heatable shakers; (d) an air cooling handling system; (e) an assay consumable storage unit for assay reagents; (f) an assay consumable storage unit for ready-to-use tips; (g) an assay consumable storage unit for spare tips; (h) an assay consumable storage unit for plates; (i) an assay consumable storage unit for tubes and troughs; and (j) a platform or table, or both, with components (a)-(c) and (e)-(h) located on the platform or table in the system in substantially the same positions relative to each other as shown in Figure 10(a), Figure 10(b), Figure 10(c), Figure 10(l), Figure 10(n) or Figure 10(o), and component (d) located on the back panel of the instrument substantially as shown in Figure 10(l), Figure 10(m) or Figure 10(n).

[0055] In an additional aspect, the present invention provides a method for producing a pharmaceutical composition comprising: (a) A single robotically controlled 8-channel pipettor; (b) a single robotically controlled assay plate gripper arm; (c) a single 96-channel assay plate washer; (d) a single plate reader; (e) one or more plate shakers having a total capacity of at least five plate shaking stations; (f) a processor adapted to execute an assay process for analyzing a plurality of samples in a 96-well plate, the processor comprising the following operations of the process: (i) a blocking step including adding blocking buffer with a pipettor, incubating for a blocking period (b), and washing with a plate washer; (ii) a sample binding step comprising adding one of the samples using a pipettor while shaking at one of the plate shaking stations and washing using a plate washer, followed by incubation for a sample incubation period(s); (iii) a detector binding step, which includes adding detection reagent using a pipettor while shaking at one of the plate shaking stations and washing using a plate washer, and incubating for a detector incubation period (d); (iv) adding read buffer using a pipettor; (v) measuring the assay signal using a reader; is performed on each well of the plate; and Including, Up to five plates can be processed in a run. The steps are performed as shown in Figure 9(d), Figure 12(m)-Figure 12(p), Figure 12(r)-Figure 12(s), Figure 13(d)-Figure 13(f), Figure 14(d), Figure 14(f)-Figure 14(l), Figure 15(b), Figure 15(d)-Figure 15(h), Figure 16(b), Figure 17(b), Figure 17(d)-Figure 17(h). Regarding automated assay systems.

[0056] Additional automated assay systems include (a) a processing deck for holding assay components providing a generally rectangular surface with a leading edge, a first side edge, a second side edge, and a trailing edge; (i) an assay consumables hotel approximately centered and cantilevered on the front end of the deck having a plurality of consumables slots sized to hold consumables meeting ANSI-SLAS specifications for the width and length of a 96-well assay plate; (ii) a plurality of pipette tip locations for holding pipette tip containers located on a first side of the deck; (iii) a plurality of plate shaker locations located along the aft edge of the deck; (iv) a set of processing locations located approximately at the center of the deck between the hotel and a shaker configured to hold consumables having dimensions conforming to ANSI-SLAS; (v) a barcode scanner located on a first side of the deck behind the pipette tip location, the barcode scanner having a scanning surface large enough to scan the bottom surface of a consumable having ANSI-SLAS compliant dimensions; the deck supporting the (b) a plate washer located below the deck and accessible through an opening in the deck between the pipette location and the assay plate processing location; (c) a gantry located above the deck that movably supports a robotic plate gripper so that the gripper can move to access locations (i) through (v) and that movably supports a robotic 8-channel pipettor so that the pipettor can access locations (ii) and (iv); (d) an assay reader positioned adjacent a first side of the deck on a platform that is at a lower vertical height than the deck, the highest point on the reader being lower than the lowest point to which the robotic grabber can travel; (e) an enclosure surrounding components (a)-(d), having a temperature controller for maintaining the components under temperature control and having a door providing user access to the front of the deck and the consumable hotel located thereon; The present invention relates to an automated assay system comprising:

[0057] Additional aspects include: (a) A single robotically controlled 8-channel pipettor; (b) a single robotically controlled assay plate gripper arm; (c) a single 96-channel pre-assay plate washer; (d) a single plate reader; (d) one or more plate shakers having a total capacity of at least five plate shaking stations; (e) a processor adapted to perform an assay process for analyzing a plurality of samples in a 96-well plate, the processor comprising the following operations: a blocking step comprising (i) adding a blocking buffer using a pipettor, incubating for a blocking period (b), and (c) washing using a plate washer; (ii) a sample binding step comprising adding one of the samples using a pipettor and incubating for a sample incubation period(s) while shaking on one of the plate shaking stations and washing using a plate washer; (iii) Shake in one of the plate shaking stations and wash using the plate washer. a detector binding step including adding a detection reagent using a pipettor and incubating for a detector incubation period (d); (iv) adding read buffer with a pipettor; (v) measuring the assay signal using a reader; a processor which executes the process in each well of the plate; Including, Up to 5 plates can be processed in a run Regarding automated assay systems. [Brief explanation of the drawings]

[0058] [Figure 1] FIG. 10 is a diagram illustrating generation and storage of consumables data, and consumables data by a consumables manufacturer. [Figure 2] FIG. 10 illustrates distribution of consumable data to customers in response to inquiries about the consumable data. [Figure 3] FIG. 1 illustrates the use of consumable data to verify authorized use of consumables in an assay system. [Figure 4] FIG. 1 illustrates the master repository on a CD server, its contents, and / or the interface to additional vendor directories. [Figure 5a-b] FIG. 1 shows an assay reader as described herein. [Figure 5c-d] FIG. 1 shows an assay reader as described herein. [Figure 6a]1A-1C are several alternative views of the assay reader described herein. [Figure 6b] 1A-1C are several alternative views of the assay reader described herein. [Figure 6c] 1A-1C are several alternative views of the assay reader described herein. [Figure 7] 1A-1C are additional views of an assay reader as described herein. [Figure 8] FIG. 1 shows an assay system described herein. [Figure 9a] 1 illustrates an assay system and the various subsystems included therein, particularly including multiple subsystems positioned on a table or platform, each subsystem operatively connected to a robotic subsystem configured to access and move one or more consumables, such as multi-well assay plates, from one subsystem of the assay system to another. [Figure 9b] 1 illustrates an assay system and the various subsystems included therein, particularly including multiple subsystems positioned on a table or platform, each subsystem operatively connected to a robotic subsystem configured to access and move one or more consumables, such as multi-well assay plates, from one subsystem of the assay system to another. [Figure 9c] 1 illustrates an assay system and the various subsystems included therein, particularly including multiple subsystems positioned on a table or platform, each subsystem operatively connected to a robotic subsystem configured to access and move one or more consumables, such as multi-well assay plates, from one subsystem of the assay system to another. [Figure 9d] 1 shows the scheduling of operations performed on the system during the performance of an assay. [Figure 10a-b]10(a)-10(b) illustrate one embodiment of an assay system and various subsystems therein, wherein the assay system of Figures 10(a)-10(b) is configured to perform on-board all sample processing steps as well as all assay processing steps required in performing an assay, and the assay system is operatively connected to a user interface configured to display to a user step-by-step instructions for appropriate sample / reagent preparation steps that must be performed manually before the system can perform an assay. [Figure 10c] FIG. 10(a)-(b) shows another iteration of the assay system shown in FIGS. 10(a)-(b). [Figure 10d] FIG. 1 shows the top view of a table supporting the equipment of an assay system. [Figure 10e-f] FIG. [Figure 10g] FIG. 10 is a perspective view showing the pipette tip entering the lid of the reagent trough. [Figure 10h] 10(g) is a top view of various cut patterns of the lid shown in FIG. 10(g). [Figure 10i] FIG. 1 is a perspective view of a lid and assay plate. [Figure 10j] FIG. 10(i) is a cross-sectional view of the lid and assay plate of FIG. [Figure 10k] FIG. 10(j) is a diagram showing an enlarged portion of FIG. [Figure 10l] FIG. 13 is a front view of the assay system shown in FIGS. 10(a)-10(c) with its inner door closed. [Figure 10m-o] FIG. 1 shows cooling patterns within the assay system. [Figure 10p] FIG. 1 illustrates the cooling pattern of an electronic enclosure. [Figure 10q] FIG. 10 shows an adjustable hinge for the door of the assay system with two degrees of freedom. [Figure 10r] FIG. 1 is a top perspective view of an assay consumable storage unit. [Figure 10s-t] FIG. 1 shows the dimensions of the frame of the assay system. [Figure 10u] FIG. [Figure 10v-y] FIG. 1 shows a portion of the wiring diagram of the assay system (1000). [Figure 10z] FIG. 10 is a top view showing the plate carrier (1036) and tip carrier (1026). [Figure 11a] FIG. 1 illustrates a particular embodiment of a data association workflow, a process by which particular data is associated with a consumable identifier. [Figure 11b] FIG. 1 illustrates the interaction between the assay system's computer system and the customer's computer system. [Figure 11c] FIG. 1 is a diagram of the components of the computer system of the assay system. [Figure 11d] 1 is a flow chart of the instrument control portion of the software. [Figure 11e] FIG. 1 illustrates an example of a software architecture. [Figure 12a-l] FIG. 1 illustrates one embodiment of a software architecture for deployment and use of Data Deployable Bundles (DDBs). [Figure 12m] FIG. 1 illustrates a script showing an exemplary general protocol. [Figure 12n-p] FIG. 12(m) shows the script of FIG. 12(m) with selected steps of the protocol turned off. [Figure 12q] FIG. 10 illustrates an exemplary instrument parameter file showing the on / off status of specific steps in a protocol. [Figure 12r] FIG. 10 illustrates another example of a general protocol. [Figure 12s] FIG. 1 illustrates a generic script with certain steps turned off. [Figure 13a-f] FIG. 1 illustrates one embodiment of the use of data deployable bundles and consumable / system data to operate an assay system in performing an assay. [Figure 14a-l]FIG. 1 shows the implementation of a V-PLEX assay on an assay system using the software described herein. [Figure 15a-h] FIG. 1 shows the implementation of a U-PLEX assay on an assay system using the software described herein. [Figure 16a-d] FIG. 1 shows the setup, optimization, and execution of an immunogenicity assay on the assay system. [Figure 17a-i] FIG. 1 illustrates the preparation, optimization, and execution of a custom singleplex sandwich immunoassay or pharmacokinetic assay in an assay system. [Figure 18a-n] FIG. 1 illustrates the assay system described herein and a consumable assay kit that can be used. [Figure 19a-b] FIG. 1 is a perspective view of a loading cart of the present invention designed for use with the assay system described herein. [Figure 19c] FIG. 1 is a plan view of a loading cart showing trays adapted to receive assay consumables. [Figure 19d-h] FIG. 1 is an exemplary plan view of a tray loaded with assay consumables. [Figure 19i] FIG. 10 shows the cooling compartment below the tray. [Figure 20a-e] FIG. 10 shows exemplary adjustments to dispense timing and ECL read patterns for an assay system of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0059] Unless otherwise defined herein, scientific and technical terms used in connection with the present invention shall have the meanings commonly understood by those skilled in the art. Furthermore, unless the context clearly dictates otherwise, singular terms shall include the plural and plural terms shall include the singular. The articles "a" and "an" herein refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, "an" means one element or more than one element.

[0060] As used herein, the term "sample" is intended to mean a biological fluid, cell, tissue, organ, or combination or portion thereof that contains or potentially contains a biomarker of a disease of interest. For example, a sample can be a tissue section of a specimen obtained by biopsy, or cells placed in or adapted to tissue culture. A sample can also be a subcellular fraction or extract, or a crude or substantially pure nucleic acid molecule or protein preparation. In one embodiment, samples analyzed in the assays of the invention are blood, peripheral blood mononuclear cells (PBMCs), separated blood cells, serum, and plasma. Other suitable samples include biopsied tissue, intestinal mucosa, saliva, cerebrospinal fluid, and urine.

[0061] Assay consumables and systems used in the present invention include a variety of devices and configurations. In one embodiment, an assay system used in the present invention includes an assay reader capable of using the assay consumable and performing a biological assay. The assay consumable includes an identifier (alternatively referred to throughout the specification as an identifier, consumable identifier, or assay consumable identifier), and the assay system, assay reader, or components thereof include an identifier controller that interacts with the identifier. As described below, the identifier is associated with information about the assay consumable (collectively referred to as "consumable data"), which may include, but is not limited to, how the consumable is manufactured and processed prior to use, and how the consumable is used in the assay system. Thus, an assay system is configured to use assay consumables in performing an 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 on the assay system or assay reader or remotely on a vendor computing system, (iii) erase the consumable data associated with the assay consumable identifier, and / or (iv) write the consumable data indexed to the consumable identifier to the assay system and / or a remote data table.

[0062] In a specific embodiment, the present invention provides an assay system configured to use an assay consumable in performing an assay, the assay consumable including an assay consumable identifier as described herein, and the assay system including: (a) a storage medium including a consumable data repository; and (b) an identifier controller adapted to read information from the consumable identifier. In one embodiment, the system includes a storage medium including a consumable data repository including local consumable data. The local consumable data stored by the assay system includes consumable identification and / or configuration information, and a system controller adapted to use the consumable in performing an assay using the consumable. The assay consumable identifier may include one or more steps of an assay protocol that can be applied by the system. For example, an assay consumable identifier may include information that can be used to identify a particular consumable, such as lot-specific information for a given lot of consumables and / or information that is specific to an individual consumable, and corresponding local consumable data stored in the assay system may include information used to identify a consumable associated with the system, such as as a member of a given lot or as an individual consumable within a lot, which may also include information used by the system once the consumable is identified to perform an assay protocol using that consumable. Additionally, the consumable data (and / or local consumable data) may include one or more analytical tools that can be applied by the system to use the consumable and analyze and interpret generated data, system and / or consumable technical support information, or a combination thereof. Additionally, the system may be configured to receive updates to the consumable data repository from the remote storage medium, where those updates include additional consumable data, including, but not limited to, additional consumable identification and / or configuration information, assay protocol information, and one or more of the following: (x) one or more analytical tools that can be applied by the system to analyze data and interpret results generated during and / or after performance of the assays; (y) assay system maintenance information; (z) system consumable promotional information; and (xx) system and / or consumable technical support information.

[0063] One embodiment of the use of identifier / consumable data in the system is illustrated in Figures 1-4. Figure 1 shows how consumable data is generated, stored, and used by a manufacturer, distributor, or supplier (referred to herein as a "vendor"). First, the vendor generates a consumable and / or collection or lot of consumables (101), and for that consumable or consumable lot, the consumable data is associated (step i) with a consumable identifier (103) generated and indexed to the consumable or consumable lot using a consumable data (CD) creation system (102). The consumable data is generated by the consumable vendor before, during, and / or after the individual consumable and / or consumable lot is made and / or distributed. The CD creation system creates a database of CD information for that consumable or lot, the CD database, in which the consumable data is stored. The CD database is sent to a CD server (104) that contains the master repository of all consumable data. Additionally, the CD creation system stores information used to associate a given consumable identifier with consumable data in the master repository. The CD creation system and / or CD server may be located at a remote computing system, i.e., an assay system and / or a computing system remote from the customer, or at a customer site, e.g., a site maintained by the vendor. Thus, as shown in Figure 1, the vendor generates consumable data for a consumable or lot (a) and associates that information with a consumable identifier (b) that indexes that consumable or lot. The CD system also generates a CD database (step ii), stores the consumable data in the CD database (step iii), and transmits the CD database to the CD server (c), which contains the master repository of all consumable data (step iv).

[0064] Figure 2 illustrates one method for distributing consumable data to customers (collectively referred to herein as "customers") or their designated users. Upon receiving an order from a customer, or once a consumable or lot has been manufactured (step i), the vendor generates, stores, and transmits a CD database to a CD server (201) (step ii). The CD database may include other fulfillment information, i.e., a summary of the order's components 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) including the consumable identifier (203) and contacts the consumable with an assay system (204) in preparation for performing the assay (step iii), which reads and / or accesses the data associated with the assay consumable identifier (203), which is used by the system to identify the consumable (202) (step iv). Step iv). The system reviews the consumable data stored locally in the system on a local storage medium (referred to as "Local CD" in Figure 2) to identify consumable data stored on that storage medium that can be used to perform an assay using a given consumable. If the storage medium contains consumable data for that consumable or lot, the consumable can be used in the system (step v). If the storage medium does not contain consumable data for that particular consumable or consumable lot, the system can query the customer for the consumable data, and the customer can communicate with the vendor to receive the required consumable data, for example, via email, compact disc, memory card / memory stick, flash drive, web data storage service, etc. (step vi). The vendor sends the customer a consumable data binary file (including, but not limited to, an encrypted XML file), for example, as an email attachment to a customer email account, the customer loads the file attachment into the assay system, and the system software stores the consumable data in the local system consumable data repository. The consumable / consumable lot can then be used in the instrument (step vii).

[0065] In an alternative embodiment, the CD Server can connect to the system through a direct interface that can automatically obtain consumable data from the CD Server if the consumable data is not available locally on the system. In this embodiment, the vendor generates, stores, and transmits a CD database for consumable orders and / or consumable lots to the CD Server, as shown in FIG. 2 and described above. The customer then receives the consumable, order, and / or lot and contacts the system with a consumable identifier to enable the system to identify the consumable or lot. The system software queries the system consumable data repository for consumable data associated with that consumable identifier, and if the consumable data is available locally on the system, the software adjusts the system based on the consumable data, if necessary. If the consumable data is not present in the system consumable data repository, the system either (i) prompts the customer to manually obtain the consumable data from the vendor, or (ii) automatically obtains the CD Server's consumable data via a direct interface with the CD Server and stores the information locally in the system consumable data repository. If the consumable data is available locally on the system, the software adjusts the system based on the consumable data, if necessary, to perform the assay. If the consumable data is available locally on the system, the consumable or lot can be used by the system to perform the assay and display the assay results to the customer. In a specific embodiment, the system software adjusts the output to the customer based on the consumable data.

[0066] Additionally, the CD Server can periodically send consumable data for new lots / consumable types of consumables to the customer assay system via, for example, email, CD, memory card / memory stick, flash drive, and / or via a remote interface between the system and the CD Server. The storage medium includes a consumable data repository containing the consumable data, and the assay system is configured to receive updates to the repository from the remote storage medium via, for example, email, CD, memory card / memory stick, flash drive, and / or via a remote interface.

[0067] Figure 3 illustrates the validation of consumable data by the system software, and the results of that procedure. First, a customer inserts a consumable (301) into the system (303) along with a consumable identifier (302) (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 that processing step to the customer. However, if the consumable data is invalid or cannot be verified, the consumable is processed by the system, but the results of its analysis are not. , consumable data will not be displayed or otherwise available to the customer until it has been verified by system software.

[0068] The present invention further provides a method for controlling customer access to an assay system and / or assay consumables by a vendor, the system including a system identifier, the method comprising: receiving the system identifier from a customer, the system identifier being transmitted to a vendor computing system; receiving, identifying the system identifier by vendor; and (i) providing full access to the device and / or assay consumables used with the device; (ii) allowing partial access to the device and / or assay consumables used with the device; or (iii) Denying access to the device and / or assay consumables used with the device; performing an operation including:

[0069] The system identifier includes information that uniquely identifies the assay system, such as a serial number or other identification code generated and used by the vendor to identify the assay system. The system identifier may be generated by the vendor during or after the manufacturing process and / or when the system is prepared for shipment or transfer to a customer.

[0070] In one embodiment, the step of enabling either full or partial access includes transmitting an access code from the vendor to the customer, thereby enabling access to the system. The access code may be a full access code or a partial access code that enables different features of the system. In one embodiment, the access code is a partial access code that allows the system to operate in a demonstration mode. The partial access code may be time-limited. Alternatively, the access code may be a full access code that allows the system to become fully operational.

[0071] As shown in FIG. 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. Additionally or alternatively, data contained in one or more directories (i)-(iii) can be provided to the master repository by an interface between the CD Server and one or more supplemental vendor directories. In one embodiment, the master repository includes (i) a master customer data directory (403), (ii) a master system identifier directory (404), and (iii) a master customer data directory (405). In a preferred embodiment, customer data is provided to the CD Server through an interface to a supplemental vendor-customer directory that maintains the customer data. The customer data can be stored in one or more supplemental vendor-customer directories, each interfaced to the CD Server. The master CD database includes multiple CD directories, each generated for a consumable or a lot of consumables. The master system identifier directory contains a unique system identifier for each system manufactured and / or distributed by the vendor, and the master customer directory and / or supplemental vendor-customer directory that interfaces with the CD Server contains information related to each customer of the vendor, such as contact information, billing information, pricing information, shipping information, order history, etc., for the customer and each of the customer's individual customers.

[0072] 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 stored in a master system identifier directory or is available through an interface between a supplemental vendor directory and the CD Server. When a system is ordered by a customer, order information and customer information, such as the purchase order, associated quote, pricing, sales or rental terms and conditions, and associated service contracts, 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 with the customer who purchased the system in the master repository, as well as any information regarding the associated purchase by that customer. Customer shipping information for the system is also available in the customer directory(ies), and once the system is shipped, the customer receives a shipping confirmation, a copy of which is also stored in the customer directory. Once the customer receives the system and, in a preferred embodiment, installation and training on the system is complete, the system software, if necessary, connects 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 that confirmation. Alternatively, if remote connection is not enabled on the system, the customer may receive a confirmation code, system login, and / or email address from the system once the system is installed and training is complete, and the customer may log in to the CD server via that confirmation code, system login, and / or email, thereby providing a customer login to the CD server that provides a separate vendor-customer interface without a direct connection between the system and the CD server.The separate vendor-customer interface may be a portal on a website hosted by the vendor and accessible to the customer via a password, and / or the customer and CD server may communicate via an email exchange server configured to send and receive emails between the customer and the CD server (collectively referred to as the "indirect interface" between the customer and the CD server). Thus, the vendor may 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 may then purchase the consumable, and the system may read the consumable identifier, verify that the consumable data is stored locally, and receive the consumable data directly or indirectly from the CD server if necessary, after which the system may use the consumable or lot.

[0073] When customers and vendors have a means to communicate through a direct or indirect interface, they can interact in a variety of ways, and because vendors have the ability to track system and consumable purchases and / or customer-specific usage information used by customers, communication between the parties can be more meaningful and productive. For example, customers can browse and / or purchase vendor products, obtain customer assistance, schedule service calls, etc., through a direct or indirect interface. Because vendors can track customer activity and purchases very closely through the consumable identifier / CD server, the vendor can tailor its interactions with customers based on that information. For example, because the vendor knows the customer's order history, the vendor can send the customer product promotional materials related to those products the customer has previously purchased / used. Similarly, because the vendor tracks information related to the customer's system, the vendor can send the customer 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 system service, warranty repair information, maintenance contract information and reminders, and the like.

[0074] In one embodiment, the vendor tracks the use of consumables by the assay customer and The consumable data stored in the system includes system-consumable usage information. To facilitate tracking of consumable usage, the assay system is configured to send system-consumable usage information directly or indirectly to the CD server. If a direct interface is enabled between the system and the CD server, system-consumable usage information can be sent automatically. However, if the direct interface is not enabled, system-consumable usage information can be provided to the CD server indirectly 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, via the direct or indirect interface, that may be relevant to the customer based on previous consumable and / or system usage. If a direct interface is enabled, the assay system can be configured to receive assay system maintenance and / or promotional information from the vendor computing system related to an individual customer's previous consumable and / or system usage.

[0075] The vendor may also track and / or communicate to the customer system maintenance information, such as, for example, monitoring system and / or system component usage, inspection history, system troubleshooting information, results of diagnostics performed on the system, control chart generation, scheduled maintenance scheduling, warranty information for the system and / or system components, or a combination thereof. The system software can be programmed to monitor various components of the system and send monitoring reports to a remote computing system and / or a maintenance technician, either automatically or when prompted. If a direct interface is not enabled, the system may prompt the customer to send monitoring reports to the CD Server via an indirect interface. Additionally or alternatively, such system monitoring reports can be accessed by a maintenance technician tasked with maintaining and / or inspecting the system, either locally or remotely. In specific embodiments where a direct interface is enabled, the CD Server monitors system component usage and / or warranty information and schedules scheduled system / component maintenance and / or upgrades by a maintenance technician based on standard system component lifespans and / or warranty terms. Additionally, the CD Server can maintain a log of the service history of a given assay system and schedule service calls by a maintenance technician (this can be done using either the direct or indirect interface). The remote computing system can also send individual assay system software updates via the direct or indirect interface.

[0076] Additionally, one or more of the following system components and / or operations can be controlled by the system software, including, but not limited to, expected motor position during normal use, position error per expected motor position, corrective action and / or attempted corrective action taken by the system in the event of a motor positioning error, and frequency of error; component usage, such as the approximate time the component has been powered on in the system; in a preferred embodiment, the system also tracks the relative life of its components under normal use conditions; locking mechanism attempts, retries, and failures; barcode identifier controller attempts, retries, and failures; approximate temperature of one or more components of the system; error warnings; database performance and capacity; instrument hard disk capacity; software and firmware versions and patches; customer login / logout; system startup and shutdown; In certain preferred embodiments involving a system designed to use assay consumables and perform electrochemiluminescence measurements, the system software may record information such as the time the analyzer camera has been powered on and approximate temperature, latch usage cycles within the system, barcode identifier controller attempts, retries, and failures, consumable lock and unlock events, ECL waveform voltage and integrated current, image processing analysis accuracy and failures, consumable type, kit, owner, It may also be programmed to monitor consumable identifiers (e.g., barcodes), timestamps for each consumable run on the system, or a combination thereof. Additionally, the system software may monitor experiments performed on the system, such as when, by whom, and what type(s) of consumable were used in the experiment. Such system usage monitoring information may be sent to the CD Server via direct and / or indirect interfaces to enable the vendor to schedule appropriate support, inspection, and / or maintenance for the system.

[0077] In another embodiment, a vendor can provide usage and / or purchasing assistance by tracking assay system usage. For example, a vendor can track consumable usage and purchase history, and based on consumable data for a given lot or consumable, the vendor can monitor the expiration date of a given lot or consumable and notify customers of the upcoming expiration date of the lot or consumable. Tracking assay system / consumable type usage also allows the vendor to track the relative schedule / frequency of consumable usage and notify customers when a customer's consumable supply needs to be replenished. If a direct interface is enabled, the system can also be configured to order / reorder consumables, and the system can further be configured to track and confirm consumable orders from the vendor. If a direct interface is not enabled, the system can monitor consumable usage and inventory and prompt customers to replenish their supply of one or more consumables. (In this regard, the system receives lot size information via consumable identifiers, and by monitoring consumable usage, the system can prompt customers when the available consumable supply for a given lot is reduced to a minimum level.) Additionally, by tracking consumable usage, the vendor can send customers information regarding custom assay design services for specific custom consumable types based on the customer's order / consumable usage history. The direct or indirect interface can also provide customer training modules, consulting services, and / or live customer service assistance capabilities (i.e., live chat) to enhance the customer's experience (collectively referred to as system and / or consumable technical support information).

[0078] In another embodiment, tracking consumable / system usage allows vendors to send promotional materials to customers. For example, when new types or lots of consumables are currently being used by a given end customer, the vendor computing system sends consumable data to the customer regarding those new products. Such promotional materials may also relate to new assay systems that may be of interest to the customer based on that customer's previous usage. The remote computing system may also send references to the customer that may relate to one or more consumables / systems used by a given customer.

[0079] These and other specific examples of consumable data are described in more detail below.

[0080] A. Assay Systems, Consumables, and Methods of Use The assay systems contemplated by the present invention may be used to perform any type of diagnostic or analytical method known in the art, including, but not limited to, clinical chemistry assays (e.g., pH, ion, gas, and metabolite measurements), hematology measurements, nucleic acid amplification assays (e.g., polymerase chain reaction (PCR) and ligase chain reaction assays), immunoassays (e.g., direct immunoassays, sandwich immunoassays, and / or competitive immunoassays, and serological assays), oligonucleotide ligation assays, and nucleic acid hybridization assays. ... may be used to perform any type of diagnostic or analytical method known in the art, including, but not limited to, nucleic acids, nucleotides, oligonucleotides, DNA, RNA, PNA, primers, probes, antibodies or fragments thereof, antigens, such as drugs or prodrugs, streptavidin, avidin, and the like. Any biological reagent that may be used in such analytical methods can be used in such a system, including, but not limited to, small molecules such as ribonucleotides and biotin.

[0081] These systems may be portable, e.g., handheld, and / or may operate in a fixed laboratory or field environment, alone or in combination with one or more additional components, assay devices, or systems. These systems can be used in a variety of applications, from field operations to laboratory environments, in a wide variety of industries, including, but not limited to, medical, clinical, forensic, pharmaceutical, environmental, veterinary, biological, chemical, agricultural, waste management, hazardous chemical, drug testing, and defense applications, such as for the detection of biological warfare agents. The assay systems, assay readers, and consumables used in the present invention can detect analytes of interest using any suitable method, including, but not limited to, optical, electromechanical, radio wave, electromagnetic, colorimetric, fluorimetric, chemiluminescent, electrochemiluminescent, radiochemical, nuclear magnetic resonance, enzymatic, fluorescent, particle count, and cell count based detection.

[0082] (i) Specific Embodiments of Assay Consumables Assay consumables include devices in which one or more steps of an assay process are performed, and such devices may include one or more test sites where assay measurements are performed. In one embodiment, an assay consumable includes at least one assay test site for an assay. The test site may include multiple separate assay domains, at least two of which contain reagents for measuring different analytes. Additionally, a consumable may include multiple test sites for multiple individual assays. Alternatively, an assay consumable may be a component that provides reagents or other assay components used by a system to perform an assay. For example, an assay consumable may be a container having one or more compartments for holding assay reagents. An assay consumable (or the test sites therein) may be disposable, or the assay consumable may be reusable. An assay consumable can be configured to perform one test or multiple tests (serial or parallel).

[0083] Test site, as used herein, refers to an area of ​​a consumable that holds, contacts, and / or interrogates a sample. A test site may include multiple separate assay domains, with at least two such domains containing reagents for measuring different analytes. A consumable may include multiple test sites that can hold, contact, or otherwise interrogate separate amounts (aliquots) of the same sample and / or larger amounts of different samples. A sector of an assay consumable refers to a group of two or more test sites on the consumable. Each test site can be used to perform a single measurement or multiple measurements on a sample volume (e.g., measurement of multiple different analytes in a multiplexed assay format). Depending on the specific requirements of the application, a consumable with multiple test sites can be configured to use all of its test sites in parallel, use its test sites at different times (e.g., allocate an unused test site to be used when a new sample is delivered to the assay system), or enable a combination of both modes of operation.

[0084] Assay consumables can be of any structure useful in diagnostic applications, and the structure can be determined by the particular assay format or detection method employed by the device. Examples of assay consumables suitable for use with the present invention include, but are not limited to, test tubes, cuvettes, flow cells, assay cartridges and cassettes (which may include integrated fluidics for assay processing), multi-well plates, slides, assay chips, lateral flow devices (e.g., strip tests), flow-through devices (e.g., dot blots), pipette tips, solid supports for biological reagents, and the like. In certain embodiments, the test sites of the assay consumable are defined by compartments of the assay consumable, such as, for example, wells, chambers, channels, flow cells, etc. Assay Consumables and / or Test Sites may include one or more components used to perform assay measurements according to one or more particular detection methodologies. Depending on the function of the consumable and the detection modality utilized by the assay system, examples of such components may include, but are not limited to, lateral flow matrices, filtration matrices, optical windows, sensors (e.g., electrochemical and optical sensors), solid supports for binding reactions (e.g., coated slides, chips, beads, pins, coated filtration or lateral flow matrices, tubing, etc.), reagents (in dry or liquid form), electrodes, analyte selection membranes, etc.

[0085] 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 affixed to the device without any modification to the structure of the device and / or the assay medium. In one embodiment, the device is placed into an analysis system, i.e., an assay system, for analysis and before, during, or after the performance of the assay, and an identifier controller in, affixed to, or associated with the assay system reads the data contained in the identifier and uses that data in the assay or after the assay is completed by the system.

[0086] In another embodiment, the assay consumable and accompanying assay system or assay reader are capable of performing multiplex assays. A multiplex assay is a type of assay in which multiple measurements are performed on a single sample, for example, by distributing the sample across multiple test sites and / or by performing multiple measurements on the amount of sample at each test site. Multiple measurements may include, but are not limited to, (i) multiple replicate measurements for an analyte, (ii) multiple measurements of a particular analyte (i.e., multiple non-identical measurements for the same analyte, e.g., measurements that differ in the format or identity of the assay reagents utilized), and / or (iii) measurements of multiple different analytes. In one specific embodiment, the assay consumable is configured to perform multiplex measurements, including at least two assays for two different analytes, at one or more test sites.

[0087] The present invention is not limited to any particular technique for performing multiplexed assays at a test site and can utilize any of the numerous techniques developed for performing multiplexed assays. Multiplexed assays that can be used with the present invention include, but are not limited to, multiplexed assays that (i) involve the use of multiple sensors, (ii) use discrete assay domains on a surface (e.g., an array) that are distinguishable based on their location on the surface, (iii) involve the use of reagents coated on particles that are distinguishable based on particle characteristics such as size, shape, color, etc., (iv) produce distinguishable assay signals based on optical properties (e.g., absorbance or emission spectra), (v) are based on temporal characteristics of the assay signals (e.g., signal time, frequency, or phase), and / or (vi) are based on some other assay feature. Thus, interpretation of multiplexed assay results can involve the use of multiplexed information, such as the identity of the assay performed at each test site, and, within a test site, any assay features (e.g., the identity of the particular sensor, the location and identity of the assay domain, etc.) used to distinguish between assays performed at the test site and / or to associate a particular assay identity with the corresponding assay signal.

[0088] In one embodiment, the assay test site contains multiple distinct assay domains, each containing one or more reagents for measuring a different analyte. Multiplexing information, including the location, identity, and composition of each assay domain, is used to identify the assay signal generated in each domain and link it to a determination of the presence or amount of the corresponding analyte (a process that may include the application of additional consumable data, such as signal thresholds and / or calibration parameters). The information may be provided as consumable data and / or may be associated with a consumable identifier.

[0089] A test site can be configured to perform multiple multiplexed measurements (e.g., it may include multiple separate assay domains, each domain containing reagents for measuring a different analyte). In one embodiment, an assay consumable may include multiple test sites. Information regarding the precise 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 (described above), including the number, identities, and differentiating characteristics 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 (e.g., the specific location, identities, and / or assay reagents of the assay domains 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. The identifier and / or consumable data may also include information regarding the assay format and specific processing steps used for the assay consumable or the test site, assay domain, and / or sector of the assay consumable. The identifier and / or consumable data may also include information regarding the analytical method that needs to be applied by the system once the assay is performed to analyze the output of the assays at a given test site, assay domain, and / or sector and, optionally, to provide a result that combines the output from multiple assays at the test site, assay domain, and / or sector.

[0090] Test sites can be configured in any suitable configuration depending on the geometry of the consumable and / or the type of assay being performed with the consumable. In one embodiment, the test sites are configured as wells and / or chambers in the assay consumable. For example, assay consumables of the present invention can be multiwell plates (e.g., 24-, 96-, 384-, or 1536-well plates), and the wells of the plate can further include a plurality of distinct assay domains (e.g., 2 or more, 4 or more, 7 or more, 25 or more, 64 or more, 100 or more, etc.). Multi-domain multiwell plates adapted for performing assay measurements using electrode-induced luminescence measurements (e.g., electrochemiluminescence measurements) are described in U.S. Application No. 10 / 238,391, filed September 10, 2002, entitled "Methods and Reader for Conducting Multiple Measurements on a Sample," which is incorporated herein by reference. The exact configuration of the domains, test sites, and / or sectors of the assay consumable, as well as the specific identity of each domain, test site, and / or sector and the reagents associated with that domain / test site / sector, can be included in the information stored in the assay consumable identifier and / or provided as consumable data. Additionally, use of a given domain, test site, and / or sector of the assay consumable can also be recorded in the identifier to track use of the consumable in the assay system.

[0091] Assay consumables can be used in multiple different assays, and this variety leads to a variety of suitable configurations of the associated consumables. In one assay format, the same analyte is measured in different assay domains within a test site, with the different assay domains designed to measure different properties or activities of the analyte. Information about the assay formats available for an assay consumable, test site, and / or assay domain can also be stored in an assay consumable identifier and / or provided as consumable data. The identifier and / or consumable data can also be used to determine the analytical method that must be applied by the system when the assay is performed to analyze the output of the assay at a given test site and / or domain and compare that output to assays at separate test sites and / or domains. It may also contain information about

[0092] An example of a multiplex assay consumable is described in U.S. Patent Publication No. 2004 / 0022677, the disclosure of which is incorporated herein by reference in its entirety. Such an assay consumable includes one or more, and in one embodiment, multiple, test sites and / or assay domains for performing one or more assay measurements simultaneously or sequentially. For example, the test sites can be configured as wells and / or chambers. These test sites and / or assay domains include one or more electrodes for inducing luminescence from the material of the test site and / or assay domain. The assay consumable may further include assay reagents, e.g., in liquid or dried form, in the test sites, e.g., wells or chambers, of the consumable.

[0093] In addition to test sites and assay domains, assay consumables or multi-well assay plates may include several additional elements, such as a plate top, a plate bottom, wells, working electrodes, counter electrodes, reference electrodes, dielectric materials, electrical connections, and assay reagents. Plate wells can be defined by holes or openings in the plate top or as depressions or indentations on the surface of the plate. Plates can have any number of wells of any size or shape arranged in any pattern or configuration and can be constructed from a variety of different materials. Exemplary embodiments of consumables that can be used in the present invention include industry-standard formats for the number, size, shape, and configuration of plates and wells, such as 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. Multi-well assay plates are well suited for applications where the plates can be used once or multiple times and are disposable. A variety of configurations for suitable assay plates can be used in the present invention, including, but not limited to, those shown in Figures 11A, 12A, 13A, 13B, 14A, 15, and 16A of U.S. Application No. 2004 / 0022677, each of which is incorporated herein by reference. As discussed above, the specific configuration and identity of the assay test sites, domains, and / or sectors of the assay consumable can be included in the information stored in the assay consumable identifier and / or provided as consumable data.

[0094] (ii) Specific Embodiments of the Assay Reader Assay consumables can be used in assay readers that can be used to induce and measure luminescence, e.g., electrode-induced luminescence or electrochemiluminescence, in assays performed in or on the assay consumable, e.g., multi-well assay plates. Assay readers can also induce and / or measure current and / or voltage, e.g., at electrodes. Assay readers may incorporate, e.g., one or more photodetectors, a light-tight enclosure, mechanisms for transporting assay plates into and out of the assay reader (and particularly into and out of the light-tight enclosure), mechanisms for aligning and orienting the assay plate with the photodetector(s) and / or electrical contacts, additional mechanisms for tracking and identifying the plate (e.g., a barcode identifier controller), mechanisms for making electrical connections to the plate, one or more sources of electrical energy for inducing luminescence, and appropriate devices, electronics, and / or software. Assay readers may also incorporate mechanisms for storing, stacking, moving, and / or dispensing one or more multi-well assay plates (e.g., a plate stacker and / or a plate conveyor). 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) by measuring light sequentially from multiple sectors or regions of the plate, and / or from the entire plate substantially simultaneously or simultaneously. The assay reader can also include additional control units to control specific functions within the system and to assist in data storage, analysis, and presentation. A variety of suitable assay reader configurations may be used in the present invention, including, but not limited to, those shown in Figures 17-23 of U.S. Application No. 2004 / 0022677, which is incorporated herein by reference.

[0095] In a specific embodiment, the assay reader is the device described and claimed in U.S. Application No. 14 / 147,216, published as U.S. 2014 / 0191109 and WO 2014 / 107576, the disclosures of which are incorporated herein by reference. Particular embodiments of the assay reader are shown in the figures of U.S. Application No. 14 / 147,216, certain views of which are reproduced herein. Figures 5(a)-5(b) show front and rear views, respectively, of device 500 with a stylized cover, and Figures 5(c)-5(d) show corresponding front and rear views, respectively, of the device without the cover. As shown, for example, in Figure 5(c), the device includes an optical detection subsystem 510 and a plate handling subsystem 520. More detailed views are provided in Figures 6(a)-6(b). The plate handling subsystem 620 includes a light-tight 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 multiple alignment features, and the housing is adapted to receive a removable drawer. The removable drawer 640 is shown in FIG. 7 in a partially open or closed position. Referring to FIG. 6(a), the housing 632 also includes one or more plate entry (and exit) openings 636 and 637, respectively, through which plates are lowered (manually or mechanically) onto or removed from the plate translation stage. A sliding light-tight door (shown as 639 in FIG. 6(c)) is used to seal the plate entry openings 636, 637 from ambient light before performing luminescence measurements. The housing top also includes an identifier controller for reading and processing data associated with identifiers on plates. In one embodiment, the identifier controller is a barcode reader (638) mounted via a light-tight seal over an opening in the top of the housing, the barcode reader configured to read the consumable identifier (e.g., barcode) of a plate mounted in a plate translation stage within the housing. In a preferred embodiment, the consumable identifier (e.g., barcode) of a plate is read as the plate is lowered into the drawer.In alternative or additional embodiments, the identifier controller may be separate from the device.

[0096] In an additional specific embodiment, the assay reader is a MESO QcuickPlex SQ120 available from Meso Scale Discovery of Rockville, Maryland.

[0097] (iii) Specific Embodiments of the Assay System One embodiment of an assay system that can be used in the present invention is shown in U.S. Application No. 12 / 844,440, published as U.S. 2011 / 0143947, which is incorporated herein by reference. In particular, as shown in FIG. 8 , the assay system may include the following components: (i) a sample rack subassembly (810), (ii) a light-tight enclosure (820), (iii) an auxiliary plate subassembly (830), (iv) a pipettor subassembly (840), (v) a dispense tip storage / disposal compartment (850), (vi) a liquid reagent subassembly (860), (vii) a well wash subassembly (870), and (viii) a power supply (880). The device is also connected to a computer through a user interface (not shown). This system uses array-based multiplex multiwell plate consumables, allowing for fully automated, random-access analysis of samples. The device achieves enhanced sensitivity and high sample throughput. The device may be adapted for use with any of a variety of detection techniques, such as, for example, changes in optical absorption, luminescence or radiation emission, changes in light scattering, and / or changes in magnetic fields. In one embodiment, the device is configured to detect luminescent emissions, such as, for example, fluorescence, phosphorescence, chemiluminescence, and electrochemiluminescence (ECL). In certain embodiments, the device is configured to detect ECL. All biological reagents needed for the assay are provided with the device, thus minimizing consumable and reagent requirements for the device. The device shown in FIG. 8 further includes one or more consumable identifier controllers (not shown) integrated into the device housing and / or positioned externally to the device housing.

[0098] An additional embodiment of an assay system of the present invention is shown in Figure 9(a). The assay system (900) includes multiple subsystems positioned on a table or platform (901), each operatively connected to a robotic subsystem (902) configured to access and move one or more consumables, such as multi-well assay plates, from one assay system subsystem to another. The multiple subsystems include an assay reader (903), an assay consumable storage unit (904), a dispense subassembly (905) including at least one dispense probe (906) fixed to a dispense head gantry (907) that provides X-, Y-, and Z-motion of the probe to and from a dispense tip washing station (908) and a plate washing subassembly (909), an orbital shaker subassembly (910), a liquid reagent subassembly (911), and an electronics subassembly including a computer (912). The computer also includes a user interface (not shown). The assay system may also include a multiwell plate preparation platform (913) positioned on the table (901) and configured to enable dispensing of fluids to and / or from one or more wells of a multiwell assay plate positioned on the preparation platform. Optionally, the platform (913) is positioned on a linear track that enables movement of the platform to and / or from the dispense subassembly (905) in a direction parallel to the plane of the table. Alternatively or additionally, one or more subcomponents of the platform and / or dispense subassembly are configured to move in the X, Y, and / or Z directions relative to one another. A robotic subsystem is configured to move one or more plates to and / or from the plate preparation platform, plate washing subassembly, orbital shaking subassembly, assay reader, and consumable storage unit.As shown in Figures 9(b)-9(c), the assay system may further include an enclosure (914) that includes one or more environmental control units, such as thermoelectric cooling units (915(i) and 915(ii) respectively), located within the enclosure. In one embodiment, the enclosure is configured to encase the assay system to maintain an internal temperature within the enclosure of approximately 20-30°C.

[0099] The assay system shown in Figure 9(a) is configured to process multi-well assay plates that have undergone manual offline sample preparation steps using an automated sample preparation system, or using an automated sample preparation system integrated with the assay system via an additional robotic subsystem. Additionally, reagents used in performing the assay in the assay plate can be provided in one or more additional assay plates, i.e., plates containing specific reagents used in performing the assay, such as, for example, a reagent plate and / or a dilution plate. In specific embodiments, samples can be added offline to the sample plate, the system uses one or more diluents and reagents that can be stored in a diluent plate and / or a reagent plate, respectively, and the assay can be performed in a test plate, i.e., a plate to which the reagents and / or reagents are added during one or more processing steps by the system.

[0100] In a specific embodiment, the system processes plates in batch mode, meaning that all wells of a plate are operated on or processed simultaneously by the system before moving to the next step and / or next plate. For example, if the system is configured to use a 96-well multiwell plate, 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 next plate. Figure 9(d) illustrates the sequence of operations of an 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 including a sample plate, a diluent plate, and a test plate; (b) 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 transferred to the orbital shaker subassembly, and the sample plate and diluent plate are returned to the storage unit. Cycle 1 is completed when the first test plate of the set completes 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 detection antibody solution to the test plate, and (d) moving the test plate to the orbital shaker subassembly and returning the detection antibody solution plate to the storage unit. Cycle 2 is completed when the first test plate completes the second incubation. The third system operation cycle (Cycle 3) includes the following steps: (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 read buffer to the test plate, (d) moving the test plate to the assay reader and returning the read buffer plate to the storage unit, and (e) reading a signal from the assay reader and moving the test plate from the assay reader to the storage unit.Throughout cycles 1-3, the assay system is configured to move plates from one subsystem to another at most every 3 minutes (3 minutes / plate).

[0101] In one embodiment, the assay reader integrated with assay system 900 is an assay reader described herein, such as, for example, device 500 shown in Figures 5-7. In a specific embodiment, the assay reader is the device described and claimed in U.S. Application No. 14 / 147,216, the disclosure of which is incorporated herein by reference. In an additional specific embodiment, the assay reader is a MESO QuickPlex SQ120 available from Meso Scale Discovery of Rockville, Maryland. Alternatively, the assay reader is a MESO SECTOR S600 available from Meso Scale Discovery of Rockville, Maryland.

[0102] The assay consumable storage unit (904) can be configured to store any type of consumable used in performing an assay on the assay reader. In a specific embodiment, the storage unit is a multiwell plate storage unit configured to store a plurality of multiwell assay plates. In one embodiment, the plate storage assembly is configured as a plurality of shelf subassemblies, each comprising a shelf unit sized to accommodate a multiwell assay plate. The shelf subassembly includes a housing top, a housing rear, a left housing wall, and a right housing wall, as well as a plurality of storage units disposed within the housing, each storage unit including a plate entry opening. The shelf subassembly may include 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.

[0103] As described above, the dispense subassembly (alone or in combination with the platform) provides independent X, Y, and Z movement of the probes to enable them to access sample plates, reagent plates, and / or test plates (as needed). The dispense subassembly may also include appropriate pumps and valves for controlling the pipettors and / or probes (not shown). Pumps are used to transport fluids through the dispense subassembly. One skilled in the art can select appropriate pumps for use in the device, including, but not limited to, diaphragm pumps, peristaltic pumps, and syringe (or piston) pumps. The pumps may also include multi-port valves to allow the pumps to push and pull fluids from different fluid lines. Alternatively, multiple pumps can be used to independently control fluids in different fluid lines.

[0104] In one embodiment, the dispense probe can use fixed or disposable dispense tips. In a specific embodiment, the dispense probe uses fixed dispense tips. Alternatively, if disposable tips are used, the disposable dispense tips can be stored in a dispense tip storage / disposal compartment (not shown). The arm / track of the pipettor subassembly allows the probe access to the tip storage / disposal compartment for tip loading in the dispense probe and tip removal after use. In addition to transferring reagents and samples from one well to another, fluid lines connected to the dispense probe may be connected to working fluids or diluents so that the probe can be used to deliver these fluids / diluents to wells. Optionally, the dispense probe may include fluid sensing capabilities, for example, using a capacitance sensor to detect when the probe contacts fluid in a tube or well. In a specific embodiment, the dispense probe includes a multi-channel dispense probe that enables simultaneous fluid transfer to multiple wells of a multi-well plate. For example, the dispense probe includes a 96-channel dispense head that enables simultaneous fluid transfer to a 96-well plate. In one embodiment, the dispensing head and corresponding fixed dispensing tips are available from Apricot Designs of Covina, California. Typically, when fixed dispensing tips are used, they are supplied by the dispensing probe supplier, such as Apricot Designs of 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 that can accommodate standard disposable tip boxes (available from Axygen, Qiagen, or Rainin) and a removable waste container for used dispensing tips. To remove a tip, the pipettor probe is translated horizontally to position the shaft within the slot and then translated vertically until the pipette tip is removed by the bracket. During operation, the particular slot to be used is selected using a set or random pattern so that used pipette tips are evenly distributed along the width of the waste container.Tip dimensions vary according to the dimensions of the dispensing probe, the amount of sample / reagent to be dispensed, and / or the dimensions of the plate the tip will be placed in. In one embodiment, the tip volume ranges from about 100 μL to 550 μL. In another embodiment, the tip volume ranges from about 100 μL to 250 μL.

[0105] The plate washing subassembly may be any suitable commercially available microtiter plate washing system, such as, for example, those available from BioTek Instruments, Inc. of Winooski, Vermont, including, but not limited to, the 405 Touch Washer, 405 LS Washer, Elc405x Select Deep Well Washer, or Elx50 Washer. Similarly, the robotic subsystem may be any suitable benchtop commercially available robotic system, such as, for example, those available from Precise Automation, Inc. of Fremont, California.

[0106] The liquid reagent subassembly includes a plurality of liquid reagent and waste compartments for use in one or more steps of an assay performed on the device. The compartment includes a compartment body enclosing an internal volume and a reagent or waste port for delivering reagents or accepting waste. The volumes of the compartments of the subassembly are adjustable so that the relative proportions of the compartment body's volume occupied by reagents and waste can be adjusted, for example, as reagents are consumed in an assay and returned to the compartment as waste. The total internal volume of the compartment body can be less than about 2 times, less than about 1.75 times, less than about 1.5 times, or less than about 1.25 times the volume of liquid stored in the body, e.g., the amount of reagent initially provided in the compartment, thus minimizing the space required for waste and reagent storage and enabling convenient one-step reagent refilling and waste removal. In certain embodiments, the device has reagent compartment slots configured to accept the compartments and, optionally, provide fluid connections to the waste and reagent ports via "push-to-fit" or "quick-fit" fittings.

[0107] Optionally, the reagent compartment and / or waste compartment are removable. In one embodiment, the reagent compartment and / or waste compartment are removable, and the device further includes a sensor, such as an optical sensor, to monitor the liquid level(s) in the reagent compartment and / or waste compartment. Alternatively, the liquid reagent subassembly may include an electronic scale to monitor the weight of fluid in the reagent and waste tanks for real-time tracking of reagent usage and availability. When the reagent compartment and / or waste compartment reaches a minimum or maximum capacity, as detected by the sensor or scale, the device alerts the user to remove the reagent compartment and / or waste compartment to refill and / or empty its contents. In one embodiment, the dispense probe motor is in communication with the sensor or scale, and the dispense probe motor is disabled by the device when the reagent compartment and / or waste compartment reaches a minimum or maximum capacity. For example, the probe sensor relays information regarding the compartment's volume to the meter software, which then pauses additional dispense operations.

[0108] The reagent compartment and / or waste compartment may be provided as a collapsible bag located in the subassembly body. One of the reagent compartment and / or waste compartment may be provided as a collapsible bag, and the other may be provided as the compartment body itself (i.e., the volume of the compartment body excluding the volume defined by any collapsible bag within the compartment body). In addition to the first reagent compartment and / or waste compartment, the reagent cartridge may further include one or more additional collapsible reagent compartments and / or waste compartments connected to one or more additional reagent and / or waste ports. Alternatively, one or the other of the reagent compartments and / or waste compartments may be constructed from blow-molded plastic. Additionally or alternatively, waste can be pumped to an external drain or container. In one embodiment, the liquid reagent subassembly also includes a reagent tank used during the performance of an assay on the device. In one specific embodiment, each reagent compartment is connected via a fluid line to a reagent tank that contains a volume of reagent during an assay. The fluid lines to the pipettor subassembly run directly from the reagent reservoir. In practice, reagents are stored in the reagent compartment and predetermined amounts of reagent are dispensed from the reagent compartment to the reagent reservoir. The device draws fluid from the reagent reservoir for use in the assay. The reagent compartment and reagent reservoir can each be connected to independent fluid sensors. The fluid sensors in the reservoir monitor the internal volume within the reservoir, and if the internal volume decreases below a predetermined level, reagent is dispensed from the reagent compartment to the reservoir. Similarly, if the internal volume of the reagent compartment decreases below a predetermined level, the fluid center signals the operator to replace or refill the reagent container. Because fluids are exchanged in the reagent compartment without interrupting the assay process by the instrument, the dual reagent compartment / reservoir assembly allows the device to continue with the assay as the assay is performed by the device. To ensure a continuous supply of fluid.

[0109] In one embodiment, the orbital shaking subassembly (910) is a balanced assay consumable shaking apparatus as described and claimed in U.S. Ser. No. 62 / 143,557, filed April 6, 2015, the disclosure of which is incorporated herein by reference in its entirety. Specifically, the orbital shaking apparatus includes (a) an orbital shaker assembly including a horizontal orbital platform, and (b) an assay consumable storage assembly positioned on the platform. The storage assembly includes (i) a shelf subassembly including a plurality of sets of vertically aligned storage units, each storage unit sized to accommodate a consumable and including a consumable locking mechanism, and (ii) a counterweight positioned within the storage assembly at a height corresponding to the center of mass of the storage assembly and the orbital platform. The orbital shaking apparatus further includes a rotational shaft extending vertically from the shaker assembly to the storage assembly, the counterweight being operably connected to the rotational shaft.

[0110] The assay system shown in Figure 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 Figure 9(a), the assay system is positioned below a table top (901) and is positioned on a table that includes one or more shelving units (916 and 917, respectively) configured to house one or more elements or subsystems of the assay system. In embodiments of the system positioned on a laboratory benchtop, the various systems can be distributed across the benchtop in the same XY plane (not shown).

[0111] The assay system (900) shown in Figures 9(a)-9(d), including the orbital shaker (910), is described in U.S. Provisional Patent Application No. 62 / 311,752, filed March 22, 2016, and International Patent Application No. PCT / US 2016 / 026242, filed April 6, 2016, which are incorporated herein by reference in their entireties.

[0112] An additional embodiment of an assay system of the present invention is shown in Figure 10 and its subsections. The assay system (1000) includes multiple subsystems positioned on a table (1001), each operably connected to a robotic subsystem (1002) configured to access and move one or more consumables, e.g., a multi-well assay plate, from one subsystem of the assay system to another. The robotic subsystem of the instrument shown in Figure 10 and its subsections includes one or more dispense subsystems (1021), each including one or more dispense tip head(s), e.g., a multi-channel dispense tip head, used to dispense / withdraw fluids into / from wells of a multi-well plate. The dispense subsystems are secured to a gantry (1022) within the robotic system, which allows the dispense tip heads to move through the assay system in the X, Y, and Z directions. The multiple subsystems within the assay system include an assay reader (1003), an assay consumable storage unit (1004), a plate washing subassembly (1005), a plate shaking subassembly (1006) including one or more independent plate shaking devices (e.g., as described above with reference to FIG. 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 electronics enclosure (1009) configured to house a system control computer, keyboard, display, wireless router, and power supply (not shown). The electronic components, designated elements (1010, 1011), are shown in FIG. 10(a) below the reader (1003) and can be positioned in the electronics enclosure (1009). The assay system also includes a table (1001) positioned to facilitate dispensing of liquids into and / or from one or more wells of a multi-well assay plate positioned on the preparation platform. The robotic subsystem may also include a platform (1012) configured to enable the platform, plate washing subassembly, shaking subassembly, assay reader, and consumable storage unit to move one or more plates to / from the platform, plate washing subassembly, shaking subassembly, assay reader, and consumable storage unit. The platform includes a consumable identifier controller (e.g., barcode reader (1013)) configured to read assay consumable identifiers positioned on the bottom of plates or tubes placed in, e.g., reagent racks or tube holders, e.g., multi-well plates, and, optionally, a dispensing tip storage compartment (1014) configured to accommodate dispensing tip boxes of varying size tips (e.g., 1015 and 1016, 1000 μl and 350 μl tips, respectively), and one or more reagent troughs positioned in 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 plate(s) and / or reagent racks, and a third consumable identifier controller (not shown) configured to read identifiers on consumable boxes located outside the system housing (not shown). In one embodiment, the third consumable identifier controller is remote from the assay system and is fixed to the outer housing of the assay system or positioned on a front or side panel of the housing of the assay system, and is configured to allow a user to contact a consumable identifier, for example, on a plate or kit, 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 or TEC (1019) located within the assay system. Although a TEC is shown as the assay system (1000), any environmental control system, heat exchanger, or cooling device can be used.

[0113] Unlike the assay system shown in FIG. 9(a), the instrument shown in FIG. 10 and its subsections is configured to perform on-board not only all assay processing steps required for assay performance, but also all sample processing steps. Furthermore, the user interface of the assay system of FIG. 10 and its subsections is configured to display step-by-step instructions to the user for the appropriate sample / reagent preparation steps that must 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 vary from one assay protocol to another. Detailed examples of various assays performed by the assay system of FIG. 10 and its subsections are described below, including, but not limited to, cytokine assays, V-PLEX assays, U-PLEX assays, S-PLEX assays, pharmacokinetic (PK) assays, immunogenicity (IG) assays, and custom sandwich immunoassays (available from Meso Scale Discovery, Rockville, MD).

[0114] Another iteration of the assay system (1000) of the present invention is shown in Figure 10(c). Some of the components shown in Figures 10(a)-10(b) have been omitted for clarity. This iteration includes one or more capture trays (1024) positioned below the platform (1012) and above the table (1001) to capture and retain liquid spillage from the various reagents, diluents, and buffers during operation of the assay system (1000). The capture trays (1024) preferably have flow paths (1025) defined thereon to direct the flow of spillage liquid from the trays (1024) to the waste storage unit (1008). Preferably, the flow paths include peripheral channels (1025b) for directing liquid away from the edges of the trays (1024) and internal flow paths (1025a) leading to the waste assembly (1008). As best shown in FIG. 10(d), the flow channel (1025) optionally has absorbent material disposed therein to absorb spilled liquid and / or direct the liquid to the waste assembly. Alternatively, the flow channel 1025 may be coated with a surfactant to reduce flow resistance.

[0115] Additionally, platform 1012 includes an additional raised platform 1026 designed to hold extra disposable tips or host additional components such as individual shakers 1006, thereby demonstrating the scalable nature of assay system 1000. A plurality of holes 1027 are provided on platform 1012 to accommodate additional labware or other functional components.

[0116] In one embodiment, the assay reader used in assay system 1000 is an assay reader described herein, such as, for example, the device 500 shown in Figures 5-7. In a specific embodiment, the assay reader is the device described and claimed in U.S. Application No. 14 / 147,216, the disclosure of which is incorporated herein by reference. In an additional specific embodiment, the assay reader is a MESO QuickPlex SQ 120 available from Meso Scale Discovery of Rockville, Maryland. Alternatively, the assay reader is a MESO SECTOR S600 available from Meso Scale Discovery of Rockville, Maryland.

[0117] The assay consumable storage unit (1004) can be configured to store any type of consumable used in performing an assay on the assay reader. In a specific embodiment, the storage unit is a multiwell plate storage unit configured to store a plurality of multiwell assay plates. In one embodiment, the plate storage assembly is configured as a shelf subassembly including a plurality of shelf units, each sized to accommodate a multiwell assay plate. The shelf subassembly includes a housing including a housing top, a housing rear, left and right housing walls, and a plurality of storage units disposed therein, 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 array, 3x3, 4x4, 5x6, or 6x5 array. In one embodiment, the subassembly includes a 2x1 array of storage units. In a specific embodiment, the storage subassembly includes a 2x1 array of 20 storage units.

[0118] In the iteration of Figure 10(c), the assay consumable storage unit (1004) is redesigned to have not only functional aspects but also decorative aspects. In this iteration, the assay consumable storage unit is a single, integrated unit with several parallel shelf surfaces (1072) connected by several vertical supports (1074), as shown in Figure 10(r). Each storage unit in the top row includes a raised corner (1076) sized and dimensioned to hold a reagent lid or loaded rack, as shown in Figure 18 below and its subdivisions, when a technician or robotic system (1002) places an assay plate or rack thereon. As shown in Figure 10(c), preferably, the bottom horizontal shelf of the assay consumable storage unit is cantilevered and single-handedly bolted securely to the platform (1012). The upper assembly of the assay consumable storage unit uses multiple, preferably two or more, bottom horizontal shelves secured to the bottom horizontal shelves, and alignment pins are used to maintain consistent positioning of the upper assembly. Preferably, the alignment pins are located away from the X and / or Y centerline to minimize improper alignment of the bottom horizontal shelf and the top assembly. Several thumb screws, preferably three or more, are used to secure the assay consumable storage unit together. Additionally, several Z adjustment screws, preferably at least three, are provided to level the assay consumable storage unit (1004) as needed.

[0119] The advantage of having the bottom horizontal shelf separate from the top assembly is that it can be used to store assay consumables. Ease of removal of unit 1004 for servicing and access to components behind unit 1004. Alignment pins and thumb screws further allow for easy and accurate subsequent reinstallation of the upper assembly to the bottom horizontal shelf.

[0120] The dispensing subassembly (1021) is supported on a gantry (1022) and is powered by one or more motors to provide independent X, Y, and Z motion to probes, such as one or more pipette tips, allowing the probes to access troughs, tubes, and / or plates (as needed). The dispensing subassembly (1021) also includes appropriate pumps and valves for controlling the pipettors and / or probes, and optionally a dispensing tip cleaning subassembly (not shown). Pumps are used to transport fluids through the dispensing subassembly. Preferably, each pipette tip is independently controllable or independently disposable by control software, a controller, and motor(s). In other words, one or more pipette tips can dispense or aspirate 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 enable the assay machine (1000) to perform a wide range of assays, calibrations, self-diagnostics, and the like. Those skilled in the art will be able to select an appropriate pump for use with the device, including, but not limited to, diaphragm pumps, peristaltic pumps, and syringe (or piston) pumps. The pump may also include a multi-port 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. In one specific embodiment, the dispensing subassembly includes an exhaust pipettor. Optionally, the dispensing probe may include a means for minimizing the probe's external wetted surface, for example, using an ultrasonic capacitance sensor or a pressure sensor, and a fluid sensing function for detecting when the probe contacts fluid in a tube or well as a means for detecting the presence of liquid in a container.

[0121] In specific embodiments, the dispense probe includes a multi-channel dispense probe that allows fluid transfer to multiple wells of a multiwell plate either through all pipette tips or through a selected number of pipette tips that are less than all available pipette tips. For example, the dispense probe includes an 8-channel dispense head that allows simultaneous and independent fluid transfer to one or more channels into a multiwell plate or one or more tubes or troughs. Alternatively, the dispense probe may include a 12-channel dispense head, a 96-channel dispense head, or a 384-channel dispense head. In specific embodiments, the dispense subassembly is supplied by Tecan Group LTD of Switzerland.

[0122] In one illustrative example, a capacitive sensor is designed between the pipette tips or between the pipettor and the dispense deck to detect contact of the disposable tip with the surface of the liquid contained in a tube, plate, or rack found on the dispense deck. The dispense deck is preferably conductive, and the pipette tips / pipettors are also conductive so that a potential difference can be applied therebetween.

[0123] A common capacitor is a parallel plate capacitor consisting of two conductive plates electrically isolated from each other by a dielectric material. In a simple parallel plate capacitor, the capacitance is inversely proportional to the distance between the two plates. Quantitatively, the capacitance (C) in farads of two overlapping plates is expressed as: C=κε o (A / d), In the above equation, κ i is the dielectric constant of the material between the two plates (dimensionless), ε o is approximately 8.854x10 -12 F m -1 is an electrical constant that is A is the overlapping area between the two plates in meters, d is the distance between the two plates in meters.

[0124] For capacitive liquid 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 between them (e.g., air, liquid, plastic / glass container) is expressed as: 1 / C=Σ1 / C i , where the capacitance of each dielectric is C=κ i ε o (A / d i ) and in the above formula κ i is the dielectric constant of the material between the two plates (dimensionless), ε o is approximately 8.854x10 -12 F m -1 is an electrical constant that is A is the overlapping area between the two plates in meters, d1 is the thickness of the given material between the two plates in meters.

[0125] In a system with multiple dielectrics, the capacitance change that occurs when the thickness of a single dielectric (e.g., air between the pipette tip and the liquid in the plate or rack) approaches zero produces a significant change in capacitance that allows the system to recognize that the pipette tip is in contact with the liquid.

[0126] The inventors have determined that the sensitivity of certain capacitive sensing systems used to detect liquids in conventional tubes and vials can be significantly increased by using conductive plates or racks made from plastics with conductive additives such as carbon, metal, or metal ions. Using a conductive rack allows the liquid levels in the conventional tubes and vials contained therein to be determined using a capacitive sensor. Preferably, 500 μl tubes should be at least 50%, preferably at least 40% or 30%, and more preferably at least 10% full. 2 ml tubes should be at least 20%, preferably at least 15% or 10%, and more preferably at least 5% full. 4 ml vials with flat bottoms should be at least 25%, more preferably at least 12.5% ​​full. 4 ml vials with concave bottoms should be at least 10%, more preferably at least 5% full.

[0127] In one embodiment, the dispensing probe uses disposable dispensing tips that are stored in a dispensing tip storage compartment (1014, 1026). Disposable dispensing tips can be stored in one or more standard disposable tip boxes (e.g., 1015 and 1016 available from Tecan Group LTD, Switzerland), and used tips can be stored in a removable waste container for used dispensing tips (1008). Tip dimensions vary according to the dimensions of the dispensing probe, the amount of sample / reagent to be dispensed, and / or the dimensions of the plate into which the tip will be placed. In one embodiment, the tip volume ranges from approximately 1000 μL to 50 μL. In another embodiment, the tip volume ranges from approximately 1000 μL to 350 μL.

[0128] As described above, the dispensing subassembly (1021) provides independent X, Y, and Z motion to the probe or pipette tip so that it can access troughs, tubes, vials, racks, and / or plates. The inventors have devised a training plate designed to initialize the assay system (1000) before first use or periodically thereafter, thereby enabling the robotic system (1002) and its gripper pad (1031) to pinpoint with greater accuracy and repeatability 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.

[0129] As best shown in FIG. 10(e), a training or instruction plate (1035) is positioned on the platform (1012). Preferably, the training plate (103 The training plate (1035) has dimensions and sizes similar to industry-standard assay plates (ANSI SLAS 1-2004) and is designed to fit within a slot (1036), also known as a plate carrier (1036), which is designed to accept the assay plate. The training plate (1035) may be a solid rectangular prism, or is preferably hollow, having a fixed perimeter and an internal web member designed to provide rigidity and stiffness. The internal web member, including curved members (1037) and substantially linear elements (1038), provides stiffness and stability. As shown, the curved members (1037) have opposing concave surfaces.

[0130] One or more reference points or pads 1040 are defined on the upper surface of the training plate 1035. During an initialization procedure for the assay system 1000, a probe, such as a pipette tip 1042, connected to the robotic system 1002 or preferably to the pipette subsystem or pipettor 1021, is brought into close proximity with the reference pad 1040, or preferably within 0.1 mm of the reference pad 1040, to determine the vertical or Z reference point. Preferably, the probe 1042 does not contact the reference pad 1040 to ensure that the probe is not deformed or bent by the contact. The capacitance sensor for the pipette subsystem 1021 described above can be used in the initialization process in conjunction with the conductive training plate 1035 to determine the Z reference point and Z maximum value of the labware without touching the probe 1042 to the reference pad 1040.

[0131] Alternatively, the initialization process can be completed with a substrate thinner than about 0.1 mm moving back and forth between the probe (1042) and the reference pad (1040). Once the moving substrate is captured between the probe and the reference pad, a Z reference point is determined. In an additional alternative, a proximity sensor based on a magnetic field that changes as a function of the distance between the probe (1042) and the reference pad (1040) can be used. Exemplary magnetic proximity sensors include Hall effect sensors.

[0132] Yet another alternative is to use an optical distance sensor. Suitable optical distance sensors are commercially available from Keyence America, SensoPart, and Omega Engineering, among others. The optical sensor is attached to or replaces the probe (1042) and then used to measure the distance to the reference pad(s) (1040).

[0133] This Z reference point is selected to be at the center of a corner well in the XY plane of an industry standard ANSI SLAS 1-2004 96-well microplate (8 rows x 12 columns) and in the vertical Z direction at or near the top surface of the industry standard ANSI SLAS 1-2004 plate. Industry standard ANSI SLAS 1-2004 dimensions and tolerances are described below. More specifically, the Z reference point is used to calculate Z max, or maximum height, in the vertical direction for all lab equipment. Advantageously, having an accurate Z max value for lab equipment improves reliability of pipetting and lab equipment setup and movement.

[0134] The training plate (1035) may be reversible, i.e., the bottom surface has the same characteristics as the top surface. In yet another variation, in addition to the Z reference point(s), X and Y reference points are also determined. In this variation, the probe (1042) contacts at least two reference pads (1040) and Cartesian coordinates (x, y, z) are recorded for each reference pad.

[0135] The training plate (1035) can be used to initialize the position of the gripper pad (1031) or to align the gripper pad with the assay plate(s) on the platform (1012). Accurate and consistent alignment is preferred to achieve proper acquisition (retrieval) and placement (insertion) coordinates of the assay plate or any other plate, rack, trough, tube, etc. The gripping area (1044) is shown in FIG. 10(f). ), the gripper pads 1031 are provided on the long and short sides of the training plate 1035. During initialization or alignment, with the training plate 1035 positioned on the platform 1012, the robotic system 1002 positions its gripper pads 1031 on either the short or long sides of the training plate 1035. To pick up and move the training plate 1035, the gripper pads 1031 will be positioned within the gripping region 1044, an area defined by several raised tracks. As the gripper pads 1031 do this, not only the Z height but also the relative distance between the pads (gripping distance), the location of the training plate in X,Y space, and the orientation (in degrees) of the gripper pads (rotational coordinates) are identified and recorded by the processor controlling the robotic system 1002. This alignment information is stored and used to command the robot gripper pad (1031) to acquire and place the lab equipment in the appropriate location.

[0136] As shown in FIG. 10( f), the outer perimeter of the first surface (1043) including the reference pad (1040) of the training plate (1035) is smaller than the outer perimeter of the opposing surface (1045) having the bead track (1041) surrounding its perimeter to provide the larger perimeter. When determining the Z reference point, the opposing surface (1045) with the larger diameter and tighter tolerance is preferably inserted into the nest on the platform (1012). This allows for a snug fit and more accurate and repeatable positioning of the reference pad (1040). When determining the position of the gripper pad (1031) of the robot arm (1002), the first surface (1043) with the smaller perimeter is preferably 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.

[0137] The training plates (1035) can be individually machined, preferably by a computer numerically controlled (CNC) milling machine, to achieve tight tolerances. The training plates can be machined to a flatness within 5 thousandths of an inch, or 0.127 mm. If there are dimensional differences between different manufactured training plates, the differences or variations can be ascertained by measuring the dimensions of the training plates, for example, with a calibrated coordinate measuring machine (CMM), and using the measured dimensions to adjust the training values ​​of the platform / assay machine (1000). The tolerances can be stored in an optional memory device and used to reconcile possible differences in measurements when different training plates are used to initialize and recalibrate an assay machine.

[0138] Preferably, the training plate (1035) is made from cast aluminum for its stiffness, strength, and light weight. A preferred cast aluminum is ATP5 (Aluminum Tooling Plate 5) or similar metal. For example, a suitable metal has a resistance of about 2,400 to about 3,000 kg / m 3 The steel should have a density in the range of about 100 to about 150 MPa, a hardness in the range of about 60 to about 80 HB, a tensile strength in the range of about 250 to about 300 MPa, and a yield strength in the range of about 100 to about 150 MPa. Other suitable steel materials may include, but are not limited to, stainless steel, brass, and rigid polymers such as polycarbonate and polystyrene.

[0139] The reference pad (1040) preferably has a diameter of approximately 1.46 mm ± 10%, and the distance from the center of the reference pad (1040) to the side of the training plate (1035) is approximately 7 mm ± 10%. As shown in FIG. 10(e), the four reference pads (1040) correspond to the centers of the four corner wells of the 96-well microplate described above. Preferably, the training 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.

[0140] In one embodiment, the training plate may have a bar code affixed to it with its serial number to allow automated access to the stored dimensional information for the training plate.

[0141] Plate washing subassemblies are available from, for example, BioTek, Winooski, Vermont. The robotic subsystem may be any suitable commercially available microtiter plate washing system, such as a plate washing subassembly including, but not limited to, the 405 Touch Washer, 405 LS Washer, Elc405x Select Deep Well Washer, or Elx50 Washer, available from Instruments, Ic. Similarly, the robotic subsystem may be a suitable benchtop commercial robotic system, such as a system available from Tecan Group LTD, Switzerland.

[0142] In a specific embodiment, the plate shaking subassembly is the balanced assay consumable shaking device described and claimed in U.S. Ser. No. 62 / 143,557, filed April 6, 2015, the disclosure of which is incorporated herein by reference in its entirety and described herein with respect to FIG. 9(a). Specifically, the shaking subassembly may include a 2x3 array, a 2x4 array, or a 2x6 array of 20 storage units. Preferably, the plate shaker (1006) is a separate thermoshaker with a heater to maintain an assay plate placed thereon at an elevated temperature. Such a thermoshaker is a BioShake 3000-T elm shaker from Q. Instruments, Jena, Germany. In one example, the plate shaker (1006) can maintain a temperature of approximately 3°C above the operating temperature of the assay system, and up to approximately 37°C with a tolerance of approximately ±0.5°C. Samples, buffers, reagents, etc. contained in the wells of the assay plate can be mixed and incubated on these shakers.

[0143] The inventors have also discovered that during an assay run, the reagents contained in the troughs (1018) and the sample / reagent mixture in the assay plate on the plate shaker (1006) undergo evaporation during the incubation and mixing period. Evaporation of reagents in the troughs (1018) represents a loss. Meanwhile, evaporation from the assay plate on the plate shaker (1006) can cause changes in the concentration of substances contained in the assay plate due to evaporation. In accordance with one aspect of the present invention, lids are designed for these containers.

[0144] As shown in FIG. 10( g), an exemplary trough lid 1028 is shown. The lid 1028 is shaped and sized to fit securely over the reagent trough 1018. The lid 1028 has a top 1029 and sidewalls sized and dimensioned to fit over the top of the trough 1018, with a pattern of cuts 1030 made in the top 1029, for example, with a laser cutter. The cuts 1030 are designed to allow the top 1029 to bend and to allow the pipette subassembly or pipettor 1021 to insert a pipette tip into the reagent trough 1018 to retrieve reagent, as shown. When the pipette tip is withdrawn, the cuts 1030 allow the top to return to its original configuration. Any pattern of cuts 1030 can be used, so long as the top 1029 bends to allow the pipette tip to enter and resumes substantially its original configuration when the pipette tip is withdrawn. An exemplary pattern of cuts 1030 is shown in Figure 10(h). However, the present invention is not limited to any particular cut pattern.

[0145] The lid (1028) limits exposure of the reagents contained in the trough (1018) to the interior space of the assay system (1000) to only the area bounded by the slits. The trough may contain a buffer such as tripropylamine (TPA), which may evaporate and cause losses. Limiting exposure limits evaporation. To further limit exposure, a second top portion (1029'), for example, having a different, opposing cut pattern, may be placed above or below the top portion (1029) to create a tortuous path for evaporated gas to escape. The lid (1028) may be made from a relatively rigid or non-elastomeric material, such as polyester, high-density polyethylene (HDPE), or polycarbonate, with the flexibility of the top portion (1029) provided by the cut pattern (1030). Alternatively, the lid (1028) may be made from an elastomeric material, such as natural or synthetic rubber, to improve flexibility; optionally, the cuts are made with a sharp cutting tool instead of a laser cutter to minimize lost material and bond areas at the cuts. Preferably, the lid (1028) is thermoformed or vacuum formed, and the cuts (1030) are die-cut. Thermoforming is a process in which a plastic sheet is heated and shaped by air pressure against a mold, while vacuum forming is a similar process, but uses a vacuum instead of pressure.

[0146] To minimize the possibility of troughs (1018) being pulled out of the trough carrier, shown without a reference number in FIG. 10(a), elastomeric blocks can be inserted between the troughs. Such elastomeric blocks have a body with a protrusion on each side facing the adjacent trough. Each block then has two protrusions, preferably with different sizes and / or volumes depending on the amount of grip desired. For example, the protrusions facing the end troughs should have a larger volume than the protrusions facing the center trough.

[0147] The plate lid 1032 shown in FIG. 10(i) does not have a cut pattern because the plate lid 1032 is placed on the assay plate 1031 after processing steps have been completed and the assay plate 1031 has been incubated and mixed on the shaker 1006. As described above, the shaker 1006 may be heated to an appropriate incubation temperature. The elevated temperature promotes evaporation, particularly when exposed to 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 mixtures in the wells 1051 in the assay plate 1033 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, for a 96-well assay plate, 96 downward-facing recesses are provided in the lid (1032).

[0148] As best shown in Figures 10(j)-10(k), the lid (1032) includes a skirt (1050) that depends from its top surface. When placed on top of a multi-well assay plate (1033), the periphery of the top surface rests on the periphery of the assay plate (1033), creating a contact line at (1052). The contact line (1052) provides a flow restriction or seal to restrict evaporated gases or prevent evaporated gases from leaving the enclosure between the assay plate (1033) and the lid (1032). Preferably, the lid (1032) does not have structural ribs on its bottom surface to prevent contact at the contact line (1052).

[0149] Additionally, in the embodiment of the lid 1032 shown in Figures 10(i)-10(k), secondary contact lines 1053 exist between the bottom surface of the lid 1032 and the top surface of each well 1051. These secondary contact lines 1053 present another obstacle to preventing evaporated vapor from escaping. The effectiveness of the secondary contact lines 1053 for each well 1051 depends on the flatness of the lid 1032 and the flatness of the top surface of the assay plate 1033. Additionally, depressions 1034 along the skirt 1050 help prevent the lid 1032 from shaking the assay plate 1051 off the shaker 1006 during shaking and incubation. Additionally, the depressions 1034 provide a barrier to condensation of evaporated vapor back into the wells 1051. It also functions as a condensation enhancer to promote condensation.

[0150] The plate lid is preferably made from polystyrene, polypropylene, or cyclic olefin copolymer (COC), or any other material commonly used in biological research.

[0151] To further minimize inconsistent evaporation and condensation, the lid (1032) is preferably made from a hydrophobic polymer or other hydrophobic material, and / or the bottom of the lid (1032) is coated with a hydrophobic coating or rendered hydrophobic.

[0152] The bottom surface of the lid (1032) can be made hydrophobic by microetching the surface to create miniaturized air pockets. These miniaturized pockets can create a rough microtopography that acts as an air buffer to prevent liquids from adhering to the surface. This is also known as the "lotus effect," named after the hydrophobic nature of lotus leaves. This effect has also been observed in gecko skin. The rough microtopography prevents water from clumping together and preventing widespread dispersion. The clumped water will form larger droplets that fall away from the lid, thereby promoting condensation. Microetching can be achieved with a laser source known as TresClean (http: / / cordis.europa.eu / project / rcn / 200832_en.html). Hydrophobic surfaces also have antibacterial properties due to their ability to repel moisture.

[0153] Suitable hydrophobic polymers include, but are not limited to, poly(tetrafluorethene), polypropylene, polyamide, polyvinylidene, polyethylene, polysiloxane, polyvinylidene fluoride, polyglactin, lyophilized dura mater, silicone, rubber, and / or mixtures thereof.

[0154] Suitable hydrophobic coatings include polyethylene, paraffin, oil, jelly, paste, grease, wax, polydimethylsiloxane, poly(tetrafluoroethene), polyvinylidene fluoride, tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer, fluorinated ethylene propylene, poly(perfluorooctylethylene acrylate) acrylate), polyphosphazenes, polysiloxanes, silica, carbon black, alumina, titania, hydrated silanes, silicones, and / or mixtures thereof. Suitable hydrophobic coatings also include, but are not limited to, perfluorooctanoate, perfluorosulfonate, ammoniacal sodium lauryl sulfate, sodium laureth sulfate, alkylbenzene sulfonates, sulfated or sulfonated fatty substances, salts of alkylaryloxypolyalkoxy alcohol sulfates, alkylbenzene sulfonates, sodium dodecylbenzene sulfonate, fluorinated surfactants, sodium lauryl sulfate, sulfosuccinic acid mixtures, dioctyl sodium sulfosuccinate, sodium sulfosuccinate. The surfactants may include surfactants such as sodium sulfosuccinate, 2-ethylhexyl sulfate sodium, ethoxylated acetylenic alcohols, high ethylene oxide octylphenols, high ethylene oxide nonylphenols, high ethylene oxide linear and secondary alcohols, ethoxylated amines of any ethylene oxide length, ethoxylated sorbitan esters, random EO / PO polymers to butyl alcohol, water soluble block EO / PO copolymers, sodium lauryl ether sulfate, and / or mixtures thereof.

[0155] In a variant, the material of the upper periphery of the plate (1033) that rests on the periphery of the assay plate (1051) forming the contact line (1052) is a tortuous barrier for gases and vapors. The surface can be roughened, for example with a wire brush or similar implement, to increase the pathways and thereby minimize the amount of vapor that escapes. The bottom surface of the lid (1032) can be roughened to increase the hydrophobicity and exhibit the Cassie-Baxter behavior described above. Microstructuring a surface is known to amplify the natural tendency of a surface, and in certain instances, the hydrophobicity of a surface can be further enhanced if the roughened surface is able to trap vapor (e.g., air or other gases) (Cassie-Baxter equation). It is also contemplated that the bottom surface of the lid (1032) can be microstructured using methods known in the art, including, but not limited to, micromachining, lithography (photolithography, soft lithography (nanoimprint lithography, capillary force lithography, micromolding in capillaries, microtransfer molding), electron beam lithography), and plasma etching, as well as creating patterns or textures on the surface using bath deposition, chemical vapor deposition, electrochemical deposition, layer-by-layer deposition via electrostatic assembly, colloidal assembly, sol-gel processing, nanosphere lithography, water droplet condensation-induced patterning, and / or microablation. Hydrophobic materials, hydrophobic coatings, and hydrophobic surface treatments are disclosed in published International Patent Application No. WO 2012 / 003111, which is incorporated herein by reference in its entirety.

[0156] Optionally, a gasket can be placed on the contact line 1052, preferably on the periphery of the lid 1032 adjacent the skirt 1050. One or more stacking features 1057 can be positioned on top of the lid 1032 around its periphery, allowing multiple lids 1032 to be stacked on top of each other without sliding off.

[0157] The liquid reagent subassembly (1007) includes multiple liquid reagent compartments and waste compartments for use in one or more steps of an assay performed on the device. The reagent / waste compartments include a compartment body enclosing an internal volume and a reagent or waste port for delivering reagents or receiving waste. The volumes of the subassembly's compartments are adjustable so that the relative proportions of the compartment body's volume occupied by reagents and waste can be adjusted, for example, as reagents are consumed in an assay and returned to the compartment as waste. The total internal volume of the compartment body can be less than about 2 times, less than about 1.75 times, less than about 1.5 times, or less than about 1.25 times the volume of liquid stored in the body, e.g., the amount of reagent initially provided in the compartment, thus minimizing the space required for waste and reagent storage and allowing convenient one-step reagent refilling and waste removal. In certain embodiments, the device has a reagent compartment slot configured to receive the compartment and provide fluid connection to the waste and reagent ports, optionally via "push-to-fit" or "quick-fit" fittings.

[0158] Optionally, the reagent compartment and / or waste compartment are removable. In one embodiment, the reagent compartment and / or waste compartment are removable, and the device further includes a sensor, such as an optical sensor, to monitor the liquid level(s) in the reagent compartment and / or waste compartment. Alternatively, the liquid reagent subassembly may include an electronic scale to monitor the weight of fluid in the reagent and waste tanks for real-time tracking of reagent usage and availability. When the reagent compartment and / or waste compartment reaches a minimum or maximum capacity, as detected by the sensor or scale, the device alerts the user to remove the reagent compartment and / or waste compartment to refill and / or empty the contents. Other liquid level detectors can be used. Another exemplary liquid level detector includes multiple thermistors positioned vertically within each compartment, for example, at the 1 / 4 mark, 1 / 2 mark, 3 / 4 mark, and full mark. Due to the different heat capacities of the liquid and air / vapor, a thermistor submerged in a liquid will produce a different electrical signal than one located in air or vapor. The liquid level detector of includes a capacitor with one conductive plate at the top of the liquid and the other conductive plate at the bottom of the compartment. The measurable capacitance of the liquid between the two conductive plates changes the distance between the two plates, which, as described above, indicates the amount of liquid contained in the compartment.

[0159] In one embodiment, the pumps or motors of the dispense subsystem (1021) are in communication with these sensors or scales, and the dispense probe motor is disabled by the device when the reagent and / or waste compartments reach minimum or maximum capacity, e.g., the probe sensors relay information about the compartment volumes to the meter software, which then pauses further dispense operations.

[0160] The reagent compartment and / or waste compartment may be provided as a collapsible bag located in the subassembly body. One of the reagent compartment and / or waste compartment may be provided as a collapsible bag, and the other may be provided as the compartment body itself (i.e., the volume of the compartment body excluding the volume defined by any collapsible bag within the compartment body). Alternatively, the reagent compartment and waste compartment may be contained within the same container and separated by a flexible, movable, or elastic membrane or separator. In addition to the first reagent compartment and waste compartment, the reagent cartridge may further include one or more additional collapsible reagent compartments and / or waste compartments connected to one or more additional reagent ports and / or waste ports. Alternatively, one or other of the reagent compartments and / or waste compartments may be constructed from blow-molded plastic.

[0161] According to another aspect of the present invention, the assay system 1000 can control the temperature inside when its panels or doors 1056 are closed. To illustrate the internal components, the assay system 1000 is shown in FIGS. 10(a)-10(c) without the housing and doors, but includes a front door and / or front panel, generally designated 1056. These doors and panels are closed before the assay system 1000 performs a run. Once the system begins a run, the internal air temperature within the area above or near the platform where the assay steps are performed preferably remains within a range of about 20°C to about 24°C, inclusive. When the operating temperature is selected depending on the particular assay being performed, the selected temperature is preferably maintained within a range of ±1°C. The temperature-controlled region may be defined from the front of the platform 1012 or consumable storage unit 1004 to approximately 6 inches forward of the rear of the deck or the rear of the deck. The control area may extend from left to right of the platform (1012) or from position 26 to position 49 as shown in FIG. 10(u) to cover the length of all shakers (1006). The assay system (1000) also has temperature sensors located in several locations to monitor the temperature(s) inside the assay system. Temperature readings are monitored by the system software described herein, and the user is notified if the operating temperature is outside of the operating range. The temperature of the liquid in a covered MSD plate placed on a plate shaker with the shaker temperature control turned off should rise by less than 2°C above the ambient deck temperature over a two-hour period.

[0162] The selected operating temperature is maintained despite heat generated by the plate shaker (1006), which may incubate the assay plate at the elevated temperatures described above, and the assay reader (1003), which includes electromechanical components and thermoelectric coolers for optical sensors such as heat-generating charge-coupled devices (CCDs) or complementary metal-oxide semiconductor (CMOS) devices. The selected operating temperature is maintained by several TECs (1019), as best shown in Figure 10(c). In this particular example, six TECs (1019) are used. However, any number may be provided. Preferably, two TECs are centered on the reader (1003) to dissipate heat generated by the reader. The remaining TECs are used to control a selected operating temperature, and a portion of the remaining TECs may optionally be centered on a heated shaker (1006). Additionally, a portion of the cooling is directed to the electronic devices (1010, 1011) or electronic devices housed in an electronics enclosure (1009) described below.

[0163] As shown in FIG. 10(m), which shows a cross-sectional side view of the assay system 1000, the TEC 1019 absorbs heat near its center, as indicated by arrow 1046, and generates cold air at the top and bottom, as indicated by arrows 1047. The cold air 1047 flows toward the front of the assay system 1000, cooling the enclosure, is reversed by a closed door or panel 1056, and returns as warm air 1046, which is absorbed by the TEC 1019. FIG. 10(n) shows a top view of all six exemplary TECs 1019. The returning warm air is directed toward a specific area adjacent to the center of the TEC. The perspective view of FIG. 10(o) shows the flow paths of the warm and cold air baffles 1048 in more detail. Each baffle (1048) preferably surrounds one or more baffle TECs (1019) as shown and forces cool air (1047) to flow upward and downward as described above. The baffles (1048) also direct returning warm air to the sides of the baffle where heat is exchanged with the TEC. Additional heat exchange occurs on the hot side of the TEC outside the assay machine (1000) enclosure, where heat absorbed from the interior of the assay machine is exchanged with the atmosphere.

[0164] Additionally, the shaker (1006) may be elevated above the platform (1002) to allow air to flow under as well as over the top of the shaker to improve convective heating.

[0165] FIG. 10(p) illustrates cooling of electronic devices (1010, 1011) preferably housed within an electronics enclosure (1009). Cooling of the enclosure (1009) utilizes the chimney effect by drawing cool air (1047) from below, pulling the cool air upward to cool the electronics (1010, 1011), and expelling warm air (1046) to the exterior of the assay machine (1000) through cooling channels (1049). Preferably, the cooling channels (1049) are positioned away from the main body of the assay machine (1000) and adjacent to the exterior wall or skin of the system as shown for more effective heat removal. One or more fans are used to draw in cool ambient air and push the air within the electronics enclosure (1009), cooling the warm air, and expelling it through the chimney (1049).

[0166] Referring back to FIG. 10(l), at least one computer screen or tablet (1058) is attached to the glass surface (1060) of the assay system (1000). A pressure transducer, typically used in a touchscreen, is attached or glued directly to the glass surface (1060) and relies on the glass surface (1060) of the assay system (1000) to transmit pressure applied by a user's fingertip to the transducer, which generates a current signal for the tablet or computer CPU. Also relying on the same glass surface (1060) to generate sound waves is at least one sound exciter (1062). The sound exciter (1062) is also attached or glued to the glass surface (1060). The exciter (1062) vibrates the glass surface (1060) to produce sound. Both touchscreens and sound exciters can be used in the graphical user interfaces (GUIs) or user interfaces (UIs) described herein.

[0167] The pressure transducer in the tablet (1058) is induced by the exciter (1062). A minimum distance between the exciter and the pressure transducer / touchscreen is preferably established to minimize or eliminate interference. Human audible frequencies range from about 20 Hz to about 20 kHz, while typical human speech occupies a significantly smaller range, e.g., from about 2048 Hz to about 8192 Hz (seventh to eighth octaves). Preferably, the pressure transducers of the tablet (1058) are designed, selected, or adjusted so that they are not sensitive to the range of human speech, allowing visual and audio devices to share the same glass surface (1060).

[0168] Additionally, the glass surface (1060) or other surfaces of the assay system (1000) may include lighting, such as LED lighting or light strings. Preferably, the LED lighting is located on the door handle of the assay system, and may also be located on the top of the assay system. These lights illuminate different colors depending on the status of the immunoassay being run. In one example, the lights may communicate a satisfactory run by emitting a constant green or blue light, flashing or pulsing green or blue while the system is running, emitting yellow or red when an error is detected, and emitting white when the assay is completed. The same colors may also be displayed on the tablet (1058).

[0169] Another aspect of the assay system 1000 relates to how panels and doors 1056, which can be heavy and bulky, are supported on the frame of the system. Referring to FIG. 10(q), a flange system 1063 includes a main hanging portion 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 portion 1066 has a pair of C-shaped openings 1067 adapted to be attached to supports 1068 on the bracket 1064. Once the vertical position of the door or panel 1056 has been satisfactorily established, bolts are threaded into the openings 1069 to secure the vertical position.

[0170] The horizontal position (XY plane) of the door or panel (1056) can also be adjusted by the cam (1070). The cam (1070) may have any shape, including a circular protrusion eccentrically mounted to the bracket (1064). More specifically, the cam (1070) is mounted via a shaft spaced from the center of the circular protrusion. A nut, preferably polygonal or more preferably hexagonal, is attached to the protrusion with an eccentric shaft. Rotation of the nut will move the main hanging body (1066) horizontally in the XY plane. The horizontal movement of the main hanging body (1066) is limited by the shape of the opening (1069). In other words, the opening (1069) has a horizontal ellipse that allows the connecting bolt a small amount of movement inside the ellipse.

[0171] Thus, the flange system 1063 allows the door or flange 1056 to be adjusted in two directions to ensure proper closure of the assay system 1000. The flange system 1063 can be used with any door or panel on the assay system.

[0172] Optionally, a video camera is positioned within the enclosure of the assay system (1000) to record the assay run and stream the video to a remote location where a user or technician can monitor the assay run without the need 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.

[0173] The assay system (1000) is designed to be stable and includes a platform (1012), all permanent components, and laboratory equipment / consumables, as shown in FIG. 10(s). The table (1001) that supports the items has a length (L) of 85 inches ± n%, a height (H) of approximately 28 inches ± n%, not including the caster wheels, and a width (W) of 33 inches ± n%. 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 (in the L direction) of approximately 16 inches ± n%. The tolerance n% is preferably 10%, more preferably 5%, and more preferably 2.5%.

[0174] Referring to FIG. 10(t), the frame (1084) has a height (H) of about 52 inches ± n%, a front overhang height (H front) of about 30 inches ± n%, a length (L) of about 84.5 inches ± n%, and a width at the top (W) of about 34.5 inches ± n%. The lower support has a long width (W2 bottom) of about 33 inches ± n% and a short width (W1 bottom) of about 18 inches ± n%. The tolerance n% is preferably 10%, more preferably 5%, and more preferably 2.5%.

[0175] The reader 1003 is advantageously positioned within the recessed opening 1082, and the plate washer 1005 is positioned within the recessed opening 1078, providing clearance for the movement of the gripper pad 1031 and pipette system or pipettor 1021 of the robotic system 1002, and freeing up space for laboratory equipment and consumables on the platform 1012. The reader 1003 is also positioned off-center, for example, on the side of the table 1001, so that heat it generates is away from the center of the assay system and is more easily dissipated. Both the gripper pad 1031 and the pipette system or pipettor 1021 share the same gantry 1022 to save space. The assay consumable storage unit 1004 is cantilevered off the front end of the platform 1012, and the shaker 1006, as described above, is located towards the rear of the platform 1012 to free up space on the platform for lab equipment or consumables, allowing a lab technician to load consumables from the front and gripper pads, and remove and install consumables from the rear. The dimensions of the table 1001 and frame 1084, combined with the locations / heights of the major components described herein, provide stability and space savings to the assay system 1000.

[0176] The electrical and electronic connections are shown in Figures 10(v)-10(y). Figure 10(v) shows the power and internet connections. The power and Ethernet module (1085) is shown on the left and in association with the UPS (1086). The UPS (1086) provides emergency power to the assay system (1000) in the event of a power interruption. The UPS (1086) is connected to the reader (1003) and processor (1087) for the assay system (1000) as well as to the router (1088). The UPS (1086) is also connected to the washer (1005) and its pump, and to the robotic system (1002).

[0177] Figure 10(w) continues the wiring diagram from Figure 10(v), showing the electrical contacts on the right. Figure 10(w) shows that the UPS is connected to another power supply (1089), a 300W AC and 24V DC unit. The power supply (1089) provides stepped-down power at 24A 5V DC to a DC power module. This 5V power module powers several sensors on both sides, including the waste pad sensor and plate washer sensor on its left side. To its right, the power module powers a light panel and a panel (1091) that illuminates the left and right doors (1092). The panel (1091) also provides power and signals to the exciter (1062), touchscreen (1058), and barcode reader (1013).

[0178] Figure 10(x) continues the diagram of Figure 10(w) and shows the controller and power PCB (1093) connected to the six TECs (1019) and their associated sensors (1094). The controller and power PCB (1093) also provides power to the fan (1095) and reader (1003).

[0179] Figure 10(y) shows the deck control PCD (1096) which provides power to five shakers (1006), a barcode reader (1098), and a thermistor sensor (1099) used to monitor the temperature associated with the assay reader (1000).

[0180] FIG. 10(z) is a plan view showing the plate carrier (1036) and tip carrier (1026).

[0181] In each of the assay systems shown in Figures 9-10, additional microprocessors and computers in the assay system can interact with the assay consumable identifiers by transferring data and commands to / from the identifiers to various microprocessors / controllers throughout the system to perform various operations of the above-identified components in the assay system as described below.

[0182] The system can adjust assay parameters before starting the assay based on the consumable data stored in the identifier and / or provided as consumable data via a direct or indirect interface. The system then makes the appropriate electrical, fluidic, and / or optical connections to the consumable (utilizing electrical, fluidic, and / or optical connectors on the consumable and the system), uses the consumable, and performs the assay. The sample can be introduced into the consumable before inserting it into the system. Alternatively, the sample is introduced by a system component after the consumable is inserted into the system. The assay may also include adding one or more assay reagents to the consumable; instructions for adding these various assay reagents can be stored in the identifier and / or provided as consumable data, and the system adds those reagents to the consumable before or during the assay according to the instructions stored in the assay consumable identifier and / or provided as consumable data, as described further below.

[0183] (iv) Assay cartridge and cartridge reader Alternatively, the assay consumable is a cartridge, the consumable further comprising elements selected from one or more fluidic components, one or more detection components, one or more assay cells, reagents for performing the assay, working electrodes, counter electrodes, reference electrodes, dielectric materials, electrical connections, dry and / or liquid assay reagents, or combinations thereof. The cartridge may further comprise at least one assay cell comprising a plurality of separate assay test sites and / or domains, each of which contains reagents for measuring a different analyte.

[0184] Examples of assay consumable cartridges that can be used in the present invention are described in U.S. Application No. 2004 / 0189311, the disclosure of which is incorporated herein by reference in its entirety. The assay consumables described therein are assay cartridges that incorporate one or more fluidic components, such as compartments, wells, chambers, fluidic conduits, fluidic ports / vents, valves, etc., and / or one or more detection components, such as electrodes, electrode contacts, sensors (e.g., electrochemical sensors, fluidic sensors, mass sensors, optical sensors, capacitive sensors, impedance sensors, optical waveguides, etc.), detection windows (e.g., windows configured to allow optical measurements on samples in the cartridge, such as measurements of absorbance, light scattering, light refraction, light reflectance, fluorescence, phosphorescence, chemiluminescence, electrochemiluminescence, etc.). Such consumables also include binding reagents, detectable labels, test strips, and the like. The consumable also includes reagents for performing the assay, such as sample processing reagents, wash solutions, buffers, etc. The reagents may be present in liquid form, solid form, and / or may be immobilized on the surface of a solid support present in the cartridge. In this embodiment, the consumable includes all components necessary to perform the assay. Additionally, the assay consumable is used in conjunction with a consumable assay reader adapted to receive the consumable and perform a specific operation on the consumable, such as controlling fluid movement, providing electrical power, or performing a physical measurement on the cartridge.

[0185] More particularly, such assay consumable cartridges have one or more assay test sites (e.g., wells, compartments, chambers, conduits, flow cells, etc.) that may include one or more assay domains (e.g., discrete locations on the assay test site surface where assay reactions occur and / or assay-dependent signals, such as electrochemical 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, e.g., a one-dimensional array of assay electrodes) to enable performance of assays based on electrochemical 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, for example, small size, low cost, disposable, multiplexed detection, ease of use, etc.

[0186] The assay consumable cartridge may contain the electronic and / or active mechanical components necessary to perform the assay measurement, such as, for example, one or more electrical energy sources, ammeters, potentiometers, photodetectors, temperature monitors or controllers, pumps, valves, etc. Alternatively, some or all of the electronic and / or active mechanical components may be located within a separate assay reader, which would also have the appropriate electrical, fluidic, and / or optical connections to the assay consumables to use the consumables and perform the assay. Using such an arrangement, the assay consumables can be designed to be low cost and disposable, while the assay reader (which retains more expensive and complex components) can be reused.

[0187] In one embodiment, the cartridge-based biochemical detection system may include a system housing containing a photodetector, the system housing adapted and configured to receive and position assay consumables and / or the photodetector for processing. The system may further include support subsystems, which may include one or more of: a storage subsystem for storing assay reagents / consumables and / or waste; a sample acquisition / preparation / storage subsystem for sample handling; a fluid handling subsystem for handling reagents, samples, waste, etc. and for providing fluids to the detection chamber via the fluid inlet line; an electrical subsystem for electrically contacting electrical contacts on the cartridge and providing electrical energy to the electrodes; and a control subsystem for controlling and coordinating operation of the system and subsystems and for acquiring, processing, and storing the optical detection signal. Information associated with the assay consumable identifier and / or provided as consumable data may include information used to control or regulate one or more of the assay system components before and / or during performance of an assay using the assay consumable.

[0188] Still further, an assay consumable may be a container that holds one or more assay reagents, including, but not limited to, one or more buffers, diluents, and / or reagents used by the assay system in performing an assay. An assay consumable identifier may be affixed to the container and / or may be affixed to the container's packaging.

[0189] B. Assay Consumable Identifier In one embodiment, the assay consumable identifier identifies the consumable, its history, and / or its use. The consumable item identifier includes a memory for storing relevant information. In one embodiment, the memory is a 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 item identifier include, but are not limited to, electronic non-volatile memory (e.g., read-only memory and flash memory), magnetic memory (e.g., hard disks, floppy disk drives, and magnetic tape), optical memory (optical disk drives), and hybrids of these techniques (magneto-optical memory).

[0190] In one embodiment, the assay consumable identifier comprises an EPROM (Erasable PROM), a type of programmable read-only memory that can be erased by exposing it to ultraviolet light. Once erased, it can be reprogrammed with new or modified data. In another embodiment, the assay consumable identifier comprises an EEPROM (Electrically Erasable PROM), a type of non-volatile electronic memory that can be electrically erased and programmed without exposure to UV light. EEPROM can be written or programmed multiple times and is selectively programmable (allowing the customer to change the value of a particular cell without erasing the programming of other cells). Thus, sections of data can be erased and replaced without having to modify or reinstall the rest of the chip's programming.

[0191] In another embodiment, the assay consumable identifier comprises flash memory, a particular type of EEPROM that is erased and programmed in large blocks. Although flash memory is technically a type of EEPROM, the term "EEPROM" is generally used to refer specifically to non-flash EEPROM that is erasable in small blocks, usually bytes. Because erase cycles are slow, the large block size used to erase flash memory gives it a significant speed advantage over conventional EEPROM when writing large amounts of data.

[0192] In another embodiment, the assay consumable identifier comprises a smart card, chip card, or integrated circuit card (ICC) (collectively referred to as "ICC"). These are small cards with embedded integrated circuits capable of processing and storing data. There are two broad categories of ICCs: i) "memory cards," which contain a nonvolatile memory storage component and, optionally, some specialized security logic, but no microprocessor; and ii) "microprocessor cards," which combine a nonvolatile memory component with a microprocessor component to enable processing of information being loaded into or read from the ICC. The ICC electronics are supported on a card, which is typically made of a plastic such as PVC or ABS. The card may contain an embedded hologram to prevent counterfeiting. Contact ICCs have conductive contact pads. When inserted into an assay reader, the compact pads on the ICC contact the electrical connectors on 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.

[0193] Another way to transfer information is via RFID, or radio frequency identification, which is similar in theory to bar code identification. With RFID, electromagnetic or capacitive coupling in the RF portion of the electromagnetic spectrum is used to transmit signals. An RFID system consists of an antenna and transceiver that reads the radio frequencies and transfers the information to a processing unit, and a transponder, or tag, which is an integrated circuit that contains the RF circuitry and the information to be transmitted.

[0194] Identification can also be achieved by reading the consumable identifier (e.g., barcode). One key difference between RFID and barcode technology is that RFID eliminates the need for line-of-sight reading that barcoding relies on. RFID scanning is also faster than code scanning. Although wavelengths in the 2.4 GHz range are absorbed by water (and 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 transmission ranges of over 90 feet.

[0195] In one embodiment, the non-volatile memory used in the present invention includes an EEPROM, flash memory, ICC, or a combination thereof. In one embodiment, the non-volatile memory is an EEPROM. In an alternative embodiment, the non-volatile memory is an RFID. In a specific embodiment, the non-volatile memory is a consumable identifier (e.g., a barcode), including but not limited to, a one-dimensional or two-dimensional consumable identifier (e.g., a barcode), or a combination thereof.

[0196] In additional alternative embodiments, more than one non-volatile memory component can be used in the present invention. For example, a first assay consumable including a first identifier can be used in the assay system, and additional assay consumables including additional identifiers can also be used in the assay system. Each identifier can include the same or different types of memory. However, there is a separate identifier controller for each different form of memory. Certain consumable data can then be stored in one identifier, and other consumable data can be stored in additional identifiers of the same or different types. For example, a system may be able to use additional assay consumables that include, for example, a consumable identifier (e.g., a barcode) as an identifier, while one assay consumable used in the system may include an EEPROM or RFID as an identifier. The assay system includes an identifier controller that can interface with the first identifier, i.e., the EEPROM or RFID, and the system further includes an additional controller that interfaces with the consumable identifier (e.g., the barcode).

[0197] The assay system of the present invention includes an identifier controller that controls the operation of the non-volatile memory and other components of the assay system. The identifier controller optionally includes, for example, an I / F controller. 2The non-volatile memory includes a microcontroller for interfacing with the non-volatile memory via a communication interface, which may incorporate conventional interface architectures and protocols, such as a C, 2-line serial bus protocol, etc. The microcontroller addresses the non-volatile memory and performs write, read, and erase operations on the memory.

[0198] The consumable identifier may be located on the consumable, or the consumable identifier may be a separate component. In either case, the system can be designed to have a unique identifier for each consumable. Alternatively, the system can be configured so that one separate consumable identifier is used to hold information relating to multiple consumables. In one example, each package of consumables has a package-specific identifier attached to (or alternatively supplied with) the package that holds information relating to the multiple consumables in the package. Optionally, each consumable also has an additional unique consumable-specific identifier attached to the consumable. This consumable-specific identifier is primarily used to uniquely identify the consumable and link the consumable to its package-specific identifier. In this embodiment, non-editable identifiers such as lot information content and / or consumable identifiers (e.g., barcodes) can be used.

[0199] The various components of the assay system may be housed together in a single unit or may be housed separately. For example, the assay system may include an assay reader and an identifier controller as separate units. The assay system may provide communication between the assay reader and the identifier controller directly, or alternatively indirectly (which may be wired or wireless communication) via additional components of the assay system. In an alternative embodiment, the identifier controller is housed within the assay reader. In such an embodiment, the assay reader may be configured such that insertion of a consumable into the assay reader during the performance of an assay causes the identifier controller to It can also be configured to allow communication between the identifier and the identifier controller (e.g., the port into which the consumable is inserted includes components for processing and / or reading the consumable and also includes components, such as electrical contacts or a wireless transmitter, for communicating with the consumable identifier). In one example, when the consumable is loaded into the assay system, an electrical connection is made between the controller and the identifier. The controller can then read, erase, and / or write consumable data from / to the identifier. Alternatively, the assay reader may have separate ports for processing / reading the consumable and for communicating with the consumable identifier. The customer places the assay consumable or package in or near the controller port such that the controller is in electrical communication with the identifier, allowing the controller to read, erase, and / or write consumable data.

[0200] In one embodiment, the identifier comprises non-volatile memory including an RFID tag, a consumable identifier (e.g., a barcode), an EPROM, an EEPROM, or a combination thereof. Additionally, the identifier may include an EEPROM including flash memory and an ICC. In a specific embodiment, the identifier is a consumable identifier (e.g., a one-dimensional or two-dimensional barcode).

[0201] C. Consumables Data The identifier is programmed, for example, during the manufacturing process or when the consumable is prepared for shipment. The identifier is associated with consumable data that can be used before, during, or after an assay or step of a multi-step assay to control the operation of an assay system, assay reader, or component of the assay system. Additionally or alternatively, some or all of the information required for use of a given consumable can be provided as consumable data. The term "consumable data" may include any information used to uniquely identify a particular assay or assay step, assay consumable, consumable domain(s), biological reagent, or sample, or to distinguish a particular assay, assay step, assay consumable, consumable domain(s), biological reagent, or sample from other assay consumables, consumable domains, biological reagents, or samples. Consumable data may include consumable information, sample information, chain of custody information, consumable / test site information, assay process information, consumable security information, or a combination thereof. The consumable data may further include information related to one or more analytical tools that can be applied by the system to analyze data generated during and / or after the performance of an assay, assay system maintenance information, system consumable promotional information, and / or system and / or consumable technical support information.

[0202] Each type of consumable data is described in more detail below, and it should be understood that each type of consumable data can be associated with a consumable identifier and / or provided as consumable data.

[0203] (i) Consumable identification and configuration information Consumable data may include consumable identification and configuration information, including, but not limited to, identification information, lot-specific analytical parameters, manufacturing process information, raw material information, expiration date, Material Safety Data Sheet (MSDS) information, product insert information (e.g., any information that may be contained in or described in product insert information that may accompany the assay consumable, such as the assay type, how the assay is performed, instructions for use of the assay consumable, assay reagents, or both), threshold and / or calibration data for one or more reagents used in the assay consumable or in an assay or step of a multi-step assay, and the location of individual assay reagents and / or samples within one or more test sites of the assay consumable.

[0204] Additionally, consumable data is lot identification information, which is different from lot-specific analytical parameters. The lot may also include information used to identify a particular lot of assay consumables, including that information that is unique to a given lot that can be used by the system, for example, to perform assays using consumables from that lot or to analyze assay results derived from consumables from that lot. In one embodiment, if the assay consumable is a multi-well assay plate or cartridge, the lot-specific analytical parameters may include, but are not limited to, the following: (i) revision level, which determines the schema used to interpret the information; (ii) consumable type; (iii) date of manufacture; (iv) lot number; (v) expiration date; (vi) crosstalk correction matrix to account for chemical cross-reactivity; (vii) threshold values ​​for the assays performed on the consumable and their respective internal negative controls; (viii) ranges for the internal positive controls; (ix) ranges for the positive control samples each assay is performed on the cartridge; (x) software checksums to ensure data integrity; (xi) in-well (or in-test site) control tolerance ranges; (xii) assay name and / or identifier; (xiii) information regarding assay quality control, including negative and positive quality control materials used to verify the operation of the assay reader and consumable; (xiv) calibration information, such as a master calibration curve; and (xv) number and names of assay calibrators and / or assay calibrator tolerance ranges.

[0205] The consumable data may include sample information such as the location of the sample within at least one test site of the assay consumable, the assay results obtained on the assay consumable for the sample, and the identity of the sample that was and / or will be the assay on the assay consumable.

[0206] Consumable data may also relate to the chain of custody, such as information regarding the control, transfer, and / or analysis of samples and / or assay consumables. Chain of custody information may be selected from customer identification, sample identification, timestamp and datestamp for the assay, location of the assay system in the laboratory during the assay, calibration and QC (quality control) status of the assay system during the assay, control and / or location information for assay consumables before and after the performance of the assay, assay results for a given sample, and customer-generated free text comments entered before, during, or after the assay is processed by the system. Additionally, chain of custody information may include time, date, manufacturing personnel, or processing parameters for one or more steps in the manufacture of the assay consumable, storage, location, and / or storage conditions for the assay consumables during steps following and / or during the manufacture of the assay consumable.

[0207] Consumable data may also include consumable / test site information, such as the type and structure of the consumable, the location and identity (e.g., structure, composition, order, concentration, and / or origin) of assay reagents included in the assay consumable, and the location and identity of assay reagents within the assay test sites of the assay consumable. The consumable data can be used to distinguish between a first test site within the consumable and a different test site within the consumable. Furthermore, the 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 to be assayed with the assay consumable, or a combination thereof. Furthermore, the consumable data is consumable / test site information, including the type and structure of the consumable, the location and identity of assay reagents included with the assay consumable, the identity of the assay reagents within the assay test sites of the assay consumable, or a combination thereof.

[0208] In additional embodiments, the consumable / test site information may include information about assays previously run by an assay reader or system at one or more test sites on the consumable, and information about assays to be run by an assay reader at one or more test sites in the consumable. Thus, once an assay is run by the system, the controller can use it to write the results of the assay to the identifier. Such information can be used by the system during the assay. This information may include, but is not limited to, raw or analyzed data collected by the system (analyzed data is data that has been subjected to statistical analysis after collection; raw data is data that has not been subjected to such statistical analysis), a list of test sites and / or domains within an assay consumable used during a given assay, a schedule of events to be performed on the assay consumable or test sites and / or domains within an assay consumable, a list of those test sites and / or domains on assay devices that have not been assayed, assay errors or system errors that occurred during a given assay or assay step, or combinations thereof.

[0209] Additionally, consumable data can be used as a security mechanism (referred to herein as "consumable security information"), for example, to verify that the correct assay consumable is being used in the system. Consumable data may include a digital signature to verify that the consumable was manufactured by an authorized vendor. In one embodiment, if an improper assay consumable is present in the system, e.g., a counterfeit consumable or a consumable that is otherwise incompatible with the assay system, the controller disables the system, the assay reader, or a component thereof. Additionally or alternatively, consumable data can be used to detect proper installation of the assay consumable in the system, e.g., proper orientation of the assay consumable or portion thereof in the assay system, thereby causing the controller to disable the system, the assay reader, or a component thereof until the assay is installed in the correct orientation. Furthermore, consumable data can also be used to detect defects in the assay consumable or assay test site and / or domain, causing the controller to disable the system, the assay reader, or a component thereof accordingly. For example, depending on the nature of the defect in the assay consumable or domain, the controller may disallow use of the assay consumable as a whole or instruct the assay reader to disallow use of a test site and / or domain or collection of test sites and / or domains of the assay consumable. In one embodiment, the assay reader may perform a diagnostic analysis on the assay consumable and / or the test sites and / or domains therein to identify defects therein, and the controller writes the results of the diagnostic analysis to the consumable's identifier. When the consumable is later used in a different assay reader, the results of this diagnostic analysis are read by the controller and used by the assay reader to adjust the use of the consumable or test sites and / or domains therein accordingly. In additional embodiments, the assay consumable may undergo a quality control process during or after manufacture, and the results of that quality control analysis may be written to the identifier for later use and / or verification by the customer of the assay consumable in the assay reader.

[0210] Consumable data may also include authorization information for a consumable or its test site and / or domain or biological reagent, such as information regarding whether a particular customer has a valid license to use a particular consumable or biological reagent, e.g., whether the customer's license is for research purposes only, the number of times the particular customer is authorized to use the particular consumable or biological reagent in a particular assay, and any limitations on that use. Such information may also include validation information regarding whether a particular consumable or biological reagent has been recalled or is otherwise unsuitable or unauthorized for use. Recall information and an optional last recall check date and / or timestamp may be written to the identifier and / or provided as consumable data.

[0211] The consumable data may further include information regarding the origin of the biological reagents used in the assay consumable, test site and / or domain, including, for example, the identity of the original sample from which it was drawn or the number of generations it was removed from the original sample. For example, if the assay reagent used in the assay is an antibody, the consumable data may include, for example, the ATCC accession number of the hybridoma. The antibody may include the identification of the hybridoma from which the antibody was derived, such as a number.

[0212] According to various embodiments, the biological samples or biological reagents provided in or with the consumables described above can be licensed for use separately from a system designed to act on the biological reagents. In various embodiments, the assay system, assay reader, or components thereof are coupled to a network that enables the system to communicate with computer systems operated by or on behalf of customers, manufacturers, and / or licensors of the biological reagents, consumables, or systems via public and / or private networks. In various embodiments, a limited license can provide for use of the licensed biological reagents, consumables, or systems for a specific biological analysis only with the licensed system. Thus, if a particular customer has a valid license, the system can authenticate the biological reagents, consumables, or systems based on, for example, a digital signature included in an identifier associated with a particular consumable and / or provided as consumable data. In various embodiments, the identifier and / or consumable data can also be used to provide for one-time use, such that the biological reagent cannot be refilled for use with the same authorization.

[0213] In certain embodiments, when the identifier is read by a system, assay reader, or component thereof with access to a biological reagent, consumable, or public or private data network operated by or on behalf of a system customer, manufacturer, and / or licensor, certain consumable data is communicated to the assay system and can be read, written, or erased locally via the assay system's identifier / controller. For example, additional consumable data such as lot-specific information, expiration date, calibration data, consumable-specific information, assay domain information, assay result information, consumable security information, or a combination thereof, can be stored locally on the identifier and not otherwise available via the assay system's network connection, whereas recall information and / or license information may be a subset of the consumable data available via a direct and / or indirect interface. In one embodiment, recall, license, and / or consumable security information is available via a network connection on the assay system and / or can be stored in a storage medium as consumable data, while the remaining consumable data is stored locally on the identifier. An assay system or assay reader includes system hardware, system firmware, system data acquisition and control software, and method or consumable data. In various embodiments, the system hardware includes electronic control and data processing circuitry, such as a microprocessor or microcontroller, memory, and non-volatile storage. In various embodiments, the system hardware also includes physical devices for manipulating biological reagents, such as robotics and sample pumps. In various embodiments, the system firmware includes low-level computer-readable instructions for performing basic operations in connection with the system hardware. In various embodiments, the system firmware includes microprocessor instructions for initializing operations on a microprocessor within the system hardware.

[0214] System data acquisition and control software is high-level software that interfaces with the system and controls the system hardware for more specific operations, such as operating a charge-coupled device (CCD) to acquire visual luminescence information for a particular biological assay. In various embodiments, the data acquisition and control software includes a software-implemented state machine 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 the idle state, it may receive instructions from a general-purpose machine to perform specific data acquisition or system control operations. In various embodiments, the general-purpose computer The computer opens a TCP / IP socket connection to the system, determines whether the system is idle, and then begins transmitting commands and / or parameters. In various embodiments, an encrypted TCP / IP connection is established, for example, using the SSH protocol. The commands and / or parameters may be in the form of ASCII-encoded, human-readable consumable and / or method information that defines the behavior of the biological system. In various embodiments, the consumables and / or methods are stored in ASCII text files. In various embodiments, a general-purpose computer uses the FTP protocol to transfer the ASCII text files to the system. In various other embodiments, the methods and / or consumables are stored in and retrieved from the identifier. The method and / or consumable information can be stored in the identifier in the form of an ASCII text file, although it is understood that the information can be represented in other data formats without departing from the present teachings.

[0215] According to various embodiments, the consumable, macro, and / or method information includes parameters that can be used by the system data acquisition and control software to perform specific data acquisition and system control operations. In various embodiments, the method and / or consumable information includes a sequence of operations to be performed by the system parameters or control parameters for use in connection with the data acquisition or control software.

[0216] (ii) Assay process information Additionally, consumable data may include assay process information regarding individual assay parameters that need to be applied by the system or assay reader during an assay. For example, such consumable data may include the order of steps for a given assay, the identities, concentrations, and / or amounts of assay reagents that need to be used or added during an assay or during particular steps of an assay, such as buffers, diluents, and / or calibrators that need to be used in the assay. Consumable data may also include the type or wavelength of light that needs to be applied and / or measured by the system or assay reader during an assay or particular steps of a 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 or other analytical methods that need to be applied to raw data collected during the assay by the system or assay reader.

[0217] In one embodiment, one or more steps of an assay protocol can be tailored to individual consumables or consumable lots. One or more steps of the protocol may vary from consumable lot to consumable lot and / or for individual consumables 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 optionally be adjusted by a system user at the user's discretion. For example, a dilution step in an assay protocol can be adjusted to account for lot-to-lot or consumable-to-consumable variations. The amount of diluent added and / or the nature of the diluent can be modified based on such variations. Similarly, the amount of a given reagent that can be added during the performance of an assay, the incubation period and / or temperature of one or more steps of the assay may be due to lot-to-lot or consumable-to-consumable variations. Each of these is a non-limiting example of consumable data that can be stored in the system's storage medium.

[0218] Additionally, the consumable data may include, for example, one or more light detectors, a light-tight enclosure, mechanisms for transporting the assay consumable into and out of the assay reader, mechanisms for aligning and orienting the assay consumable with one or more light detector(s) and / or electrical contacts of the assay reader, additional mechanisms and / or data storage media for tracking and / or identifying the assay consumable, one or more electrical elements for inducing light emission, and / or other information. The information includes information that directly or indirectly controls components of the assay system, such as an energy source, a mechanism for storing, stacking, moving, and / or dispensing one or more consumables, a mechanism for measuring light from the consumable from multiple test sites on the consumable sequentially, substantially simultaneously, or simultaneously during the assay, or a combination thereof.

[0219] The consumable data may also include assay process information, including assay parameters applied by the assay reader during the assay, the order of steps applied by the assay reader during the assay, the identities, concentrations, and / or amounts of assay reagents used or added during the assay, the type or wavelength of light applied and / or measured by the assay reader during the assay, the temperature applied by the assay reader during the assay, the incubation time for the assay, statistical or analytical methods applied by the assay reader to raw data collected during the assay, or a combination thereof (such assay process information may optionally be adjusted by the user). In a specific embodiment, the assay performed using the consumable is a multi-step assay, and the assay process information relates to a step or steps of the multi-step assay. In this embodiment, the consumable / test site information includes information about an assay previously performed by the assay reader on one or more test sites of the consumable, information about an assay performed by the assay reader or its components on one or more test sites in the consumable, or a combination thereof.

[0220] The consumable data may further include information about the consumable, test site, domain, sector, or biological reagent or sample, for example, because individual operations are performed on the consumable, test site, domain, sector, or biological reagent or sample during manufacture of the consumable or while an assay or step is being performed on the consumable, test site, domain, sector, or biological reagent or sample. For example, if an assay consumable includes multiple assay test sites, domains, and / or sectors, the assay system may perform an assay or step of a multi-step assay 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, such as raw data or analyzed data generated during the assay or assay step, in the identifier, 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. The assay consumable can be stored for later use, and when the customer is ready to use another test site, domain, and / or sector of the assay consumable, the controller reads the consumable data stored in the assay consumable's identifier to identify which test sites, domains, and / or sectors have been used, which have not yet been used, and / or the results of their assays. The controller can then instruct the assay system, assay reader, or components thereof to perform an assay or assay step on the unused test site, domain, and / or sector.

[0221] Additionally, a given assay protocol may require a collection of consumables of a particular type. Thus, if a customer inputs a particular type of assay consumable, such as a multi-well assay plate, for use with a particular assay protocol, one or more additional assay consumables may be required to run that assay protocol on the system, such as, for example, one or more reagents may be required for use with the multi-well assay plate. Each of the required consumables may include a consumable identifier along with information regarding the consumable requirements for the assay protocol. When one of the required consumables is input into the assay system, the identifier controller may generate an identifier for that consumable. When interacting with a consumable identifier, the system examines the components present in the system and compares the results to the consumable requirements associated with the consumable identifier, stored in a storage medium, and / or provided as consumable data. If any required consumables are not present or are present in insufficient inventory, the system prompts the customer to enter additional required consumables for the assay protocol based on the information stored in the required consumable identifier. If more than one assay consumable is used in the system, the meter correctly identifies the first assay consumable and any associated consumables based on the consumable requirements associated with 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 meter does not identify the associated consumable in the system within a predetermined period of time. If a mismatched assay consumable is loaded into the meter, the system notifies the customer. If there is no matching set of assay consumables available (e.g., a multi-well assay plate and a given reagent for a particular assay), the system will not run the sample. The system checks assay consumable expiration dates before the start of an assay, and the system warns the customer and prevents the use of expired consumables. If consumables have expired before sample aspiration, the system will not process the sample. If a partially used assay consumable is installed in a different instrument, consumable use automatically begins with the next available unused well.

[0222] The identifier can also be used to track the amount of time a given consumable has been in the assay system. Thus, when an assay consumable is inserted into or contacted with the assay system, a timer is started in the assay system and the start time is recorded in the identifier. When an assay is started by the system at the consumable or at a test site, domain, and / or sector within the consumable, the time is also recorded in the identifier. When the instrument, system, or a component thereof is stopped (e.g., by turning off the power), the timer is stopped and the time is recorded in the identifier. Thus, whenever the timer is stopped, the accumulated load time is recorded in the identifier.

[0223] (iii) Analysis tools In another embodiment, the consumable data further includes one or more analytical tools that can be applied by the system to analyze data generated during and / or after the performance of the assay. Furthermore, such analytical tools may include instructions for the customer and / or the system to generate specific output by the system software after the performance of the assay, such as, for example, a format for a data report and / or the results of the analysis tailored based on the consumable data. Alternatively or additionally, the analytical tools may further include one or more statistical algorithms that can be applied to the data by the system. For example, the consumable data may include a selection of one or more statistical algorithms that can be used to analyze data resulting from use of a given consumable, and the customer can optionally select an appropriate algorithm for the desired data analysis. The consumable data may also include information that can be used by the customer to select an appropriate algorithm for their needs, such as technical notes or references related to the selection of the algorithm.

[0224] Analytical tools may vary from consumable lot to consumable lot and / or for individual consumables within a given lot. In this embodiment, the consumable data is used by the system to adjust analytical processing tools applied by the system software in performing the assay or after the assay is completed and results are generated and / or displayed. Such analytical processing tools include, but are not limited to, assay thresholds and / or calibration curves that can be applied to one or more steps of the assay protocol that can be modified based on differences in the consumable. Specific Embodiments In the present invention, for a given consumable type and / or desired use, the consumable data may include project management tools for scheduling the performance of one or more assays or steps thereof using a given consumable or collection of consumables in the system. Additionally, such analytical processing tools may optionally be tailored by the system user at the user's discretion. The analytical tools may be transmitted to the customer via a direct or indirect interface between the system and the customer.

[0225] (iv) Assay system maintenance information The consumable data may further include system maintenance information for the customer, including, but not limited to, system monitoring reports, system component usage, inspection history, system troubleshooting information, results of diagnostics performed on the system, control chart generation, scheduled maintenance scheduling, warranty information for the system and / or system components, or combinations thereof. The system software can be programmed to monitor various components of the system and send monitoring reports to a remote computing system and / or a maintenance technician, either automatically or when prompted. If a direct interface is not enabled, the system may prompt the customer to send monitoring reports to the CD Server via an indirect interface. Additionally or alternatively, such system monitoring reports can be accessed by a maintenance technician tasked with maintaining and / or inspecting the system, either locally or remotely. In this embodiment, the maintenance technician can communicate with the customer regarding instrument repair or assistance with the instrument via the direct or indirect interface. In certain embodiments where specific interfaces are enabled, the CD Server monitors system component usage and / or warranty information and schedules scheduled system / component maintenance and / or upgrades by a maintenance technician based on standard system component lifespans and / or warranty terms. However, the system can be programmed to automatically monitor such information about the system, and if the direct interface is not enabled to allow a service technician to access the system's status, the system can send the output of such monitoring activity to the CD Server via the indirect interface and periodically prompt the customer to determine if system service or maintenance is required. Additionally, the CD Server can maintain a log of the service history of a given assay system and schedule service calls by a service technician (this can be done using either the direct or indirect interface).Additionally, the remote computing system can transmit individual assay system software upgrades via a direct or indirect interface.

[0226] (v) System - Consumables Promotion Information In another embodiment, the consumables data includes promotional materials, for example, when new types or lots of consumables become available, particularly those products traditionally used by a given customer. Such promotional materials may also relate to new assay systems, modifications to current systems, and / or optional installations or improvements to current systems, particularly those modifications, installations, or improvements to systems owned or operated by the customer and / or those modifications, installations, or improvements that may be of interest to the customer based on that customer's previous use. This type of consumables data may also include references, brochures, product inserts, technical and application notes, technical presentations, conference information, and promotional seminars, particularly those that may relate to one or more consumables / systems used by a given customer. Such promotional information may be provided to the customer through a direct or indirect interface between the customer and the vendor.

[0227] (vi) Technical support information Consumable data also includes, for example, product insert and data sheet information, The consumable data may also include technical support information that can assist the customer in using the consumable or system, such as information related to related products with which the consumable is intended to be used, instructions for use, training materials, tutorials, recommended use and / or storage information, data analysis templates, template reports, calibration curves, lot-specific QC data, validated quantitation limits, and troubleshooting methods and / or algorithms. For consumables that include or are equipped with one or more additional consumables, such as reagents, the consumable data may also include reagent catalog numbers, reagent lot-specific information, reagent manufacturing dates, reagent expiration dates, instructions for use, training materials, tutorials, recommended use and / or storage information, etc. Technical support information may also include receiving feedback or assistance through a direct or indirect interface with a technical support representative, such as, for example, customer training modules, consulting services, and / or live customer service assistance capabilities (i.e., live chat) to enhance the customer's experience. It is understood that the technical support information may relate to the consumable, the system, or both.

[0228] 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] JPEG0007803996000002.jpg91162

[0229] D. Specific Embodiments of Data Association Workflows A specific embodiment of a data association workflow, i.e., the process by which specific data is associated with and stored in a consumable identifier, is shown in Figure 11. In the first step of Figure 11, a vendor receives a request for a consumable, either from a sales order or from an internal request to replenish existing inventory. The vendor maintains a central database (1100) for various types of data, as described herein, which also includes one or more processors (1101) configured to process data queries, extract data from one or more databases or data tables in the central database, and generate, transmit, and / or store data sets in response to the data queries. An order (1102) has a unique identifier associated with it, such as an order number (1103), which is stored in one or more vendor data tables, such as an order data table (1104). Each customer, whether external or internal, is also associated with a unique identifier, such as a customer number (1105), which is stored in a customer data table. The customer data table includes customer contact information, shipping address(es), etc. for one or more individuals or organizations associated with that customer. For example, if a customer is a business with many locations, the customer can be uniquely identified in the customer data table by a single customer number, each associated with the business's various locations, or each business location can be uniquely identified by a single customer number. If a customer is internal, such as a department within a vendor's organization requesting replenishment of consumable inventory, the customer data table may also have one or more subdirectories or data tables for internal departments. Thus, the customer data table includes a unique customer number for the customer (e.g., Customer X), the order data table includes each unique order number (e.g., Order Y), and there is also a customer-order association data table (1106) that stores the association between each customer and their order (e.g., Customer X Order Y).

[0230] The order is received by a manufacturing engineer and a unique consumable identifier (e.g., a consumable identifier (e.g., a barcode) as described above) for that particular consumable is created and the consumable identification The data is stored in a consumable identifier data table (1107). Thus, in one embodiment, all data uniquely associated with the consumable is associated with a consumable identifier, which is stored in the consumable identifier data table. Alternatively, different types of data related to a product, such as quality-related data or manufacturing-related data, can be stored in individual data-specific data tables, with each entry indexed by the consumable identifier. Thus, either all data uniquely associated with the consumable is stored in the consumable identifier data table, or the data is stored in a series of individual data-specific data tables indexed by the consumable identifier; when data is needed for the consumable, the consumable identifier is scanned via the consumable identifier controller, and the data associated with the consumable is downloaded to the computing system requesting the data for the consumable. The system also includes a customer number-order number-consumable identifier association data table (1108), whereby for each customer, order, and consumable, there is a unique association stored in the data table between customer X, order number Y, and consumable identifier Z (customer X - order number Y - consumable identifier Z). Additional unique identifiers may also be associated with an order, such as a catalog number, salesperson number, order subcomponent, etc. Each association with an order number may be stored in one or more additional data tables in the system. Based on the type of consumable requested in the order, the technician queries one or more manufacturing and / or order fulfillment data tables to identify the set of consumable data needed to manufacture the consumable or fulfill the order (Consumable Specification Data Table (1109)). Data is associated with the consumable identifier, the consumable is manufactured, or ordered, and additional sets of consumable data associated with the manufacture of the consumable or fulfillment of the order are associated with the consumable identifier. Consumable data associated with that consumable or lot thus far in the manufacturing process is stored in the consumable identifier data table. The manufacturing process may also include a quality control system in which products undergo one or more quality control steps.Unique data from each quality control step performed on a consumable or lot is associated with the 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 forwarded to the shipping department, and shipping event-data is associated with the consumable identifier, e.g., packing date, shipping date, etc., and the consumable identifier data table and / or shipping specific data table are updated accordingly.

[0231] While Figure 11 and the accompanying description relate to consumables, consumable data, etc., it should be apparent that the same process outlined in Figure 11 can be used to associate data with instruments, kits containing multiple components, etc. For example, if the consumable is a kit containing multiple components, when the order is forwarded to manufacturing and the manufacturing engineer queries the consumable specification data table for data regarding how the kit will be manufactured, the consumable specification data table will provide a list of the components of the kit, with each component of the kit including a unique component identifier that is associated with the kit identifier in the system.

[0232] As described above with reference to FIG. 1 , consumable (lot and / or instrument) data is generated by the vendor before, during, and / or after an individual consumable and / or consumable lot is produced and / or distributed. The CD creation system creates a database of CD information for that consumable or lot, i.e., a CD database in which the consumable data is stored. The CD database is transmitted to a CD server (104) that contains a master repository of all consumable data. Additionally, the CD creation system stores information used to associate a given consumable identifier with the consumable data in the master repository. The CD creation system and / or CD server may be located on a remote computing system, i.e., a computing system remote from the assay system and / or customer, such as a site maintained by the vendor. In one embodiment, the remote computing system is a data hub or a third party (e.g., Amazon Web Services) The data hub may include any suitable data structure; for example, each customer may have a separate data structure on the data hub that is shielded from and distinct from other customers' data structures on the data hub. As shown in FIG. 2, upon receipt of an order from a customer or when a consumable or lot is manufactured (step i), the vendor generates, stores, and transmits a CD database to a CD server (201) on the data hub (step ii). The CD database may include order fulfillment information, i.e., a summary of the components of a given customer's order, so that the system can verify that all components of the order have been supplied to the customer. The customer receives a consumable (202) including a consumable identifier (203) and contacts the consumable with an assay system (204) in preparation for performing an assay (step iii), which reads the information associated with the consumable identifier (203), which is used by the system to identify the consumable (202) (step iv). The system reviews consumable data stored locally on the system on a local storage medium (referred to as "Local CD" in Figure 2) to identify consumable data stored on the storage medium that can be used to perform an assay using a given consumable. If the storage medium contains consumable data for that consumable or lot, the consumable can be used in the system (step v). If the storage medium does not contain consumable data for that particular consumable or consumable lot, the system can query the customer for the consumable data, and the customer can communicate with the vendor to receive the required consumable data (step vi), for example, via email, compact disc, memory card / stick, flash drive, web data storage service, etc. The vendor sends the customer a consumable data binary file (including, but not limited to, an encrypted XML file), for example, as an email attachment to the customer's email account, the customer loads the file attachment into the assay system, and the system software stores the consumable data in the local system consumable data repository.The consumable / consumable lot can then be used in the instrument (step vii).

[0233] In an alternative embodiment, the CD Server can connect to the system via a direct interface that allows consumable data to be automatically obtained from the CD Server if the consumable data is not available locally on the system. In this embodiment, as shown in FIG. 2 and described above, the vendor generates, stores, and transmits a CD database for consumable orders and / or consumable lots to the CD Server. The customer then receives the consumables, orders, and / or lots and contacts the system with consumable identifiers to enable the system to identify the consumables or lots. The system software queries the system consumable data repository for consumable data associated with the consumable identifiers, 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 either (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 the direct interface with the CD Server and stores the information locally in the system consumable data repository. When the consumable data is available locally on the system, the software adjusts the system based on the consumable data, if necessary, to perform the assay. When the consumable data is available locally on the system, the consumable or lot can be used by the system to perform the assay and display the assay results to the customer. In a specific embodiment, the system software adjusts the output to the customer based on the consumable data.

[0234] As discussed above, consumable and / or meter data can be transmitted to the data hub via software to allow the vendor to collect data related to the customer, the meter, the consumable, and / or the vendor. Software can be programmed on the meter to collect this data automatically and / or the software can be configured to collect this data in any manner selected by the customer at the time of meter installation. In one embodiment, the following consumable data is collected by the instrument and transmitted to the data hub: unique consumable identifiers used on the instrument at the customer's location, as well as the analysis layout for experiments performed using one or more unique consumables. For instruments installed in a networked system, i.e., a customer-maintained computer network to which two or more instruments are connected, the software can collect the following consumable data: consumable statistics, e.g., detected signal, CV, average, image center, etc.; control and calibrator performance, e.g., % recovery, detected signal data, etc.; identity of consumable identifiers uploaded on one or more networked instruments; audit logs; and / or instrument logs.

[0235] In another embodiment, an exemplary system for coordinating communications between processors present in the assay system (1000) and a computer located at a user's facility, also known as a Laboratory Information Management System (LIMS), is shown in Figure 11(b). The LIMS (1120) is linked to the various processors of the assay system (1100) through a Data Integration Agent (DIA) (1122). The DIA (1122) is preferably an API (Application Programming Interface) and is an interface between the LIMS (1120) and the Workbench software (1124), including a user interface (UI) and database (DB) (1126).

[0236] To start an assay run, the LIMS (1120) sends a request (arrow 1) to the DIA (1122). The DIA (1122) then forwards and / or translates the request (arrow 1) to the DB (1126). The Workbench (1124), which is connected to the DB (1126), uses a UI to guide the user / lab technician through the assay protocol(s), either to the assay system (1000) or to another assay system (900). performs the immunoassays and reports the results to DB (1126) as raw ECL data (arrow 3) and / or as ECL data with analysis from reader (1003) (arrow 2). DIA (1122) retrieves the ECL data from DB (1126), converts the ECL data to XML (Extensible Markup Language) and sends it to LIMS (1120) (arrow 5). LIMS (1120) may query DIA (1122) over connection (arrow 4) regarding the status of the assay run.

[0237] Figure 11(c) shows the relationship of the Workbench / UI (1124) to other systems and processors in the assay system (1000). The Workbench / UI (1124) is connected to components with their own processors, such as the robotic system (1002) including the pipettor (1021) and gripper pad (1031). The Workbench / UI (1124) is also connected, either wired or, preferably, wirelessly through a router (1130), to the processors of the tablet (1058) and reader (1003) that actually display the UI. As mentioned above, the Workbench / UI (1124) is also connected to the LIMS (1120). A barcode scanner or consumer ID controller (1013) will read consumable identifiers (e.g., barcodes) or unique IDs from any lab equipment or assay kits. As explained further below, the consumable identifier (e.g., barcode) or unique ID will inform the Workbench / UI of the type of labware or assay to be run from the kit. If any additional information or data is required, it can be downloaded from an external server or cloud (1130).

[0238] The software that runs the assay system (1000) has three main components: (i) a user interface (UI) that guides a user through the process of selecting, loading, and running the immunoassays described herein; (ii) the functionality and performance of the robotic system (1002), as well as the errors reported; an instrument control system that also controls operational qualification and performance qualification; (iii) a data service that stores ECL results and user priorities as described above in connection with FIG. 11(b); Includes.

[0239] Referring to Figure 11(d), the Workbench / UI will send requests to the instrument control system, which has three listening modules: (i) a system listener (1132), a command listener (1134), and an error command listener (1136). The system listener (1132) listens for requests during qualification of the assay system before and during scheduled maintenance, as described below in connection with the operational qualification and performance qualification systems. The command listener (1134) listens for requests to instruct the robotic system, including the pipettor (1021) and robotic gripper pad (1031), to perform steps of an immunoassay. The error response listener (1136) listens for error codes broadcast from various components of the assay system (1000).

[0240] Errors are categorized 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 not detecting a single sample; and (iii) interactive recoverable errors, such as the door to the assay system (1000) not being properly closed. Preferably, errors will return a flag in the results file and cause a visual or audio alert. In the event of a power loss, the instrument control portion of the software will use any universal power supply (UPS) that needs to be stored in the instrument and will control the shutdown of the instrument.

[0241] In accordance with another aspect of the present invention, the UI portion of the software is constructed using plug-ins, also known as applications or applets. Once an assay system has been validated or qualified, an operator generally does not want to revalidate or optimize the system for software updates. Revalidation is necessary when components of a software system are interconnected. In other words, when one component depends on input or instructions from another component to function, then the components are interconnected. Thus, a feature of the present invention of the UI or Workbench is that its components are decoupled from each other. That is, each component may be a standalone piece of software. These standalone pieces require minimal instructions from the master organizer to run.

[0242] Referring to Figure 11(e), a 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 instrument control components and data services mentioned above, can be connected to the master organizer (1140).

[0243] The master organizer (1140) acts like a traffic controller, sending start or stop requests to each component when it is necessary to operate or stop that component. Communication between components is carried over 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 a log file of events during an assay run, fires important events, such as reading an assay plate, when commanded or requested by the master organizer (1140). The master organizer 1140 may notify the application network 1146. Publication or notification will not occur without the master organizer 1140.

[0244] These communications between components do not create a level of connectivity that requires revalidation of the Workbench / UI platform if one component requires a software update. Instead, the master organizer (1140) may act as a conduit for passing data from one component to another.

[0245] An application can be created by an application implementation (1150) that obtains code from a storage medium, such as a base application (1152) that may reside in the application framework (1146). The base application (1152) stores code accessible by the application implementation (1150) for use by the UI during an assay run. The application created by the application implementation (1150) can be kept or deleted when the master organizer (1140) commands the stop framework (1142) to stop, as shown in FIG. 11(e). The application implementation (1150), which is shown to be external to the UI platform, can be a separate software component connected to the master organizer bus.

[0246] Because of this decoupled architecture, if one component needs a software update, that one component needs to be recertified, but the entire software system does not need to be recertified.

[0247] In another embodiment, other major components may have a similar architecture. For example, the instrument control component may have its own master organizer to control traffic between internal components with processors, such as the robotic system (1002), pipettor (1021), robotic gripper (1031), plate washer (1005), tablet (1058), reader (1003), etc. A software update to one of the internal components of the instrument control would not require revalidation of the instrument control, and would not require revalidation of the software of the assay system (1000).

[0248] Additionally, the major software components, namely the workbench / UI, instrument control, and data services, are connected to the master organizer and can share the same software architecture.

[0249] An example of the UI is shown below. [Table 2] The major components of the UI are shown in the left column, and the steps within each component are shown in the right column. The UI walks the user through these steps to perform an assay from start to finish.

[0250] Figures 12(a) to 12(l) show the Meso Scale model for Rockville, Maryland. 1 shows an exemplary software framework for collecting, deploying, and locating global product data (GPD) for multi-well assay kits and plates available from Discovery. While the following description and accompanying figures relate specifically to plates and kits, it is understood that the software framework and methods described herein are applicable beyond plates and kits to assay systems, instruments, and additional assay consumables.

[0251] A GPD is associated with a consumable identifier, such as a Global Product Identifier (GPI). A GPD is a flexible data container that contains a collection of consumable data as described herein, which may include the following non-limiting list of data for a given consumable, such as a plate, assay reagent container (reagent rack), or assay kit: Consumable physical properties, such as plate type, geometry, and graphs of plate characteristics Image processing parameters Detection parameters Plate coating, assay allocation Partial plate information Recommended reagent layout Assay Protocol Assay workflow or script and GPI-associated instrument parameters Test kit contents such as product inserts and reagents - Recommended analysis information such as curve fitting Recommended Reports Customer order information such as expiry dates of consumables and consumable lot information

[0252] As shown in Figure 12(a), a Data Deployable Bundle (DDB) is a container configured to organize and collect related 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 software packages that run on customer assay systems. A GPD is an example of a DDB. Some additional examples of DDBs include, but are not limited to, new assays, new plate types, new consumable types, etc. Different types of products, such as consumables and instruments or assay systems, are each associated with a different DDB. For example, an assay system may include a unique identifier, as described above, that includes system identifier authentication, assay system information, and other information, such as, for example, Physical characteristics of the system, such as system components, configuration, etc. Subsystem characteristics, configuration, etc. Associated consumable types The workflow used to guide users through the use of the system Customer order information such as system manufacturing information The DDB for that assay system may include other technical data related to the assay system, such as, but not limited to, the assay system's function, protocol, and / or assay parameters.

[0253] Each DDB has a DDB identifier (UID), a version number, and a deployable bundle description file. The UID and version number together uniquely identify the DDB. The description file describes the DDB contents and instructions for processing the DDB, including a description of the steps required to integrate the DDB into a local assay system software package. The DDB provides a deployment framework for distributing GPDs. The data contained within the DDB may be in separate file structures or in a single file structure. The file format may be XML, key-value pair, or both. DDBs can be distributed through multiple forms, such as a vendor e-commerce site or as an email attachment.

[0254] To install the DDB, files are stored locally on the assay system in a designated directory, as shown in Figure 12(b). Using a plug-and-play framework, the local software system detects the bundle and processes it for incorporation into the software. The local software then processes the bundle and any files available in the software. The DDB includes a registry, which is a directory that lists information about the services and data available to it. The DDB uses the registry to register what data is available from it, and the DDB instructs 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 from one DDB to another, for example, from one plate to another.

[0255] The DDB includes a unique DDB UID and version. As shown in FIG. 12(c), the DDB may include data that is persisted to a local data store, such as the DDB UID and version. When a DDB contains large data sets, the data is persisted to efficiently access the types of data needed during system operation. The data is persisted by identifying one or more data types in the DDB and storing that data in a local database structured for the type(s) of data. In one embodiment, the entire contents of the DDB are persisted, i.e., reconstructed locally in separate data sets. 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 DDB data that requires persisting to a data store, the DDB UID and version are saved to track what has been stored. This eliminates unnecessary data store operations in the same DDB by detecting that the data is already stored.

[0256] Generally, software understands and works with a specific version of a data format. The DDB framework supports different versions of data formats and different versions of software that work together for easier maintenance. Figure 12(d) shows 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, with the framework shown in Figure 12(d), the DDB does not need to be re-released to work with new software versions, and one DDB can be created that works with multiple versions of software. DDB files are upgraded and / or downgraded as needed, one or more files are stored and / or persisted locally, and a DDB processor (factory) converts raw class data into data types or formats that can be used by the software to perform assays or assay steps in the assay system.

[0257] As shown in FIG. 12(c), a typical DDB for a plate might include the following consumable data: Plate static data contains data about the plate type. These are the properties associated with the physical plate, regardless of the type of instrument used to process it. Some example properties are: Number of well columns / rows Number of spots per well Plate processing data includes data used to process / run plates. Rating data is typically instrument specific. Some example characteristics are: ○Number of sectors / circuits ○ The detection parameters used to read the plate, e.g. camera binning, waveform, etc. ○ Image processing characteristics used to generate ECL results ○Plate type gain ○Spot gain Optical crosstalk matrix The kit includes assay data and kit information. Some example data would be as follows: Assay spot allocation Assay protocol Data analysis parameters ○Product insert · Lot contains specific data for the test kit or plate produced for the order.

[0258] Figure 12(f) shows an example of how a GPD DDB is deployed, and Figure 12(g) is a diagram of an example of the DDB xml and files in a GPD DDB. As shown in Figure 12(g), the DDB xml describes the data in the DDB and how to process it, the GPD is a container of data that references data by UID and version, and the GPI to GPD mapping provides indexing data for the associated GPI. Furthermore, Figure 12(g) shows that other data can also be bundled inside the DDB.

[0259] Figure 12(h) shows how GPD data is located. The software includes a GPD service processor that interacts with the registry to locate the GPD data. Using the GPD, the software identifies the type of data and characteristics of the data needed for a given consumable and filters the registry for the needed data. As described above, if the needed data is contained in the local registry, the GPD service queries the master repository for the needed data and downloads it locally. Most searches use the UID as the search criteria, which is available in the GPI to GPD mapping. The GPD factory takes the UID and retrieves the GPD data from the appropriate data store for the system software (in the example shown in Figure 12(h) , Client 1 is, for example, the assay system software, and Client 2 is, for example, an associated standalone software system that provides the user interface functionality for Client 1's software, e.g., a remote laptop or desktop computer). Below are two possible options for how the retrieval of data can occur: (a) The DDB registers all data it provides. The GPD service queries the registry for matches. Some aspects of this search approach include, but are not limited to: The registry contains many entries and all data can be accessed directly through the registry. Searches may be slow depending on the registry implementation. (b) A DDB directly registers a selected subset of data items. The DDB also registers search providers that can be used to locate data instead of directly exposing all available data. A GPD service indirectly uses the DDB's search providers by going through a registry. Aspects of this search approach include, but are not limited to: DDB manages the data it provides and hides details that it does not need to expose , or filter. Less information is published to the registry, making it smaller. This method is suitable for factories and systems with limited resources.

[0260] These search options are not mutually exclusive: a GPD service implementation may support both, allowing each DDB to define what is exposed.

[0261] Figure 12(i) shows option (b), where the factory is responsible for accessing the final data. In this example, the assay system software interacts with the GPD service to access the data, and the GPD service uses a registry to look up the requested data or a GPD factory that can provide the data. The GPD factory is registered as a provider of the data, and the GPD factory retrieves the data from the data store and returns it.

[0262] For example, a vendor produces a lot of consumables, such as plates, where each plate has a GPI. There is a DDB for that lot of consumables, which contains a single UID and all GPIs in that lot, regardless of how large the lot is associated with that individual lot-specific UID. When a consumer purchases a plate that is part of that lot and the plate GPI is read by the assay system, the software identifies the type and characteristics of the data needed for that plate and filters the registry for the needed data. As described above, if the needed data is not included in the local registry, the GPD service queries the master repository for the needed data and downloads that data locally. Using the GPI, the software queries the local and remote databases for the UID, and it installs the needed GPD locally, which can be used immediately to process that individual plate or later if another plate from the same lot is processed by the system.

[0263] As shown in Figures 12(j)-12(l), a GPD goes through different stages in its lifecycle from installation to erasure of data. These stages include, but are not limited to: All data for a DDB is collected and packaged into one DDB file for deployment. The DDB file is delivered to the software in the agreed directory. The DDB tells the software what needs to be done. The DDB controls how it needs to be processed. GPD data is extracted and stored in the software system according to instructions. The UID and version are used to track whether the GPD data has been processed before and can be omitted. Some GPD data is extracted to the file system as needed, and the location of the data is stored in the database. The rest of the data is put into a database. Once the file has been processed, it no longer contains data that is no longer in the system and the file is moved from the extraction directory to the archive / backup directory. · Software clients use the GPD service to retrieve GPD data. Using GPI to GPD mapping, the software can determine which GPD data should be used with a given plate. After reading, the software plate data storage contains a read-only copy of the data from the GPD about the plate, and the data generated from processing it.

[0264] Examples of interactions between GPD-DDB and GPI are described below.

[0265] A GPD may include a general assay protocol, e.g., steps in an assay, that includes all steps for several assays, preferably within one type of assay, such as, for example, immunoassays, including pharmacokinetic assays, immunogenicity assays, U-PLEX assays, V-PLEX assays, and other types of assays. A particular specific assay protocol for one type of assay may not require all of the steps in the general assay protocol. Instead of preparing a unique assay protocol for each specific assay, a GPD of the present invention includes the general assay protocol as well as an instrument parameter file associated with the GPIs of the specific assay.

[0266] As shown in Figure 12(m), a protocol or script for a streptavidin plate, indirect assay is shown. This protocol or script includes several steps, including, but not limited to, diluting samples for plates 1-5, blocking the plate, coating the plate, incubating the sample, preparing the first detection incubation, preparing the second detection incubation, and reading the assay plate. For other assays of this type, the second detection step is not activated, as shown in Figure 12(n). Another assay may not require the coating plate step, as shown in Figure 12(o). Another assay of this type does not require the coating plate step, and the second detection step is not required, as shown in Figure 12(p). The following table summarizes the assay protocols of Figures 12(m)-12(p). [Table 3] 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

[0267] In this embodiment, all steps of Assay 1 are performed, so this protocol is a general protocol for custom sandwich immunoassays, including pharmacokinetic assays. The General Protocol preferably serves as a part of the GPD. Attached to the GPD is an instrument parameter file associated with a GPI unique to Assay 1. The instrument parameter file will 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 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 second detection will be off, while the remaining flags will be on.

[0268] The general protocol will be the same for all of these exemplary assays 1-4 and other compatible assays of this type, except for the instrument parameter files for assays 1-4, which are much smaller files in size than the general protocol. An exemplary instrument parameter file, which is a computer-readable file in text format, is shown in Figure 12(q). Several flags are located at the bottom of this text file. Some of the flags are on, or true, and some are off, or false. Assays 1-4 include pharmacokinetic assays.

[0269] In this embodiment, before a particular assay is run, the GPI for that particular assay, such as a consumable identifier (e.g., barcode) on the outer box of a kit containing the labware 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 onto its associated GPI by the assay system's processor. The processor will then determine whether a generic protocol or script is included in the system's processor / memory and whether an instrument parameter file associated with the GPI is already stored in the system's memory. If not, the processor can download the generic protocol, which is preferably stored in binary format to minimize its size, and the instrument parameter file, which can be stored in text format, from an external system or server or from the cloud.

[0270] Another table below shows another example of a general protocol or script for a bridging immunogenicity assay and a specific instrument parameter file associated with GPI for an IG assay with acid treatment, and another specific instrument parameter file associated with BPI for an IG assay without acid treatment. [Table 4]

[0271] The use of a general protocol for multiple assays along with individual instrument parameter files with on / off flags uniquely associated with the GPIs of a particular assay provides an improvement to immunoassays, and more particularly immunoassays using ECL, and certain computer techniques used with automated immunoassays.

[0272] The protocol or script embodiments shown in connection with Figures 12(m)-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 several options to turn on or off other features just prior to the start of the assay run. In the case of sandwich immunoassays such as Assays 1-4 described above, the user interface The system may allow one or more of the following non-limiting options to the user / lab technician: Assay type: direct or indirect Plate type Standard curve setup including number of points on the curve, dilution factors, etc. Control setup, including the number of controls per plate and the dilution factor per control Sample setup including the replicate number of each unknown and the respective dilution factor Washing plate: Y / N Blocking: Y / N including blocking amount, incubation time, and subsequent washing plate Coating: Y / N including coating amount, online / offline incubation, incubation time, and subsequent washing plates (Y / N) Sample incubation including sample volume, online / offline incubation, incubation time, and subsequent wash plate (Y / N) For indirect assays: unlabeled / biotinylated detection species incubation: detection species amount, online / offline incubation, incubation time, subsequent washing plate (Y / N) STAG-labeled detection species incubation: detection species amount, online / offline incubation, incubation time, subsequent washing plate (Y / N) Reading buffer incubation: On / Off, incubation time

[0273] For the Bridging Immunogenicity Assay, the following are some of the user-selectable options: Plate type Standard curve setup including number of points on the curve, dilution factors, etc. Control setup, including the number of controls per plate and the dilution factor per control Sample setup including the replicate number of each unknown and the respective dilution factor Acid treatment (Y / N) including ratio of acid to diluted sample and incubation time Sample incubation time, including mastermix to sample ratio Pre-start cleaning delay (Y / N) Blockage (Y / N) including blockage volume and subsequent wash plate (Y / N) Sample incubation on plates including sample volume, online / offline incubation, incubation time, and subsequent washing plate (Y / N) Reading buffer incubation: On / Off, incubation time

[0274] One embodiment of the assay system shown in Figure 10 and assays performed in its subsections is shown in Figures 13(a)-13(f). Figure 13(a) shows a schematic representation of certain subsystems of the assay system (1300) involved in performing an assay positioned on a table or platform (1301), each subsystem operatively connected to a robotic subsystem (not shown). The multiple 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, for example, on a multi-well plate, a dispensing tip storage compartment (1307) configured to accommodate dispensing tip boxes of tips of varying sizes as needed (e.g., 1308 and 1309, 1000 μl and 350 μl tips, respectively) and including a dispensing tip disposal chute (1310) connected to a waste compartment (not shown), and one or more sample / reagent tube carriers (1311).

[0275] As shown in FIG. 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 available consumable data (1314) associated with that identifier (alternatively, or in addition, the system can query a data hub for additional consumable data, as described above). A representative list of consumable data that can be associated with the identifier is shown in FIG. 13(b), including, but not limited to, a list of components, calibrator values, control values, recipient customer number, order number, catalog number, the consumable's associated assay protocol, and others. The assay protocol (1315) includes one or more steps to be performed by the user and / or by the components of the assay during the performance of the assay. For those steps to be performed by the user (1316), the software displays those steps to the user via the user interface of the assay system (1317). All of the manual steps can be displayed simultaneously in the user interface, or each manual step can be displayed individually in the user interface, with the software prompting the user to confirm completion of that step in the user interface before displaying the next manual step. Once a manual step is completed, the software proceeds to the next step in the assay protocol. Each step in 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) moving the test plate to the plate shaking subsystem, and (b) starting the plate shaking subsystem for a specified duration.Each of these substeps requires the software to send one or more commands to the subsystem or its components that complete the required subsystem. For example, moving a test plate to the plate shaking subsystem requires the software to instruct one or more motors in the robotics subsystem to move to the test plate, retrieve the test plate, and move the test plate to a specified location in the plate shaking subsystem. Each of the subsystem operations is identified in the software's protocol script.

[0276] The assay system then needs to 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 buffers can be filled or refilled (manually) as needed, and waste containers or tanks can be emptied (manually) as needed. The software can also instruct the plate washing subsystem to run maintenance scripts and prepare the washing subsystem as needed. Additionally, the user can manually refill or replace the assay system's disposable tip box. The user can also prepare the software for assay execution either on a remote networked computer or directly on the assay system user interface. Consumables, such as kits, can be selected by the user on the user interface, and the number of samples to be run in the assay can be selected. The user can also review a list of consumables required for the assay (displayed by the software on the user interface) to verify that all required consumables are available. The user can then submit the defined experiment to the system software for initiation and completion. As described above, the software prompts the user to complete manual steps as necessary and follow any software prompts to prepare the system for assay execution. The user initiates the assay run in the user interface, the system is locked, and the software script for the protocol is initiated.

[0277] In one embodiment of a V-PLEX assay, e.g., a cytokine assay, performed in the assay system of Figure 13(b), the following manual steps are required, with the software displaying each step in the user interface and optionally requesting the user via the user interface to confirm that each step is completed: a) Unpack the consumables kit; b) Thaw the reagents according to the consumables' instructions; c) Dilute the ECL reading buffer 2X using deionized water; d) Dilute the wash buffer to 1X using deionized water; e) Reconstitute the lyophilized calibrators by adding 1000 μL of Diluent A and mix the wells by vortexing; f) Reconstitute the lyophilized controls by adding 250 μL of Diluent A to the vial and mix the wells by vortexing.

[0278] A calibrator is a sample with a known concentration of an analyte relevant to the assay that is used to determine and apply a fit curve to unknown samples. Calibrators are generally provided at a high concentration 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 an analyte relevant to the assay that is used to determine system performance and whether the assay is functioning correctly. Either calibrators or controls are used in immunoassays, and some assays use both calibrators and controls.

[0279] As shown in Figure 13(c), the appropriate consumables and reagents are loaded into the assay system. Briefly, disposable dispense tips are loaded onto the platform, an empty dilution plate, an empty test plate, and a preloaded sample plate are loaded onto the platform, troughs are filled with ECL read buffer and sample diluent and loaded onto the platform's trough carriers, and a 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) on the user interface and can highlight each subsystem to assist in the proper installation of each consumable or reagent in the subsystem. Once the loading steps are complete, the software prompts the user to close the door to the assay system, locks the door to the system, and initiates a loading verification script configured to verify that each consumable and reagent is properly loaded into the instrument in the correct position and orientation. If any consumable or reagent is improperly loaded, the system door will unlock and the software will display a warning on the user interface and instruct the user to manually adjust the improperly loaded consumable or reagent.

[0280] For example, a protocol for conducting a V-PLEX assay, such as a cytokine assay, on the assay system is shown in Figure 13(d). As described above with respect to Figure 13(b), each step in the protocol corresponds to one or more sub-steps and subsystem operations, and the software includes the necessary scripts and sub-scripts required to instruct the system to perform each step, sub-step, and operation required to complete the assay. The order of steps and timing of events in the assay protocol is shown in Figure 13(e), and a summary of the steps is shown in Figure 13(f).

[0281] Figures 14(a)-14(i) illustrate the implementation of a V-PLEX assay in the assay system shown in Figure 14. The V-PLEX assay is commercially available from Meso Scale Discovery, LLC (Rockville, Maryland). Similar to Figure 13(a), Figure 14(a) shows the layout of the various subsystems of the assay system. FIG. 14(b) shows the configuration of the plate storage subassembly for performing one or more V-PLEX assays on the assay system; similarly, FIG. 14(c) shows the orientation of the reagent tubes and troughs in the tube carrier (panel (i)), trough carrier (panel (ii)), and reagent rack (panel (iii)). FIGS. 14(d)-14(i) show various assay protocols for V-PLEX kits; as noted above, the protocol that needs to be used with a given item or catalog number is the consumable data associated with the kit and kit subcomponent consumable identifiers. FIGS. 14(j) and 14(k) show two exemplary timing sequences or scripts for V-PLEX protocols. FIG. 14(l) shows the updated protocol for the V-PLEX kit shown in FIG. 14(d).

[0282] 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 proper preparation of samples and / or reagents for use in the assay system. For example, in addition to the V-PLEX assay described in detail above, the assay systems and software are also configured to perform U-PLEX and S-PLEX assays (available from Meso Scale Discovery, Rockville, Maryland). Both U-PLEX and S-PLEX assays require a specific number of preparation steps and optional optimization steps, and the software is configured to display personalized step-by-step protocols for those preparation and optimization steps to the user. 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 prior to running the assay in the assay system. Figures 15(a)-15(b) show assay protocols implemented in the assay system for a single plate U-PLEX assay, and Figures 15(c)-15(f) show assay protocols implemented in the assay system for a multi-plate U-PLEX assay. Figures 15(a)-15(h) show two exemplary timing sequences or scripts for U-PLEX protocols. In addition to the specific assay protocols identified herein above, the assay system can be configured to perform the following types of assays, with the software configured to guide the user through the sample / reagent preparation steps via the user interface: Pharmacokinetic assays, preparation, optimization, and assay execution Immunogenicity assays, preparation, optimization, and assay execution Custom sandwich immunoassays: preparation, optimization, and assay execution Reaction rate measurement Assay Development Panels Antibody screening Calibration curve titration Manually reading prepared consumable test plates Plate incubation IQ / OQ / PQ (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ))

[0283] The U-PLEX and V-PLEX assays may comprise the following steps when automated to run on an assay system such as assay system (1000) or (900). Automated Assay Sequencing 1 Check plate inventory 2 Prepare the washer 3. Binding the antibody to the U-PLEX linker 4. Incubate the capture antibody with the linker 5. Add stop solution to the bound antibody-linker solution 6. Incubate the stop solution 7. Prepare the capture antibody mixture 8. Prepare capture antibody dilution 9. Apply the capture antibody mixture to the MSD plate 10. Perform Coating Incubation 11 Applying blocking agent to MSD plate 12 Apply sample dilutions to the MSD plate 13 Perform a blocking incubation 14 Apply dilutions to dilution plate(s) 15. Generate a calibration curve 16 Dilute the control vial 17. Make control dilutions 18. Prepare sample dilutions 19 Wash the MSD assay plate Apply 20 dilutions to MSD assay plates 21 Perform sample incubation 22 Prepare the detection antibody mixture 23. Prepare the detection antibody mixture with blocking agent 24 Apply detection antibody mixture to MSD plate 25. Perform the Detection Incubation 26 Apply detection antibody and dilutions to MSD plates 27. Performing Homogeneous V-PLEX Assay Incubations 28 Apply read buffer to plate 29 Read the plate with an ECL reader 30. Tidy up the process

[0284] (i) Preparation, optimization, and execution of immunogenicity assays Immunogenicity is the property, or the degree to which a substance possesses, that enables it to elicit an immune response by generating anti-drug antibodies. Bridging immunogenicity assays are used to detect the presence of these anti-drug antibodies in samples to characterize the immune response to pharmaceutical substances. Figure 16(a) shows the complexes used in the bridging immunogenicity (IG) assay on Meso Scale Discovery's MULTI-SPOT® platform or MUlTI-ARRAY® platform (available from Meso Scale Discovery, LLC., Rockville, MD). To form the complex, a biotinylated drug, a SULFO-TAG™-labeled (STAG) drug, and an anti-drug antibody (ADA) are incubated together, with the biotinylated drug and the STAG drug each binding to a different portion of the ADA. The drug / ADA complex is then incubated on an MSD test plate containing streptavidin or avidin spots, and the biotinylated drug binds to the streptavidin or avidin at the plate spots (Figure 16(a)). A block diagram of the standard IG assay protocol is shown in Figure 16(b). Figure 16(d) shows an exemplary deck layout used for a bridging IG assay performed in an assay system (1000) that does not include acid treatment.

[0285] IG assays are preferably optimized before implementation in the laboratory. A standard IG protocol includes the following parameters: (i) duration of incubation, (ii) plate type(s), (iii) anti-drug antibody selection, (iv) concentration of biotinylated drug, (v) concentration of STAG drug, (vi) concentration of ELISA antibody, (vii) concentration of ELISA antibody, (viii) concentration of ELISA antibody, (viiii) concentration of ELISA antibody, (viiii) concentration of ELISA antibody, (viiv ...iii) concentration of ELISA antibody, (viiii) concentration of ELISA antibody, (viiii) concentration of ELISA antibody, (viiii) concentration of ELISA antibody, (viiii) concentration of ELISA antibody, (viiii) concentration of ELISA Include multiple parameters that can be evaluated during optimization, including, but not limited to, (vi) determination of minimum dilution ratio (MDR), (vii) evaluation of assay response to free drug in the sample, and / or (viii) evaluation of acid dissociation to improve free drug tolerance, each of which is important to the overall determination of the final protocol.

[0286] To optimize the IG assay with the assay system shown in Figure 10 and its subsections, the user is provided with a system development pack that includes a sample incubation plate (0.3 mL), a sample dilution plate (1.1 mL), a plate lid, reagent tubes, and a kit set that may include the following components: [Table 5]

[0287] Each component in the development pack, as well as the development pack itself, includes a consumable identifier (e.g., a barcode) with consumable data associated with the consumable identifier. A system barcode reader reads the consumable identifier (e.g., a barcode) and downloads and installs the DDB stored in the consumable identifier (e.g., barcode). The DDB includes a DDB unique identifier, a DDB version, a DDB xml file, consumable static information, consumable processing information, and combinations thereof. For example, if a component includes a multi-well assay plate, the consumable type information includes the number of columns of wells, the number of rows of wells, the number of binding domains per well, and combinations thereof, and the consumable processing information includes data used by the assay system in performing assays using the plate and / or processing of assay data resulting from performing assays using the plate. In specific embodiments, the consumable processing information includes the number of sectors per plate, the number of circuits per plate, the detection parameters used by the assay system to read the plate, the image processing characteristics used to generate ECL results, the plate type gain, the binding domain gain, the optical crosstalk matrix, and combinations thereof.

[0288] The system then identifies relevant consumable data from the local data repository and / or from one or more remote consumable data databases required to process that consumable and coordinates one or more actions to be performed on or to optimize that consumable, including, but not limited to, the appropriate protocol and optimization parameters for the IG assay. The system executes these steps before, during, and / or after performing an assay based on product data. A specific embodiment of the IG optimization workflow is shown in Figure 16(c) and includes the following steps: (i) testing various anti-drug antibodies, (ii) optimizing the concentrations of biotinylated and STAG-labeled drugs, (iii) performing a sample matrix tolerance assessment, and / or (iv) performing a free drug tolerance assessment. At each step, the user may evaluate whether to use an acid dissociation protocol as part of the final protocol. Furthermore, the user may evaluate multiple assay plate types at each step of the process (e.g., QUICKPLEX® 96-well STREPTAVIDIN GOLD™ plate vs. QUICKPLEX® 96-well high-binding avidin gold plate). The user may choose to omit one or more of these steps, and the software allows the user to omit one or more steps and / or manually enter parameters / data, such as drug concentration, that would be generated at the omitted step.

[0289] The consumable data for the development pack includes the protocol of the IG optimization workflow and each of the steps or subprotocols to be performed for that consumable. The first step in this embodiment of the IG optimization workflow is ADA selection, in which the system prompts the user to design an experiment on the system that will be used by the system to determine an appropriate ADA as a control for the assay. The user interface prompts the user to enter the following data regarding the anti-drug antibody to be tested: The number of dilutions of each ADA to be tested (either 8 dilutions or 12 dilutions) Number of ADAs to test (2-6 different ADAs per plate depending on the number of dilutions selected) · Name of each ADA to be tested (for tracking purposes) User chooses whether to include the zeroth dilution. Concentration of the dilution to be tested

[0290] The user interface also prompts the user to (i) select the length of incubation (30 minutes to 4 hours on the instrument or a length of time determined by the user off the instrument), (ii) whether to include an acid dissociation step, (iii) add plates of varying types if necessary, and (iv) whether to apply the same reagents to all plates. Experiments can be run on up to five plates. The system runs an ADA selection experiment and displays the results of that experiment in the user interface, allowing the user to select an ADA optimum as the assay control.

[0291] The user interface then prompts the user to perform a second experiment to determine the concentrations of biotinylated and STAG-labeled drugs to use in the assay (the relative affinities of the biotinylated and SULFO-TAG-labeled drugs for ADA may differ). The user interface prompts the user to make the following selections for this optimization experiment: Enter the following data for the detected species being tested: Number of detection species dilutions (4 concentrations of biotinylated drug and 4 concentrations of STAG-labeled drug per plate) Dilution factor for each detected species User selects whether to include the zeroth dilution. Enter the following data for the ADA to be tested: Number of ADA dilutions (up to a maximum of 3 dilutions per plate) ADA dilution concentration Select the length of incubation (30 minutes to 4 hours on the instrument or a length of time determined by the user away from the instrument). ·Choose whether to include an acid dissociation step. Add variable type plates. · Choose whether to apply the same reagent (i.e., the same reagent source) to all plates.

[0292] Experiments can be performed on up to five plates. The system then performs the drug concentration optimization experiment and displays the results of the experiment in the user interface.

[0293] The user interface then prompts the user to perform a third experiment to determine a minimum dilution ratio (MDR) for each sample matrix that will allow the user to evaluate the signal produced by the assay in the presence of different sample matrix concentrations. The user interface prompts the user to make the following selections for the MDR optimization experiment: Enter the following data for the ADA sample to be tested: Number of ADA dilutions to test (either 8 or 12 dilutions per plate) ADA dilution concentration User selects whether to include the zeroth dilution. Enter the following data for the sample matrix to be tested: Number of matrix dilutions (2-6 dilutions per plate depending on the number of ADA dilutions being tested) Dilution factor for each dilution User selects whether to include the zeroth dilution. Users can use different sample matrices on each plate (e.g., serum, citrate plasma, EDTA plasma, etc.). Select the length of incubation (30 minutes to 4 hours on the instrument or a length of time determined by the user away from the instrument). ·Choose whether to include an acid dissociation step. · Add plates of varying types, assuming the run has enough capacity. · Choose whether to apply the same reagent (i.e., the same reagent source) to all plates.

[0294] Experiments can be performed on up to five plates. The system then performs the MDR optimization experiment and displays the results of the experiment in the user interface.

[0295] Finally, the user interface prompts the user to perform a fourth free drug tolerance evaluation experiment to determine the effect of free drug on the assay and whether the use of acid dissociation is necessary to improve the free drug tolerance of the assay. For free drug tolerance evaluation, the user has the option to run the protocol with or without acid dissociation, and / or perform a comparison of untreated and acid-treated plates. The user interface prompts the user to make the following selections for the free drug tolerance evaluation experiment: Enter the following data for the ADA sample to be tested: Number of ADA dilutions to test (either 8 or 12 dilutions per plate) ADA dilution concentration User selects whether to include the zeroth dilution. Enter the following data for the free drug being tested: Number of free drug dilutions (2-6 dilutions per plate depending on the number of ADA dilutions being tested) Dilution factor for each dilution User selects whether to include the zeroth dilution. Select the length of incubation (30 minutes to 4 hours on the instrument or a length of time determined by the user away from the instrument). · Choose whether to use an acid dissociation step and / or perform a comparison of acid-treated and untreated plates. · Add plates of varying types, assuming the run has enough capacity. · Choose whether to apply the same reagent (i.e., the same reagent source) to all plates.

[0296] Experiments can be performed on up to five plates. The system then performs the free drug tolerance evaluation experiment and displays the results of the experiment in the user interface.

[0297] The immunogenicity (IG) assay, when automated for execution in an assay system such as assay system (1000) or (900), may comprise the following steps. Automated Assay Sequencing 1 Check plate inventory 2 Prepare the washer 3. Creating Drug Mixtures 4. Applying the drug mixture to the sample incubation 5. Apply dilutions to dilution plate(s) 6. Generating a Standard Curve 7. Make control dilutions 8. Making sample dilutions 9. Applying blocking agents to MSD plates 10. Perform Blocking Incubation 11 Apply dilutions to sample incubation plate 12 Perform sample incubation 13 Wash the MSD test plate 14 Apply the incubated sample to the MSD test plate 15. Perform MSD Test Plate Incubation 16. Apply read buffer to plate 17 Read the plate with an ECL reader 18. Tidy up the process

[0298] (ii) Preparation, optimization, and execution of pharmacokinetic assays Pharmacokinetics is the study of the time course of drug absorption, distribution, metabolism, and excretion. Pharmacokinetic (PK) assays are used to measure drug concentrations in samples from the same patient over time. These assays can be direct or indirect immunoassays, and they are preferably optimized before laboratory implementation. A standard PK assay performed on Meso Scale Discovery's MULTI-SPOT® or MUlTI-ARRAY® platforms is shown in Figure 17(a). First, an MSD plate is coated with a capture species. The capture species is immobilized on the MSD plate and can be an antibody, protein, antigen, carbohydrate, lysate, etc. The detection species and analyte are applied to the coated MSD test plate. The detection species can include a STAG-labeled antibody per se (direct format), a STAG-labeled streptavidin and biotinylated detection antibody (indirect format), a STAG-labeled anti-species antibody, and an unlabeled detection antibody (indirect format), etc. The detection species can be premixed with the sample, or the detection species can be applied directly to the test plate. A block diagram of the implementation of a direct PK assay and two different types of indirect PK assays is shown in Figure 17(b) (panels (i)-(ii), respectively). i)) is shown.

[0299] Figure 17(d) shows the general protocol sequence for custom sandwich immunoassays, Figures 17(e)-17(h) show the labeled protocols and reagents, and Figure 17(i) shows the deck layout for these assays.

[0300] Standard PK protocols include multiple parameters that can be optimized, including but not limited to: Incubation duration (1 hour to overnight) Plate type The type and / or concentration of trapped species Type and / or concentration of blocking solution Concentration of unlabeled / biotinylated detection species (indirect assays only) Concentration of STAG-labeled detected species Evaluating assay sensitivity by varying the known concentration of drug in the sample

[0301] To optimize a PK assay with the assay system shown in FIG. 10 and its subsections, the user is provided with a system development pack that includes a sample dilution plate (1.1 mL), a plate lid, reagent tubes, and a kit set that may include the following components: [Table 6]

[0302] Each component in the development pack, as well as the development pack itself, contains a consumable identifier (e.g., barcode) with consumable data associated with the consumable identifier. A system barcode reader reads the consumable identifier (e.g., barcode) and downloads and installs the DDB stored in that consumable identifier (e.g., barcode). The DDB contains a DDB unique identifier, DDB version, DDB xml file, consumable static information, consumable The consumable processing information may include, for example, the number of columns of wells, the number of rows of wells, the number of binding domains per well, and combinations thereof, and the consumable processing information may include data used by the assay system in performing an assay using the plate and / or processing of assay data resulting from performing an assay using the plate. In specific embodiments, the consumable processing information may include the number of sectors per plate, the number of circuits per plate, detection parameters used by the assay system to read the plate, image processing characteristics used to generate ECL results, plate type gain, binding domain gain, optical crosstalk matrix, and combinations thereof.

[0303] The system barcode reader reads the consumable identifier (e.g., barcode) and downloads the appropriate protocol and optimization parameters for the PK assay. A specific embodiment of the PK optimization workflow is shown in Figure 17(c) and includes the following steps: (i) optimizing the plate coating process, (ii) optimizing the blocker type and / or concentration, (iii) optimizing the detection species concentration, and / or (iv) evaluating the assay sensitivity. The user may choose to omit one or more of these steps, and the software allows the user to omit one or more steps and / or manually enter the parameters / data that would be generated in the omitted steps.

[0304] A suggested sequence of assay optimization experiments for the indirect assay is as follows: Step 1: Optimize the type and / or concentration of capture species Step 2: Optimize the type and / or concentration of blocker Step 3A: Optimize the concentrations of biotinylated / unlabeled and Sulfo-TAG labeled detection species Step 4: Test for drug sensitivity

[0305] A suggested sequence of assay optimization experiments for the direct assay is as follows. Step 1: Optimize the type and / or concentration of capture species Step 2: Optimize the type and / or concentration of blocker Step 3B: Optimize the concentration of the Sulfo-TAG labeled detection species Step 4: Test for drug sensitivity

[0306] To optimize the acquisition process, the software prompts the user to enter the following data in preparation for the experiment: The user enters the following data about the sample to be tested: Number of sample dilutions (either 8 or 12 dilutions per plate) Sample dilution factor User selects whether to include the zeroth dilution. The user enters the following data for the capture species being tested: Type of capture species and / or number of dilutions (up to a maximum of 6 per plate, depending on the number of sample dilutions being tested) Dilution factors for each type of capture species (if multiple dilutions per type are used) User selects whether to include the zeroth dilution. The user selects the length of incubation (1 hour to 4 hours on the instrument or a length of time determined by the user away from the instrument). · The user adds plates of varying types, assuming the run has sufficient capacity. · The user chooses whether or not to apply the same reagent (i.e., the same reagent source) to all plates.

[0307] Experiments can be performed on up to five plates. The system then performs the experiment and displays the results of the experiment in the user interface.

[0308] To optimize the blocking process, the software prompts the user to enter the following data in preparation for the experiment: The user enters the following data about the sample to be tested: Number of sample dilutions (either 8 or 12 dilutions per plate) Sample dilution factor User selects whether to include the zeroth dilution. The user enters the following data regarding the blocker to be tested: Blocker type and / or number of dilutions (up to a maximum of 6 per plate depending on the number of sample dilutions being tested) Dilution factors for each type of blocker (if multiple dilutions per type are used) The user selects the length of incubation (1 hour to 4 hours on the instrument or a length of time determined by the user away from the instrument). · The user adds plates of varying types, assuming the run has sufficient capacity. · The user chooses whether or not to apply the same reagent (i.e., the same reagent source) to all plates.

[0309] Experiments can be performed on up to five plates. The system then performs the experiment and displays the results of the experiment in the user interface.

[0310] To optimize the detection species concentration for the indirect assay, the software prompts the user to enter the following data for the experiment: The user enters the following data about the sample to be tested: Number of sample dilutions (either 8 or 12 dilutions per plate) Sample dilution factor The user enters the following data for the detected species being tested: Number of detection species and / or dilutions (4 concentrations of unlabeled / biotinylated detection species and 4 concentrations of STAG-labeled detection species per plate) Dilution factor for each type of detected species User selects whether to include the zeroth dilution The user selects the length of incubation (1 hour to 4 hours on the instrument or a length of time determined by the user away from the instrument). · The user adds plates of varying types, assuming the run has sufficient capacity. · The user chooses whether or not to apply the same reagent (i.e., the same reagent source) to all plates.

[0311] Experiments can be performed on up to five plates. The system then performs the experiment and displays the results of the experiment in the user interface.

[0312] To optimize the detection species concentration for the direct assay, the software prompts the user to enter the following data for the experiment: The user enters the following data about the sample to be tested: Number of sample dilutions (either 8 or 12 dilutions per plate) Sample dilution factor The user enters the following data for the detected species being tested: Number of STAG detection species and / or dilutions (up to a maximum of 6 per plate, depending on the number of sample dilutions being tested) Dilution factor for STAG detection species User selects whether to include the zeroth dilution The user selects the length of incubation (1 hour to 4 hours on the instrument or a length of time determined by the user away from the instrument). · The user adds plates of varying types, assuming the run has sufficient capacity. · The user chooses whether or not to apply the same reagent (i.e., the same reagent source) to all plates.

[0313] Experiments can be performed on up to five plates. The system then performs the experiment and displays the results of the experiment in the user interface.

[0314] Finally, to assess assay sensitivity, the software prompts the user to enter the following data for the experiment: The user enters the following data about the sample to be tested: Number of sample dilutions (up to 12 dilutions per plate) Sample dilution factor User selects whether to include the zeroth dilution. The user selects the length of incubation (1 hour to 4 hours on the instrument or a length of time determined by the user away from the instrument). · The user adds plates of varying types, assuming the run has sufficient capacity. · The user chooses whether or not to apply the same reagent (i.e., the same reagent source) to all plates.

[0315] Experiments can be performed on up to five plates. The system then performs the experiment and displays the results of the experiment in the user interface.

[0316] A pharmacokinetic (PK) assay, when automated to run on an assay system such as assay system (1000) or (900), may comprise the following steps: Automated Assay Sequencing 1 Check plate inventory 2 Prepare the washer 3 Apply dilutions to dilution plate(s) 4. Generating a Standard Curve 5. Making Control Dilutions 6. Prepare sample dilutions 7. Applying blocking agents to MSD plates 8. Perform the blocking incubation 9 Wash the MSD assay plate 10. Creating the Coating Solution 11 Apply coating solution to MSD plate 12. Perform the coating incubation 13 Apply dilutions to MSD assay plates 14 Perform sample incubation 15. Prepare the detection solution 16. Make the secondary detection solution 17 Apply secondary detection solution to the MSD plate 18. Perform the Secondary Detection Incubation 19 Apply detection solution to the MSD plate 20. Perform the Detection Incubation 21 Apply read buffer to plate 22 Read the plate with an ECL reader 23. Clean up the process

[0317] E. Consumables Holders and Kits The features of the assay system (1000) enable the system to perform a large number of assays. These features give users the ability to simultaneously order all necessary reagents in a specialized assay reagent holder or all necessary consumables in a kit to perform a particular assay. Such assay reagent holders and kits are available from Meso Scale Diagnostics of Rockville, Maryland. Exemplary assay reagent holders include, but are not limited to, assay reagent holders (e.g., custom racks for MSD-equipped reagents). Kits specialized for use with the disclosed instruments, systems, and methods include assay reagent holders and other consumables, such as troughs, tubes, and assay plates (e.g., multi-well assay plates). A V-PLEX kit is described below. However, suitable kits may include kits for any assay, including X-PLEX, U-PLEX, S-PLEX, pharmacokinetic (PK), immunogenicity (IG), and custom.

[0318] MSD kits, such as the V-PLEX Plus kit, require the packaging and shipping of lyophilized calibrators and controls in glass vials and detection reagents in plastic tubes. These items are typically inserted into foam inserts packaged in cardboard shipping boxes. The contents of a V-PLEX kit are shown in Figure 18(a). Ten plastic tubes containing different detection reagents are typically included with each V-PLEX kit. The number of plastic tubes the user must manage is tripled for the U-PLEX kit; up to 30 vials containing linker, capture, and detection reagents may be required to run a fully populated 10-spot plate. The potential for confusion with such a large number of tubes can be considerable. Therefore, there is a need for positive identification of each tube and its contents. Equally important is the ability to ship and present the tubes in an automated, friendly, and compact format.

[0319] The present invention provides a rack capable of holding a novel, custom industry-standard format (see the American National Standards Institute / Laboratory Automation Screening Association standard for microplates, available at http: / / www.slas.org / default / assets / File / ANSI SLAS_1-2004_FootprintDimensions.pdf, which is incorporated herein by reference in its entirety), control and calibrator vials, and plastic tubes containing reagents, as well as methods for using or operating such a rack. The rack (1200) is sized and dimensioned to conform to the ANSI-SLAS standard for microplates. The rack (1200) has a body or frame (1201) designed with a plurality of hollow columns (1203) adapted to receive vials (1206) and tubes (1208). Each hollow column (1203) has an opening (1204) at the bottom below each vial (1206) and tube (1208). The hollow column (1203) and opening (1204) may have different sizes or diameters as shown in Figures 18(b)-18(c) to accommodate vials, tubes made of different sizes as well as other liquid containers, and the opening (1204) may be covered with a transparent or translucent cover or left uncovered. The vials and tubes have an identifying barcode on the bottom, and the opening (1204) is one-dimensional, as best shown in Figure 18(d). The rack 1200 may have a unique consumable identifier (e.g., barcode) affixed to any surface thereof, including the bottom, top, or one or more sides. A barcode reader 1209 with its field of view (FOV) facing upward can scan these consumable identifiers (e.g., barcodes). These openings provide viewing access for such a two-dimensional barcode reader, allowing the rack 1200 and its contents 1206, 1208 to be placed directly on top of the barcode reader's 1209 platen and read without the need to manipulate each tube or vial to be read, as shown in FIG. 18(e). The rack 1200 may have a unique consumable identifier (e.g., barcode) affixed to any surface thereof, including the bottom, top, or one or more sides.

[0320] The rack is designed to be graspable by a robotic gripper for compatibility with automated plate handling systems, such as the gripper pads 1031 of the robotic subsystem 1002 shown in Figures 10(a)-10(c). As best shown in Figure 18(f), the rack 1200 has rungs 1202 similar to the rungs 1044 on the instructor or training plate 1035. The rungs 1202 are sized and dimensioned to be grasped, lifted, and moved by the gripper pads 1031 within the enclosure of the assay system 1000.

[0321] Rack 1200 also includes snap-on inserts 1212 for compatibility with different types or sizes of tubes and vials, as shown in Figures 18(g)-18(j). Inserts 1212 have a generally cylindrical shape and include top and bottom openings 1214 and 1216 adapted to receive tubes or vials. Bottom opening 1216 abuts against bottom rim 1218 of opening 1204 to retain insert 1212 within hollow column 1203. Bottom opening 1216 also includes a rim to prevent tubes or vials from being pushed out from within the bottom of rack 1200, as best shown in Figure 18(i). Additionally, insert 1212 has a plurality of snaps 1220 for engaging with bottom rim 1218 of opening 1204 and external ribs 1222 for providing structural support to the insert.

[0322] The consumable identifier (e.g., barcode) can be printed or affixed to the tube or vial if the base is relatively flat. For tubes or vials with hollow rimmed bases, such as those shown in Figures 18(h) and 18(i), the consumable identifier (e.g., barcode) can be printed or affixed to a solid plug or puck sized and dimensioned to fit within the rimmed bases of these tubes or vials. Alternatively, the consumable identifier (e.g., barcode) can be printed on a membrane, such as gold foil or polymer membrane, that is attached to the rimmed base, for example by induction sealing.

[0323] In addition to the consumable identifier (e.g., a barcode) on the bottom of ...

Claims

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

2. 10. The assay consumable storage unit of claim 1, wherein the shelf assembly comprises an MxN linear array of vertically aligned sets of storage units, where M and N are integers.

3. 10. The assay consumable storage unit of claim 1, wherein the upper horizontal member comprises alignment features for container bottoms that conform to ANSI SLAS.

4. 4. The assay consumable storage unit of claim 1, wherein the upper horizontal member comprises alignment features for lids of assay reagent holders that are larger than the container bases according to ANSI SLAS.

5. The assay consumable storage unit is a single, integrated unit. The assay consumables storage unit according to any one of claims 1 to 4.

6. Each storage unit at the top of the shelf assembly includes a raised corner sized and dimensioned to hold a reagent lid or equipped rack. The assay consumables storage unit according to any one of claims 1 to 5.

7. The assay consumable storage unit includes alignment pins located away from the X and / or Y centerlines to minimize incorrect alignment of the base and shelf assembly. The assay consumables storage unit according to any one of claims 1 to 6.

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