Automated analysis system and method for implementing analysis in system

Abstract

The present invention relates to methods, devices, and systems for correlating consumable data with analytical consumables for use in biological analysis. An analysis system and related consumables are provided, wherein the analysis system adjusts one or more steps of an analysis protocol based on consumable data, in particular for the consumables. Various types of consumable data are described, as well as methods of performing analyses by an analysis system using the data. The invention also relates to consumables (e.g., kits and reagent containers), software, data deployment packages, computer readable media, carts, instruments, systems, and methods for performing automated biological analyses.

Description

[0001] This application is a divisional application of a PCT international patent application with application number 202110512717.4, filing date of July 22, 2016, and invention title of "Automated Analysis System and Method of Conducting Analysis in Such System".

[0002] Cross - reference to related applications

[0003] This application claims priority to a U.S. Provisional Patent Application filed on July 23, 2015, with application number 62 / 195,956 and title "Integrated Consumable Data Management System and Platform".

[0004] Also cited are co - pending U.S. application number 12 / 844,345 (filed on July 27, 2010), U.S. Provisional Application numbers 61 / 400,441 (filed on July 27, 2010) and 61 / 462,024 (filed on January 27, 2011). Also cited is U.S. application number 13 / 191,000 (now U.S. Patent No. 8,770,471) filed on July 26, 2011 and U.S. application number 14 / 719,818 filed on May 22, 2015. The entire content of each of these applications is incorporated herein by reference. Field of the Invention

[0005] The teachings of the present invention relate to methods, devices, and systems for correlating consumable data with analytical consumables used in bioanalysis. It also relates to consumables (e.g., kits and reagent containers), software, data deployment packages, computer - readable media, loading carts, instruments, systems, and methods for performing automated bioanalysis. Background of the Invention

[0007] A variety of methods and systems have been developed for conducting analyses. These methods and systems are required in a variety of applications, including medical diagnosis, 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 for bioanalysis, the reagents and consumables are typically coded and labeled by the manufacturer for tracking purposes. Additionally, multiple analytical parameters must be tracked in order to understand the analytical results of any given analysis, typically requiring the input of multiple parallel tracking systems supplied by the manufacturer, the consumer, or both.

[0008] The automation of immunoassays presents a series of challenges. Repeatability and / or reproducibility remain the goal of all automated analysis systems. Summary of the Invention

[0010] One aspect of the present invention is an automated analysis system for performing bioassays, such as immunoassays and more particularly electrochemiluminescence (ECL) immunoassays. The automated analysis system of the present invention is capable of performing assay runs with reproducible results. Variables that have been identified and minimized in the preparation for assay runs (e.g., sample or calibrator dilution), the loading of assay consumables onto the instrument, and the potential human or machine errors that can occur during assay runs. Other aspects include consumables, instruments, loading carts, software, data deployment packages, computer-readable media, and methods for performing bioassays.

[0011] Variables that have been minimized in different aspects of the present invention include one or more of the following. Variations in sample concentration between the wells in a porous assay tray due to evaporation of the liquid during incubation are minimized. The positions and orientations of the clamping pads and pipettes of a robotic system for a particular assay system are trained by a precision training plate. A heat exchanger is provided to maintain a selected operating temperature in the assay system. The same assay runs are generally completed within a predictable period to ensure reproducibility. Consumables for a specific assay are provided in a kit to ensure that the appropriate consumables and their amounts are available for the assay run. The loading of consumables into the assay system is standardized to minimize errors. Dedicated assay consumable storage units (e.g., microplate stackers, plate carriers, spare pipette tip container carriers, trough carriers) on the assay instrument minimize loading and assay execution errors. For example, due to user safety, ergonomics, or consumable disposal considerations, the configuration and position of the microplate stacker minimize loading errors. The user interface guides the user through the selection of the assay protocol for the loading and running of the consumables. A loading cart is provided to act as an intermediate consumable loading station to assist the user in properly loading the consumables into the assay system. The operation and performance verification of the assay system of the present invention have been automated and a verification kit is provided to ensure that the verification is properly performed and reproducible. Automated assay steps are performed with tight timing tolerances to ensure between-run and between-plate reproducibility. A dedicated plate reader is configured to read assay plates in a sequence that minimizes the timing differences between the addition of the read buffer to the time of reading the signal from one well and another well even within a single plate. Multiple background signal noises in the ECL reader are measured and deviated from the actual ECL readings. The dispensing and / or aspiration capabilities of the pipettes and plate washers are calibrated.

[0012] Other improvements include, but are not limited to, a software architecture that minimizes re-verification of a software system when the software system receives a software update, and the establishment of a general protocol applicable to multiple assays paired with instrument parameter files unique to a particular assay, where the particular assay turns on or off specific components of the general protocol to customize the protocol for the particular assay. A dedicated lid is provided to minimize reagent loss from the container due to evaporation while maintaining the ability of the pipette to access the reagent.

[0013] One embodiment of the invention is an assay system configured to use assay consumables in the performance of an assay, the assay consumables including an assay consumable identifier that includes an assay consumable data deployment package (DDB) containing data for the assay consumable, and the assay system including:

[0014] (a) A storage medium that includes a consumable data repository and a data register containing local consumable data;

[0015] (b) A consumable identifier controller adapted to read and install the DDB onto the storage medium; and

[0016] (c) A consumable data service processor adapted to query the data register and one or more databases of remote consumable data to identify and download consumable data required for the performance of the assay by the assay system using the assay consumable.

[0017] Another embodiment of the invention is a data deployment package (DDB) that includes one or more data files containing consumable data related to an assay consumable and its use in an assay system, the one or more data files including a DDB unique identifier, a DDB version, a DDB xml file, consumable static information, consumable processing information, and combinations thereof.

[0018] 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, where the assay system is configured to use assay consumables in the performance of the assay, the assay consumables including an assay consumable identifier including the DDB described herein, and the assay system including:

[0019] (a) A storage medium that includes a consumable data repository and a data register containing local consumable data;

[0020] (b) A consumable identifier controller adapted to read and install the DDB onto the storage medium; and

[0021] (c) A consumable data service processor, adapted to query the data register and databases of one or more remote consumable data, so as to identify and download the consumable data required for the implementation of the analysis by an analysis system using the analyzed consumables;

[0022] The method includes the following steps:

[0023] (a) Read the DDB from the consumable identifier;

[0024] (b) Store the DDB in the consumable data repository;

[0025] (c) Identify consumable data from the consumable data repository and optionally download consumable data from databases of one or more remote consumable data;

[0026] (d) Adjust one or more operations performed by the system before, during, and / or after implementing the analysis based on the consumable data; and

[0027] (e) Implement the analysis using the analyzed consumables in the analysis system.

[0028] Another embodiment relates to a holder for analyzing reagents, which includes 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 observe at least one or two consumable identifiers located on the bottom of the reagent containers. The regions can be at least two different sizes to receive at least two analysis containers of different sizes. The regions and the holes or windows can be circular and the diameter of the holes or windows can be smaller than the regions, or the regions and the holes or windows can be linear and the diameter of the holes or windows can be smaller than the regions.

[0029] The holder can include a frame, at least one optional insert, and at least one optional mask. The mask can be attached to the top of the frame, and the insert can be positioned within the frame and below the mask. Two regions of the holder can include cylindrical holes in the frame or the optional insert or both. The at least two regions can include holes in the mask. The at least two holes can be holes coated with transparent plastic in the frame.

[0030] The footprint size of the container preferably conforms to the ANSI - SLAS size of a microplate. The height of the container can also conform to the ANSI - SLAS height of a microplate.

[0031] In one embodiment, the insert is a foam and is inserted into at least two cylindrical holes of the frame to fill the at least two reagent containers. The insert may be positioned between the reagent container and an area larger than the reagent container. The insert may define the cylindrical holes of the analytical reagent container and fill the frame.

[0032] The mask may define a plurality of regions, where the number of mask regions may be equal to or less than the number of regions in the container, frame, or insert and the mask may limit the number of analytical containers received by the analytical reagent container. Preferably, the mask includes a label regarding the reagent.

[0033] The holder may have an analytical consumable identifier attached thereto. The analytical consumable identifier is located on the bottom, side, or top of the container. The holder may also include at least one reagent container. The reagent container contains an analytical reagent. The analytical reagent may be a reagent for V-PLEX, U-PLEX, immunogenicity (IG), pharmacokinetics (PK), or a custom assay. The label may define the analytical reagent for V-PLEX, U-PLEX, immunogenicity (IG), pharmacokinetics (PK), or a custom assay.

[0034] The analytical reagent container or the frame may be made of a conductive plastic. The holder may have a lid. The lid may be fully or mostly transparent. The analytical container may include an analytical consumable identifier on its bottom, observable from the bottom of the container. The region is configured to receive at least one tube and at least one vial.

[0035] The holder may have (a) a frame having a bottom and sides, the bottom being generally rectangular in shape and having dimensions conforming to ANSI-SLAS standards, and defining the holder hole or window, (b) an insert fitting within the frame, having insert holes sized to hold a tube or vial and arranged to align the tube or vial with the holder hole or window, (c) a mask located above the insert, having mask holes matching the insert holes to allow the tube or vial to be inserted into the insert, the mask also providing identification information regarding the tube or vial, and (d) optionally, a lid to enclose the vial within the holder

[0036] The consumable identifier may be a 2-D or 1-D barcode. The 2-D or 1-D barcode may be printed on a plastic carrier inserted into a notch in the bottom of the tube or vial, or on a foil disc heat-sealed against a notch on the bottom of the tube or vial.

[0037] The analysis tube or vial comprises a tube or vial having one or more of the following analysis reagents: (i) calibration material; (ii) control material; (iii) capture reagent; (iv) detection reagent; (v) diluent or (vi) linking reagent.

[0038] The invention also relates to an analysis kit comprising any of the analysis containers as discussed above in a cardboard container. Preferably, the kit has an analysis consumable identifier on the cardboard container. The kit may also have at least one analysis consumable plate in the cardboard container. The analysis consumable plate may be a porous analysis plate and may have an analysis consumable identifier. The kit may also have at least one trough or tube or both.

[0039] The invention also relates to a lid configured to cover the top surface of a porous plate, comprising a serrated edge depending on the top portion of the lid, wherein the serrated edge is adapted to fit the outer perimeter of the top surface of the porous plate, wherein the top surface of the plate is sized and dimensioned to contact the outer parameters of the porous plate, and the lid may also have a plurality of micro-recesses extending from the top portion of the lid towards the porous plate. The plurality of micro-recesses may correspond to a plurality of holes in the porous plate and are configured to extend into the plurality of holes. The top surface of the lid is adapted to contact at least one upper lip of the plurality of holes.

[0040] The lid may not be made of an integrated plastic or elastomeric material, or be made of a hard plastic or polystyrene.

[0041] The invention also relates to a lid configured to cover the top surface of a porous plate, comprising a serrated edge depending on the top portion of the lid, wherein the serrated edge is adapted to fit the outer perimeter of the top surface of the porous plate, wherein the top surface of the plate is sized and dimensioned to contact the outer parameters of the porous plate. The lid is optionally hydrophobic. The lid may be made of a hydrophobic polymer, or the bottom surface of the top portion of the lid may be made hydrophobic. The bottom surface may be micro-etched to create a rough surface to trap air such that the bottom surface exhibits Cassie - Baxter behavior as a barrier against moisture.

[0042] Alternatively, the bottom surface may be coated with a hydrophobic coating or surfactant. The lid may also have a plurality of micro-recesses extending from the top portion of the lid towards the porous plate. The plurality of micro-recesses may correspond to a plurality of holes in the porous plate, and the plurality of micro-recesses are configured to extend into the plurality of holes.

[0043] The present invention also relates to a lid configured to attach to a reagent container and adapted to allow a probe to enter and exit, which includes a top surface, wherein the top surface includes a profile pattern that separates the top surface into sections, wherein when the probe enters the reagent container, the sections bend downward and when the probe exits, the sections generally resume their original orientation. The probe can be at least one pipette tip.

[0044] The profile pattern can include at least one curve, at least one serpentine line, at least one generally circular line, or parallel straight lines. The lid can be made of a non - elastomeric material or an elastomeric material. The lid can be used to cover a reagent trough.

[0045] The present invention also relates to a loading cart adapted to be used with an analysis system, the loading cart including a computer screen and a mobile body including at least one shelf and support for the computer screen, wherein the shelf includes at least one tray, wherein a plurality of slots are defined in the tray and wherein the slots are sized and dimensioned to receive a variety of consumables to perform an analysis. The computer screen is adapted to display a user interface that shows a first arrangement of a plurality of consumable containers on the at least one tray.

[0046] The computer screen can be the screen of a tablet computer or connected to a personal computer or a laptop computer. The computer screen can be controlled by a processor on an analyzer. The computer screen can be connected to the processor on the analyzer via a WiFi or Bluetooth connection.

[0047] The plurality of slots on the loading cart can be defined on the top surface or both surfaces of the at least one tray (i.e., the tray is reversible). The slots can be slots of different sizes, which are adapted to receive a variety of consumables of different sizes.

[0048] The support for the computer screen can be an adjustable support. The adjustable support can generally rotate about a vertical axis and / or can tilt about an axis generally orthogonal to the vertical axis. The at least one shelf is a top shelf. The cart can also have a bottom shelf and / or a middle shelf. The cart can have a compartment below the at least one tray or the top tray and the compartment is adapted to store coolant. The compartment can also have a drain port, and the bottom surface of the compartment can be concave. The mobile body of the cart should be supported by at least one caster, and the caster can be a hubless caster.

[0049] The loading vehicle can accommodate a variety of consumables, such as at least one porous plate, and the at least one porous plate can include at least one analysis plate or at least one dilution plate. The variety of consumables can include at least one container for reagents. The variety of consumables can include at least one tube or at least one trough. An example of the tray is illustrated in FIG. 19.

[0050] The present invention also relates to an analytical preparation system for preparing an analytical component, the preparation system comprising:

[0051] (a) An analytical system having a processor, the processor containing information about the components required for performing an analytical run;

[0052] (b) A loading vehicle, which includes a shelf for assembling the components to be used in the analysis and a support for holding a mobile computing device;

[0053] (c) A mobile computing device, which includes a computer screen;

[0054] wherein the mobile computing device includes networking capabilities to access the information on the processor, and a graphical user interface to provide the information to the user on the computer screen and to direct the placement of the analytical components on the loading vehicle.

[0055] The loading vehicle can be the loading vehicle described above. The loading vehicle can also include a consumable identifier reader, and the graphical user interface is configured to accept the identifier information provided by the user using the reader when placing the analytical components on the vehicle and to use the information to confirm the validity of the components and transfer the identification information to the processor.

[0056] The present invention also relates to a method of instructing a user to load consumables onto an analytical system, which includes using the loading vehicle discussed above. The method can include arranging a variety of consumables on the loading station according to a first arrangement displayed by a user interface on a screen.

[0057] The present invention further relates to a method of loading consumables into an analytical system for performing an analysis, the method comprising the steps of:

[0058] a. Receiving a variety of consumables,

[0059] b. Arranging the variety of consumables on an intermediate consumable loading station according to a first arrangement displayed by a user interface on a screen located on the intermediate consumable loading station,

[0060] c. Moving the intermediate consumable loading station to the analytical system,

[0061] d. Transfer the plurality of consumables to the analysis system according to a second arrangement, wherein the first arrangement is substantially the same as the second arrangement.

[0062] Preferably, the intermediate consumable loading station includes a mobile cart and the screen is a computer screen. The computer screen is movably attached to the cart, or is rotatable about a vertical axis and / or tiltable relative to the vertical axis. This method may also include the step of cooling at least one of the plurality of consumables. Step (b) may include depositing the plurality of consumables into a plurality of slots defined on the top surface of the mobile cart. The plurality of consumables may include at least one porous plate or at least one container of a reagent.

[0063] The present invention also relates to a plate sized and dimensioned to the size and dimensions of an ANSI - SLAS format assay plate and including an outer rectangular perimeter and at least one support member connecting a first side of the rectangular perimeter to a second side of the perimeter, wherein at least one reference pad is located on a first major surface of the plate and corresponds to the position of at least one well in the ANSI - SLAS format assay plate, wherein when the plate is positioned in a plate carrier in the analysis system, the position of the at least one reference pad in one dimension of a three - dimensional coordinate system can be measured by a probe of the analysis system.

[0064] The probe can measure the capacitance between the probe and the at least one reference pad. The plate is preferably conductive. The ANSI - SLAS format assay plate is an 8×12 well plate and the at least one reference pad corresponds to the corner wells on the ANSI - SLAS format assay plate.

[0065] The plate may also have at least two opposing clamping regions located on a side connecting two major surfaces of the plate, wherein the clamping regions are adapted to be clamped by a clamping arm of a robotic system. The outer rectangular perimeter closest to the first major surface is smaller than the outer rectangular perimeter closest to the second major surface, wherein the first and second major surfaces are substantially parallel.

[0066] The plate is preferably made of cast aluminum and / or machined from cast aluminum.

[0067] On the other hand, it relates to a plate for teaching or training an automated instrument, sized and dimensioned to the size and dimensions of an ANSI - SLAS format assay plate and including an outer rectangular perimeter and at least one support member connecting a first side of the rectangular perimeter to a second side of the perimeter, wherein at least one reference pad is located on a first major surface of the plate and corresponds to the position of at least one well in the ANSI - SLAS format assay plate,

[0068] Wherein when the plate is positioned in a plate holder in an analysis system, the position of the at least one reference pad in one dimension of a three-dimensional coordinate system can be measured by a probe of the analysis system.

[0069] On the other hand, there is provided a method of training or teaching a robotic gripper or pipette, the method comprising using the plate as described above.

[0070] One aspect of the present invention also relates to an analysis consumable storage unit adapted to be attached to a platform in an analysis system, comprising a bottom base and a shelving assembly having a plurality of sets of vertically arranged storage units, wherein each storage unit is sized and dimensioned to receive a consumable for performing an analysis by the analysis system,

[0071] wherein the shelving assembly comprises a plurality of horizontal members connected by a plurality of upright vertical supports,

[0072] wherein the bottom base is attached to the platform in a cantilever manner and the shelving assembly is movably attached to the bottom base by at least two locating pins and by at least one threaded connector having a finger-actuable head.

[0073] On the other hand, there is provided an analysis system. The analysis system includes an analysis system configured to use an analysis consumable in the performance of an analysis, the analysis consumable including an analysis consumable identifier associated with a data deployment package (DDB) for the analysis consumable, and the analysis system includes:

[0074] (a) a storage medium including a consumable data repository and a data register containing local consumable data;

[0075] (b) a consumable identifier controller adapted to read and install the DDB to the storage medium; and

[0076] (c) a consumable data service processor adapted to query the data register and at least one remote consumable data database to identify and download consumable data required for the performance of an analysis by the analysis system using the analysis consumable.

[0077] An additional analysis includes an analysis system including a housing, wherein the housing includes a continuous glass member, wherein a touch screen for a computer screen is formed by a first portion of the continuous glass member and an array of pressure transducers, and wherein a sound emitter is formed by a second portion of the continuous glass member and at least one acoustic exciter.

[0078] Other analyses include automated analysis systems adapted to receive consumables in the implementation of the analysis, the analysis system including a robot-controlled pipette and a robot-controlled clamping arm, an analysis reader, a plate washer, and at least one optionally heatable oscillator, at least one heat exchanger, and at least one processor, the processor being adapted to execute at least one instruction to minimize potential errors during the loading of the consumables and during the running of the analysis.

[0079] wherein the consumables include at least one analysis 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 calibrant, a diluent, and an antibody.

[0080] wherein the at least one instruction includes at least one of the following:

[0081] Instructions for the user interface to guide the user to load the consumables into the analysis system.

[0082] Instructions for the robot clamping arm to place a lid on the at least one analysis test plate when the at least one analysis test plate is placed on the oscillator.

[0083] Instructions for at least one heat exchanger to maintain a selected temperature within the analysis system, and

[0084] Instructions to run an analysis on at least one analysis test plate, wherein the at least one analysis plate includes a plurality of analysis test plates, and wherein each analysis test plate is completed within a generally same period of time.

[0085] On the other hand, it relates to a method for operating an automated analysis system to minimize potential errors during loading of consumables for analysis and during running of the analysis.

[0086] wherein the analysis system includes a robot-controlled pipette and a robot-controlled clamping arm, an analysis reader, a plate washer, and at least one oscillator and incubator, at least one heat exchanger, and at least one processor.

[0087] wherein the analysis system is adapted to receive consumables, the consumables including at least one analysis 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 calibrant, a control, a diluent, an antibody, a reagent, and a buffer.

[0088] The method includes at least one of the following steps:

[0089] Instructing the user interface to guide the user to load the consumables into the analysis system.

[0090] Instruct a robotic gripper arm to place a lid on at least one assay test plate when the at least one assay test plate is placed on an oscillator and an incubator,

[0091] Instruct at least one heat exchanger to maintain a selected temperature within an assay system, and

[0092] Instruct at least one processor to run an assay on at least one assay test plate, wherein the at least one assay plate comprises a plurality of assay test plates, and wherein each assay test plate is completed within a generally same period of time.

[0093] The present invention also relates to an automated assay system configured to use assay consumables in the performance of an assay, the assay system comprising at least one processor and at least one storage medium,

[0094] wherein the storage medium stores instructions for the processor to perform the assay,

[0095] wherein the instructions are separated into a plurality of components, the plurality of components comprising:

[0096] A safety component,

[0097] A user interface component,

[0098] An instrument control component, and

[0099] A data service component,

[0100] wherein each component operates generally independently of one another and generally without interaction with one another,

[0101] wherein the components are connected to a master coordinator and the master coordinator instructs each component when to operate.

[0102] The present invention further relates to an assay system configured to use assay consumables in the performance of a first assay, wherein the first assay comprises a unique assay identifier, the assay system comprising

[0103] A reader adapted to read the unique assay identifier, and

[0104] A processor that accesses a general protocol file and an instrument parameter file,

[0105] wherein the general protocol file contains a general assay protocol comprising assay steps applicable to a plurality of assays including the first assay,

[0106] wherein the instrument parameter file contains a plurality of flags in an on or off state,

[0107] Wherein, the processor turns on or off the analysis steps in the general analysis scheme according to the flag to implement the first analysis.

[0108] The additional analysis system relates to an automated analysis system configured to minimize variations in users, instruments, and analysis methods, and the system includes at least one of the following:

[0109] Components for minimizing user errors in system loading

[0110] Components for minimizing user errors in selecting an automated workflow

[0111] Components for minimizing sample dilution errors

[0112] Components for minimizing system board handling errors

[0113] Components for minimizing system pipetting errors

[0114] Components for minimizing temperature variations

[0115] Components for minimizing evaporation or condensation in analysis consumables

[0116] Components for controlling the oscillation frequency of at least one oscillator, and

[0117] Components for minimizing the complexity of maintenance procedures.

[0118] On the other hand, the automated analysis system is configured to minimize variations in users, instruments, and analysis methods, and the system includes a robotic clamping arm and a robotic pipettor and also includes software and instrument components for at least one of the following:

[0119] Performing a sample dilution step;

[0120] Selecting and performing the correct analysis workflow for a given analysis;

[0121] Controlling an air cooling and handling system and thereby maintaining a prescribed temperature within a prescribed tolerance in the analysis workflow area of the system;

[0122] Maintaining consistent timing among runs, plates, and wells; and

[0123] Allowing a user to perform different analysis workflows without having to reconfigure or revalidate the workflow software.

[0124] Other aspects include an automated analysis system that includes robotic clamping arms and robotic pipettes and at least the following additional components: (a) a plate carrier, (b) a tip box carrier, (c) five optionally heatable shakers, (d) an air cooling and disposal system, (e) an analytical consumable storage unit for analytical reagents, (f) an analytical consumable storage unit for immediately use tips, (g) an analytical consumable storage unit for stockpiling tips, (h) an analytical consumable storage unit for plates, (i) a location for attaching an analytical consumable storage unit for tubes and slots, and (j) a platform or a table or both; wherein the components (a)-(c) and (e)-(h) are located on the platform or table within the system at substantially the same location relative to each other as shown in FIGS. 10(a), (b), (c), (l), (n) or (o), and wherein component (d) is located on the rear panel of the instrument, substantially as shown in FIGS. 10(l), (m) or (n).

[0125] In another aspect, the present invention relates to an automated analysis system that includes

[0126] (a) A single robot-controlled 8-channel pipette

[0127] (b) A single robot-controlled analytical plate clamping arm

[0128] (c) A single 96-channel analytical plate washer

[0129] (d) A single plate reader

[0130] (e) One or more plate shakers with a total capacity having at least 5 plate oscillation positions

[0131] (f) A processor adapted to perform an analytical process for analyzing a plurality of samples in a 96-well plate, wherein the following actions of the process are performed in each well of the plate

[0132] (i) A blocking step that includes adding a blocking buffer with the pipette, incubating for a blocking period (b), and washing with the plate washer

[0133] (ii) A sample binding step that includes adding one of the samples with the pipette, incubating for a sample incubation period (s) while oscillating on one of the plate oscillation positions, and washing with the plate washer

[0134] (iii) A detection agent binding step that includes adding a detection reagent with the pipette, incubating for a detection agent incubation period (d) while oscillating on one of the plate oscillation positions, and washing with the plate washer

[0135] (iv) Adding a reading buffer with the pipette

[0136] (v) Measure the analysis signal with the reader

[0137] Wherein,

[0138] Up to 5 plates can be processed during operation

[0139] The steps are carried out as shown in Figures 9(d), 12(m)-(p), 12(r)-(s), 13(d)-(f), 14(d), (f)-(l), 15(b), 15(d)-(h), 16(b), 17(b), 17(d)-(h).

[0140] The additional automated analysis system relates to an automated analysis system, which includes

[0141] (a) A processing deck for holding analysis components, which provides a generally rectangular surface with a leading edge, a first side edge, a second side edge and a trailing edge; the deck supports

[0142] (i) An analysis consumable collector plate that is generally centered on the leading edge of the deck with multiple consumable slots and extends a cantilever, the consumable slots being sized to hold consumables that meet the ANSI-SLAS specifications for the width and length of a 96-well analysis plate

[0143] (ii) Multiple pipette tip positions for holding pipette tip containers located on the first side of the deck

[0144] (iii) Multiple plate oscillator positions located along the trailing edge of the deck

[0145] (iv) A set of processing positions located generally at the center of the deck, between the collector plate and an oscillator configured to hold consumables having dimensions compliant with ANSI-SLAS

[0146] (v) A barcode scanner located on the first side of the deck, behind the pipette tip positions, the barcode scanner having a scanning surface large enough to scan the bottom surface of consumables having dimensions compliant with ANSI-SLAS

[0147] (b) A plate washer located below the deck and accessible through a pore in the deck between the pipette position and the analysis plate processing position

[0148] (c) A gantry located above the deck, which movably supports a robotic plate gripper such that the gripper can be moved to access positions (i)-(v) and movably supports a robotic 8-channel pipette such that the pipette can access positions (ii) and (iv)

[0149] (d) An analysis reader adjacent to the first side of the deck, on a platform located at a vertical height lower than the deck, where the highest point on the reader is lower than the lowest point where the robotic gripper can move

[0150] (e) A cover surrounding components (a)-(d), having a temperature controller for maintaining the components under temperature control and having a door that provides user access to the front side of the deck and the consumable manifold located thereon

[0151] On the other hand, it relates to an automated analysis system, which includes

[0152] (a) A single robot-controlled 8-channel pipette

[0153] (b) A single robot-controlled analysis plate clamping arm

[0154] (c) A single 96-channel plate washer

[0155] (d) A single plate reader

[0156] (d) One or more plate shakers with a total capacity having at least 5 plate oscillation positions

[0157] (e) A processor adapted to perform an analysis process for analyzing multiple samples in a 96-well plate, where the following operations are performed in each well of the plate

[0158] (i) A blocking step, which includes adding a blocking buffer with the pipette, incubating for a blocking period (b), and washing with the plate washer

[0159] (ii) A sample binding step, which includes adding one of the samples with the pipette, incubating for a sample incubation period (s) while oscillating on one of the plate oscillation positions, and washing with the plate washer

[0160] (iii) A detection agent binding step, which includes adding a detection reagent with the pipette, incubating for a detection agent incubation period (d) while oscillating on one of the plate oscillation positions, and washing with the plate washer

[0161] (iv) Adding a reading buffer with the pipette

[0162] (v) Measuring an analysis signal with the reader

[0163] Where [[ID=;]]

[0164] Up to 5 plates can be processed during operation. Brief Description of the Drawings

[0166] Figure 1Describe the generation and storage of consumable data and the consumable data provided by consumable manufacturers.

[0167] Figure 2 Describe allocating consumable data to a customer in response to a query for consumable data.

[0168] Figure 3 Describe the use of consumable data for verifying the authorized use of consumables in an analysis system.

[0169] Figure 4 Describe the main repository on the CD server, its contents, and / or the interface with additional vendor catalogs.

[0170] Figures 5(a)-(d) illustrate the analysis reader described herein.

[0171] Figures 6(a)-(c) illustrate several alternative views of the analysis reader described herein.

[0172] Figure 7 Describe additional views of the analysis reader described herein.

[0173] Figure 8 Describe the analysis system described herein.

[0174] Figures 9(a)-(c) illustrate the analysis system and the various subsystems included in the system. Specifically, the system includes a plurality of subsystems positioned on a table or platform, wherein each subsystem is operatively connected to a robotic subsystem configured to move one or more consumables (e.g., a porous assay plate) from one subsystem of the analysis system to another subsystem. Figure 9(d) shows the scheduling of operations implemented in the system during the conduct of an analysis.

[0175] Figures 10(a)-(b) illustrate an embodiment of the analysis system and the various subsystems within the system. The analysis system illustrated in Figures 10(a)-(b) is configured to perform all sample processing steps on a plate and all analysis processing steps required in the conduct of an analysis, and it is also operatively connected to a user interface configured to stepwise display instructions to a user regarding appropriate sample / reagent preparation steps that should be manually performed prior to the system conducting the analysis.

[0176] Figure 10(c) illustrates another iteration of the analysis system shown in Figures 10(a)-(b). Figure 10(d) shows the top surface of the table of the apparatus supporting the analysis system.

[0177] Figures 10(e)-(f) are perspective views of a training plate.

[0178] Figure 10(g) is a perspective view showing a pipette tip entering the lid of a reagent reservoir. Figure 10(h) shows top views of various cross-sectional modes of the lid shown in Figure 10(g).

[0179] Figure 10(i) is a perspective view of the cover and assay plate. Figure 10(j) is a cross-sectional view of the cover and assay plate shown in Figure 10(i). Figure 10(k) is an enlarged portion of Figure 10(j).

[0180] Figure 10(l) is a front view of the analysis system shown in Figures 10(a)-(c) with its internal door closed. Figures 10(m)-(o) illustrate the cooling mode within the analysis system. Figure 10(p) illustrates the cooling mode of the electron hood.

[0181] FIG10( q ) shows an adjustable hinge of the door of the analysis system, which has two degrees of freedom.

[0182] FIG. 10( r ) is a top perspective view of the analytical consumables storage unit.

[0183] Figure 10(s)-(t) show the dimensions of the framework of the analysis system.

[0184] Figure 10(u) shows a top view of the platform.

[0185] Figures 10(v)-(y) show some of the wiring diagrams of the analysis system (1000), wherein Figure 10V-a -, 10V-b, 10V-c and 10V-d are enlarged portions of FIG. 10(v), as shown thereon, wherein Figure 10W-a 、 10W-b , 10W-c, 10W-d, 10W-e, 10W-f, 10W-g and 10W-h are enlarged portions of FIG. 10( w ), as shown thereon, Figure 10X-a 、 10X-b , 10X-c, 10X-d and 10X-e are enlarged portions of FIG. 10( x ), as shown thereon, and wherein Figure 10Y-a 、 10Y-b , 10Y-c and 10Y-d are enlarged portions of FIG. 10( y ), as shown thereon.

[0186] FIG10( z ) is a top view showing the plate bracket ( 1036 ) and the tip bracket ( 1026 ).

[0187] Figure 11(a) illustrates a specific implementation of a data association workflow, which is a process where certain data is associated with a consumable identifier. Figure 11(b) is a diagram showing the interaction between the computer system of the analysis system and the computer system of the customer. Figure 11(c) is a diagram of the components of the computer system of the analysis system. Figure 11(d) is a flowchart of the instrument control part of the software. Figure 11(e) is a diagram showing an embodiment of the software architecture.

[0188] Figures 12(a)-(l) illustrate an embodiment of the software architecture for the deployment and use of a data deployment package (DDB).

[0189] Figures 12(M-a, M-b) illustrate scripts showing exemplary general scenarios. Figures 12(N-a, N-b), Figures 12(O-a, O-b), Figure 12P show the script of Figure 12(m), where selected steps in the scenario are turned off.

[0190] Figures 12(q-a, q-b) show an exemplary instrument parameter file, which shows the on / off status of certain steps in the scenario.

[0191] Figures 12(R-a, R-b) are another embodiment of the general scenario. Figures 12(S-a, S-b) are the general script, where certain steps are turned off.

[0192] Figures 13(a)-(c), Figures 13(D-a, D-b), Figures 13(E-a, E-b), and Figure 13(f) illustrate an embodiment of the use of a data deployment package and consumable / system data to operate an analysis system in the implementation of an analysis.

[0193] Figures 14(a)-(i), Figures 14(J-a, J-b), Figures 14(K-a, K-b), and Figure 14(l) illustrate the implementation of V-PLEX analysis on an analysis system using the software described herein.

[0194] Figures 15(a)-(b), Figures 15(C-a, C-b), Figures 15(D-a, D-b), Figures 15(E-a, E-b), Figure 15(f), Figures 15(G-a, G-b), Figures 15(H-a, H-b) illustrate the implementation of U-PLEX analysis on an analysis system using the software described herein.

[0195] Figures 16(a)-(d) illustrate the preparation, optimization, and execution of immunogenicity analysis in an analysis system.

[0196] Figures 17(a)-(d), 17(E-a, E-b), 17(F-a, F-b), 17(G-a, G-b), 17(H-a, H-b) and 17(i) illustrate the preparation, optimization, and execution of customized single sandwich immunoassays or pharmacokinetic assays in the assay system.

[0197] Figures 18(a)-(n) illustrate a consumable assay kit that can be used with the assay system described herein.

[0198] Figures 19(a)-(b) are perspective views of the inventive loading vehicle designed for the assay system described herein. Figure 19(c) is a top view of the loading vehicle, showing a tray adapted to receive assay consumables. Figures 19(d)-(h) are exemplary top views of trays loaded with assay consumables. Figure 19(i) shows a cooling compartment below the tray.

[0199] Figures 20(a)-(e) show exemplary adjustments for pipetting timing and ECL read mode for use in the assay system of the present invention.

[0200] As used herein, figures that are provided as subparts on separate sheets (e.g., Figure 10V-a , 10V-b , 10V-c and 10V-d) and have two suffixes separated by a hyphen are enlarged portions of a single figure (e.g., Figure 10(v) or 10V). These enlarged figures are referred to uniformly in the following specification without the second suffix, e.g., Figure 10(v) or 10V.

[0201] DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

[0202] Unless otherwise specified herein, scientific and technical terms used in conjunction with the present invention shall have the meanings commonly understood by one of ordinary skill in the art. Additionally, unless otherwise required herein, singular terms shall include pluralities and plural terms shall include singulars. The articles "a" and "an" are used herein to refer to one or more than one (i.e., at least one) of the grammatical objects of the article. By way of example, "an element" means one element or more than one element.

[0203] As used herein, the term "sample" is intended to mean any biological fluid, cell, tissue, organ, or combination or portion thereof that includes or potentially includes a biomarker for a disease of interest. For example, a sample can be a tissue section of a sample obtained by biopsy, or cells placed in or adapted for use in a tissue culture. A sample can further be a subcellular fraction or extract, or a crude or substantially pure preparation of nucleic acid molecules or proteins. In one embodiment, the sample analyzed in the assays of the present invention is blood, peripheral blood mononuclear cells (PBMCs), isolated blood cells, serum, and plasma. Other suitable samples include biopsy tissue, intestinal mucosa, saliva, cerebrospinal fluid, and urine.

[0204] The assay consumables and systems for use in the present invention include a variety of devices and configurations. In one embodiment, an assay system for use in the present invention includes an assay reader capable of performing a bioassay using an assay consumable. The assay consumable contains an identifier (alternatively referred to herein as an identifier, consumable identifier, or assay consumable identifier), and the assay system, assay reader, or components thereof contain an identifier controller that interacts with the identifier. As described below, the identifier is associated with information regarding the assay consumable, which can include, but is not limited to, how the consumable was manufactured and disposed of prior to use and how the consumable is used in the assay system (collectively referred to as "consumable data"). Thus, the assay system is configured to use the assay consumable in the performance of an assay, and the assay system includes an identifier controller that is 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, the data being indexed by the assay consumable identifier, wherein the consumable data is stored locally on the assay system or assay reader or remotely on a vendor computing system; and optionally, (iii) erase consumable data associated with the assay consumable identifier; and / or (iv) write consumable data indexed by the consumable identifier to the assay system and / or a remote data table.

[0205] In one specific embodiment, the present invention provides an analytical system configured to use an analytical consumable in the conduct of an assay, wherein the analytical consumable includes an analytical consumable identifier as described herein and the analytical system includes (a) a storage medium containing 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 that includes a consumable data repository containing local consumable data. The local consumable data stored to the analytical system includes consumable identification and / or configuration information and one or more steps of an analytical protocol that can be used by the system to conduct an assay using the consumable. For example, the analytical consumable identifier includes information that can be used to identify a specific consumable, such as batch-specific information about a given batch of consumables and / or information specific to an individual consumable, and the corresponding local consumable data stored to the analytical system includes information for identifying the consumable associated with the system (e.g., as a member of a given batch or as an individual consumable within a batch) and it also includes information that is used by the system once the consumable is identified to conduct the analytical protocol using the consumable. Additionally, the consumable data (and / or local consumable data) can include one or more analytical tools that can be used by the system to analyze and interpret data generated using the consumable, the system, and / or consumable technical support information or a combination thereof. Further, the system can also be configured to receive updates to the consumable data repository from a remote storage medium, wherein those updates include additional consumable data, including but not limited to additional consumable identification and / or configuration information, analytical protocol information, and one or more of the following: (x) one or more analytical tools that can be used by the system to analyze and interpret results generated during and / or after the conduct of an assay, (y) analytical system maintenance information, (z) system-consumable upgrade information, and (xx) system and / or consumable technical support information.

[0206] One embodiment of the use of the identifier / consumable data in the system is described in Figure 1-4 below. Figure 1Shows how consumable data is generated, stored, and used by a manufacturer, wholesaler, or supplier (referred to herein as "supplier"). First, the supplier generates a consumable and / or a set or batch of consumables (101) and, with respect to the consumable or batch of consumables, uses a consumable data (CD) establishment system (102) to generate consumable data and associate it with a consumable identifier (103) indexed to the consumable or batch of consumables (step i). The consumable data is generated by the consumable supplier before, during, and / or after an individual consumable and / or batch of consumables is manufactured and / or distributed. The CD establishment system generates a database of CD information about the consumable or batch, i.e., a CD database, to which the consumable data is stored. The CD database is sent to a CD server (104), which includes a master repository of all consumable data. Additionally, the CD establishment system stores information for associating a given consumable identifier with the consumable data in the master repository. The CD establishment system and / or CD server are located on a remote computing system (i.e., remote from the analysis system and / or the customer or the customer's computing system), such as a site maintained by the supplier. Thus, as Figure 1 shown, the supplier generates consumable data about a consumable or batch (a) and associates the information with a consumable identifier (b) indexed to the consumable or batch. The CD system also (step ii) generates a CD database; (step iii) stores the consumable data in the CD database; and (step iv) sends the CD database to a CD server (c), which includes a master repository of all consumable data.

[0207] Figure 2 Describes a method for distributing consumable data to a customer or a designated user of the customer (collectively referred to herein as "customer"). When an order is received from the customer or when the consumable or batch is manufactured (step i), the supplier generates, stores, and sends the CD database to the CD server (201) (step ii). The CD database may include order fulfillment information, i.e., an overview of the components of an order for a given customer, such 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 exposes the consumable to an analysis system (204) ready for implementation of the analysis (step iii), which reads and / or accesses data associated with the analysis consumable identifier (203) and the information is used by the system to identify the consumable (202) (step iv). The system reviews the consumable data locally stored on a local storage medium on the system (in Figure 2(referred to herein as "local CD") to identify the consumable data stored to the storage medium and available for use in performing an analysis using a given consumable. If the storage medium includes consumable data regarding the consumable or lot of consumables, then the consumable is available for use in the system (step v). If the storage medium does not include consumable data regarding the specific consumable or lot of consumables, then the system may query the customer for the consumable data and the customer may communicate with the supplier to receive the necessary consumable data, such as via email, compact disk, memory card / stick, flash drive, network data storage service, etc. (step vi). The supplier sends the consumable data binary file (including but not limited to an encrypted XML file) to the customer, for example in the form of an email attachment to the customer's email account, and the customer loads the file attachment into the analysis system and the system software stores the consumable data to the local system consumable data repository. The consumable / lot of consumables may then be used with the instrument (step vii).

[0208] In an alternative embodiment, if the CD server is not locally available to the system, then the CD server may be connected to the system via a direct interface that automatically obtains consumable data from the CD server. In this embodiment, the supplier generates, stores, and sends the CD database to the CD server for the consumable order and / or lot of consumables, as Figure 2 shown and as described above. Subsequently, the customer receives the consumable, order, and / or lot and exposes the system to the consumable identifier such that the system is able to identify the consumable or lot. The system software queries the system consumable data repository for the consumable data associated with the consumable identifier and if the consumable data is locally available to the system, then the software adjusts the system based on the consumable data as necessary. If the consumable data does not exist in the system consumable data repository, then the system will (i) prompt the customer to manually obtain the consumable data from the supplier, or (ii) automatically obtain the consumable data from the CD server via the direct interface with the CD server and locally store the information in the system consumable data repository. Once the consumable data is locally available to the system, the software adjusts the system based on the consumable data as necessary and performs the analysis. Once the consumable data is locally available to the system, the consumable or lot is available for use in the system to perform the analysis and display the analysis results to the customer. In a specific embodiment, the system software adjusts the output for the customer based on the consumable data.

[0209] In addition, the CD server may periodically send consumable data for new batches / consumable types of consumables to the customer analysis system, for example via email, CD, memory card / stick, flash drive, and / or via a remote interface between the system and the CD server. The storage medium contains a consumable data repository including the consumable data and the analysis system is configured to receive an update of the repository from the remote storage medium, for example via email, CD, memory card / stick, flash drive, and / or via a remote interface.

[0210] Figure 3 Describe the results of verifying the consumable data and the program by the system software. First, the customer inserts a consumable (301) having a consumable identifier (302) into the system (303) (or otherwise brings the consumable identifier into contact with the controller on the system) and the system software identifies the consumable via the consumable identifier (302). The system will attempt to associate the identifier with consumable data locally stored on the system repository. If the consumable data is verified and valid, then the system will process the consumable and display the results of the processing steps to the customer. But if the consumable data is invalid or cannot be verified, then although the consumable will be processed by the system, the results of the analysis will not be displayed to the customer or otherwise made available to the customer until the consumable data is verified by the system software.

[0211] In addition, the present invention provides a method for a supplier to control access to an analysis system and / or analysis of consumables by a customer, wherein the system includes a system identifier, and the method includes receiving the system identifier from the customer, wherein the system identifier is sent to the supplier computing system; the supplier authenticates the system identifier; and performing operations including:

[0212] (i) enabling full access to the device and / or analysis of consumables for the device;

[0213] (ii) enabling partial access to the device and / or analysis of consumables for the device; or

[0214] (iii) denying access to the device and / or analysis of consumables for the device.

[0215] The system identifier includes information that uniquely identifies the analysis system, such as a serial number or other identification code generated and used by the supplier to identify the analysis system. The system identifier is generated by the supplier during or after the manufacturing process and / or when the system is being prepared for shipment or transfer to the customer.

[0216] In one embodiment, the steps enabling full or partial access include sending an access code from a vendor to a customer, thereby enabling access to the system. The access code may be a full or partial access code enabling different functions in the system. In one embodiment, the access code is a partial access code enabling the system to operate in a demonstration mode. The partial access code may be time-restricted. Alternatively, the access code may be a full access code enabling the system to operate fully.

[0217] As Figure 4 shown, the CD server (401) includes a main repository (402) that contains one or more directories of (i) consumable data; (ii) system data; and (iii) customer data. Alternatively or additionally, the data contained in one or more of directories (i)-(iii) may be supplied to the main repository by an interface between the CD server and one or more supplementary vendor directories. In one embodiment, the main repository contains (i) a main customer data directory (403); (ii) a main system identifier directory (404); and (iii) a main customer data directory (405). In a preferred embodiment, customer data is supplied to the CD server via an interface with a supplementary vendor-customer directory that maintains the customer data. The customer data may be stored in one or more supplementary vendor-customer directories, each of which is connected via an interface to the CD server. The main CD database contains a plurality of CD directories, each generated for a consumable or a batch of consumables. The main system identifier directory includes unique system identifiers for each system manufactured and / or distributed by a vendor. And access to the main customer directory and / or the supplementary vendor-customer directory of the CD server includes information for each customer related to the vendor, such as contact information, billing information, pricing information, shipping information, order history, etc. for the customer and individual customers at the customer's location.

[0218] In a particular embodiment, when the system is manufactured and / or prepared for shipment, the supplier generates a system identifier for the system. The system identifier is stored in a master system identifier directory or is available via an interface between a supplemental supplier directory and the CD server. If the system is ordered by a customer, then order information (e.g., purchase order, related quote, pricing, terms and conditions of sale or lease, related service agreement, etc.) and customer information are stored in the master customer directory and / or one or more supplemental supplier-customer directories accessing the CD server. In this regard, the unique system identifier for the system is associated with the customers who have purchased the system in the master repository and any information regarding the related purchases by the customers. Shipping information for the system to the customer is also available in the customer directory and once the system is shipped, the customer receives a shipping confirmation, a copy of which is also stored in the customer directory. The customer receives the system and in a preferred embodiment, once installation and training on the system are complete, the system software connects to the CD server via a remote interface between the system and the CD server as needed to enable interaction between the two. The system initially connects to the CD server to confirm that system installation and training have been completed and are successful, and the CD server records the confirmation. Alternatively, if a remote connection is not achieved on the system, then once the system is installed and training is complete, the customer receives a confirmation code, system registration, and / or email address from the system, and the customer can register on the CD server via the confirmation code, system registration, and / or email, thereby providing customer registration to the CD server, which provides an independent supplier-customer interface without establishing a direct connection between the system and the CD server. The independent supplier-customer interface can be an entry accessible via a password on a supplier-hosted customer access website, and / or the customer and the CD server can 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 supplier can communicate with the customer via a direct system-CD interface (referred to as the "direct interface") and / or via the indirect interface. As described above, the customer can then purchase consumables, the system will read the consumable identifier and confirm that consumable data is stored locally, receive consumable data directly or indirectly from the CD server as necessary, and then the system will enable the use of the consumable or lot.

[0219] Once a customer and a vendor have means of communicating via a direct or indirect interface, the customer and the vendor can interact in a variety of ways and because the vendor has the ability to track customer-specific usage information of systems and consumables purchased and / or used by the customer, communication between the parties can be more meaningful and productive. For example, the customer can browse and / or purchase vendor products via the direct or indirect interface, receive customer assistance, schedule service calls, etc. Because the vendor can track customer activities and purchases very closely via the consumable identifier / CD server, the vendor can tailor its interaction with the customer based on that information. For example, because the vendor is aware of the customer's order history, the vendor can send customer upgrade materials for products related to those the customer has previously purchased / used. Similarly, because the vendor has tracked information related to the customer's system, the vendor can send customer preventive maintenance tips and reminders, general or specific customer training and seminars based on the customer's unique needs (and informed by the tracked consumable data for that customer), and information about system service, warranties, service contract information and reminders, etc.

[0220] In one embodiment, the vendor tracks consumable data that analyzes the customer's use of consumables and stores it in an analysis system, including system-consumable usage information. To facilitate consumable usage tracking, the analysis system is configured to send the system-consumable usage information directly or indirectly to the CD server. If a direct interface is implemented between the system and the CD server, then the system-consumable usage information can be sent automatically. However, if a direct interface is not implemented, then the 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 the 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 use the information from the directory to send consumable data via the direct or indirect interface, which can be customer-related based on previous consumable and / or system usage. If a direct interface is implemented, then the analysis system can be configured to receive analysis system maintenance and / or upgrade information from a vendor computing system that involves previous consumable and / or system usage of individual customers.

[0221] The supplier may also track and / or communicate system maintenance information to the customer, such as monitoring system and / or system component usage, service history, system troubleshooting information, results of diagnostic programs run on the system, control charts, periodic maintenance schedules, warranty information regarding the system and / or its components, or combinations thereof. The system software may be programmed to monitor various components of the system and automatically or when prompted, send monitoring reports to a remote computing system and / or to service technicians. If a direct interface is not implemented, then the system may prompt the customer to send monitoring reports to the CD server via an indirect interface. Alternatively or additionally, the system monitoring reports may be accessed by service technicians tasked with performing on-site or remote maintenance and / or service of the system. In one specific embodiment in which a direct interface is implemented, the CD server monitors system component usage and / or warranty information and schedules periodic system / component maintenance and / or upgrades by service technicians based on standard system component lifetimes and / or warranty periods. Additionally, the CD server may maintain a log of service history for a given analysis system and schedule service calls by service technicians (which may be done using a direct or indirect interface). The remote computing system may also send individual analysis system software upgrades via a direct or indirect interface.

[0222] In addition, one or more of the following system components and / or actions may be monitored by the system software, including but not limited to the expected motor position during normal usage, the position error for each expected motor position, the corrective actions and / or attempted corrective actions taken by the system in the event of a motor positioning error, and the error frequency; component usage, such as the approximate time that components in the system are powered on, and in a preferred embodiment, the system also tracks the relative life of the components under normal usage conditions; lock mechanism attempts, retries, and failures; barcode identifier controller attempts, retries, and failures; the approximate temperature of one or more components in the system, error warnings, database performance and capacity, instrument hard drive capacity, software and firmware versions and patches, customer registration / deregistration, system startup and shutdown, etc. In a particularly preferred embodiment of a system designed to perform electrochemiluminescence measurements using assay consumables, the system software may also be programmed to monitor the time the analyzer camera has been powered on and its approximate temperature, the usage cycles of latches within the system, barcode identifier controller attempts, retries, and failures, consumable lock and unlock events, ECL waveform voltage and integrated current, image processing analysis accuracy and failures, consumable type, kit, owner, consumable identifier (e.g., barcode), and the timestamp or combinations thereof for each consumable run in the system. In addition, the system software may also monitor the experiments performed in the system, such as when, by whom, and the type of consumables used in the experiment. The system-usage monitoring information may be sent to the CD server via a direct and / or indirect interface to enable the vendor to schedule appropriate support, service, and / or maintenance on the system.

[0223] In another embodiment, by tracking the use of the analysis system, the vendor can provide usage and / or purchase assistance. For example, the 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 data for the given lot or consumable and notify the customer of approaching expiration dates for the lot or consumable. Tracking the use of the analysis system / consumable type can also enable the vendor to track the relative scheduling / frequency of consumable use and notify the customer that the customer's consumable supply needs replenishment. If a direct interface is implemented, the system can also be configured to order / reorder consumables and the system can be further configured to track and confirm the vendor's consumable orders. If a direct interface is not implemented, the system can monitor consumable usage and inventory levels and prompt the customer to replenish the supply of one or more consumables. (In this regard, when the system receives batch information via a consumable identifier and by monitoring consumable usage, it can prompt the customer when the supply of consumables available in a given batch has been reduced to a minimum level.) Additionally, by tracking consumable usage, the vendor can send customer information regarding customized analysis design services for specific customized consumable types based on the customer's order / consumable usage history. The direct or indirect interface can also provide a customer training module, consulting services, and / or real-time customer service assistance capabilities to enhance the customer experience (i.e., live chat) (collectively referred to as system and / or consumable technical support information).

[0224] In another embodiment, tracking consumable / system usage enables the vendor to send upgrade materials to the customer, such as when new types or lots of consumables historically used by a given end customer become available, the vendor's computing system sends the customer consumable data regarding those new products. The upgrade materials can also relate to new analysis systems that may be of interest to the customer based on the customer's previous usage. The remote computing system can also send customer literature references that can relate to one or more consumables / systems used by a given customer.

[0225] These and other specific examples of consumable data are described in more detail below.

[0226] A. Analysis Systems, Consumables, and Methods of Use

[0227] Use the analysis system covered by the present invention to implement any type of diagnostic or analysis method known in the art. The analysis methods include, but are not limited to, clinical chemistry analysis (e.g., measurement of pH, ions, gases, and metabolites), hematological measurement, nucleic acid amplification analysis (e.g., polymerase chain reaction (PCR) and ligase chain reaction analysis), immunoassay (e.g., direct, sandwich, and / or competitive immunoassay and serological analysis), oligonucleotide ligation analysis, and nucleic acid hybridization analysis. Any biological reagent that may be used in the analysis methods can be used in the system, including but not limited to nucleic acids, nucleotides, oligonucleotides, DNA, RNA, PNA, primers, probes, antibodies or fragments thereof, antigens, small molecules (e.g., drugs or prodrugs, streptavidin, avidin, and biotin).

[0228] These systems can be portable (e.g., handheld) and / or operate within a fixed laboratory or field setting, either alone or in combination with one or more additional components, analytical devices, or systems. These systems can be used for a variety of applications, from field operations to laboratory settings, in a variety of industries, including but not limited to medicine, clinical, forensic, pharmaceutical, environmental, veterinary, biological, chemical, agricultural, waste management, hazardous chemicals, drug testing, and for defense applications, such as the detection of biological agents. The analysis systems, analysis readers, and consumables used in the present invention can detect the analyte of interest by any suitable method, including but not limited to detection based on optics, electromechanics, radio waves, electromagnetics, colorimetry, fluorescence analysis, chemiluminescence, electrochemiluminescence, radiochemistry, nuclear magnetic resonance, enzymes, fluorescence, particle counting, and cell counting.

[0229] (i) Specific embodiments of the analysis consumables

[0230] The analysis consumables include devices in which one or more steps of the analysis method are implemented and the devices may include one or more test sites in which the analysis measurements are implemented. In one embodiment, the analysis consumables include at least one analysis test site for analysis. The test site may include a plurality of different analysis domains, at least two of which include reagents for measuring different analytes. Additionally, the consumables may include a plurality of test sites for a variety of individual analyses. Alternatively, the analysis consumables may be a component that provides the reagents or other analysis components used by the system to implement the analysis. For example, the analysis consumables may be a container having one or more compartments for holding analysis reagents. The analysis consumables (or the test sites therein) may be single-use or they may be reusable. The analysis consumables may be configured to perform one test or multiple tests (sequentially or in parallel).

[0231] As used herein, a test site is a consumable area that holds, contacts, and / or interrogates a sample. A test site can include multiple different assay domains, at least two of which include reagents for measuring different analytes. A consumable can contain multiple test sites that can hold, contact, or otherwise interrogate different volumes (aliquots) of the same sample and / or different volumes of different samples. Partitioning of an assay consumable refers to the grouping of two or more test sites of the consumable. Each test site can be used to perform a single measurement or multiple measurements (e.g., measurement of multiple different analytes in a multiplex assay format) on a volume of sample. 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, to use its test sites at different times (e.g., when a new sample is delivered to the assay system, assign an unused test site for use), or can implement a combination of both operating modes.

[0232] The analytical consumable can be any structure suitable for diagnostic applications and the structure can be indicated by the specific analytical format or detection method used by the device. Examples of analytical consumables suitable for the present invention include, but are not limited to, test tubes, cuvettes, flow cells, analytical cartridges and cassettes (which may include integrated jet technology for analytical processing), microplates, slides, analytical chips, lateral flow devices (e.g., strip tests), flow-through devices (e.g., dot blots), pipette tips, solid phase supports for biological reagents, etc. In certain embodiments, the test sites in the analytical consumable are defined by compartments in the analytical consumable, such as wells, chambers, channels, flow cells, etc. The analytical consumable and / or test sites may include one or more components for performing analytical measurements according to one or more specific detection methods. Depending on the function of the consumable and the detection format used by the analytical system, examples of the components may include, but are not limited to, lateral flow matrices, filtration matrices, optical windows, sensors (e.g., electrochemical and optical sensors), solid phase supports for binding reactions (e.g., coated slides, chips, beads, pins, coated filtration or lateral flow matrices, tubes, etc.), reagents (dry or in liquid form), electrodes, analyte-selective membranes, etc. In one embodiment, the analytical consumable can be a device incorporating a conventional lateral flow test strip (e.g., an immunoassay test strip) as the analytical medium. In this example, the device is molded to include the identifier or the identifier is attached to the device without any modification to the structure of the device and / or the analytical medium. In one embodiment, the device is placed in the analytical system (i.e., the analytical system) for analysis and before, during, or after the performance of the analysis, an identifier controller within the analytical system, attached to the analytical system, or associated with the analytical system reads the data contained on the identifier and uses the data in the analysis or after the analysis is completed by the system.

[0233] In another embodiment, the analytical consumable and the accompanying analytical system or analytical reader are capable of performing multiplexed analysis. Multiplexed analysis is a type of analysis in which multiple measurements are performed on a single sample, such as by distributing the sample across multiple test sites and / or by performing multiple measurements on each volume of the sample in an individual test site. The multiple measurements may include, but are not limited to, (i) multiple repetitions of the measurement of an analyte; (ii) multiple measurements of a particular analyte (i.e., multiple non-identical measurements of the same analyte, such as measurements that differ in format or the identity of the analytical reagent used); and / or (iii) measurements of multiple different analytes. In a specific embodiment, the analytical consumable is configured to perform multiplexed measurements at one or more test sites, the measurements including at least two assays for two different analytes.

[0234] The present invention is not limited to a specific method for performing multiplex measurements at a test site and can use any of a variety of techniques that have been developed for performing multiplex measurements. Multiplex measurements that can be used in the present invention include, but are not limited to, multiplex measurements that (i) involve the use of multiple sensors; (ii) use individual analysis domains (e.g., arrays) on a surface, which domains can be distinguished based on their position on the surface; (iii) involve the use of reagents coated on particles, which particles can be distinguished based on particle characteristics such as size, shape, color, etc.; (iv) generate analysis signals that can be distinguished based on optical properties (e.g., absorbance or emission spectra), (v) based on temporal characteristics of the analysis signals (e.g., the time, frequency, or phase of the signal), and / or (vi) based on some other analytical feature. Accordingly, the interpretation of multiplex analysis results can involve the use of multiplex information, such as the identity of the analyses performed at each test site and within a test site, any analytical feature used to distinguish the analyses performed at a test site and / or to make the identity of a specific analysis dependent on the corresponding analysis signal (identity of a specific sensor, position and identity of an analysis domain, etc.).

[0235] In one embodiment, an analysis test site contains a plurality of different analysis domains and each domain contains one or more reagents for measuring different analytes. Multiplex information, including the position, identity, and composition of each analysis domain, is used to identify the analysis signals generated at each domain and to correlate them with the determination of the presence or amount of the corresponding analyte (a process that can include the application of additional consumable data such as signal thresholds and / or calibration parameters). The multiplex information can be provided in the form of consumable data and / or associated with the consumable identifier.

[0236] The test sites can be configured to perform multiple multiplexed measurements (e.g., it can include multiple different assay domains, where each domain contains reagents for measuring different analytes). In one embodiment, the assay consumable can include multiple test sites. Information regarding the precise configuration of the one or more test sites, assay domains, and / or one or more partitions in the consumable can be included in the information saved to the assay consumable identifier and / or provided in the form of consumable data. This information can include the location and identity of the test sites, assay domains, and / or one or more partitions, as well as multiplexing information (as described above), which includes the number, identity, and distinguishing characteristics of the individual measurements within a test site, assay domain, and / or partition (e.g., the specific location, identity, and / or assay reagents of the assay domains within each test site). Additionally, the use of the test sites, assay domains, and / or partitions in the assay consumable can also be recorded to the identifier to track the use of the consumable in the assay system. The identifier and / or consumable data can also include information regarding the assay format and specific processing steps to be used for the assay consumable or the test sites, assay domains, and / or partitions of the assay consumable. The identifier and / or consumable data can also include information regarding the assay method, which should be applied by the system once the assay is performed to analyze the output of the assay performed in a given test site, assay domain, and / or partition and optionally provide the results of combining the outputs of multiple assays performed in the test site, assay domain, and / or partition.

[0237] The 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, the assay consumable of the present invention can be a multi-well plate (e.g., a 24-, 96-, 384-, or 1536-well plate), and the wells of the plate can further comprise a plurality (e.g., 2 or more, 4 or more, 7 or more, 25 or more, 64 or more, 100 or more, etc.) of different assay domains. A multi-domain multi-well plate adapted to allow assay measurements to be performed using electrode-induced luminescence measurements (e.g., electrochemiluminescence measurements) is described in U.S. Application No. 10 / 238,391, filed Sep. 10, 2002, entitled "Methods and Reader for Conducting Multiple Measurements on a Sample", which is hereby incorporated by reference. The exact configuration of the domains, test sites, and / or partitions in the assay consumable, as well as the specific identity of each domain, test site, and / or partition and the reagents incorporated into the domain / test site / partition, can be included in the information stored to the assay consumable identifier and / or provided in the form of consumable data. Additionally, the use of a given domain, test site, and / or partition in the assay consumable can also be recorded to the identifier to track the use of the consumable in the assay system.

[0238] The assay consumable can be used in a variety of different assays and this diversity gives rise to a variety of suitable configurations of the associated consumable. In one assay format, the same analyte is measured at different assay domains within a single test site, the different assay domains being designed to measure different properties or activities of the analyte. Information regarding the assay formats that can be used in the assay consumable, test site, and / or assay domain can also be stored to the assay consumable identifier and / or provided in the form of consumable data. The identifier and / or consumable data can also include information regarding the assay method that should be applied by the system once an assay has been performed to analyze the output of the assay performed in a given test site and / or domain and to compare the output with the assay performed in an independent test site and / or domain.

[0239] An example of a multiplex analysis consumable is described in U.S. 2004 / 0022677, the disclosure of which is incorporated herein by reference in its entirety. The analysis consumable includes one or more and in one embodiment a plurality of test sites and / or analysis domains for performing one or more analytical measurements simultaneously or sequentially. For example, the test sites can be configured as wells and / or chambers. These test sites and / or analysis domains contain one or more electrodes for inducing luminescence of a material in the test sites and / or analysis domains. The analysis consumable can further include, for example, analysis reagents in liquid or dry form in the test sites (e.g., wells or chambers) of the consumable.

[0240] In addition to the test sites and analysis domains, the analysis consumable or multi-well analysis plate can further include several additional elements, such as a plate top, a plate bottom, wells, working electrodes, counter electrodes, reference electrodes, dielectric materials, electrical connections, and analysis reagents. The wells of the plate can be defined by holes or openings in the plate top, or in the form of indentations or micro-indentations on the surface of the plate. The plate can have any size or shape, a plurality of wells arranged in any pattern or configuration, and can be made of a variety of different materials. Exemplary embodiments of consumables useful in the present invention include industry standard formats for the number, size, shape, and configuration of the plate and wells, such as 96-, 384-, and 1536-well plates, wherein the wells are configured in a two-dimensional array. Other formats can include single-well plates, 2-well plates, 6-well plates, 24-well plates, and 6144-well plates. The multi-well analysis plate can be used once or can be used multiple times and is well suited for applications where the plate is disposable. A variety of configurations for suitable analysis plates can be used in the present invention, including but not limited to those depicted in FIGS. 11A, 12A, 13A, 13B, 14A, 15, and 16A of U.S. Application No. 2004 / 0022677, each of which is incorporated herein by reference. As stated above, the specific configuration and identity of the analytical test sites, domains, and / or partitions of the analysis consumable can be included in the information stored to the analysis consumable identifier and / or provided in the form of consumable data.

[0241] (ii) Specific embodiments of the analysis reader

[0242] An assay consumable can be used in an assay reader that can be used to induce and measure luminescence, such as electrode-induced luminescence or electrochemiluminescence, in or on an assay consumable (e.g., a porous assay plate). The assay reader can also induce and / or measure current and / or voltage, for example, at an electrode. The assay reader can incorporate, for example, one or more light detectors; an opaque hood; a mechanism for transporting the assay plate into and out of the assay reader (and specifically, into and out of the opaque hood); a mechanism for aligning the assay plate with the light detector and / or with an electrical contact and orienting the assay plate; an additional mechanism for tracking and identifying the plate (e.g., a barcode identifier controller); a mechanism for making an electrical connection with the plate, one or more electrical energy sources for inducing luminescence, and appropriate devices, electronics, and / or software. The assay reader can also include a mechanism for storing, stacking, moving, and / or dispensing one or more porous assay plates (e.g., a plate stacker and / or a plate conveyor). The assay reader can be configured to measure light from a porous assay plate by measuring light sequentially from a plurality of partitions or regions (i.e., a grouping of a plurality of adjacent assay domains within the plate) and / or generally simultaneously or simultaneously from the entire plate. The assay reader can also incorporate additional microprocessors and computers to control certain functions within the system and to assist in the storage, analysis, and presentation of data. A variety of configurations for a suitable assay reader can be used in the present invention, including but not limited to those depicted in FIGS. 17-23 of U.S. Application No. 2004 / 0022677, which is incorporated herein by reference.

[0243] In one specific embodiment, the assay reader is the device described and claimed in U.S. Application Serial No. 14 / 147,216, published as US 2014 / 0191109 and WO 2014 / 107576, the disclosures of which are incorporated herein by reference. Specific embodiments of the assay reader are illustrated in the figures of U.S. Serial No. 14 / 147,216 and some of those figures are reproduced herein. FIGS. 5(a)-(b) show, respectively, a front view and a rear view of a device 500 with a stylized overlay, and FIGS. 5(c)-(d) show, respectively, corresponding front and rear views of the device without the overlay. As shown, for example, in FIG. 5(c), the device includes a light detection subsystem 510 and a plate handling subsystem 520. A more detailed view is provided in FIGS. 6(a)-(b). The plate handling subsystem 620 includes an opaque hood 630 that includes a housing 631 having a top 632, a bottom 633, a front 634, and a rear 635. The housing also includes a plurality of mating features and the housing is adapted to receive a removable drawer. The removable drawer 640 is in Figure 7As shown in [reference], in a partially open or closed position. Referring to Fig. 6(a), the top 632 of the housing also includes one or more plate insertion (and ejection) apertures 636 and 637, through which the plate is lowered onto or removed from the plate translation table (manually or mechanically). Before performing the luminescence measurement, a slidable light-tight door (shown as 639 in Fig. 6(c)) is used to seal the plate insertion apertures 636, 637 from ambient light. In addition, the top of the housing further includes an identifier controller for reading and processing data associated with the identifier on the plate. In one embodiment, the identifier controller is a barcode reader (638) installed in an aperture in the top of the housing via a light-tight seal, wherein the barcode reader is configured to read a consumable identifier (e.g., barcode) on a plate placed on the plate translation table within the housing. In a preferred embodiment, the consumable identifier (e.g., barcode) on the plate is read once the plate has been lowered into the drawer. In an alternative or additional embodiment, the identifier controller may be provided separately from the device.

[0244] In another specific embodiment, the analysis reader is a MESO QuickPlex SQ 120, available from MesoScale Discovery, Rockville, MD.

[0245] (iii) Specific embodiments of the analysis system

[0246] One embodiment of the analysis system useful in the present invention is described in U.S. application serial number 12 / 844,440, published as US 2011 / 0143947, which is hereby incorporated by reference herein. Specifically, as Figure 8As shown, the analysis system may include the following components: (i) a sample holder subassembly (810); (ii) an opaque cover (820); (iii) an auxiliary board subassembly (830); (iv) a pipette subassembly (840); (v) a pipette 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 attached to a computer via a user interface (not shown). This system enables fully automated random access analysis of samples using array-based multiplexed microplate consumables. The device achieves enhanced sensitivity and high sample throughput. It can be adapted for any of a variety of detection techniques, such as changes in optical absorbance, emission of luminescence or radiation, changes in light scattering, and / or changes in magnetic fields. In one embodiment, the device is configured to detect the emission of luminescence, such as fluorescence, phosphorescence, chemiluminescence, and electrochemiluminescence (ECL). In a particular embodiment, the device is configured to detect ECL. All of the biological reagents required for analysis can be provided in the device, thus minimizing the consumable and reagent requirements of the device. Figure 8 The device depicted in Figure 8 further includes one or more consumable identifier controllers (not shown), incorporated within the housing of the device and / or located external to the device housing.

[0247] Another embodiment of the analytical system of the present invention is shown in FIG. 9(a). The analytical system (900) includes a plurality of subsystems positioned on a table or platform (901), wherein each subsystem is operatively connected to a robotic subsystem (902) configured to access and move one or more consumables (e.g., a porous assay plate) from one subsystem of the analytical system to another. The plurality of subsystems includes an assay reader (903); an assay consumable storage unit (904); a pipetting subassembly (905) that includes at least one pipetting probe (906) attached to a pipetting head gantry (907), the pipetting head gantry providing X, Y, and Z movement of the probe to and from a pipette tip wash station (908) and a plate wash subassembly (909)); an orbital shaker subassembly (910); a liquid reagent subassembly (911); and an electronics subassembly that includes a computer (912). The computer also includes a user interface (not shown). The analytical system may further include a porous plate preparation platform (913) positioned on the table (901) and configured to enable liquid to be pipetted into and / or out of one or more wells of a porous assay plate positioned on the preparation platform. Optionally, the platform (913) is positioned on a linear track that enables the platform to move to and / or from the pipetting subassembly (905) in a direction parallel to the plane of the table. Alternatively or additionally, one or more subcomponents of the platform and / or the pipetting subassembly are configured to move in X, Y, and / or Z directions relative to each other. The robotic subsystem is configured to move one or more plates to and / or from the plate preparation platform, the plate wash subassembly, the orbital shaker subassembly, the assay reader, and the consumable storage unit. As shown in FIGS. 9(b)-(c), the analytical system may further include a housing (914) that includes one or more environmental control units disposed within the housing, such as thermoelectric cooling units (915(i) and 915(ii), respectively). In one embodiment, the housing is configured to enclose the analytical system such that the internal temperature within the housing is maintained at approximately 20-30°C.

[0248] The analysis system depicted in FIG. 9(a) is configured to process a porous analysis plate that has undergone an off-line sample preparation step, which can be performed manually, using an automated sample preparation system, or using an automated sample preparation system integrated with the analysis system via an additional robotic subsystem. Additionally, reagents for performing the analysis in the analysis plate can be provided in one or more additional analysis plates, such as reagent plates and / or dilution plates, i.e., plates that contain specific reagents for performing the analysis. In a specific embodiment, the sample can be added off-line to a sample plate, the system uses one or more diluents and reagents that can be stored separately in a diluent plate and / or a reagent plate, and the analysis can be performed in a test plate (i.e., the plate to which the sample and / or reagent are added by the system during one or more processing steps).

[0249] In one specific embodiment, the system processing plate in batch mode (i.e., all the wells of the plate) is operated on the system or simultaneously processed by the system before the system moves to the next step and / or the next plate. For example, if the system is configured to use a 96-well microplate, then all 96 wells of the plate are simultaneously subjected to each processing step on the analysis system before the system moves to the next step and / or the next plate. FIG. 9(d) shows the operation sequence of the analysis system operating in batch mode. In this embodiment, the first system operation cycle (Cycle 1) includes the following steps: (a) moving a set of plates to the storage unit of the analysis system, the set including a sample plate, a diluent plate, and a test plate; (b) respectively removing diluent and sample from the diluent and sample plates and adding them to the test plate; and (c) moving the test plate to the orbital shaker assembly and returning the sample and diluent plates to the storage unit. Cycle 1 is completed when the first test plate of the set has completed the first incubation. The second system operation cycle (Cycle 2) includes the steps of (a) moving the test plate to the plate washing subsystem and washing the test plate; (b) moving the test plate and the detection antibody solution plate to the plate preparation platform; (c) adding the detection antibody solution to the test plate; and (d) moving the test plate to the orbital shaker assembly and returning the detection antibody solution plate to the storage unit. Cycle 2 is completed when the first test plate has completed 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 the read buffer plate to the plate preparation platform; (c) adding the read buffer to the test plate; (d) moving the test plate to the analysis reader and returning the read buffer plate to the storage unit; (e) reading the signal from the analysis reader and moving the test plate from the analysis reader to the storage unit. Through Cycles 1-3, the analysis system is configured to move plates from one subsystem to another up to every three minutes (3 min / plate).

[0250] In one embodiment, the assay reader integrated with the assay system 900 is an assay reader as described herein, such as the device 500 illustrated in FIGS. 5-7. In a specific embodiment, the assay reader is the device described and claimed in U.S. Application Serial No. 14 / 147,216, the disclosure of which is incorporated herein by reference. In another specific embodiment, the assay reader is a MESO QuickPlex SQ 120, available from Meso Scale Discovery, Rockville, MD. Alternatively, the assay reader is a MESO SECTOR S600, available from Meso Scale Discovery, Rockville, MD.

[0251] The assay consumable storage unit (904) can be configured to store any type of consumable used with the assay reader in the implementation of the assay. In a specific embodiment, the storage unit is a multi-well plate storage unit configured to store a plurality of multi-well assay plates. In one embodiment, the plate storage assembly is configured as a shelving sub-assembly that includes a plurality of shelving units, each sized to accommodate a multi-well assay plate. The shelving sub-assembly includes a housing that includes a housing top, a housing back, left and right housing walls, and a plurality of storage units disposed within the housing, where each storage unit includes a plate introduction aperture. The shelving sub-assembly can include an M×N linear array of storage units, where M and N are integers, such as a 2×1, 2×2, 3×3, or 4×4 array. In one embodiment, the sub-assembly includes a 2×1 array of storage units. And in a specific embodiment, the shelving sub-assembly is a 2×1 array of twenty storage units.

[0252] As described above, the pipetting sub-assembly (either alone or in combination with the platform) provides independent X, Y, and Z movement of the probe to bring it close to the sample plate, reagent plate, and / or test plate as desired. The pipetting sub-assembly can also include appropriate pumps and valves (not shown) for controlling the pipette and / or probe. The pump is used to drive fluid through the pipetting sub-assembly. Those skilled in the art should be able to select an appropriate pump for the device, including but not limited to diaphragm pumps, peristaltic pumps, and syringe (or piston) pumps. The pump also includes a multi-port valve to allow the pump to push and pull fluid from different fluid lines. Alternatively, multiple pumps can be used to independently control the fluid in different fluid lines.

[0253] In one embodiment, the pipetting probe may use a fixed or disposable pipette tip. In a specific embodiment, the pipetting probe uses a fixed pipette tip. Alternatively, if disposable tips are used, the disposable pipette tips may be stored in a pipette tip storage / disposal compartment (not shown). The arm / track of the pipettor subassembly allows the probe to access the tip storage / disposal compartment for tip loading onto the pipetting probe and tip removal after use. In addition to transferring reagents and samples from one well to another, the fluid line connected to the pipetting probe may also be connected to a working fluid or diluent so that the probe can be used to deliver these fluids / diluents to the wells. Optionally, the pipetting probe may include fluid sensing capabilities, such as using a capacitance sensor to detect when the probe contacts a fluid in a tube or well. In a specific embodiment, the pipetting probe includes a multi-channel pipetting probe that enables simultaneous fluid transfer to multiple wells of a multi-well plate. For example, the pipetting probe includes a 96-channel pipetting head capable of simultaneously performing fluid transfer to a 96-well plate. In one embodiment, the pipetting head and corresponding fixed pipette tips may be obtained from Apricot Designs, Covena, CA. Generally, if fixed pipette tips are used, they are supplied by the vendor of the pipetting probe, such as Apricot Designs, Covena, CA. If disposable pipette tips are used, the tips may be stored in a tip compartment and disposed of, the tip compartment including a housing for one or more individual drawers that can accommodate standard disposable tip cartridges (obtainable from Axygen, Qiagen, or Rainin) and a removable waste container for used pipette tips. To remove a tip, the pipetting probe is translated horizontally to position the shaft in the slot and then translated vertically until the pipette tip is pulled off by the carriage. During operation, the specific slot used is selected using a set pattern or a random pattern so that used pipette tips are evenly distributed along the width of the waste container. The size of the tip varies according to the size of the pipetting probe, the volume of the sample / reagent dispensed, and / or the size of the plate in which the tip is placed. 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 the 250 μL range.

[0254] The plate washer subassembly can be any suitable commercial microtiter plate washing system, such as a plate washer subassembly available from BioTek Instruments, Inc., Winooski, VT, including but not limited to the 405Touch washer, the 405LS washer, the Elc405x Select deep well washer, or the Elx50 washer. Similarly, the robotic subsystem can be any suitable benchtop commercial robotic system, such as a system available from Precise Automation, Inc., Fremont, CA.

[0255] The liquid reagent subassembly includes a plurality of liquid reagent and waste compartments and is used for one or more steps of the assays performed in the device. The reagent / waste compartments include a compartment body enclosing an internal volume and reagent and waste ports for delivering reagents or receiving waste. The volume of the compartments in the subassembly is adjustable such that the relative ratio of the volume of the compartment body occupied by the reagent and waste can be adjusted, for example when the reagent is consumed in the assay and returned to the compartment as waste. The total internal volume of the compartment body can be about 2 times lower, about 1.75 times lower, about 1.5 times lower, or about 1.25 times lower than the volume of the liquid stored in the body (e.g., the volume of the reagent initially provided in the compartment), thus minimizing the space required for waste and reagent storage and allowing for convenient single-step reagent replenishment and waste removal. In some embodiments, the device has a reagent compartment slot configured to receive the compartment and provides fluid connection to the waste and reagent ports, optionally via a "one-touch connection" or "quick connect" fitting.

[0256] Optionally, the reagent and / or waste compartments are movable. In one embodiment, the reagent and / or waste compartments are movable and the device further includes a sensor, such as an optical sensor, to monitor the fluid level in the reagent and / or waste compartments. Alternatively, the liquid reagent subassembly can include an electronic scale to monitor the fluid weight in the reagent and waste reservoirs, thereby tracking reagent usage and availability in real time. Once the reagent and / or waste compartment reaches a certain minimum or maximum capacity as detected by the sensor or scale, the device warns the user to remove the reagent or waste compartment to replenish and / or empty the contents. In one embodiment, the motor of the pipetting probe is in communication with the sensor or scale and when the reagent and / or waste compartment reaches the minimum or maximum capacity, the device disables the pipetting probe motor, e.g., the probe sensor relays information about the capacity of the compartment to the instrument software, which then halts further pipetting actions.

[0257] The reagent and waste compartments may be provided in the form of collapsible bags located in the subassembly body. One of the reagent and waste compartments may be provided in the form of a collapsible bag and the other compartment may be provided as the compartment body itself (i.e., the volume in the compartment body excluding the volume defined by any collapsible bag in the compartment body). In addition to the first reagent and waste compartment, the reagent cartridge may further include one or more additional collapsible reagent and / or waste compartments connected to one or more additional reagent and / or waste ports. Alternatively, one or the other of the reagent and waste compartments may be constructed of blow-molded plastic. Alternatively or additionally, waste may be pumped to an external drain or container. In one embodiment, the liquid reagent subassembly further includes a reagent reservoir used during the performance of the analysis in the device. In a specific embodiment, each reagent compartment is connected via a fluid line to a reagent reservoir that holds a volume of reagent used during the analysis. The fluid line leads directly from the reagent reservoir to the pipette subassembly. In practice, the reagent is stored in the reagent compartment and a predetermined volume of the reagent is dispensed from the reagent compartment to the reagent reservoir. The device draws fluid for analysis from the reagent reservoir. The reagent compartment and the reagent reservoir may each be connected to a separate fluid sensor. The fluid sensor in the reservoir monitors the internal volume within the reservoir and if the internal volume drops below a predetermined level, then reagent is dispensed from the reagent compartment to the reservoir. Similarly, if the internal volume of the reagent compartment drops below a predetermined level, then the fluid sensor sends a signal to the operator to replace or refill the reagent container. The dual reagent compartment / reservoir assembly enables the device to continuously supply fluid to the analysis when the analysis is performed by the device, as the fluid is replaced in the reagent compartment without interrupting the analysis process of the instrument.

[0258] In one embodiment, the orbital shaker assembly (910) is a counterbalanced analytical consumable shaker device as described and claimed in U.S. Serial No. 62 / 143,557, filed April 6, 2015, the disclosure of which is hereby incorporated by reference in its entirety. Specifically, the orbital shaker device includes (a) an orbital oscillator assembly including a horizontal orbital run platform, and (b) an analytical consumable storage assembly positioned on the platform. The storage assembly includes (i) a shelving subassembly including a plurality of sets of vertically arranged storage cells, sized to receive consumables therein and including a consumable latching mechanism; and (ii) a counterweight positioned within the storage assembly at a height corresponding to the center of the body of the storage assembly and the orbital platform. The orbital shaker device further includes a rotating shaft extending in a vertical direction from the oscillator assembly to the storage assembly and the counterweight is operatively connected to the rotating shaft.

[0259] The analytical system illustrated in FIG. 9 may include a table or platform, such as 901, or the system may be established and configured on a laboratory bench top. In the system depicted in FIG. 9(a), the analytical system is positioned on a table including one or more shelving units (916 and 917, respectively), the shelving units being positioned beneath the table top (901) and configured to house one or more components or subsystems of the analytical system. In one embodiment of a system positioned on a laboratory bench top, multiple subsystems may be distributed on the bench top in the same X-Y plane (not shown).

[0260] In Figure 9(a)-9(d) the analytical system (900) (including the orbital shaker (910)) illustrated in is described in U.S. Provisional Patent Application Serial No. 62 / 311,752, filed March 22, 2016, and International Patent Application Serial No. PCT / US2016 / 026242, filed April 6, 2016, the disclosures of which are hereby incorporated by reference in their entireties.

[0261] Another embodiment of the analytical system of the present invention is shown in FIG. 10 and its sub - parts. The analytical system (1000) includes a plurality of subsystems positioned on a table (1001), where each subsystem is operatively connected to a robotic subsystem (1002) configured to access and move one or more consumables (e.g., a porous assay plate) from one subsystem of the analytical system to another. The robotic subsystem of the instrument depicted in FIG. 10 and its sub - parts includes one or more pipetting subsystems (1021), each pipetting subsystem including one or more pipetting tip heads for dispensing / aspirating fluid to / from the wells of a porous plate, such as a multi - channel pipetting tip head. The pipetting subsystems are attached to a gantry (1022) within the robotic system, and the gantry enables the pipetting tip heads to move in the X, Y, and Z directions through the analytical system. The plurality of subsystems within the analytical system includes an assay reader (1003); an assay consumable storage unit (1004); a plate washing sub - assembly (1005)); a plate oscillation sub - assembly (1006), which includes one or more independent plate oscillation devices (e.g., as described above with reference to element 910 of FIG. 9, except that the oscillator 910 has its own assay consumable storage unit and can simultaneously oscillate and incubate multiple plates); a liquid reagent sub - assembly (1007); a solid waste storage unit (1008) and a liquid waste storage unit (1020); and an electronics enclosure (1009) configured to house a system control computer, a keyboard, a display, a wireless router, and a power supply (not shown). Electronic components are designated as elements (1010, 1011), which are shown in FIG. 10(a) below the reader (1003) and may also be located in the electronics enclosure (1009). The analytical system may also include a platform (1012) positioned on the table (1001) and configured to enable liquid pipetting to / from one or more wells of a porous assay plate positioned on the preparation platform. The robotic subsystem is configured to move one or more plates to / from the platform, the plate washing sub - assembly, the oscillation sub - assembly, the assay reader, and the consumable storage unit.The platform includes a consumable identifier controller (e.g., a barcode reader (1013)) configured to read an assay consumable identifier, such as located on a microplate, e.g., on the bottom of a plate or tube placed in a reagent rack or tube holder; a pipette tip storage compartment (1014) configured to hold pipette tip boxes of variable tip sizes (e.g., 1015 and 1016, 1000 μl and 350 μl tips, respectively) when needed; one or more sample / reagent tube carriers (1017) and one or more reagent troughs (1018) located in one or more respective carriers. Optionally, the system includes a second consumable identifier controller (1023) located above the platform and configured to read an identifier on the side of a plate and / or reagent rack; and a third consumable identifier controller (not shown) configured to read an identifier on a consumable cartridge located external to the system housing (not shown). In one embodiment, the third consumable identifier controller is remote from the assay system, attached to the housing of the assay system, or located on the front or side panel of the housing of the assay system and configured to enable a user to contact a consumable identifier, such as on a plate or kit, with the third consumable identifier controller before the consumable is used in the system. The assay system may further include one or more environmental control units disposed within the assay system, such as a thermoelectric cooling unit or TEC (1019). Although a TEC is illustrated with the assay system (1000), any environmental control system, heat exchanger, or cooling device may be used.

[0262] Unlike the assay system depicted in FIG. 9(a), the instrument shown in FIG. 10 and its sub-parts is configured to perform all sample processing steps on a plate as well as all assay processing steps required in the implementation of an assay. Additionally, the user-interface of the assay system of FIG. 10 and its sub-parts is configured to stepwise display instructions to the user regarding appropriate sample / reagent preparation steps that should be manually performed before the assay is implemented in the system. The sample / reagent preparation steps and the individual assay steps performed by one or more subsystems of the assay system may vary between one assay protocol and another. Detailed examples of various assays performed by the assay system of FIG. 10 and its sub-parts are described below, including but not limited to the implementation of cytokine, V-PLEX, U-PLEX, S-PLEX, pharmacokinetics (PK), immunogenicity (IG) assays, and custom sandwich immunoassays (available from Meso Scale Discovery, Rockville, MD), as well as the optimization of PK, IG, and custom sandwich immunoassays.

[0263] Another iteration of the analysis system (1000) of the present invention is illustrated in FIG. 10(c). Some of the components shown in FIGS. 10(a)-(b) are omitted for clarity. This iteration includes one or more grab trays (1024) positioned below the platform (1012) and above the table (1001) to grab and hold liquid that spills from various reagents, diluents, and buffers during operation of the analysis system (1000). The grab tray (1024) preferably has flow channels (1025) defined thereon to direct the spilled liquid from the tray (1024) towards the waste storage unit (1008). Preferably, the flow channels include a peripheral channel (1025b) to direct the liquid away from the edge of the tray (1024), and an internal flow channel (1025a) that leads to the waste assembly (1008). Optionally, the flow channels (1025) have absorbent material disposed therein to absorb the spilled liquid and / or carry the liquid away by capillary action towards the waste assembly (1020), as best illustrated in FIG. 10(d). Alternatively, the flow channels (1025) may be coated with a surfactant to reduce the flow resistance.

[0264] In addition, the platform (1012) also includes additional raised pedestals (1026) that are designed to hold additional disposable tips or accommodate additional components, such as individual oscillators (1006), thereby demonstrating the expandable nature of the analysis system (1000). A plurality of holes (1027) are provided in the platform (1012) to receive additional laboratory wares or other functional components.

[0265] In one embodiment, the analysis reader for the analysis system 1000 is the analysis reader as described herein, such as the device 500 illustrated in FIGS. 5-7. In a specific embodiment, the analysis reader is the device described and claimed in U.S. application serial number 14 / 147,216, the disclosure of which is incorporated herein by reference. In another specific embodiment, the analysis reader is the MESO QuickPlex SQ 120, available from Meso Scale Discovery, Rockville, MD. Alternatively, the analysis reader is the MESO SECTOR S600, available from Meso Scale Discovery, Rockville, MD.

[0266] The assay consumable storage unit (1004) can be configured to store any type of consumable for the assay reader in the implementation of the assay. In a specific embodiment, the storage unit is a multi-well plate storage unit configured to store a plurality of multi-well assay plates. In one embodiment, the plate storage assembly is configured as a shelving sub-assembly that includes a plurality of shelving units, each sized to accommodate a multi-well assay plate. The shelving sub-assembly includes a housing that includes a housing top, a housing back, left and right housing walls, and a plurality of storage units disposed within the housing, wherein each storage unit includes a plate insertion aperture. The shelving sub-assembly can include an M×N linear array of storage units, where M and N are integers, such as a 2×1, 2×2, 3×3, 4×4, 5×6, or 6×5 array. In one embodiment, the sub-assembly includes a 2×1 array of storage units. In a specific embodiment, the storage sub-assembly includes a 2×1 array of twenty storage units.

[0267] In the iteration of FIG. 10(c), the assay consumable storage unit (1004) was redesigned to have both decorative and functional aspects. In this iteration, the assay consumable storage unit is a single integral unit having a plurality of parallel shelving surfaces (1072) connected by a plurality of vertical supports (1074), as shown in FIG. 10(r). Each storage unit in the top row includes a raised corner (1076) sized and dimensioned to retain the lid of the reagent or the equipped support illustrated in FIG. 18 and the sub-parts therebelow when a technician or a robotic system (1002) places an assay plate or a support thereon. As shown in FIG. 10(c), preferably the bottom horizontal shelf of the assay consumable storage unit is firmly tightened independently in a cantilever manner to the platform (1012). The upper assembly of the assay consumable storage unit is fastened to the bottom horizontal shelf using a plurality of, preferably two or more, mating pins for maintaining a consistent positioning of the upper assembly. Preferably, the mating pins are located outside the X and / or Y centerlines to minimize improper mating of the bottom horizontal shelf and the top assembly. A plurality of, preferably three or more, wing screws are used to fasten the assay consumable storage unit together. Additionally, a plurality of, preferably at least three, Z-direction adjustment screws are provided to level the assay consumable storage unit (1004) when necessary.

[0268] The advantage of having a bottom horizontal shelf mounted independently of the upper assembly is that it is easy to remove the assay consumable storage unit (1004) for servicing and accessing components behind the unit (1004). The mating pins and the wing screws further allow the upper assembly to be easily and precisely reconnected to the bottom horizontal shelf thereafter.

[0269] The pipetting subassembly (1021) is supported on a gantry (1022) and powered by one or more motors to provide independent X, Y, and Z motion to a probe (such as one or more pipette tips) to bring it close to wells, tubes, and / or plates as needed. The pipetting subassembly (1021) also includes appropriate pumps and valves for controlling the pipette and / or probe, and optionally a pipette tip washing subassembly (not shown). The pump is used to drive fluid through the pipetting subassembly. Preferably, each pipette tip can be independently controlled or independently allocated by control software, a controller, and motors. In other words, one or more pipette tips can dispense or aspirate liquid independently of other pipette tips. Additionally, the spacing between adjacent pipette tips can be changed by the control software and motors. These degrees of freedom allow the analyzer (1000) to perform a variety of analyses, calibrations, self-diagnostics, etc. Those skilled in the art should be able to select appropriate pumps for the device, including but not limited to diaphragm pumps, peristaltic pumps, and syringe (or piston) pumps. The pump also includes a multi-port valve to allow the pump to push and pull fluid from different fluid lines. Alternatively, multiple pumps can be used to independently control the fluid in different fluid lines. In one specific embodiment, the pipetting subassembly includes an aspirating pipette. Optionally, the pipetting probe can include fluid sensing capabilities, such as using ultrasonic capabilities or pressure sensors to detect when the probe contacts the fluid in a tube or well, as a means of minimizing the external wetted surface of the probe and detecting the presence of liquid in the container.

[0270] In one specific embodiment, the pipetting probe includes a multi-channel pipetting probe that enables fluid to be transferred through all pipette tips or through a selected number of pipette tips less than all available pipette tips to multiple wells of a microplate. For example, the pipetting probe includes an 8-channel pipetting head that can simultaneously and independently transfer fluid into one or more channels into a microplate or one or more tubes or wells. Alternatively, the pipetting probe can include a 12-, 96-, or 384-channel pipetting head. In one specific embodiment, the pipetting subassembly is supplied by Tecan Group LTD, Switzerland.

[0271] In an exemplary embodiment, a capacitance sensor is designed between the pipette tip or pipette and the pipetting deck to detect the contact of the disposable tip with the surface of the liquid contained within a tube, plate, or holder found on the pipetting deck. The pipetting deck is preferably conductive and the pipette tip / pipette is also conductive such that a voltage potential can be applied therebetween.

[0272] A common capacitor is a parallel plate capacitor, which consists of two conductive plates that are electrically insulated from each other by a dielectric material. In a simple, parallel plate capacitor, the capacitance is inversely proportional to the distance between the two plates. Quantitatively, the capacitance (C) in farads of two overlapping plates is expressed as:

[0273] C = κε o (A / d), where

[0274] κ i is the dielectric constant (dimensionless) of the material between the two plates

[0275] ε o is the electric constant, which is approximately 8.854×10 -12 F·m -1 ,

[0276] A is the overlapping area in meters between the two plates, and

[0277] d is the distance in meters between the two plates.

[0278] Regarding capacitance level sensing, the capacitance of the system takes into account the various dielectrics continuously found between the pipette tip and the pipette deck. Quantitatively, the total capacitance (C) in farads of two overlapping plates with various dielectrics (e.g., air, liquid, plastic / glass container) between them is expressed as:

[0279] 1 / C = ∑1 / C i , where the capacitance of each dielectric is individually calculated as

[0280] C = κ i ε o (A / d i ), and where

[0281] κ i is the dielectric constant (dimensionless) of the given material between the two plates

[0282] ε o is the electric constant, which is approximately 8.854×10 -12 F·m -1 ,

[0283] A is the overlapping area in meters between the two plates, and

[0284] d i is the thickness in meters of the given material between the two plates.

[0285] In a system having multiple dielectrics, a capacitance change occurs when the thickness of a single dielectric (e.g., air between the pipette tip and the liquid in the plate or holder) approaches zero, resulting in a significant change in capacitance, thereby allowing the system to recognize that the pipette tip is contacting the liquid.

[0286] The inventors have determined that the sensitivity of a specific capacitance sensing system for detecting liquids in conventional tubes and vials can be significantly increased by using a conductive plate or holder made of a plastic with a conductive additive such as carbon, metal, or metal ions. Using the conductive holder, the liquid levels held in the conventional tubes and vials contained in the holder can be determined using the capacitance sensor. Preferably, a 500 μl tube should be filled to at least 50%, preferably at least 40% or 30%, and more preferably at least 10%. A 2 ml tube should be filled to at least 20%, preferably at least 15% or 10%, and more preferably at least 5%. A 4 mL vial with a flat bottom should be filled to at least 25%, more preferably at least 12.5%. A 4 mL vial with a concave bottom should be filled to at least 10%, more preferably at least 5%.

[0287] In one embodiment, the pipetting probe uses disposable pipette tips that are stored in pipette tip storage compartments (1014, 1026). The disposable pipette tips can be stored in one or more standard disposable tip boxes (e.g., 1015 and 1016, available from Tecan Group LTD, Switzerland), and the used tips can be stored in a removable waste container (1008) for used pipette tips. The size of the tips varies according to the size of the pipetting probe, the volume of the sample / reagent dispensed, and / or the size of the plate in which the tips are placed. In one embodiment, the tip volume ranges from approximately 1000 μL to 50 μL. In another embodiment, the tip volume ranges from about 1000 μL to 350 μL.

[0288] As stated above, the pipetting subassembly (1021) provides independent X, Y, and Z movement to the probe or pipette tip to bring it close to wells, tubes, vials, holders, and / or plates. The inventors have invented a training plate that is designed to initialize the analysis system (1000) periodically before or after the first use, such that the X, Y, and Z positions of the pipetting subassembly (1021) and its pipette tip, and the X, Y, Z, G (clamping distance), and R (rotation) of the robotic system (1002) and its clamping pads (1031) can be pinpointed with high accuracy and repeatability.

[0289] As best illustrated in FIG. 10(e), a training or teaching plate (1035) is positioned on a platform (1012). Preferably, the training plate (1035) has dimensions and size similar to an industry standard assay plate (ANSI SLAS 1-2004) and is designed to fit into a slot (1036), also referred to as a plate carrier (1036), which is designed to receive the assay plate. The training plate (1035) can be a solid right-angle prism or, preferably, hollow, having a rigid perimeter and internal webs designed to provide hardness and stiffness. Internal webs are provided for stiffness and stability and include curved bars (1037) and generally linear elements (1038). As shown, the curved bars (1037) have opposite concavities.

[0290] One or more reference points or pads (1040) are defined on the top 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 a robotic system (1002) or preferably to a pipetting subsystem or pipette (1021) is brought into close proximity to, or preferably within 0.1 mm of, the reference pad (1040) to determine a 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. A capacitance sensor for the pipetting subsystem (1021) described above can be used with the conductive training plate (1035) during this initialization process to determine the Z-reference point and Z-maximum of a laboratory ware without contacting the reference pad (1040) with the probe (1042).

[0291] Alternatively, the initialization process can be accomplished with a substrate thinner than about 0.1 mm that is moved back and forth between the probe (1042) and the reference pad (1040). The Z-reference point is determined when the moving substrate is grasped between the probe and the reference pad. In another alternative, a proximity sensor based on a magnetic field that varies with the distance between the probe (1042) and the reference pad (1040) can be used. Exemplary magnetic proximity sensors include Hall effect sensors.

[0292] In another alternative, an optical distance sensor is used. Suitable optical distance sensors are available from Keyence America, SensoPart, Omega Engineering, etc. The optical sensor is attached to or replaces the probe (1042) and is then used to measure the distance to the reference pad (l040).

[0293] This Z-reference point is selected to be midway between the corner holes in the X-Y plane of an industry standard ANSI SLAS1-2004 96-well microplate (8 rows × 12 columns) and at or near the top surface of the industry standard ANSI SLAS1-2004 plate in the vertical Z direction. The dimensions and tolerances of the industry standard ANSI SLAS1-2004 are discussed below. More specifically, the Z-reference point is used to calculate the Z-maximum or highest height in the vertical direction for all laboratory ware. Advantageously, having an accurate Z-maximum for laboratory ware improves the reliability of pipetting, placement, and movement of the laboratory ware.

[0294] The training plate (1035) can be flippable, i.e., the bottom surface has the same features as the top side. In another variation, X-reference and Y-reference points are also determined in addition to the Z-reference point. In this variation, the probe (1042) is brought into contact with at least two reference pads (1040) and Cartesian coordinates (x, y, z) are recorded for each reference pad.

[0295] The training plate (1035) can also be used to initialize the position of the clamping pads (1031) or to match the clamping pads to an assay plate on the platform (1012). A precise and consistent match is preferably achieved to enable proper acquisition (retrieval) and placement (insertion) coordinates for the assay plate or any other plate, holder, well, tube, etc. Clamping areas (1044) are provided on the long and short sides of the training plate (1035), as best shown in FIG. 10(f). During initialization or matching with the training plate (1035) positioned on the platform (1012), the robotic system (1002) positions its clamping pads (1031) on the short or long side of the training plate (1035). The clamping pads (1031) will be positioned within the clamping areas (1044), which are areas defined by multiple raised lines, in order to pick up and move the training plate (1035). When the clamping pads (1031) are so positioned, the relative distance between the pads (clamping distance), the position of the training plate in X,Y space, the orientation (in degrees) of the clamping pads (rotation coordinates), and the Z-elevation are also known to the processor controlling the robotic system (1002) and this matching information is stored and used to guide the robotic clamping pads (1031) to acquire or place laboratory ware in the proper position.

[0296] As shown in FIG. 10(f), the outer perimeter of the first surface (1043) of the reference pad (1040) containing the training plate (1035) is less than the outer perimeter of the opposing surface (1045), which has a water bead line (1041) around the perimeter to provide a greater outer perimeter. When determining the Z-reference point, preferably the opposing surface (1045) with the larger diameter and tighter tolerance is inserted into the nest on the platform (1012). This allows a sliding fit of the reference pad (1040) and more precise and repeatable positioning. When determining the position of the clamping pad (1031) of the robotic arm (1002), preferably the first surface (1043) with the smaller perimeter is inserted into the nest on the platform (1012). This allows the clamping pad (1031) to lift the training plate (1035) without having to exceed any frictional forces caused by the contact between the training plate and the nest.

[0297] The training plates (1035) can be individually manufactured by machine, preferably with tight tolerances by a computer numerical control (CNC) grinder. The training plates can be manufactured by machine to a flatness of five thousandths of an inch or 0.127 mm. If there are dimensional differences between differently manufactured training plates, the differences or variations are determined, for example, by measuring the dimensions of the training plates on a calibrated coordinate measuring machine (CMM) and using the measured dimensions to adjust the training values of the platform / analyzer (1000). The tolerances can be stored in any storage device and are used to reconcile possible differences in measured values when initializing and recalibrating an analyzer with different training plates.

[0298] Preferably, the training plates (1035) are made of cast aluminum for their stiffness, strength, and light weight. The preferred cast aluminum is aluminum plate 5 (ATP 5) or a similar metal. For example, a suitable metal should have a density in the range of about 2,400 to about 3,000 kg / m 3 range, 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 materials include, but are not limited to, stainless steel, brass, titanium, and hard polymers such as polycarbonate and polystyrene.

[0299] The reference pads (1040) preferably have a diameter of about 1.46 mm ± 10% and a distance from the center of the reference pad (1040) to the side of the training plate (1035) of about 7 mm ± 10%. As shown in FIG. 10(e), four reference pads (1040) correspond to the centers of four corner holes in the 96-well microplate discussed above. Preferably, the training plates (1035) are anodized and more preferably gold anodized. Each training plate (1035) has a part number and revision number attached and preferably edged thereon, and a serial number attached thereto.

[0300] In one embodiment, the training plate may have a bar code with its serial number affixed thereto to allow automated access to the dimensional information stored for the training plate.

[0301] The plate washer subassembly can be any suitable commercial microtiter plate washing system, such as a plate washer subassembly available from BioTek Instruments, Inc., Winooski, VT, including but not limited to the 405Touch washer, 405LS washer, Elc405x Select deep well washer, or Elx50 washer. Similarly, the robotic subsystem can be any suitable benchtop commercial robotic system, such as a system available from Tecan Group LTD, Switzerland.

[0302] In one embodiment, the plate oscillator subassembly comprises a counterbalanced analytical consumable oscillator device as described and claimed in U.S. Ser. No. 62 / 143,557, filed Apr. 6, 2015, and described herein with reference to FIG. 9(a), the disclosure of U.S. Ser. No. 62 / 143,557 being hereby incorporated by reference in its entirety. Specifically, the oscillator subassembly can include a 2×3, 2×4, or 2×6 array of twenty storage units. Preferably, the plate oscillator (1006) is an individual thermal oscillator having a heater to maintain the analytical plate disposed thereon at an elevated temperature. The thermal oscillator can be purchased as a BioShake3000-T elm oscillator from Q. Instruments, Jena, Germany. In one embodiment, the plate oscillator (1006) can maintain a temperature that is about 3° C. higher and up to about 37° C. higher than the operating temperature of the analytical system and with a tolerance of about ±0.5° C. Samples, buffers, reagents, etc. contained in the wells of the analytical plate can be mixed and incubated on these oscillators.

[0303] The inventors have also found that the reagents contained in the trough (1018) during an analysis run and the sample / reagent mixture in the analytical plate during incubation and mixing on the oscillator (1006) undergo evaporation. Evaporation of the reagents in the trough (1018) represents a loss, while evaporation of the analytical plate on the oscillator (1006) can cause a change in the concentration of the materials contained in the analytical plate due to evaporation. According to one aspect of the invention, lids are designed for these containers.

[0304] As illustrated in FIG. 10(g), an exemplary slot lid (1028) is illustrated. The lid (1028) is formed and sized to fit securely onto the reagent slot (1018). The lid (1028) has a top (1029) sized and dimensioned to fit over the top of the slot (1018) and sidewalls, with a pattern of cuts (1030) created, for example, by a laser cutter in the top (1029). The cuts (1030) are designed to allow the top (1029) to flex and allow a pipette tip of a pipette tube assembly or pipettor (1021) to insert into the reagent slot (1018) to retrieve the reagent, as shown. When the pipette tip is withdrawn, the cuts (1030) allow the top to resume its original configuration. Any pattern of cuts (1030) may be used as long as the top (1029) flexes to allow the pipette tip to enter and substantially resumes its original configuration when the pipette tip is withdrawn. An exemplary pattern of cuts (1030) is shown in FIG. 10(h); however, the present invention is not limited to any particular cut pattern.

[0305] The lid (1028) limits exposure of the reagent contained in the slot (1018) to the internal space in the analysis system (1000) to only the combined area of the cuts. Generally, an open slot may contain a buffer such as tripropylamine (TPA) which may evaporate, resulting in loss. Limiting the exposure limits evaporation. To further limit the exposure, a second top (1029') having another cut pattern, for example, in a relative orientation, may be placed on top of or beneath the top (1029) to create a tortuous path for the evaporating gas to escape. The lid (1028) may be made of a relatively rigid material or an inelastic material such as polyester, high density polyethylene (HDPE), or polycarbonate, and the flexibility of the top (1029) is provided by the cut pattern (1030). Alternatively, the lid (1028) may be made of an elastomeric material such as natural or synthetic rubber to improve flexibility and optionally, the cuts are made with a sharp cutting tool instead of a laser cutter to minimize lost material and the combined area of the cuts. Preferably, the lid (1028) is thermoformed or vacuum formed and the cuts (1030) are die cut. Thermoforming is a process of heating a plastic sheet over a mold and forming its shape with air pressure and vacuum forming is a similar process but uses vacuum instead of air pressure.

[0306] To minimize the likelihood that the slots (1018) are pulled out of the slotted bracket (not shown with reference numerals in Fig. 10(a)), elastomeric blocks can be inserted between the slots. The elastomeric blocks have a protruding body on each side facing an adjacent slot. Each block will then have two protrusions, and preferably the protrusions have different sizes and / or volumes, depending on the amount of clamping required. For example, the protrusion facing the end slot should have a greater volume than the protrusion facing the center slot.

[0307] As illustrated in Fig. 10(i), the plate lid (1032) does not have a profiling mode because after the processing step is completed and the assay plate (1031) is incubated and mixed on the oscillator (1006), the plate lid (1032) is placed on the assay plate (1031). As discussed above, the oscillator (1006) can be heated to an appropriate incubation temperature. High temperatures promote evaporation, especially when exposed to the environmental conditions inside the assay system (1000). The lid (1032) preferably includes a plurality of downward-facing micro-recesses (1034). Vapors evaporating from the sample / reagent mixture in the wells (1051) within the assay plate (1033) preferably condense at the micro-recesses (1034) and the condensate will drip back into the wells (1051). Preferably, one micro-recess (1034) is positioned above each well (1051) in the assay plate (1033). For example, with respect to a 96-well assay plate, 96 downward-facing micro-recesses are provided on the lid (1032).

[0308] As best shown in Figs. 10(j)-(k), the lid (1032) includes a top-surface-dependent serrated edge (1050). When placed on top of the multi-well assay plate (1033), the outer perimeter of the top surface rests on the outer perimeter of the assay plate (1033), thereby establishing a contact line at (1052). The contact line (1052) provides a throttle or seal to limit or prevent evaporative 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 interfere with the contact at the contact line (1052).

[0309] Additionally, in the embodiment of the lid (1032) shown in FIGS. 10(i)-(k), the second contact lines (1053) are between the bottom surface of the lid (1032) and the top surface of each hole (1051). These second contact lines (1053) provide another barrier to impede the escape of the evaporated vapor. The effectiveness of the second contact lines (1053) with respect to each hole (1051) depends on the flatness of the lid (1032) and the flatness of the top surface of the assay plate (1033). The micro-indentations (1034) together with the serrated edges (1050) also help prevent the lid (1032) from sliding off the assay plate (1051) during oscillation and incubation on the oscillator (1006). Additionally, the micro-indentations (1034) also act as condensation enhancers to facilitate the return of the evaporated condensate into the holes (1051).

[0310] The plate lid is preferably made of polystyrene, polypropylene, or cycloolefin copolymer (COC) or any other material commonly used in biological research.

[0311] To further minimize inconsistent evaporation and condensation, the lid (1032) is preferably made of a hydrophobic polymer or other hydrophobic material and / or the bottom of the lid (1032) is coated with a hydrophobic coating or made hydrophobic.

[0312] The bottom surface of the lid (1032) can be made hydrophobic by micro-etching the surface to create micron-sized air pockets. These micron-sized air pockets can create a rough microtopography that acts as an air buffer to prevent liquids from sticking to the surface. This is also referred to as the "lotus effect" named after the hydrophobic properties of lotus leaves. This effect is also observed on the skin of geckos. The rough microtopography does not allow water to accumulate to prevent widespread distribution. The accumulated water will form larger droplets and fall away from the lid, thereby facilitating condensation. The micro-etching can be achieved by a laser source called TresClean ( http: / / cordis.europa.eu / project / rcn / 200832en.html ). The hydrophobic surface also has antimicrobial properties due to its ability to repel moisture.

[0313] Suitable hydrophobic polymers include but are not limited to poly(tetrafluoroethylene), polypropylene, polyamide, polyethylenediene, polyethylene, polysiloxane, polyvinylidene fluoride, poly(lactic-co-glycolic acid), freeze-dried dura mater, silicone, rubber, and / or mixtures thereof.

[0314] Suitable hydrophobic coatings may also include, but are not limited to, polyethylene, paraffin wax, oil, gelling agents, pastes, greases, waxes, polydimethylsiloxane, poly(tetrafluoroethylene), poly(vinylidene fluoride), tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer, fluorinated ethylene propylene, poly(perfluorooctyl ethyl acrylate), polyphosphazene, polysiloxane, silica, carbon black, alumina, titanium dioxide, hydrated silane, silicone, and / or mixtures thereof. Suitable hydrophobic coatings may also include surfactants such as perfluorooctanoate, perfluorooctanesulfonate, ammonium lauryl sulfate, sodium lauryl ether sulfate, alkylbenzene sulfonate, sulfonated or sulfated fatty materials, salts of sulfated alkylaryloxypolyalkoxy alcohols, alkylbenzene sulfonate, sodium dodecylbenzene sulfonate, fluorosurfactants, sodium lauryl sulfate, sulfosuccinate mixtures, sodium dioctyl sulfosuccinate, sodium sulfosuccinate, sodium 2-ethylhexyl sulfate, ethoxylated acetylenic alcohols, highly oxidized ethylene octylphenol, highly oxidized ethylene nonylphenol, highly oxidized ethylene straight-chain and secondary alcohols, ethoxylated amines of any ethylene oxide length, ethoxylated sorbitan esters, random EO / PO polymers on butanol, water-soluble block EO / PO copolymers, sodium lauryl ether sulfate, and / or mixtures thereof.

[0315] In one variation, the material forming the contact line (1052) on the outer periphery on top of the plate (1033) resting on the outer periphery of the analysis plate (1051) may be roughened, for example, by a wire brush or similar instrument to increase the tortuous path for gases and vapors, thereby minimizing the amount of vapor escape. The bottom surface of the lid (1032) may be roughened to increase its hydrophobicity as discussed above, thus exhibiting Cassie - Baxter behavior. It is known that microstructuring a surface extends the natural tendency of the surface, and in some cases, if the roughened surface can trap vapors (such as air or other gases), the hydrophobicity of the surface can be further enhanced (Cassie - Baxter equation). It is also contemplated that the bottom surface of the lid (1032) may be microstructured using methods known in the art, including but not limited to using micromachining, lithography (lithography, soft lithography (nanoimprint lithography, capillary force lithography, micro - molding in capillaries, transfer micro - molding), electron beam lithography), and plasma etching; as well as chemical bath deposition, chemical vapor deposition, electrochemical deposition, layer - by - layer deposition via electrostatic assemblies, colloidal assemblies, sol - gel methods, nanosphere lithography, water droplet condensation - induced patterning, and / or micro - abrasion to create patterns or textures on the surface. Hydrophobic materials, coatings, and surface treatments are disclosed in published international patent application WO 2012 / 003111, which is incorporated herein by reference in its entirety.

[0316] Optionally, the washer may be placed adjacent to the contact line (1052), preferably on the outer periphery of the lid (1032) adjacent to the tooth edge (1050). One or more stacking features (1057) may be positioned on top of the lid (1032) around its periphery such that multiple lids (1032) may be stacked on top of each other without sliding off.

[0317] The liquid reagent subassembly (1007) includes a plurality of liquid reagent and waste compartments and is for one or more steps of an analysis to be performed in the device. The reagent / waste compartment includes a compartment body enclosing an internal volume and reagent and waste ports for delivering the reagent or receiving the waste. The volume of the compartments in the subassembly is adjustable such that the relative ratio of the volume of the compartment body occupied by the reagent and waste can be adjusted, for example when the reagent is consumed in the analysis and returned to the compartment as waste. The total internal volume of the compartment body may be about 2 times lower, about 1.75 times lower, about 1.5 times lower, or about 1.25 times lower than the volume of the liquid stored in the body (e.g., the volume of the reagent initially provided in the compartment), thus minimizing the space required for waste and reagent storage and allowing convenient one-step reagent replenishment and waste removal. In certain embodiments, the device has a reagent compartment slit configured to receive the compartment and provides fluid connection to the waste and reagent ports, optionally via a one-touch connection or a quick-connect fitting.

[0318] Optionally, the reagent and / or waste compartment is movable. In one embodiment, the reagent and / or waste compartment is movable and the device further includes a sensor, such as an optical sensor, to monitor the fluid level in the reagent and / or waste compartment. Alternatively, the liquid reagent subassembly may include an electronic scale to monitor the fluid weight in the reagent and waste reservoirs, thereby tracking reagent usage and availability in real time. Once the reagent and / or waste compartment reaches a certain minimum or maximum capacity as detected by the sensor or scale, the device warns the user to remove the reagent or waste compartment to replenish and / or empty the contents. Other level detectors may be used. An exemplary level detector includes a plurality of thermistors vertically arranged within each compartment, e.g., at the 1 / 4, 1 / 2, 3 / 4, and full marks. Due to the different heat capacities of the liquid and air / vapor, the thermistors immersed in the liquid generate an electrical signal different from that of the thermistors located in the air or vapor. Another level detector includes a capacitor having one conductive plate at the top of the liquid and another conductive plate at the bottom of the compartment. As described above, the measurable capacitance of the liquid between the two plates varies with the distance between the two plates, thus indicating the amount of liquid contained in the compartment.

[0319] In one embodiment, the pump or motor of the pipetting subsystem (1021) is in communication with these sensors or scales and when the reagent and / or waste compartments reach a minimum or maximum volume, the device fails to operate the pipetting probe motor. For example, the probe sensor relays information regarding the volume of the compartment to the instrument software, which then causes further pipetting actions to cease.

[0320] The reagent and waste compartments may be provided by collapsible bags located within the subassembly body. One of the reagent and waste compartments may be provided by a collapsible bag and the other compartment may be provided by the compartment body itself (i.e., the volume within the compartment body excluding the volume defined by any collapsible bags within the compartment body). Alternatively, the reagent and waste compartments may be housed within the same container and separated by a flexible, movable, or elastic membrane or partition. In addition to the first reagent and waste compartments, the reagent cartridge may further include one or more additional collapsible reagent and / or waste compartments connected to one or more additional reagent and / or waste ports. Alternatively, one or the other of the reagent and waste compartments may be constructed of blow-molded plastic.

[0321] According to another aspect of the present invention, the analysis system (1000) is capable of controlling the internal temperature when its panel or door (1056) is closed. Although not shown with its enclosure and door in FIGS. 10(a)-(c) in order to illustrate the internal components, the analysis system (1000) includes a front door and / or panel generally designated as (1056). These doors and panels are closed before the analysis system (1000) performs an operation. Once the system begins operation, it is preferred that the internal air temperature in the area above and adjacent to the platform where the analysis steps are performed be maintained within a range including approximately 20°C to approximately 24°C. Once the operating temperature is selected depending on the particular analysis being run, the selected temperature is preferably maintained within ±1°C. The temperature control area may be defined as extending from the front of the platform (1012) or the analysis consumable storage unit (1004) to approximately six inches in front of the back of the deck or to the back of the deck. The control area may also extend from the left side to the right side of the platform (1012), or from position 26 to position 49, as shown in FIG. 10(u), for example to cover the length of all oscillators (1006). The analysis system (1000) also has temperature sensors located at multiple locations to monitor the temperature inside the analysis system. The temperature readings are monitored by the software of the system described herein, and if the operating temperature is outside the operating range, the user is notified. The temperature of the liquid in the capped MSD plate on the plate oscillator where the oscillator temperature control is turned off should rise no more than 2°C above the ambient deck temperature over a two-hour duration.

[0322] The selected operating temperature is maintained, although the plate oscillation device (1006) of the assay plate may generate heat when incubated at high temperatures as discussed above, and the assay reader (1003) contains electromechanical components and thermoelectric coolers for heat-generating optical sensors such as charge-coupled device (CCD) or complementary metal-oxide semiconductor (CMOS) devices. The selected operating temperature is maintained by a plurality of TECs (1019), as best illustrated in FIG. 10(c). In this particular embodiment, six TECs (1019) are used; however, any number may be deployed. Preferably, two TECs are concentrated on the reader (1003) to dissipate the heat generated by the reader. The remaining TECs are used to control the selected operating temperature and some of the remaining TECs may be concentrated on the optionally heated oscillator (1006). Additionally, some cooling is directed at the electronic devices (1010, 1011) or the electronic devices housed in the electronic enclosure (1009) discussed below.

[0323] As illustrated in FIG. 10(m) showing a cross-sectional side view of the assay system (1000), the TEC (1019) absorbs heat near its middle portion, as shown by arrow (1046), and generates cold air at the top and bottom, as shown by arrows (1047). The cold air (1047) flows towards the front of the assay system (1000), thereby cooling the enclosure, and is redirected and returns as warm air (1046) due to the closed door or panel (1056), where the heat is absorbed by the TEC (1019). FIG. 10(n) shows a top view, where all six exemplary TECs (1019) are illustrated. The returning warm air is directed towards certain areas closest to the center of the TEC. FIG. 10(o) is a perspective view that more particularly shows the flow of warm and cold air and the partition (1048). Each partition (1048) preferably encloses one or more TECs (1019) as shown, thereby forcing the cold air (1047) to flow up and down, as discussed above. The partition (1048) also brings the returning warm air to the sides of the partition, where the heat is exchanged by the TEC. Additional heat exchange occurs on the hot side of the TEC, outside the enclosure of the analyzer (1000), where the heat absorbed from inside the analyzer is exchanged with the atmosphere.

[0324] Additionally, the oscillator (1006) may be raised above the platform (1002) to allow air to flow underneath and over the top of the oscillator to improve convective heat transfer.

[0325] Figure 10(p) illustrates the cooling of electronic devices (1010, 1011), which are preferably housed in an electronic enclosure (1009). The cooling of the enclosure (1009) uses the chimney effect by drawing in cold air (1047) from the bottom and pulling the air upward to cool the electronic devices (1010, 1011), and expelling warm air (1046) through a cooling channel (1049) to the outside of the analyzer (1000). Preferably, the cooling channel (1049) is located away from the main part of the analyzer (1000) and adjacent to the outer wall or housing of the system as shown for more efficient heat removal. One or more fans are used to draw in cold ambient air and push the air into the electronic enclosure (1009) to cool and expel the warm air through the chimney (1049).

[0326] Returning to Figure 10(l), at least one computer screen or tablet (1058) is attached to the glass surface (1060) of the analysis system (1000). A pressure transducer typically used for a touch screen is attached to or directly adhered to the glass surface (1060) and relies on the glass surface (1060) of the analysis system (1000) to transmit the pressure applied by the user's fingertip to the transducer to generate an electrical signal for the CPU of the tablet or computer. At least one acoustic exciter (1062) also relies on the same glass surface (1060) to generate sound waves. The acoustic exciter (1062) is also attached to or adhered to the glass surface (1060). The exciter (1062) vibrates the glass surface (1060) to cause sound. The touch screen and the acoustic exciter can both be used for the graphical user interface (GUI) or user interface (UI) described herein.

[0327] To minimize or eliminate interference caused by the vibrations generated by the exciter (1062) to the pressure transducer of the tablet (1058), a minimum distance is preferably established between the exciter and the pressure transducer / touch screen. While the human audio frequency ranges from about 20 Hz to about 20 kHz, typical human vocalizations occupy a significantly smaller range, such as about 2048 Hz to about 8192 Hz (the 7th to the 8th octaves). Preferably, the pressure transducer in the tablet (1058) is designed, selected, or adjusted such that it does not respond to the human vocalization range, so that the same glass surface (1060) can be shared by visual and audio devices.

[0328] Additionally, the glass surface (1060) or other surface on the front of the analysis system (1000) may contain lights, such as LED lights or strings of lights. Preferably, the LED lights are located on the door handles of the analysis system and may also be located on the top of the analysis system. These lights can illuminate different colors depending on the status of the immunoassay being run. In one embodiment, the lights can convey satisfactory operation by emitting a constant green or blue light, a flashing or pulsating green or blue light when the system is running, a yellow or red light when an error is detected, and a white light when the system is complete. The same colors can also be displayed on the tablet (1058).

[0329] Another aspect of the analysis system (1000) relates to how the panel and door (1056) are supported on the frame of the system, and the panel and door can be heavy and bulky. Referring to FIG. 10(q), the flange system (1063) includes a main overhanging portion (1066) and a movable bracket (1064) movably mounted on a track (1065) to allow the bracket (1064) to move up and down in the Z-direction. The main overhanging portion (1066) has a C-shaped opening (1067) adapted to receive a pair of supports (1068) mounted on the bracket (1064). Once the vertical position of the door or panel (1056) is satisfactorily established, bolts are screwed into the opening ((1069) to fix the vertical position.

[0330] The horizontal position (X-Y plane) of the door or panel (1056) can also be adjusted by a cam (1070). The cam (1070) can have any shape, including a circular lug mounted off-center on the bracket (1064). More specifically, the cam (1070) is attached via an axis that is separated from the center of the circular lug. A nut (preferably polygonal and more preferably hexagonal) is attached to the lug at the off-center axis. Rotation of the nut will horizontally move the main overhanging body (1066) in the X-Y plane. The horizontal movement of the main overhanging 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 to move slightly within the ellipse.

[0331] Thus, the flange system (1063) allows the door or flange (1056) to be adjusted in two directions to ensure that the analysis system (1000) can be properly closed. The flange system (1063) can be used on any and all doors and panels on the analysis system.

[0332] Optionally, a camera is positioned within the enclosure of the analysis system (1000) to record the analysis run and stream video to a remote location where a user or technician can monitor the analysis run without having to be present at the analysis system. The video can also be saved and stored for future reference. The camera can be mounted on the frame of the analysis system (1000) described below.

[0333] The analysis system (1000) is designed to be stable and as shown in Figure 10(s), the support platform (1012), all permanent components and the table (1001) for laboratory ware / consumables have a length (L) of 85 inches ± n%, a height (H) of approximately 28 inches ± n% (excluding casters), and a width (W) of 33 inches ± n%. When assembled to the table (1001), each caster has a height of approximately 4.5 inches ± n%. The opening (1078) for the plate washer (1005) is approximately 5.5 inches ± n% × 10 inches ± n%. The opening (1080) for the solid waste storage unit is approximately 4.5 inches ± n% × 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 even more preferably 2.5%.

[0334] Referring to Figure 10(t), the frame (1084) has a height (H) of approximately 52 inches ± n%, a front overhang height (Hfront) of approximately 30 inches ± n%, a length (L) of approximately 84.5 inches ± n%, and a width (W) at the top of approximately 34.5 inches ± n%. The bottom support has a long width (W2 bottom) of approximately 33 inches ± n% and a short width (W1 bottom) of approximately 18 inches ± n%. The tolerance n% is preferably 10%, more preferably 5% and even more preferably 2.5%.

[0335] The reader (1003) is advantageously positioned within a recessed opening (1082) and the plate washer (1005) is positioned within a recessed opening (1078) to provide clearance for the movement of the clamping pad (1031) for the robotic system (1002) and the pipetting system or pipette (1021), and to leave room for laboratory wares and consumables on the platform (1012). The reader (1003) is also positioned away from the center, for example, on the side of the table (1001), such that the heat generated by it remains away from the center of the assay plate and is more easily dissipated. The clamping pad (1031) and the pipetting system or pipette (1021) share the same gantry (1022) in order to save space. The assay consumable storage unit (1004) projects a cantilever to the leading edge of the platform (1012) and the oscillator (1006) is positioned towards the back of the platform (1012), as discussed above, to leave room for laboratory wares or consumables on the platform, and to enable laboratory technicians to load consumables from the front and the clamping pad and to pick up and place the consumables from the back. The combination of the dimensions of the table (1001) and the frame (1084) and the positions / elevations of the main components described herein provide stability and space savings for the assay system (1000).

[0336] The electrical and electronic connections are shown in FIGS. 10(v)-(y). FIG. 10(v) shows the power supply and Internet connections. The power supply and Ethernet module (1085) is shown on the left and is connected to the UPS (1086). When the power supply is cut off, the UPS (1086) provides emergency power to the assay system (1000). The UPS (1086) is also connected to the processor (1087) for the reader (1003) and the assay system (1000), as well as the router (1088). The UPS (1086) is also connected to the washer (1005) and its pump and is connected to the robotic system (1002).

[0337] FIG. 10(w) continues the wiring diagram of FIG. 10(v) and shows the right side of the electrical contacts. FIG. 10(w) shows that the UPS is connected to another power supply (1089), which is a 300W AC and 24V DC unit. The power supply (1089) supplies stepped-down power to the DC power module at 5V DC at 24A. This 5V power module supplies power to a plurality of sensors on both sides, such as the waste crusher sensor, the plate washer sensor, etc. on its left side. On its right side, it supplies power to the panel (1091), which powers the lamp panel and illuminates the left and right doors (1092). The panel (1091) also supplies power and signals to the actuator (1062), the touch screen (1058), and the barcode reader (1013).

[0338] Figure 10(x) continues the illustration of Figure 10(w) and shows the control and power PCB (1093), which is connected to six TECs (1019) and their associated sensors (1094). The control and power PCB (1093) also powers the fan (1095) and the reader (1003).

[0339] Figure 10(y) shows the deck control PCD (1096), which powers five oscillators (1006), a bar code reader (1098), and a thermistor sensor (1099) for monitoring and analyzing the temperature associated with the reader (1000).

[0340] Figure 10(z) is a top view, which shows the board carrier (1036) and the tip carrier (1026).

[0341] In each of the analysis systems depicted in Figures 9 - 10, the additional microprocessors and computers in the analysis system can interact with the identifier by causing data and commands for / from the analysis consumable identifier to be transferred through the system to a plurality of microprocessors / controllers to perform the various operations of the components listed above within the analysis system as described below.

[0342] The system can adjust the analysis parameters based on the consumable data saved to the identifier and / or provided as consumable data via a direct or indirect interface before initiating the analysis. Thereafter, the system makes the appropriate electrical, fluidic, and / or optical connections (using electrical connectors, fluidic connectors, and / or optical connectors on the consumable and the system) with the consumable and performs the analysis using the consumable. The sample can be introduced into the consumable before inserting the consumable into the system. Alternatively, the sample can be introduced by the components of the system after the consumable is inserted into the system. The analysis can also involve adding one or more analysis reagents to the consumable and the instructions regarding the addition of those different analysis reagents can be saved to the identifier and / or provided as consumable data and the system adds those reagents to the consumable according to the instructions saved to the analysis consumable identifier and / or provided as consumable data before or during the analysis, as further described below.

[0343] (iv) Analytical cartridge and cartridge reader

[0344] Alternatively, the analytical consumable is a cartridge and the consumable further includes elements selected from one or more fluid components, one or more detection components, one or more analysis cells, reagents for performing an analysis, a working electrode, a counter electrode, a reference electrode, a dielectric material, an electrical connection, a drying and / or liquid analysis reagent, or a combination thereof. The cartridge may further include at least one analysis cell that includes a plurality of different analysis test sites and / or zones, each of these test sites and / or zones including a reagent for measuring a different analyte.

[0345] Examples of analytical consumable cartridges useful 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 analytical consumable therein is an analytical cartridge that incorporates one or more fluid components such as compartments, pores, chambers, fluid conduits, fluid inlets / outlets, valves, etc., and / or one or more detection components such as electrodes, electrode contacts, sensors (e.g., electrochemical sensors, fluid sensors, mass sensors, optical sensors, capacitance sensors, impedance sensors, optical waveguides, etc.), detection windows (e.g., windows configured to permit optical measurements of a sample in the cartridge, such as measurements of absorbance, light scattering, light refraction, light reflection, fluorescence, phosphorescence, chemiluminescence, electrochemiluminescence, etc.). The consumable may also include reagents for performing an analysis such as binding reagents, detectable labels, sample processing reagents, wash solutions, buffers, etc. The reagents may be in liquid form, solid form, and / or immobilized on the surface of a solid phase support present in the cartridge. In this embodiment, the consumable includes all components necessary for performing the analysis. Additionally, the analytical consumable is used in conjunction with a consumable analysis reader that is adapted to receive the consumable and perform certain operations on the consumable such as controlling fluid movement, supplying power, performing physical measurements on the cartridge, etc.

[0346] More specifically, the analytical consumable cartridge has one or more analysis test sites (e.g., pores, compartments, chambers, conduits, flow cells, etc.) that may include one or more analysis zones for performing a plurality of analytical measurements (e.g., individual locations on the surface of the analysis test site where an analytical reaction occurs and / or where an analysis-dependent signal is induced, such as an electrochemical or electrode-induced luminescence signal). In this embodiment, the analysis zones are supported on an analytical electrode (in one embodiment, an array of analytical electrodes, such as a one-dimensional array of analytical electrodes) to permit analysis based on electrochemical or electrode-induced luminescence measurements. The analysis zones are optionally defined by a dielectric layer deposited on the electrode. Additionally, the analytical consumable may have one or more attributes that make it suitable for "point-of-care" clinical measurements such as small size, low cost, disposable, multiplex detection, ease of use, etc.

[0347] The analysis consumable cartridge may include necessary electronic components and / or active mechanical components for performing analytical measurements, such as one or more electrical energy sources, ammeters, potentiometers, light detectors, temperature monitors or controllers, pumps, valves, etc. Alternatively, some or all of the electronic and / or active mechanical components are arranged in a separate analysis reader. The analysis reader will also have appropriate electrical, fluid, and / or optical connections to the analysis consumable to use the consumable for analysis. With this arrangement, the analysis consumable can be designed to be low-cost and disposable, while the analysis reader (which has more expensive and complex components) is reused.

[0348] In one embodiment, a cartridge-based biochemical detection system may include a system housing containing an optical detector, wherein the system housing is adapted and configured to receive and position an analysis consumable and / or an optical detector for processing. The system may further include a support subsystem, which may include one or more of the following: a storage subsystem for storing analysis reagents / consumables and / or waste; a sample collection / pre-treatment / storage subsystem for sample handling; a fluid handling subsystem for handling the reagents, samples, waste, etc. and for providing fluid to the detection chamber via a fluid inlet line; an electrical subsystem for making electrical contact with the cartridge and supplying electrical energy to electrodes; and a control subsystem for controlling and coordinating the operation of the system and subsystems and for acquiring, processing, and storing optical detection signals. Information associated with the analysis consumable identifier and / or provided as consumable data may include information for controlling or regulating one or more of the analysis system components before and / or during the analysis using the analysis consumable.

[0349] Additionally, the analysis consumable may be a container holding one or more analysis reagents, including but not limited to one or more buffers, diluents, and / or reagents used by the analysis system to perform the analysis. The analysis consumable identifier may be attached to the container and / or to the packaging for the container.

[0350] B. Analysis Consumable Identifier

[0351] In one embodiment, the analytical consumable identifier includes a memory for storing information related to the consumable, its history, and / or its use. In one embodiment, the memory is non-volatile memory. Non-volatile memory is computer memory that retains stored information without the need for power. Examples of non-volatile memory that can be used for the consumable 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 mixtures of these methods (e.g., magneto-optical memory).

[0352] In one embodiment, the analytical consumable identifier includes an erasable programmable read-only memory (EPROM), 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 analytical consumable identifier includes an electrically erasable programmable read-only memory (EEPROM), a class of non-volatile electronic memory that can be erased and reprogrammed electrically without exposure to UV light. EEPROM can be written or reprogrammed more than once and can be selectively programmed (a customer can change the values of certain pools without erasing the programming of other pools). Thus, a partition of data can be erased and replaced without changing or reinstalling the remainder of the programming of the chip.

[0353] In another embodiment, the analytical consumable identifier includes flash memory, a specific type of EEPROM that is erased and programmed in large blocks. Although flash memory is technically a type of EEPROM, the term "EEPROM" is generally used to specifically refer to non-flash EEPROM that can be erased in small blocks, typically bytes. Because erase cycles are slow, the large block size used for flash memory erasure gives it a significant speed advantage over traditional EEPROM when writing large amounts of data.

[0354] In another embodiment, the analytical consumable identifier comprises a smart card, chip card, or integrated circuit card (ICC) (collectively referred to as "ICC"). These cards are small cards embedded with integrated circuits that can process and store data. There are two broad categories of ICCs; i) "memory cards", which contain non-volatile memory storage components and optionally, more specific security logic, but do not contain a microprocessor, and ii) "microprocessor" cards, which combine non-volatile memory components with microprocessor components and enable processing of information being read into or out of the ICC. The ICC electronic components are supported on a card typically made of a plastic such as PVC or ABS. The card may include an embedded hologram to avoid forgery. Contact ICCs have conductive contact pads. When inserted into an analytical reader, the contact pads on the ICC contact electrical connectors in the identifier controller to allow transfer of information between the identifier controller and the ICC, e.g., allowing the identifier controller to read, erase, or write information on the ICC.

[0355] Another method of transferring information is via RFID, i.e., radio frequency identification, which is theoretically similar to barcode identification. When using RFID, electromagnetic or electrostatic coupling in the RF part of the electromagnetic spectrum is used to transmit signals. An RFID system consists of an antenna and a transceiver and a transponder or tag, where the transceiver reads the radio frequency and transfers the information to a processing device, and the transponder or tag is an integrated circuit containing an RF circuit and the information to be transmitted.

[0356] Authentication can also be achieved by reading an analytical consumable identifier (e.g., barcode). One of the key differences between RFID and barcode technology is that RFID eliminates the line-of-sight reading on which barcode generation depends. Additionally, RFID scanning can be performed at a greater distance than barcode scanning. High-frequency RFID systems (850 MHz to 950 MHz and 2.4 GHz to 2.5 GHz) provide a transmission range of over 90 feet, although the wavelength in the 2.4 GHz range is absorbed by water (the human body) and thus has limitations.

[0357] In one embodiment, the non-volatile memory for use in the present invention comprises EEPROM, flash memory, ICC, or a combination thereof. In one embodiment, the non-volatile memory is EEPROM. In an alternative embodiment, the non-volatile memory is RFID. In a specific embodiment, the non-volatile memory is an analytical consumable identifier (e.g., barcode), including but not limited to one-dimensional or two-dimensional analytical consumable identifiers (e.g., barcode), or a combination thereof.

[0358] In an additional alternative embodiment, two or more non-volatile memory components may be used in the present invention. For example, a first assay consumable containing a first identifier may be used in the assay system, and an additional assay consumable containing an additional identifier may also be used in the assay system. Each identifier may include the same or different types of memory. However, for each different form of memory, there will be a separate identifier controller. And certain consumable data may be stored on one identifier and other consumable data may be stored on the same or different types of additional identifiers. For example, an assay consumable for the system may include an EEPROM or RFID as an identifier, while the system may also use an additional assay consumable containing, for example, a consumable identifier (e.g., a barcode) as an identifier. The assay system will include an identifier controller capable of interfacing with the first identifier (i.e., EEPROM or RFID), and the system will further include an additional controller that will interface with the consumable identifier (e.g., a barcode).

[0359] 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 a microcontroller to interface with the non-volatile memory via a communication interface, which may incorporate conventional interface architectures and protocols, such as I 2 C (a two-wire serial bus protocol). The microcontroller addresses the non-volatile memory and performs write, read, and erase operations on the memory.

[0360] The consumable identifier may be located on the consumable or it may be a separate component. In either case, the system can be designed to have a unique identifier for each consumable. Alternatively, the system may be configured such that a single separate consumable identifier is used to hold information related to multiple consumables. In one embodiment, each consumable package has a package-specific identifier mounted on (or alternatively, supplied within) the package that holds information related to the multiple consumables within the package. Optionally, each consumable also carries an additional unique consumable-specific identifier attached to the consumable. Such consumable-specific identifiers are primarily used to uniquely identify the consumable and associate it with the information on the package-specific identifier. In this embodiment, batch information content and / or non-editable identifiers, such as consumable identifiers (e.g., barcodes), may be used.

[0361] The various components of the analysis system can be housed together in a single unit or can be housed independently. For example, the analysis system can include an analysis reader and an identifier controller as separate units. The analysis system provides connectivity (which can be wired or wireless connectivity) directly between the analysis reader and the identifier controller or, alternatively, indirectly through additional components of the analysis system. In an alternative embodiment, the identifier controller is housed within the analysis reader. In this embodiment, the analysis reader can be configured such that inserting the consumable into the analysis reader during the conduct of an analysis also enables the establishment of connectivity between the consumable identifier and the identifier controller (e.g., where the mouth into which the consumable is inserted includes components for processing and / or reading the consumable and also includes components for establishing connectivity with the consumable identifier, such as electrical contacts or radio transmitters). In one embodiment, when the consumable is loaded into the analysis system, an electrical contact is created between the controller and the identifier. The controller can then read, erase, and / or write consumable data from / to the identifier. Alternatively, the analysis reader can have a separate mouth for processing / reading the consumable and for establishing connectivity with the consumable identifier. The customer places the analysis consumable or packaging in or near the controller mouth such that an electrical contact is created between the controller and the identifier to enable the controller to read, erase, and / or write consumable data.

[0362] In one embodiment, the identifier includes a non-volatile memory containing an RFID tag, a consumable identifier (e.g., a bar code), an EPROM, an EEPROM, or a combination thereof. Additionally, the identifier can include an EEPROM containing a flash memory and an ICC. In a specific embodiment, the identifier is a consumable identifier (e.g., a one-dimensional or two-dimensional bar code).

[0363] C. Consumable Data

[0364] 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 to control the operation of the analysis system, the analysis reader, or components of the analysis system before, during, or after an analysis or steps of a multi-step analysis. Alternatively or additionally, some or all of the information required for the use of a given consumable can be provided as consumable data. The term "consumable data" can include any information used to uniquely identify a particular analysis or analysis step, an analytical consumable, a consumable domain, a biological reagent or sample, or to distinguish a particular analysis, analysis step, analytical consumable, consumable domain, biological reagent or sample from other analytical consumables, consumable domains, biological reagents or samples. Consumable data can include consumable information, sample information, chain-of-custody information, consumable / test site information, analytical process information, consumable safety information, or combinations thereof. Consumable data can further include information related to one or more analytical tools that can be used by the system to analyze data generated during and / or after the performance of an analysis; analysis system maintenance information; system-consumable upgrade information; and / or system and / or consumable technical support information.

[0365] 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 the consumable identifier and / or provided as consumable data.

[0366] (i) Consumable identification and configuration information

[0367] Consumable data can include consumable identification and configuration information, which includes but is not limited to batch identification information, batch-specific analysis parameters, manufacturing process information, raw material information, expiration dates, material safety data sheet (MSDS) information, product insert information (i.e., any information that may be included or described in the product insert that will accompany the analytical consumable, such as the type of analysis, how the analysis is performed, instructions for the use of the analytical consumable, analytical reagent, or both, etc.), threshold and / or calibration data for one or more reagents used for the analytical consumable or for an analysis or steps of a multi-step analysis, and the location of individual analytical reagents and / or samples within one or more test sites of the analytical consumable.

[0368] Consumable data may also include lot identification information, i.e., information used to identify a particular lot of analytical consumables, which is different from lot-specific analytical parameters, including the information specific to a given lot that can be used by the system, such as to perform an analysis with consumables from that lot or to analyze the results of an analysis derived from consumables from that lot. In one embodiment, if the analytical consumable is a porous assay plate or cartridge, then the lot-specific analytical parameters may include, but are not limited to, the following: (i) a revision level that determines the mode used to interpret the information; (ii) the consumable type; (iii) the manufacturing date; (iv) the lot number; (v) the expiration date; (vi) a crosstalk correction matrix to account for chemical cross-reactivity; (vii) a threshold for the assays to be performed in the consumable and each internal negative control; (viii) a range for each internal positive control; (ix) a range for each assay to be performed in the cartridge for the positive control sample; (x) a software checksum to ensure data integrity; (xi) an acceptable range for the control in the wells (or test sites); (xii) the 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 the consumable; (xiv) calibration information, such as a master calibration curve; and (xv) the number and name of the assay calibrants and / or the assay calibrant acceptance range.

[0369] Consumable data may include sample information, such as the location of the sample within at least one test site of the analytical consumable, the analytical results obtained on the analytical consumable regarding the sample, and the identity of the sample that has been and / or will be analyzed in the analytical consumable.

[0370] Consumable data may also relate to the chain of custody, e.g., information regarding the control, transfer, and / or analysis of the sample and / or analytical consumable. The chain of custody information may be selected from customer identification, sample identification, time and date stamps for the analysis, the location of the analytical system in the laboratory during the analysis, the calibration and quality control (QC) status of the analytical system during the analysis, the custody and / or location information for the analytical consumable before and after the performance of the analysis, the analytical results for a given sample, and free text comment entries created by the customer before, during, or after the system processes the analysis. Additionally, the chain of custody information may include the time, date, manufacturing personnel, or processing parameters for one or more steps during the manufacture of the analytical consumable, and the custody, location, and / or storage conditions for the analytical consumable after manufacture and / or between steps during the manufacture of the analytical consumable.

[0371] Consumable data may also include consumable / test site information, such as consumable type and structure, the location and identity of analytical reagents included within the analytical consumable (e.g., structure, composition, sequence, concentration, and / or origin), and the location and identity of the analytical reagents within the analytical test sites of the analytical consumable. The consumable data may also be used to distinguish a first test site within the consumable from a different test site within the consumable. Additionally, the consumable data may include sample information, which includes the location of the sample within at least one test site of the analytical consumable; analytical results obtained on the sample on the analytical consumable; the identity of the sample that has been and / or will be analyzed in the analytical consumable; or a combination thereof. Additionally, the consumable data is also consumable / test site information, which includes consumable type and structure; the location and identity of analytical reagents included with the analytical consumable; the location and identity of the analytical reagents within the analytical test sites of the analytical consumable; or a combination thereof.

[0372] In an additional embodiment, the consumable / test site information may include information about analyses previously performed by an analytical reader or system on one or more test sites of the consumable, and information about analyses to be performed by the analytical reader on one or more test sites within the consumable. Thus, once the analysis is performed by the system, the controller may be used to write the results of the analysis to the identifier. The information includes, but is not limited to, raw or analyzed data collected by the system during the analysis (where analyzed data is data that has been subjected to statistical analysis after collection and raw data is data that has not been subjected to the statistical analysis), a list of test sites and / or domains within the analytical consumable used during a given analysis, a schedule of events to be performed on the analytical consumable or test sites and / or domains within the analytical consumable, a list of those test sites and / or domains within the analytical device that have not been subjected to analysis, analytical or system errors generated during a given analysis or analytical step, or a combination thereof.

[0373] Additionally, the consumable data can be used as a security mechanism, for example, to confirm that the correct analytical consumable is being used in the system (referred to herein as "consumable safety information"). The consumable data can include a digital signature to prove that the consumable is manufactured by a designated supplier. In one embodiment, if an inappropriate analytical consumable is present in the system, such as a counterfeit consumable or a consumable that is otherwise incompatible with the analytical system, then the controller will malfunction the system, the analytical reader, or its components. Alternatively or additionally, the consumable data can be used to detect the proper placement of the analytical consumable in the system, for example, the proper orientation of the analytical consumable or a portion thereof in the analytical system, such that the controller will malfunction the system, the analytical reader, or its components until the analytical consumable is placed in the correct orientation. Additionally, the consumable data can also be used to detect defects in the analytical consumable or the analytical test site and / or domain, and the controller will malfunction the system, the analytical reader, or its components accordingly. For example, depending on the nature of the defect in the analytical consumable or domain, the controller may not allow the use of the entire analytical consumable or instruct the analytical reader not to allow the use of the test site and / or domain or a set of test sites and / or domains in the analytical consumable. In one embodiment, the analytical reader can perform a diagnostic analysis on the analytical consumable and / or the test site and / or domain therein to identify the defect, and the controller will write the result of the diagnostic analysis to the identifier on the consumable. If the consumable is later used in a different analytical reader, then the result of this diagnostic analysis will be read by the controller and used by the analytical reader to adjust the use of the consumable or the test site and / or domain in the consumable accordingly. In another embodiment, the analytical consumable can be subjected to a quality control process during or after its manufacture, and the result of the quality control analysis can be written to the identifier for later use and / or verification by the customer of the analytical consumable in the analytical reader.

[0374] The consumable data can further include authorization information for the consumable or its test site and / or domain or the biological reagent, such as information on whether a particular customer has a valid license to use a particular consumable or biological reagent, including the number of times the customer is permitted to use the particular consumable or biological reagent in a particular analysis and the restrictions (if any) on such use, such as whether the customer's license is for research purposes only. The information can also include verification information on whether a particular consumable or biological reagent has been recalled or has otherwise become inappropriate or unauthorized for use. The recall information and optionally the last recall check date and / or timestamp can be written to the identifier and / or provided as part of the consumable data.

[0375] Consumable data may further include information regarding the origin of the biological reagent used to analyze the consumable, test site, and / or domain, including, for example, the identification of the original sample from which the biological reagent was generated or the number of generations removed from the original sample. For example, if the analytical reagent used for analysis is an antibody, the consumable data may include the identification of the hybridoma from which the antibody was generated, such as the ATCC accession number of the hybridoma.

[0376] According to multiple embodiments, the biological sample or reagent in or provided with the consumable described above may be separately licensed from the system designed to operate on the biological reagent. In multiple embodiments, the analytical system, analytical reader, or components thereof are coupled to a network that allows the system to establish connectivity with a computer system operated by or on behalf of the customer, manufacturer, and / or licensor of the biological reagent, consumable, or system across a public and / or private network. In multiple embodiments, a limited license may specify the use of the licensed biological reagent, consumable, or system for a particular biological analysis performed only on the licensed system. Accordingly, if a particular customer has a valid license, the system may authenticate the biological reagent, consumable, or system based on, for example, a digital signature contained in an identifier associated with the particular consumable and / or provided as consumable data. In multiple embodiments, the identifier and / or consumable data may also be used to specify a single use such that the biological reagent cannot be refilled for the same authentication.

[0377] In some embodiments, when the identifier can be read by a system, an assay reader, or a component thereof that can utilize a public or private data network operated by or on behalf of the customer, manufacturer, and / or licensor of the bioreagent, consumable, or system, certain consumable data can be made communicable with the assay system and read, written, or erased locally via an identifier / controller on the assay system. For example, recall and / or license information can be a subset of consumable data that is accessible via a direct and / or indirect interface, while additional consumable data can be stored locally on the identifier and otherwise not accessible via a network connection on the assay system, such as lot-specific information, expiration dates, calibration data, consumable-specific information, assay domain information, assay result information, consumable safety information, or combinations thereof. In one embodiment, recall, license, and / or consumable safety information can be accessible via a network connection on the assay system and / or stored as consumable data to the storage medium, and the remaining consumable data is stored locally on the identifier. The assay system or assay reader includes system hardware, system firmware, system data acquisition and control software, and methods or consumable data. In multiple embodiments, the system hardware includes electronic control and data processing circuitry, such as a microprocessor or microcontroller, memory, and non-volatile memory. In multiple embodiments, the system hardware further includes physical devices to manipulate bioreagents, such as robots and sample pumps. In multiple embodiments, the system firmware includes low-level, computer-readable instructions for performing basic operations in conjunction with the system hardware. In multiple embodiments, the system firmware includes microprocessor instructions for initializing operations on a microprocessor in the system hardware.

[0378] The system data acquisition and control software is high-level software that establishes an interface with the system firmware to control the system hardware for more specific operations, such as operating a charge-coupled device (CCD) to acquire visual luminescence information regarding a specific bioanalysis. In multiple embodiments, the data acquisition and control software includes a software-implemented state machine that provides states such as: (i) idle; (ii) running; (iii) paused; and (iv) error. In multiple embodiments, when the state machine is in the idle state, it can receive instructions from the general-purpose machine to perform specific data acquisition or system control operations. In multiple embodiments, the general-purpose computer opens a TCP / IP socket connection with the system, determines whether the system is in the idle state and then begins to transmit instructions and / or parameters. In multiple embodiments, an encrypted TCP / IP connection is established using, for example, the SSH protocol. The instructions and / or parameters can be in the form of ASCII-encoded, human-readable consumable and / or method information that defines the behavior of the biological system. In multiple embodiments, the consumable and / or method is stored in the form of an ASCII text file. In multiple embodiments, the general-purpose computer transfers the ASCII text file to the system using the FTP protocol. In multiple other embodiments, the method and / or consumable information is stored in the identifier and read from the identifier. The method and / or consumable information can be stored in the identifier in the form of an ASCII text file, but it should be understood that the information can be embodied in other data formats without departing from the teachings of the present invention.

[0379] According to multiple 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 multiple embodiments, the method and / or consumable information contains a sequence of operations to be performed by system or control parameters used in conjunction with the data acquisition or control software.

[0380] (ii) Analytical process information

[0381] Additionally, the consumable data may include analytical process information regarding individual analytical parameters to be applied by the system or the analytical reader during the analysis. For example, the consumable data may include the sequence of steps for a given analysis, the identity, concentration, and / or amount of analytical reagents (e.g., buffers, diluents, and / or calibrants to be used in the analysis) to be used or added during the analysis or during specific steps of the analysis. The consumable data may also include the type or wavelength of light to be applied and / or measured by the system or the analytical reader during specific steps of the analysis or multi-step analysis; the temperature to be applied by the system or the analytical reader during the analysis; the incubation time for the analysis; and the statistical or other analytical methods to be used by the system or the analytical reader for the raw data collected during the analysis.

[0382] In one embodiment, one or more steps of the analytical protocol may be tailored for individual consumables or consumable lots. One or more steps of the protocol may vary between consumable lots and / or between individual consumables and consumables within a given lot and the consumable data stored to the system includes instructions for those steps that tailor the analytical protocol. This type of consumable data may be used by the system to adjust one or more operations performed by the system before, during, and / or after the analysis is performed by the system. Additionally, this type of consumable data may optionally be adjusted by the system user at the user's discretion. For example, the dilution step in the analytical protocol may be adjusted to account for lot-to-lot or consumable-to-consumable differences. The amount of diluent added and / or the nature of the diluent may be changed based on the differences. Similarly, the amount of a given reagent that may be added during the performance of the analysis, the incubation period, and / or the temperature for one or more steps of the analysis may also depend on lot-to-lot or consumable-to-consumable differences. Each of these is a non-limiting example of consumable data that may be saved to the storage medium of the system.

[0383] Furthermore, the consumable data contains information that directly or indirectly controls components of the analytical system (e.g., one or more photodetectors, light-tight enclosures); mechanisms for transporting the analytical consumables into and out of the analytical reader; mechanisms for matching and orienting the analytical consumables to electrical contacts in the one or more photodetectors and / or in the analytical reader; additional mechanisms and / or data storage media for tracking and / or identifying the analytical consumables; one or more electrical energy sources for inducing luminescence; mechanisms for storing, stacking, moving, and / or dispensing one or more consumables; mechanisms for measuring light from the consumables during the analysis, the light originating from multiple test sites on the consumables sequentially, substantially simultaneously, or simultaneously; or combinations thereof.

[0384] Consumable data may also include assay process information, which includes assay parameters to be applied by the assay reader during the assay; the sequence of steps to be applied by the assay reader during the assay; the identity, concentration, and / or amount of assay reagents to be used or added during the assay; the type or wavelength of light to be applied and / or measured by the assay reader during the assay; the temperature to be applied by the assay reader during the assay; the incubation time for the assay; the statistical or analytical method to be used by the assay reader for the raw data collected during the assay; or a combination thereof (the assay process information may optionally be adjusted by the user). In a specific embodiment, the assay performed with the consumable is a multi-step assay and the assay process information relates to one or more steps of the multi-step assay. In this embodiment, the consumable / test site information includes information about an assay previously performed by the assay reader at one or more test sites of the consumable; information about an assay to be performed by the assay reader or its components at one or more test sites within the consumable; or a combination thereof.

[0385] Consumable data may additionally include information about the consumable, test site, domain, partition, or biological reagent or sample when an individual operation is performed on the consumable, test site, domain, partition, or biological reagent or sample, such as during the manufacture of the consumable, test site, domain, partition, or biological reagent or when an assay or step is being performed on the consumable, test site, domain, partition, or biological reagent or sample. For example, if an assay consumable includes multiple assay test sites, domains, and / or partitions, then the assay system may perform an assay or steps of a multi-step assay on a single test site, domain, and / or partition of the assay consumable. Once the assay or assay step is completed by the assay system, the controller records the results of the assay to the identifier, such as the raw or analyzed data generated during the assay or assay step, and / or the controller records which test site, domain, and / or partition of the assay consumable was used during the assay or assay step, and / or which test site, domain, and / or partition of the assay consumable has not been used. The assay consumable may be stored for later use and when the customer is ready to use another test site, domain, and / or partition of the assay consumable, the controller reads the consumable data stored on the identifier of the assay consumable to identify which test sites, domains, and / or partitions have been used, have not been used, and / or the results of those assays. The controller may then instruct the assay system, assay reader, or its components to perform an assay or assay step on the unused test site, domain, and / or partition.

[0386] In addition, a given assay protocol may require a set of specific types of consumables. Thus, if a customer inputs a specific type of assay consumable (e.g., a multi-well assay plate) for a specific assay protocol, then one or more additional assay consumables may be required to perform the assay protocol in the system, e.g., one or more reagents may be required to be used with the multi-well assay plate. Each of the required consumables may include a consumable identifier having information about the consumable requirements for the assay protocol. When one of the required consumables is input into the assay system and the identifier controller interacts with the consumable identifier for the consumable, the system will obtain the inventory levels of the components present in the system and compare the results with the consumable requirements associated with and / or stored to the storage medium and / or provided as consumable data with the consumable identifier. If any of the required consumables are not present or are present in insufficient supply, then the system will prompt the customer to input additional required consumables for the assay protocol based on the information stored on the required consumable identifier. If two or more assay consumables are used in the system, then the instrument will correctly identify the first assay consumable and any associated consumables based on the consumable requirements associated with the identifiers for each consumable. The system will verify that the assay consumables and associated consumables are loaded onto the system before a sample run. In the case where only the first assay consumable is loaded into the system without the corresponding associated consumables, if the instrument does not identify the associated consumables within the system within a predetermined period, then the system will prompt the customer to load the associated consumables. The system will inform the customer whether incorrectly matched assay consumables are loaded onto the instrument. If there is no available matching set of assay consumables (e.g., a multi-well assay plate and a given reagent for a specific assay), then the system will not run the sample. The system will check the assay consumable expiration date before the start of the assay and the system will warn the customer and prevent the use of expired consumables. If the consumable has expired before sample aspiration, then the system will not process the sample. If a partially used assay consumable is installed in a different instrument, then consumable usage will automatically start with the next available unused well.

[0387] The identifier can also be used to track the time that a given analytical consumable has been present in the analytical system. Thus, when the analytical consumable is inserted into or comes into contact with the analytical system, a timer in the analytical system is started and the start time is recorded to the identifier. When the analysis is initiated by the system on the consumable or on test sites, regions, and / or partitions within the consumable, the time is also recorded to the identifier. If the instrument, system, or its components are turned off (e.g., by turning off the power), then the timer stops and the time is recorded to the identifier. Thus, whenever the timer stops, the cumulative on-board time is recorded to the identifier.

[0388] (iii) Analytical tool

[0389] In another embodiment, the consumable data further includes one or more analytical tools that can be used by the system to analyze data generated during and / or after the conduct of the analysis. Additionally, the analytical tool can include instructions for the customer and / or the system to generate a specific output by the system software after the conduct of the analysis, such as a data report and / or format for the results of the analysis trimmed based on the consumable data. Alternatively or additionally, the analytical tool can further include one or more statistical algorithms that can be used by the system for the data. For example, the consumable data can include a selection of two or more statistical algorithms that can be used to analyze data generated due to the use of a given consumable and the customer can optionally select an appropriate algorithm for the desired data analysis. The consumable data can also include information that can be used by the customer to select an appropriate algorithm for his or her needs, such as technical notes or literature references related to the algorithm selection.

[0390] The analytical tool can vary between consumable batches and / or between individual consumables within a given batch. In this embodiment, the consumable data is used by the system to adjust the analytical processing tools applied by the system software during the conduct of the analysis or after the analysis is completed and the results are generated and / or displayed. The analytical processing tools include, but are not limited to, analytical thresholds and / or calibration curves, which can be used in one or more steps of an analytical protocol that can also be varied based on consumable differences. In a specific embodiment, for a given consumable type and / or desired use, the consumable data can include project management tools that schedule the conduct of one or more analyses or steps thereof using a given consumable or a set of consumables in the system. Additionally, the analytical processing tools can optionally be adjusted by the system user at the user's discretion. The analytical tool can be sent to the customer via a direct or indirect interface between the system and the customer.

[0391] (iv) Analytical system maintenance information

[0392] The consumable data may further include system maintenance information for the customer, including but not limited to system monitoring reports, system component usage, service history, system troubleshooting information, results of diagnostic programs run on the system, control charts, periodic maintenance schedules, warranty information for the system and / or its components, or combinations thereof. The system software may be programmed to monitor various components of the system and automatically or when prompted, send monitoring reports to a remote computing system and / or to a service technician. If a direct interface is not implemented, then the system may prompt the customer to send the monitoring report to the CD server via an indirect interface. Alternatively or additionally, the system monitoring reports may be accessed by a service technician tasked with performing on-site or remote maintenance and / or service of the system. In this embodiment, the service technician may communicate with the customer regarding service or assistance with the instrument via a direct or indirect interface. In a specific embodiment where a direct interface is implemented, the CD server monitors system component usage and / or warranty information and schedules periodic system / component maintenance and / or upgrades by the service technician based on standard system component lifetimes and / or warranty periods. However, the system may be programmed to automatically monitor the information on the system and if the direct interface does not enable the service technician to evaluate the state of the system and determine if system service or maintenance is required, then it may periodically prompt the customer to send the output of the monitoring activities to the CD server via an indirect interface. Additionally, the CD server may maintain a log of the service history for a given analysis system and schedule service calls by the service technician (which may be done using a direct or indirect interface). The remote computing system may also send individual analysis system software upgrades via a direct or indirect interface.

[0393] (v) System - Consumable Upgrade Information

[0394] In another embodiment, the consumable data includes upgrade materials, such as when new types or batches of consumables become available, especially those products historically used by a given customer. The upgrade materials may also relate to new analysis systems, modifications to current systems, and / or optional accessories or improvements to current systems, especially those modifications, attachments, or improvements specifically related to systems owned or operated by the customer and / or those modifications, attachments, or improvements that may affect the customer's columns based on the customer's prior use. This type of consumable data may also include literature references, brochures, product inserts, technical and application notes, technical presentations, conference information, and upgrade seminars, especially those that may relate to one or more consumables / systems used by a given customer. The upgrade information may be provided to the customer via a direct or indirect interface between the customer and the supplier.

[0395] (vi) Technical Support Information

[0396] Consumable data also includes technical support information that can assist the customer in using the consumable or the system, such as product inserts and brochure information, information on related products intended to be used with the consumable, instruction manuals, training materials, guides, recommended use and / or storage information, data analysis templates, template reports, calibration curves, lot-specific QC data, verified limits of quantification, and troubleshooting methods and / or algorithms. With respect to consumables that include one or more additional consumables (e.g., reagents) or consumables provided with the one or more additional consumables (e.g., reagents), the consumable data may also include reagent catalog numbers, reagent lot-specific information, reagent manufacturing dates, reagent expiration dates, instruction manuals, training materials, guides, recommended use and / or storage, etc. Technical support information may also include receiving feedback or assistance via a direct or indirect interface with a technical support representative, such as a customer training module, consulting services, and / or real-time customer service assistance capabilities to enhance the customer experience (i.e., live chat). It should be understood that the technical support information may pertain to the consumable, the system, or both.

[0397] In one specific embodiment, Table 1 includes a list of consumable data that can be associated with the consumable identifier and / or exchanged between the CD server and the system via a direct or indirect interface.

[0398] Table 1.

[0399]

[0400] D. Specific Embodiments of the Data Association Workflow

[0401] A specific implementation of a data association workflow (a process in which certain data is associated with and stored to a consumable identifier) is illustrated in FIG. 11. In the first step of FIG. 11, a supplier receives a request for a consumable from a sales order or from an internal request to replenish existing inventory levels. The supplier maintains a central database (1100) for multiple types of data as described herein and the central database also includes one or more processors (1101) configured to process data queries, extract data from one or more databases or data tables within the central database and generate, issue and / or store data sets in response to data queries. An order (1102) has a unique identifier associated therewith, such as an order number (1103), and the order number is stored in one or more supplier data tables, such as an order data table (1104). Each customer (whether external or internal) is also associated with a unique identifier, such as a customer number (1105), and each customer number is stored in a customer data table. The customer data table includes customer contact information, delivery addresses, etc. for one or more individuals or organizations associated with the customer. For example, if the customer is a company with multiple locations, then the customer may be uniquely identified by a single customer number, each customer number being associated in the customer data table with the multiple locations of the company, or each location of the company may be uniquely identified by a single customer number. If the customer is internal (e.g., a department within the supplier's organization), then when requesting replenishment of consumable inventory levels, the customer data table may also include one or more sub-directories or data tables for the internal department. Thus, the customer data table includes a unique customer number for a 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 number Y).

[0402] The order is received by a manufacturing technician and a unique consumable identifier is established for the specific consumable (e.g., as described above, a consumable identifier such as a barcode), and the consumable identifier is stored in a consumable identifier data table (1107). Thus, in one embodiment, all data uniquely associated with the consumable is associated with the consumable identifier and is also stored in the consumable identifier data table. Alternatively, different types of data related to the product (e.g., quality-related data or manufacturing-related data) can be stored in individual data-specific data tables and each entry is indexed by the consumable identifier. Thus, 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 and if data regarding the consumable is needed, then the consumable identifier is scanned via a consumable identifier controller and the data associated with the consumable is downloaded to a computing system requesting data regarding the consumable. The system also includes a customer number-order number-consumable identifier related data table (1108) such that for each customer, order, and consumable, there is a unique association (customer number X - order number Y - consumable identifier Z) between customer X, order number Y, and consumable identifier Z, and this association is stored in the data table. Additional unique identifiers can also be associated with the order, such as catalog number, salesperson number, order sub-component, etc. Each association with the order number can be stored in one or more additional data tables in the system. Based on the type of consumable required in the order, the technician queries one or more manufacturing and / or order fulfillment data tables in the system to identify the set of consumable data (consumable specification data table (1109)) required for the manufacture of the consumable or the fulfillment of the order. The data is associated with the consumable identifier for which the consumable is manufactured or the order is fulfilled, and an additional set of consumable data related to the manufacture of the consumable or the fulfillment of the order is associated with the consumable identifier. Consumable data related to the consumable or lot during the manufacturing process to date is saved to the consumable identifier data table. The manufacturing process can also include a quality control system where the product undergoes one or more quality control steps. Unique data resulting from each quality control step performed on the consumable or lot is associated with the consumable identifier and the consumable identifier data table and / or quality data-specific data tables are updated to include this data. The consumable or lot (1110) is then transferred to the shipping section, shipping event - data is associated with the consumable identifier, such as packaging date, shipping date, etc., and the consumable identifier data table and / or shipping-specific data tables are updated accordingly.

[0403] It will be apparent that while Figure 11 and the accompanying description refer to consumables, consumable data, etc., the same process outlined in Figure 11 can be used to associate data with an instrument, a reagent kit comprising multiple components, etc. For example, if the consumable is a reagent kit comprising multiple components, then when the order is transferred to manufacturing and a manufacturing technician queries the consumable specification data sheet for data regarding how to manufacture the reagent kit, the consumable specification data sheet will provide a list of the components of the reagent kit and each component of the reagent kit will include a unique component identifier that is correlated with the reagent kit identifier in the system.

[0404] As mentioned above Figure 1 As described, consumable (batch and / or instrument) data is generated by the supplier before, during and / or after individual consumables and / or batches of consumables are manufactured and / or distributed. The CD establishment system generates a database of CD information about the consumables or batches, i.e., a CD database, in which the consumable data is stored. The CD database is sent to a CD server (104), which includes a master repository for all consumable data. In addition, the CD establishment system stores information for associating a given consumable identifier with the consumable data in the master repository. The CD establishment system and / or CD server is located on a remote computing system (i.e., away from the analysis system and / or the customer or the customer's computing system), such as a site maintained by the supplier. In one embodiment, the remote computing system is a data bus or cloud-based system, for example, a system hosted by a third party (e.g., Amazon Web Services) but maintained by the supplier. The data bus may include any suitable data structure, for example, each customer may have an independent data structure on the data bus, which is secure and different from other customer data structures on the data bus. As Figure 2 As described in , upon receipt of an order from a customer or when the consumable or batch is manufactured (step i), the supplier generates, stores and sends a CD database on the data bus to a CD server (201) (step ii). The CD database may include order fulfillment information, i.e. an overview of the components of an order for a given customer, so that the system can verify that all components of the order have been supplied to the customer. The customer receives a consumable (202) including a consumable identifier (203) and brings the consumable into contact with an analysis system (204) prepared for implementation of the analysis (step iii), the system reads the information associated with the consumable identifier (203) and the information is used by the system to identify the consumable (202) (step iv). The system reviews the consumable data stored locally in a local storage medium on the system (at Figure 2(referred to herein as "local CD") to identify the consumable data stored to the storage medium and available for use in performing an analysis using a given consumable. If the storage medium includes consumable data regarding the consumable or lot of consumables, then the consumable is available for use in the system (step v). If the storage medium does not include consumable data regarding the specific consumable or lot of consumables, then the system may query the customer for the consumable data and the customer may communicate with the supplier to receive the necessary consumable data, such as via email, compact disk, memory card / stick, flash drive, network data storage service, etc. (step vi). The supplier sends the consumable data binary file (including but not limited to an encrypted XML file) to the customer, for example in the form of an email attachment to the customer's email account, and the customer loads the file attachment into the analysis system and the system software stores the consumable data to the local system consumable data repository. The consumable / lot of consumables may then be used with the instrument (step vii).

[0405] In an alternative embodiment, if the CD server is not locally available to the system, then the CD server may be connected to the system via a direct interface that automatically obtains the consumable data from the CD server. In this embodiment, the supplier generates, stores, and sends the CD database to the CD server for a consumable order and / or lot of consumables, as Figure 2 shown and as described above. Subsequently, the customer receives the consumable, order, and / or lot and exposes the system to the consumable identifier such that the system is able to identify the consumable or lot. The system software queries the system consumable data repository for the consumable data associated with the consumable identifier and if the consumable data is locally available to the system, then the software adjusts the system based on the consumable data as necessary. If the consumable data does not exist in the system consumable data repository, then the system will (i) prompt the customer to manually obtain the consumable data from the supplier, or (ii) automatically obtain the consumable data from the CD server via the direct interface with the CD server and locally store the information in the system consumable data repository. Once the consumable data is locally available to the system, the software adjusts the system based on the consumable data as necessary and performs the analysis. Once the consumable data is locally available to the system, the consumable or lot may be used in the system to perform the analysis and display the analysis results to the customer. In a specific embodiment, the system software adjusts the output for the customer based on the consumable data.

[0406] As described above, consumable and / or instrument data can be sent to the data bus via the software, such that the vendor can collect data related to the customer, instrument, consumable, and / or vendor. The software can be programmed on the instrument to automatically collect this data and / or it can be an optional element selected by the customer upon installation of the instrument. In one embodiment, the following consumable data is collected by the instrument and sent to the data bus: the specific consumable identifier for the instrument at the customer location and the analysis layout of experiments performed using one or more specific consumables. For an instrument installed on 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, such as detection signal, CV, mean, image center; performance of controls and calibrants, such as % recovery, detection signal data; identity of consumable identifiers uploaded to one or more instruments connected to the network; audit logs; and / or instrument logs.

[0407] In another embodiment, an exemplary system (also referred to as a laboratory information management system (LIMS)) that coordinates the connectivity between the processors present in the analysis system (1000) and a computer located at the user's facility is shown in FIG. 11(b). The LIMS (1120) is connected to the multiple processors in the analysis system (1100) via a data integration agent server (DIA) (1122). The DIA (1122) is preferably an application programming interface (API) and is an interface between the LIMS (1120) and the bench software (1124) (such as a user interface (UI) and a database (DB) (1126)).

[0408] To initiate an analysis 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 bench (1124) is connected to the DB (1126), uses the UI to guide the user / laboratory technician through the analysis protocol, and the analysis system (1000) or another analysis system (900) runs an immunoassay and reports the results to the DB (1126) in the form of raw ECL data from the reader (1003) (arrow 3) and / or in the form of analyzed ECL data (arrow 2). The DIA (1122) receives the ECL data from the DB (1126) and converts the ECL data into extensible markup language (XML) and sends it to the LIMS (1120) (arrow 5). The LIMS (1120) can send a query regarding the status of the analysis run to the DIA (1122) via the connection (arrow 4).

[0409] Figure 11(c) illustrates the relationship between the Workbench / UI (1124) and the processors in other systems and the analysis system (1000). The Workbench / UI (1124) is connected to components having their own processors, such as the robotic system (1002) including pipettes (1021) and clamping pads (1031). The Workbench / UI (1124) is also connected wirelessly, either via a wire or preferably via a router (1130), to the processors of the tablet (1058) and the reader (1003) that actually display the UI. As discussed above, the Workbench / UI (1124) is also connected to the LIMS (1120). A barcode scanner or customer ID controller (1013) reads consumable identifiers (e.g., barcodes) or unique IDs from any laboratory ware or assay kit. As further discussed below, the consumable identifier (e.g., barcode) or unique ID will inform the Workbench / UI of the type of laboratory ware 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 the cloud (1130).

[0410] The software running the analysis system (1000) contains three main components:

[0411] (i) A user interface (UI) that guides the user through the process of selecting, loading, and running immunoassays as described herein

[0412] (ii) An instrument control system that controls the operation of the robotic system (1002) and the operation and performance verification, as well as reported errors, and

[0413] (iii) The data service described above in connection with Figure 11(b) that stores ECL results and user preferences.

[0414] 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 the confirmation of the analysis system before use and during regular maintenance, which are described below in connection with the operation and performance verification system. The command listener (1134) listens for requests indicating the steps of the immunoassay to be performed by the robotic system (including pipettes (1021) and robotic clamping pads (1031)). The error response listener (1136) listens for error code broadcasts from multiple components of the analysis system (1000).

[0415] Errors are classified into three types: (i) irrecoverable errors that result in data loss, such as communication errors with the reader (1003), (ii) unnoticed recoverable errors, which are errors detected by the software but do not require user intervention to recover, such as failure to detect a single sample, and (iii) interactively recoverable errors, such as the door of the analysis system (1000) not being properly closed. Preferably, the error will return a flag in the generated file and will produce a visual or audio warning. In the case of power loss, the instrument control part of the software will use a universal power supply system (UPS) to control the shutdown of the instrument, and the universal power supply system should be stored in the instrument.

[0416] According to another aspect of the present invention, the UI part of the software is built using plug-ins (also referred to as applications or applets). Once the analysis system has been verified or validated, the operator generally does not want to re-verify or re-validate the system due to software upgrades. Re-verification is necessary when the components of the software system are interconnected. In other words, when a component depends on inputs or instructions from other components to function, then the components are interconnected. Therefore, the UI or workbench of the present invention is characterized in that its components are decoupled from each other. This means that each component can be an independent piece of software. These independent pieces only need to execute the minimum instructions from the main organizer.

[0417] Referring to FIG. 11(e), the main organizer (labeled OSGI) (1140) is connected to the components of the UI platform. In this embodiment, the main organizer (1140) is shown in the form of a bus or message bus and is connected to a plurality of components, such as a security / login / logout component (1142), a UI (1144), an application framework (1146), and an event framework (1148). Other components can be connected to the main organizer bus (1140), such as the instrument control component and the data service component discussed above.

[0418] The main organizer (1140) operates similar to a traffic controller and sends start or shutdown requests to the components when it is necessary to operate or shut down the components. The communication between the components is implemented through the main organizer bus, except that the main organizer (1140) can instruct the components to send information or data to each other. For example, in FIG. 11(e), when directed or requested by the main organizer (1140), the event framework (1148) that creates and maintains a log file of events during the analysis run can announce or notify significant events, such as the reading of the analysis plate, to the application framework (1146). In the absence of the main organizer (1140), such announcement or notification would not exist.

[0419] These connections between components do not rise to the level of connectivity that would require revalidation of the workbench / UI platform (if a component requires a software upgrade). Alternatively, the main organizer (1140) can also act as a conduit to transfer data passing from one component to another.

[0420] An application can be established by an application implementation (1150) that obtains code from a storage medium, such as a base application (1152) that may be present in the application framework (1146). The base application (1152) stores code that can be accessed by the application implementation (1150) for use by the UI during analysis runs. When the main organizer (1140) instructs the closure of the closure framework (1142), the application established by the application implementation (1150) can be retained or removed, as illustrated in FIG. 11(e). The application implementation (1150) is shown outside the UI platform and can be another software component connected to the main organizer bus.

[0421] Due to this decoupled architecture, if a component requires a software upgrade, then that one component should be revalidated, rather than the entire software system.

[0422] In another embodiment, other major components can have a similar architecture. For example, the instrument control component can have its own internal main organizer to control the traffic between its internal components having processors, such as a robotic system (1002), a pipettor (1021), a robotic gripper (1031), a plate washer (1005), a plate (1058), a reader (1003), etc. A software upgrade for one of the internal components of the instrument control will not require revalidation of the instrument control and will not require revalidation of the software of the analysis system (1000).

[0423] The major software components (i.e., the workbench / UI, the instrument control, and the data service) can also be connected to the main organizer and share the same software architecture.

[0424] An example of the UI is shown below.

[0425]

[0426]

[0427] 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 guides the user through these steps to perform the analysis.

[0428] Figures 12(a)-(l) illustrate an exemplary software framework for the collection, deployment, and location of Global Product Data (GPD) for porous assay kits and plates available from Meso Scale Discovery, Rockville, MD. While the following description and figures specifically relate to plates and kits, it should be understood that the software frameworks and methods described herein also apply to assay systems, instruments, and additional assay consumables other than plates and kits.

[0429] The GPD is associated with a consumable identifier, such as a Global Product Identifier (GPI). The GPD is a flexible data container that contains a collection of consumable data as described herein, which may include the following non-limiting list of data for a given consumable (e.g., a plate, an assay reagent container (reagent holder), or an assay kit):

[0430] · Physical consumable characteristics, such as plate characteristics, e.g., plate type, geometry, pattern

[0431] · Image processing parameters

[0432] · Detection parameters

[0433] · Plate coating, assay assignment

[0434] · Partial plate information

[0435] · Recommended sample layout

[0436] · Assay protocol

[0437] · Assay workflows or scripts and instrument parameters associated with the GPI

[0438] · Contents of the test kit, such as product inserts, reagents

[0439] · Recommended assay information, such as fitting curves

[0440] · Recommended reports

[0441] · Customer order information, such as expiration of the consumable, consumable lot information, etc.

[0442] As shown in FIG. 12(a), a Data Deployment Package (DDB) is a container configured to organize and collect relevant consumable data (e.g., data related to individual consumables). The DDB is assembled by the vendor and deployed to the vendor software product. The DDB provides a framework for deploying new information or data to the customer, such as a software package operating on the customer analysis system. The GPD is an instance of the DDB. Some additional instances of the DDB include, but are not limited to, new analytics, new plate types, new consumable types, etc. Different types of products (e.g., consumables and instruments or analysis systems) are each associated with different DDBs. For example, the analysis system includes a unique identifier as described above, and the identifier is associated with the DDB for the analysis system, which may include, but is not limited to, system identifier authentication, analysis system information, and other technical data related to the analysis system, such as:

[0443] · Physical system characteristics, such as system components, configuration, etc.

[0444] · Subsystem characteristics, configuration, etc.

[0445] · Associated consumable type

[0446] · A workflow guide for guiding users through system usage

[0447] · Customer order information, such as system manufacturing information, etc.

[0448] Each DDB has a DDB identifier (UID), a version number, and a deployment package profile. The UID and version number together uniquely identify the DDB. The profile describes the DDB content and the instructions for processing the DDB, including a description of the steps required to integrate the DDB into the local analysis system software package. The DDB provides a deployment framework for allocating the GPD. The data contained within the DDB can be in a stand-alone file structure or in one file structure. The format of the file can be XML, key-value pairs, etc. The DDB can be distributed via various forms, such as the vendor e-commerce site or an email attachment.

[0449] As shown in Fig. 12(b), for installing the DDB, the file is partially placed on the analysis system in a specified directory. Using a plug-and-play framework, the local software system detects the package and processes it to incorporate it into the software. The local software contains a register which is a directory listing information about the services and data available on the software. The DDB registers what data is available to be obtained from itself using the register and the DDB guides the local software on how it should proceed. The DDB also includes a filtering processor that controls the data exposed in the register and the characteristics of the exposed data, for example to resolve or remove data conflicts that may occur between one DDB and another, such as between one board and another board.

[0450] The DDB includes a unique DDB UID and version. As shown in Fig. 12(c), the DDB may include data that will persist to the local data store, such as the DDB UID and version. The data is persisted so that if the DDB includes a large data set, then the data types required during system operation can be effectively accessed. The data is persisted by identifying one or more data types in the DDB and storing the data in a local database structured for the data types. In one embodiment, the complete content of the DDB is persisted, i.e., restructured locally in a separate data set. In a specific embodiment, the DDB UID, version, board static data (data about the board type) and / or board processing data (data for processing and / or running the board) are persisted. In another specific embodiment, the DDB UID, version and board static data are persisted. During DDB installation, the software determines whether the DDB has data to be persisted and whether the data has already been persisted using the DDB UID and version. After persisting the DDB data that needs to persist to the data store, the DDB UID and version are saved to track what has been stored. This eliminates unnecessary data storage operations for the same DDB by detecting that the data has already been stored.

[0451] Generally speaking, software understands and processes specific versions of data formats. The DDB framework supports different versions of data formats and different versions of software for easier maintenance. Figure 12(d) illustrates how different software versions of DDB can coexist in the software. As shown in Figure 12(d), the software is configured to upgrade previous data format versions and the software is backward compatible with older DDB versions. Similarly, DDB can provide a downgrade to previous data format versions. By providing a downgrade, the DDB can be backward compatible with previous software versions. Thus, in the framework illustrated in Figure 12(d), DDB does not need to be re-released to cooperate with new software versions and can establish a DDB that works with multiple versions of the software. DDB files are upgraded and / or downgraded as needed, one or more files are stored locally and / or persisted, and the DDB processor (agent factory) converts the original categorical data into a data type or format that can be used by the software to perform an analysis or analysis step on the analysis system.

[0452] As shown in Figure 12(e), a typical DDB for a plate may include the following consumable data:

[0453] · The plate static data contains data about the plate type. These are characteristics related to the physical plate, regardless of the type of instrument that will be used to process the plate. Some example characteristics:

[0454] ○ The number of columns / rows of holes

[0455] ○ The number of spots per hole

[0456] · The plate processing data contains data for processing / running the plate. The plate processing data is typically instrument-specific. Some example characteristics:

[0457] ○ The number of partitions / circuits

[0458] ○ The detection parameters for reading the plate, such as camera binning, waveforms, etc.

[0459] ○ The image processing characteristics for generating ECL results

[0460] ○ Plate type gain

[0461] ○ Spot gain

[0462] ○ Optical crosstalk matrix

[0463] · The kit contains data (such as assays), and kit information. Some example data will be:

[0464] ○ Assay spot assignment

[0465] ○ Assay protocol

[0466] ○ Data analysis parameters

[0467] ○ Product insert

[0468] · The batch contains specific data regarding the test kits or plates established for an order.

[0469] Figure 12(f) illustrates how an embodiment of the GPD DDB is deployed and Figure 12(g) is a diagram of an instance of the DDB xml and the files within the GPD DDB. As illustrated in Figure 12(g), the DDB xml describes the data within the DDB and how the data is processed, the GPD is a data container that refers to the data by UID and version, and the GPI to GPD mapping provides index data for the relevant GPI. Additionally, Figure 12(g) shows that other data can also be encapsulated within the DDB.

[0470] Figure 12(h) shows how GPD data is located. The software includes a GPD service processor that interacts with the register to locate GPD data. Using the GPD, the software identifies the type of data required for a given consumable and the characteristics of the data and filters the register for the required data. As described above, if the required data is not included in the local register, then the GPD service queries the main repository for the required data and downloads the data locally. Most searches use the UID as the search criterion and the UID can be obtained from the GPI to GPD mapping. The GPD proxy factory obtains the UID and receives GPD data from the appropriate data store for the system software (in the embodiment illustrated in Figure 12(h), client 1 is, for example, the analysis system software, and client 2 is, for example, a related stand-alone software system that provides user-interface functionality for the software in client 1, such as at a remote laptop or desktop computer). The following are two possible options for how the data search can occur:

[0471] (a) The DDB registers all the data it provides. The GPD service queries the register for matches. Some aspects of this search method include but are not limited to:

[0472] · The register contains multiple entries and all data can be accessed directly through the register.

[0473] · The search can be slow, depending on the register implementation.

[0474] (b) The DDB only directly registers a selected subset of data items. It also registers search providers that can be used to locate data, instead of directly exposing all available data. The GPD service indirectly uses the search of the DDB provided by searching the register. Aspects of this search method include but are not limited to:

[0475] · The DDB manages the data it provides, hiding or filtering details it does not need to expose.

[0476] · Less information is published to the register, making it smaller.

[0477] · This approach is well - suited for proxy factories and resource - constrained systems.

[0478] These search options are not mutually exclusive. The GPD service implementation can support both and expose each DDB definition.

[0479] Figure 12(i) illustrates option (b), where the proxy factory is responsible for accessing the final data. In this embodiment, the analysis system software interacts with the GPD service to access data and the GPD service uses the register internally to search for the requested data or uses a GPD proxy factory that can provide the data. The GPD proxy factory is registered as a provider of data and it receives data from the data store and returns the data.

[0480] For example, a supplier manufactures a batch of consumables, such as boards, and each board has a GPI. The batch of consumables will be present in the DDB and the DDB has a single UID and all GPIs within the batch (regardless of how large the batch is) will be associated with the individual batch - specific UID. When a customer purchases a board that is a member of the batch and the board GPI is read by the analysis system, the software identifies the type of data required for the board and the characteristics of the data and filters the register for the required data. As described above, if the required data is not included in the local register, then the GPD service queries the main repository for the required data and downloads the data locally. Using the GPI, the software queries the local and remote databases for the UID and locally installs the required GPD, which can be immediately used to process the individual board or, if another board from the same batch is processed by the system, can be used at a later time.

[0481] As shown in Figures 12(j) - (l), the GPD searches different stages in its life cycle from installation to data retrieval. These stages include, but are not limited to:

[0482] · All data for the DDB is collected and packaged in a DDB file for deployment.

[0483] · The DDB file is delivered to the software in a predefined directory.

[0484] · The DDB instructs the software what needs to be done. It controls how it should be processed.

[0485] · The GPD data is extracted according to the instructions and stored in the software system. The UID and version are used to track whether the GPD data has been previously processed and can be skipped.

[0486] · Some GPD data will be extracted to the file system when appropriate and the location of the data is saved in the database.

[0487] · The remaining part of the data is placed in the database.

[0488] · Once the file has been processed, it no longer has any data that was not previously in the system and it will be moved from the deployment directory to the archive / backup directory.

[0489] · The software client uses the GPD service to receive GPD data.

[0490] · Using the GPI-to-GPD mapping, the software can determine which GPD data should be used with a given plate.

[0491] · After reading, the software board data memory will contain a read-only copy of the data from the GPD for the plate and the data generated by processing it.

[0492] Examples of the interaction between GPD-DDB and GPI are discussed below.

[0493] The GPD may include a general analysis protocol (e.g., steps in an analysis), which contains all the steps of multiple analyses preferably within one type of analysis (e.g., immunoassay, which includes pharmacokinetic analysis, immunogenicity analysis, U-PLEX, V-PLEX analysis, and other types of analysis). Certain specific analysis protocols within one type of analysis may not require all the steps in the general analysis protocol. Instead of preparing a unique analysis protocol for each specific analysis, the GPD of the present invention includes a general analysis protocol and an instrument parameter file related to the GPI of the specific analysis.

[0494] As shown in FIG. 12(m), a streptavidin plate, a protocol or script for indirect analysis is shown. This protocol or script contains multiple steps, including but not limited to diluting the samples for plates 1-5, blocking the plate, coating the plate, incubating the samples, preparing the first detection incubation, preparing the second detection incubation, and reading the analysis plate. For another analysis in this type of analysis, the second detection step is not initiated, as shown in FIG. 12(n). Another analysis may not require the plate coating step, as shown in FIG. 12(o), and another analysis in this type of analysis may not require the plate coating step and may not require the second detection step, as shown in FIG. 12(p). The following table outlines the analysis protocols in FIGS. 12(m)-(p).

[0495]

[0496]

[0497] Analysis 1: Custom analysis, streptavidin plate, indirect analysis

[0498] Analysis 2: Custom analysis, streptavidin plate, direct analysis

[0499] Analysis 3: Custom analysis, uncoated plate, indirect analysis, off-line coating

[0500] Analysis 4: Custom analysis uncoated plate, direct analysis, off-line coating

[0501] In this embodiment, since all steps in Analysis 1 are performed, this scheme may serve as a general scheme for a customized sandwich immunoassay, said analysis including pharmacokinetic analysis. The general scheme is preferably part of the GPD. Accompanying the GPD is an instrument parameter file related to the GPI specific to Analysis 1. The instrument parameter file will include a plurality of flags or switches. Each flag or switch will be on ("1" or "true") or off ("0" or "false"). Regarding Analysis 1, all flags in the instrument parameter file will be on. Regarding Analysis 2, the flag related to the second detection agent will be off, while the remaining flags will be on. Regarding Analysis 3, the flag related to the coating of the plate will be off, while the remaining flags will be on. Regarding Analysis 4, the flags related to the coating of the plate and the second detection agent will be off, while the remaining flags will be on.

[0502] The general scheme will be the same for all of these exemplary Analyses 1-4 and for other compatible analyses in this analysis type, but the instrument parameter files for Analyses 1-4 are files that are much smaller in size than the general scheme and are different. An exemplary instrument parameter file is illustrated in FIG. 12(q), which is a computer-readable file in text format. A plurality of flags are located at the bottom of this text file. Some flags are on or true and some are off or false. Analyses 1-4 include pharmacokinetic analysis.

[0503] In this embodiment, prior to running a specific assay, the GPI for that specific assay, such as a consumable identifier (e.g., barcode) on the outer box of a kit containing laboratory ware and consumables for that specific assay (such as an assay kit available from Meso Scale Diagnostics), is read by a barcode reader or other processor. The GPI is mapped by the processor of the assay system to its associated GPD. This processor will then determine whether the general protocol or script is included in the processor / memory of the assay system and whether an instrument parameter file associated with the GPI has been stored in the memory of the system. If not, then the processor may download the general protocol and the instrument parameter file, the general protocol preferably being stored in binary format to minimize its size, and the instrument parameter file being stored in text format from an external system or server or from the cloud.

[0504] Another table below illustrates another example of a general protocol or script for a bridging immunoassay, and a specific instrument parameter file associated with the GPI for an IG assay with acid treatment, and another specific instrument parameter file associated with the BPI for an IG assay without acid treatment.

[0505]

[0506]

[0507] Using a general protocol for multiple assays where individual instrument parameter files have on / off flags uniquely associated with the GPI of a specific assay provides an improvement to specific computer technologies used with immunoassays and more specifically immunoassays using ECL and automated immunoassays.

[0508] The embodiment of the protocol or script shown in conjunction with FIGS. 12(m)-(s) may represent a best practice recommended to the user. The user interface may allow the user / laboratory technician to further fine-tune by giving the user multiple options to turn other features on or off immediately before the start of an assay run. With respect to the sandwich immunoassay, such as assays 1-4 discussed above, the user interface may give the user / laboratory technician one of multiple non-limiting options below.

[0509] · Assay type: direct or indirect

[0510] · Plate type

[0511] · Standard curve settings, including the number of points on the curve, dilution factors, etc.

[0512] · Control settings, including the number of controls on each plate, dilution factors for each control

[0513] · Sample setup, including the number of duplicates for each unknown and the dilution factor for each

[0514] · Wash plate: Y / N

[0515] · Blocking: Y / N, including blocking volume, incubation time, and subsequent wash of the plate

[0516] · Coating: Y / N, including coating volume, in-line / off-line incubation, incubation time, and subsequent wash of the plate (Y / N)

[0517] · Sample incubation, including sample volume, in-line / off-line incubation, incubation time, and subsequent wash of the plate (Y / N)

[0518] · For indirect analysis: Incubation of unlabeled / biotinylated detection substance: Detection substance volume, in-line / off-line incubation, incubation time, and subsequent wash of the plate (Y / N)

[0519] · Incubation of STAG-labeled detection substance: Detection substance volume, in-line / off-line incubation, incubation time, and subsequent wash of the plate (Y / N)

[0520] · Incubation with read buffer: On / Off, incubation time

[0521] Regarding the bridging immunogenicity assay, the following are some options available to the user.

[0522] · Plate type

[0523] · Standard curve setup, including the number of points on the curve and dilution factors, etc.

[0524] · Control setup, including the number of controls on each plate and the dilution factor for each control

[0525] · Sample setup, including the number of duplicates for each unknown and the dilution factor for each

[0526] · Acid treatment (Y / N), including the ratio of acid to diluted sample and incubation time

[0527] · Sample incubation time, including the ratio of master mix to sample

[0528] · Wash shortly before start (Y / N)

[0529] · Blocking Y / N, including blocking volume and subsequent wash of the plate (Y / N)

[0530] · Incubation of sample on the plate, including sample volume, in-line / off-line incubation, incubation time, and subsequent wash of the plate (Y / N)

[0531] ·Reading buffer incubation: On / Off, incubation time

[0532] An embodiment of the assay implemented in the assay system illustrated in FIG. 10 and its sub-parts is shown in FIGS. 13(a)-(f). FIG. 13(a) shows a schematic diagram of certain subsystems in an assay system (1300) involved in the implementation of the assay positioned on a table or platform (1301), where each subsystem is operatively connected to a robotic system (not shown). The plurality of subsystems includes an assay reader (1302); an assay consumable storage unit (1303); a plate washing subassembly (1304); a plate oscillator subassembly (1305); the platform includes a consumable identifier controller (e.g., a barcode reader (1306)) configured to read assay consumable identifiers, e.g., positioned on a multi-well plate; a pipette tip storage compartment (1307) configured to house pipette tip boxes of variable sizes (e.g., 1308 and 1309, 1000 μl and 350 μl tips respectively) when needed and further includes a pipette tip disposal chute (1310) connected to a waste compartment (not shown); and one or more sample / reagent tube carriers (1311).

[0533] As shown in FIG. 13(b), when an assay consumable (e.g., a microplate) is inserted into the assay system (1300), the barcode reader (1306) reads the consumable identifier (1313) on the consumable and downloads the available consumable data (1314) associated with the identifier (alternatively or additionally, the system may query the data bus for additional consumable data as described above). A representative list of consumable data that may be associated with the identifier is provided in FIG. 13(b) and includes, but is not limited to, components, calibrant values, control values, customer acceptance numbers, order numbers, catalog numbers, associated assay protocols for the consumable, etc. The assay protocol (1315) contains one or more steps to be performed by the user and / or by components of the assay system during the conduct of the assay. With respect to 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 manual steps may be displayed simultaneously on the user-interface or each manual step may be displayed individually on the user-interface and the software will prompt the user on the user-interface to confirm completion of the step before displaying the next manual step. Once the manual step is completed, the software will proceed to the next step in the assay protocol. Each step in the assay protocol that is to be performed by the assay subsystem may contain one or more sub-steps (1318 and 1319 respectively), and each sub-step may contain one or more assay subsystem operations (e.g., 1320 - 1322 respectively). For example, if one step of the assay protocol is to incubate a test plate in the plate oscillator subsystem, then that step may include at least the following sub-steps: (a) move the test plate to the plate oscillator subsystem and (b) start the plate oscillator subsystem for a specified duration. Each of these sub-steps requires the software to send one or more commands to the subsystem or its components to complete the required sub-step, e.g., moving the test plate to the plate oscillator subsystem requires the software to command one or more motors in the robotic subsystem to move to the test plate and pick up the test plate and move the test plate to a specified location in the plate oscillator subsystem. Each of the subsystem operations is identified in the protocol script in the software.

[0534] The analysis system should then prepare for the analysis implementation before (if any) the manual analysis steps can be completed. For example, the software can instruct the analysis reader to evaluate a demonstration porous analysis plate to ensure proper performance of the analysis reader. The wash buffer can be filled or replenished (manually) when needed, and the waste container or reservoir can be emptied (manually) when necessary. The software can also instruct the plate wash subsystem to execute a maintenance script when needed and start up the wash subsystem. In addition, the user can manually refill or replace the disposable tip box in the analysis system. The user can also prepare the software for the analysis implementation on a remote, networked computer or directly on the analysis system user interface. The consumables (e.g., kits) can be selected by the user on the user-interface, and the number of samples to be run in the analysis can be selected. The user can also review the list of required consumables for the analysis (displayed by the software on the user-interface) and confirm that all required consumables are available. The user can then submit the start and completion of a specified experiment to the system software. As described above, the software will prompt the user to complete any manual steps when needed and follow any software prompts to prepare the system for the analysis implementation. The user starts the analysis run on the user-interface, locks the system, and starts the software script for the protocol.

[0535] In one embodiment of the V-PLEX (e.g., cytokine) assay implemented on the analysis system of FIG. 13(b), the following manual steps are required and the software displays each step on the user-interface, optionally requiring the user to confirm via the user-interface that each step has been completed:

[0536] a) Unpack the consumable kit;

[0537] b) Thaw the reagents according to the consumable instructions;

[0538] c) Dilute the ECL read buffer 2-fold with deionized water;

[0539] d) Dilute the wash buffer 1-fold with deionized water;

[0540] e) Reconstitute the lyophilized calibrator by adding 1000 uL of diluent A and mix well by vortexing;

[0541] f) Reconstitute the lyophilized control by adding 250 uL of diluent A to the vial and mix well by vortexing.

[0542] A calibrator is a sample of an analyte relevant to the assay with a known concentration, used to determine that the calibration curve is applicable to unknown samples. Calibrators are generally provided at high concentrations and diluted to prepare solutions of lower concentrations. Typically, up to eight (8) points are used to prepare the calibration curve. A control is also a sample of an analyte relevant to the assay with a known concentration, used to determine system performance and whether the assay is being performed accurately. Calibrators or controls are used in immunoassays, and in some assays both calibrators and controls are used.

[0543] Appropriate consumables and reagents are loaded into the assay system as depicted in FIG. 13(c). Briefly, disposable pipette tips are loaded onto the platform, empty dilution plates, empty test plates, and a pre-loaded sample plate is loaded onto the platform, wells are filled with ECL read buffer and sample diluent and loaded into the well carriers on the platform, and a reagent rack is loaded with empty antibody mixture tubes, control vials, calibrator vials, detection antibody tubes, and antibody diluent tubes. The software can display the subsystem layout depicted in FIG. 13(c) on the user interface, highlighting the subsystems to assist in the proper placement of each consumable or reagent in the subsystem. Once the loading step is complete, the software prompts the user to close the door of the assay system, the software locks the door of the system and initiates a loading confirmation script that is configured to confirm that each consumable and reagent has been properly loaded in the correct position and orientation in the instrument. If any consumable or reagent has been improperly loaded, the system door will unlock and the software will display a warning on the user interface indicating manual adjustment after use of the improperly loaded consumable or reagent.

[0544] A protocol for the implementation of a V-PLEX (e.g., cytokine) assay on the assay system is shown in FIG. 13(d). As described above with reference to FIG. 13(b), each step of the protocol corresponds to one or more sub-steps and subsystem operations, and the software includes the required scripts and sub-scripts to direct the system to perform each step, sub-step, and operation required to complete the assay. The sequence of steps and the timing of events in the assay protocol are shown in FIG. 13(e) and an overview of the steps is provided in FIG. 13(f).

[0545] Figures 14(a)-(i) illustrate the implementation of V-PLEX assays on the assay system depicted in FIG. 14. The V-PLEX assays are available from Meso Scale Discovery, LLC. (Rockville, MD). As in FIG. 13(a), FIG. 14(a) illustrates the layout of the various subsystems in the assay system. FIG. 14(b) shows the configuration of the plate storage subassembly for implementing one or more V-PLEX assays in the assay system and, likewise, FIG. 14(c) shows the orientation of reagent tubes and wells in tube carriers (panel (i)), well-shaped carriers (panel (ii)), and reagent holders (panel (iii)). FIGS. 14(d)-(i) show the various assay protocols for the V-PLEX kits and, as described above, the protocol to be used with a given item number or catalog number is the consumable data associated with the consumable identifier of the kit and reagent cassette subassembly. FIGS. 14(J-a, J-b) (relating to "V-PLEX stepwise assay, 5-plate run") and FIGS. 14(K-a, K-b) (relating to "V-PLEX homogeneous assay, 5-plate run") show two exemplary timing sequences or scripts for the V-PLEX protocols. FIG. 14(l) shows an upgraded protocol for the Sthe V-PLEX stepwise protocol sequence shown in FIG. 14(d).

[0546] The analytical systems and software described herein can be configured to perform a variety of different types of analyses and, based on the type of analysis and protocol, the user interface is configured to stepwise display to the user commands for the proper preparation of samples and / or reagents for the analytical system. For example, in addition to the V-PLEX assays described in detail above, the analytical systems and software are also configured to perform U-PLEX and S-PLEX assays (available from Meso Scale Discovery, Rockville, MD). Both U-PLEX and S-PLEX assays require a number of preparation and optional optimization steps, and the software is configured to display to the user individualized stepwise protocols for those preparation and optimization steps. For example, the U-PLEX protocol requires the preparation of one or more reagents according to specific reagent preparation protocols and the display of those steps to the user via the user interface prior to performing the assay on the analytical system. FIGS. 15(a)-(b) illustrate an assay protocol as performed on the analytical system for a single plate U-PLEX assay, and FIGS. 15(c)-(f) illustrate an assay protocol as performed on the analytical system for a multi-plate U-PLEX assay. FIGS. 15(G-a, G-b) (relating to "U-PLEX singlets, 5 plate run (same as custom singlets, streptavidin plate, direct assay)") and FIGS. 15(H-a, H-b) (relating to "U-PLEX 10-Plex multiplex, 5 plate run") show two exemplary timing sequences or scripts for the U-PLEX protocol. In addition to the specific assay protocols identified above, the analytical system can also be configured to perform the following types of analyses and the software is configured to guide the user through the sample / reagent preparation steps via the user interface:

[0547] · Pharmacokinetic analysis, preparation, optimization, and analysis execution

[0548] · Immunogenicity analysis, preparation, optimization, and analysis execution

[0549] · Custom sandwich immunoassay: preparation, optimization, and analysis execution

[0550] · Kinetic measurements

[0551] · Assay development panel

[0552] · Antibody screening

[0553] · Calibration curve titration

[0554] · Manually read prepared consumable test plates

[0555] · Plate incubation

[0556] ·IQ / OQ / PQ (Installation Qualification (IQ); Operational Qualification (OQ); Performance Qualification (PQ))

[0557] The U-PLEX and V-PLEX assays may have the following steps when automated to run in an analytical system (such as analytical system (1000) or (900)):

[0558] Automated analysis sequence

[0559] 1 Stock plate

[0560] 2 Start the washer

[0561] 3 Couple the antibody to the U-PLEX linker

[0562] 4 Incubate the capture antibody with the linker

[0563] 5 Add stop solution to the coupled antibody-linker solution

[0564] 6 Incubate the stop solution

[0565] 7 Prepare the capture antibody mixture

[0566] 8 Prepare the capture antibody diluent

[0567] 9 Apply the capture antibody mixture to the MSD plate

[0568] 10 Perform the coating incubation

[0569] 11 Apply the blocker to the MSD plate

[0570] 12 Apply the sample diluent to the MSD plate

[0571] 13 Perform the blocking incubation

[0572] 14 Apply the diluent to the dilution plate

[0573] 15 Generate the calibration curve

[0574] 16 Dilute the control vial

[0575] 17 Establish the control diluent

[0576] 18 Establish the sample diluent

[0577] 19 Wash the MSD assay plate

[0578] 20 Apply the diluent to the MSD assay plate

[0579] 21 Perform the sample incubation

[0580] 22 Prepare the detection antibody mixture

[0581] 23 Preparation of a detection antibody mixture with blockers

[0582] 24 Application of the detection antibody mixture to an MSD plate

[0583] 25 Perform the detection incubation

[0584] 26 Application of the detection antibody and diluent to an MSD plate

[0585] 27 Perform the homogeneous V-PLEX assay incubation

[0586] 28 Application of the read buffer to the plate

[0587] 29 Read the plate on an ECL reader

[0588] 30 Clean-up process

[0589] (i) Immunogenicity assay preparation, optimization and performance

[0590] Immunogenicity is the property of a substance to be able to elicit an immune response by generating anti-drug antibodies or the degree to which a substance has this property. Bridging IG assays are used to detect the presence of these anti-drug antibodies in a sample in order to characterize the immune response to the drug substance. Figure 16(a) shows the complex used for bridging immunogenicity (IG) assays on a or platform (available from Meso Scale Discovery, LLC., Rockville, MD). To form the complex, a biotinylated drug, a SULFO-TAG TM labeled (STAG) drug and the anti-drug antibody (ADA) are incubated together and the biotinylated drug and the STAG drug each bind to a different domain of the ADA. The drug / ADA complex is incubated on an MSD test plate with spots containing streptavidin or avidin and the biotinylated drug binds to streptavidin or avidin in the plate spots (Figure 16(a)). A block diagram of a standard IG assay protocol is shown in Figure 16(b). Figure 16(d) illustrates an exemplary deck layout intended for a bridging IG assay without acid treatment to be performed on an assay system (1000).

[0591] IG analysis is preferably optimized prior to implementation in the laboratory. The standard IG protocol includes a number of parameters that can be evaluated during optimization, including but not limited to: (i) duration of incubation; (ii) plate type; (iii) anti-drug antibody selection; (iv) concentration of biotinylated drug; (v) concentration of STAG-drug; (vi) determination of the minimum dilution ratio (MDR); (vii) evaluation of the assay response to free drug in the sample; and / or (viii) evaluation of acid dissociation to improve free drug tolerance. Each of these parameters is important for the overall determination of the final protocol.

[0592] To optimize the IG assay on the assay system shown in FIG. 10 and its sub-parts, a system development kit is provided to the user, which includes a sample incubation plate (0.3 mL), a sample dilution plate (1.1 mL), a plate lid, reagent tubes, and a collection of kits that may include the following components:

[0593] Table 1.

[0594]

[0595] The development kit itself and each of its internal components include a consumable identifier (e.g., barcode) with consumable data associated therewith. The system barcode reader reads the consumable identifier (e.g., barcode) and downloads and installs the DDB stored to the consumable identifier (e.g., barcode). The DDB includes a DDB unique identifier, a DDB version, a DDB xml file, consumable static information, consumable handling information, and combinations thereof. For example, if the component includes a multi-well assay plate, then 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 handling information contains data used by the assay system in the implementation of an assay using the plate and / or the processing of assay data resulting from the implementation of an assay using the plate. In one specific embodiment, the consumable handling information includes the number of partitions per plate, the number of circuits per plate, the detection parameters used by the assay system to read the plate; the image processing characteristics for generating ECL results; plate type gain; binding domain gain; optical crosstalk matrix; and combinations thereof.

[0596] The system then identifies relevant consumable data from a local data repository and / or from one or more remote consumable data databases required to process the consumable, and adjusts one or more operations performed or to be performed by the system based on the consumable data (including but not limited to appropriate protocols and optimization parameters for IG analysis) before, during, and / or after the performance of the analysis. A specific embodiment of the IG optimization workflow is shown in Figure 16(c) and includes the following steps: (i) screening multiple anti-drug antibodies; (ii) optimizing the concentrations of biotin-labeled drug and STAG-labeled drug; (iii) performing a sample matrix tolerance assessment; and / or (iv) performing a free drug tolerance assessment. At each step, the user can also evaluate whether to use an acid dissociation protocol as part of the final protocol; in addition, the user can evaluate multiple assay plate types (e.g., 96-well Streptavidin GOLD TM Board Pair 96-well high binding avidin gold plate). The user may make the choice to skip one or more of these steps and the software allows the user to skip one or more steps and / or manually enter parameters / data, such as drug concentrations, to be generated in the skipped steps.

[0597] The consumables data for the development kit includes a protocol for the IG optimization workflow and each of the steps or sub-protocols implemented for the consumables. The first step in this embodiment of the IG optimization workflow is ADA selection, and the system prompts the user in designing an experiment to be performed by the system to determine the appropriate ADA as a control for the assay. The user-interface will prompt the user to enter the following data regarding the anti-drug antibody to be tested:

[0598] The number of dilutions of each ADA tested (8 or 12 dilutions)

[0599] Number of ADAs tested (2-6 different ADAs per plate, depending on the number of dilutions chosen)

[0600] The name of each ADA tested (for tracking purposes)

[0601] ·Users will choose whether to include zero dilution

[0602] Concentration of the dilution to be tested

[0603] The user interface also prompts the user to (i) select the length of incubation (30 minutes to 4 hours on the instrument or a user-determined length of time off the instrument), (ii) whether to include an acid dissociation step, (iii) add different plate types if necessary, and (iv) select whether to apply the same reagent to all plates. The experiment can be performed on up to 5 plates. The system then performs an ADA selection experiment and displays the results of the experiment on the user interface to enable the user to select the most appropriate ADA as an analytical control.

[0604] The user-interface then prompts the user to perform a second experiment to determine the concentrations of the biotin-labeled drug and the STAG-labeled drug used in the assay (the relative affinities of the biotin-labeled drug and the Sulfo-tag-labeled drug for the ADA may differ). The user interface prompts the user to make the following selections regarding this optimization experiment:

[0605] Enter the following data about the test substance to be tested:

[0606] Number of test substance dilutions (4 concentrations of biotin-labeled drug and 4 concentrations of STAG-labeled drug per plate)

[0607] Dilution factor for each test substance

[0608] The user will choose whether to include zero dilution

[0609] Enter the following data about the ADA sample to be tested:

[0610] Number of ADA dilutions (up to 3 dilutions per plate)

[0611] Concentration of ADA dilution

[0612] • Select the length of incubation (30 min to 4 hours on the instrument or a user-determined length of time off the instrument).

[0613] Choose whether to include an acid dissociation step.

[0614] Added different types of boards.

[0615] • Select whether to apply the same reagents (ie, same reagent source) to all plates.

[0616] The experiment can be performed on up to 5 plates.The system then performs a drug concentration optimization experiment and displays the results of the experiment on the user-interface.

[0617] Next, the user-interface prompts the user to perform a third experiment to determine the minimum dilution ratio (MDR) for each sample matrix, which enables the user to evaluate the signals generated by the assay in the presence of different sample matrix concentrations. The user interface prompts the user to make the following choices regarding the MDR optimization experiment:

[0618] · Enter the following data regarding the ADA sample to be tested:

[0619] · The number of dilutions of the ADA being tested (8 or 12 dilutions per plate)

[0620] · The concentration of the ADA dilutions

[0621] · The user will choose whether to include a zero dilution

[0622] · Enter the following data regarding the sample matrix to be tested:

[0623] · The number of dilutions of the matrix (2 - 6 dilutions per plate, depending on the number of ADA dilutions being tested.)

[0624] · The dilution factor for each dilution

[0625] · The user will choose whether to include a zero dilution

[0626] · The user may use different sample matrices for each plate (e.g., serum, citrate plasma, EDTA plasma, etc.)

[0627] · Select the length of incubation (30 min to 4 hours on the instrument or a length of time off the instrument determined by the user).

[0628] · Select whether to include an acid dissociation step.

[0629] · Add plates of varying types, assuming there is adequate capacity in the run.

[0630] · Select whether to apply the same reagents (i.e., the same reagent source) to all plates.

[0631] The experiment can be performed on up to 5 plates. The system then performs the MDR optimization experiment and displays the results of the experiment on the user-interface.

[0632] Finally, the user-interface prompts the user to perform a fourth free drug tolerance assessment experiment to determine the effect of the free drug on the assay and whether it is necessary to use acid dissociation to improve the free drug tolerance of the assay. Regarding the free drug tolerance assessment, the user has the option to perform a protocol with or without acid dissociation and / or to perform a comparison between untreated and acid-treated plates. The user interface prompts the user to make the following choices regarding the free drug tolerance assessment experiment:

[0633] · Enter the following data regarding the ADA sample to be tested:

[0634] · The number of dilutions of the ADA being tested (8 or 12 dilutions per plate)

[0635] · The concentration of the ADA dilutions

[0636] · The user will select whether to include a zero dilution

[0637] · Enter the following data regarding the free drug to be tested:

[0638] · The number of dilutions of the free drug (2 - 6 dilutions per plate, depending on the number of ADA dilutions being tested.)

[0639] · The dilution factor for each dilution.

[0640] · The user will select whether to include a zero dilution.

[0641] · Select the length of incubation (30 min to 4 hours on the instrument or a length of time off the instrument determined by the user).

[0642] · Select whether to use acid dissociation and / or whether to perform a comparison between acid - treated and untreated plates.

[0643] · Add plates of the variant type, assuming there is sufficient capacity in the run.

[0644] · Select whether to apply the same reagent (i.e., same reagent source) to all plates.

[0645] The experiment can be performed on up to 5 plates. The system then performs a free - drug tolerance assessment experiment and displays the results of the experiment on the user - interface.

[0646] The immunogenicity (IG) analysis, when automated to run in an analysis system (such as analysis system (1000) or (900)), can have the following steps:

[0647] Automated analysis sequence

[0648] 1 Stock plate

[0649] 2 Start the scrubber

[0650] 3 Prepare the drug mixture

[0651] 4 Apply the drug mixture to the sample incubation plate

[0652] 5 Apply the diluent to the dilution plate

[0653] 6 Generate the standard curve

[0654] 7 Prepare the control diluent

[0655] 8 Prepare the sample diluent

[0656] 9 Apply the blocker to the MSD plate

[0657] 10 Perform the blocking incubation

[0658] 11 Apply the diluent to the sample incubation plate

[0659] 12 Perform the sample incubation

[0660] 13 Wash the MSD test plate

[0661] 14 Apply the incubated sample to the MSD test plate

[0662] 15 Perform the MSD test plate incubation

[0663] 16 Apply the read buffer to the plate

[0664] 17 Read the plate on the ECL reader

[0665] 18 Clean-up process

[0666] (ii) Pharmacokinetic analysis preparation, optimization and execution

[0667] Pharmacokinetics is the study of the time course of drug absorption, distribution, metabolism, and excretion. Pharmacokinetic (PK) analysis is used to measure drug concentrations in samples from the same patient over time. These assays are direct or indirect immunoassays and are preferably optimized prior to implementation in the laboratory. On Meso Scale Discovery's or The standard PK analysis implemented on the platform is shown in Fig. 17(a). First, the MSD plate is coated with a capture substance. The capture substance is immobilized on the MSD plate and can be an antibody, protein, antigen, carbohydrate, lysate, etc. The detection substance and the analyte are applied to the coated MSD test plate. The detection substance can include a separately STAG-labeled antibody (direct format), STAG-labeled streptavidin and biotin-labeled detection antibody (indirect format), STAG-labeled anti-substance antibody and unlabeled detection antibody, etc. (indirect format). The detection substance can be premixed with the analyte or it can be directly applied to the test plate. Block diagrams for the implementation of direct PK analysis and two different types of indirect PK analysis are shown in Fig. 17(b) (panels (i)-(iii) respectively).

[0668] Fig. 17(d) (relating to "customized sandwich immunoassay") shows the general protocol sequence for a customized sandwich immunoassay. Figs. 17(e)-(h) show the protocol and the labeled reagent holders, and Fig. 17(i) shows the deck layout for these assays. Figure 17(e)-a and 17(e)-b relates to "protocol for direct analysis, streptavidin or avidin plate and reagent holder". Figure 17(f)-a and 17(f)-b relates to "protocol for direct analysis, uncoated plate and reagent holder". Figure 17(g)-a and 17(g)-b relates to "protocol for indirect analysis, streptavidin or avidin plate and reagent holder". Figure 17(h)-a and 17(h)-b relates to "protocol for indirect analysis, uncoated plate and reagent holder".

[0669] The standard PK protocol includes a number of parameters that can be optimized, including but not limited to:

[0670] · Duration of incubation (1 hour to overnight)

[0671] · Plate type

[0672] · Type and / or concentration of capture substance

[0673] · Type and / or concentration of blocker

[0674] · Concentration of unlabeled / biotin-labeled detection substance (only for indirect analysis)

[0675] · Concentration of STAG-labeled detection substance

[0676] · Evaluation of assay sensitivity by varying the known concentration of the drug in the sample

[0677] To optimize PK analysis on the analytical system shown in Figure 10 and its sub - parts, a system development kit is provided to the user, which includes a sample dilution plate (1.1 mL), a plate lid, reagent tubes, and a set of kits that may include the following components:

[0678] Table 2.

[0679]

[0680]

[0681] The development kit itself and each component within it include consumable identifiers (e.g., barcodes) with consumable data associated therewith. The system barcode reader reads the consumable identifiers (e.g., barcodes) and downloads and installs the DDB stored to the consumable identifiers (e.g., barcodes). 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 the component includes a multi - well assay plate, then 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 contains data used by the analytical system in the implementation of the assay using the plate and / or the processing of assay data resulting from the implementation of the assay using the plate. In a specific embodiment, the consumable processing information includes the number of partitions per plate, the number of circuits per plate, the detection parameters used by the analytical system to read the plate; the image processing characteristics for generating ECL results; plate type gain; binding domain gain; optical crosstalk matrix; and combinations thereof.

[0682] The system barcode reader reads the consumable identifiers (e.g., barcodes) and downloads the appropriate protocols and optimization parameters for PK analysis. 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 analyte concentration; and / or (iv) evaluating assay sensitivity. The user may choose to skip one or more of these steps and the software allows the user to skip one or more steps and / or manually enter the parameters / data that would have been generated in the skipped steps.

[0683] The recommended sequence for the assay optimization experiment for indirect analysis is as follows:

[0684] · Step 1: Optimize the capture analyte type and / or concentration

[0685] · Step 2: Optimize the blocker type and / or concentration

[0686] · Step 3A: Optimize the concentration of biotinylated / unbiotinylated analyte and sulfo-tag-labeled analyte

[0687] · Step 4: Test drug sensitivity

[0688] The recommended sequence of the assay optimization experiment for direct analysis is as follows:

[0689] · Step 1: Optimize the capture material type and / or concentration

[0690] · Step 2: Optimize the blocker type and / or concentration

[0691] · Step 3B: Optimize the concentration of sulfo-tag-labeled analyte

[0692] · Step 4: Test drug sensitivity

[0693] To optimize the capture process, the software will prompt the user to enter the following data prepared for the experiment:

[0694] · The user will enter the following data regarding the sample to be tested:

[0695] · The number of sample dilutions (8 or 12 dilutions per plate)

[0696] · The dilution factor for the sample

[0697] · The user will select whether to include zero dilution

[0698] · The user will enter the following data regarding the capture material to be tested:

[0699] · The capture material type and / or the number of dilutions (up to 6 per plate, depending on the number of sample dilutions being tested)

[0700] · The dilution factor for each type of capture material (if using more than one dilution of each type)

[0701] · The user will select whether to include zero dilution

[0702] · The user will select the length of incubation (1 hour to 4 hours on the instrument or a length of time off the instrument determined by the user).

[0703] · The user can add plates of variant types, provided there is sufficient capacity in the run.

[0704] · The user will select whether to apply the same reagent (i.e., the same reagent source) to all plates.

[0705] The experiment can be performed on up to 5 plates. The system then performs the experiment and displays the results of the experiment on the user interface.

[0706] To optimize the blocking process, the software will prompt the user to enter the following data to be used in the experiment:

[0707] · The user will enter the following data regarding the sample to be tested:

[0708] · The number of sample dilutions (8 or 12 dilutions per plate)

[0709] · The dilution factor for the sample

[0710] · The user will select whether to include a zero dilution

[0711] · The user will enter the following data regarding the blocker to be tested:

[0712] · The type of blocker and / or the number of dilutions (up to 6 per plate, depending on the number of sample dilutions being tested)

[0713] · The dilution factor for each type of blocker (if using more than one dilution of each type)

[0714] · The user will select the length of incubation (1 hour to 4 hours on the instrument or a length of time off the instrument determined by the user).

[0715] · The user can add plates of varying types, provided there is sufficient capacity in the run.

[0716] · The user will select whether to apply the same reagent (i.e., the same reagent source) to all plates.

[0717] The experiment can be performed on up to 5 plates. The system then performs the experiment and displays the results of the experiment on the user-interface.

[0718] To optimize the concentration of the detection substance for indirect analysis, the software will prompt the user to enter the following data to be used in the experiment:

[0719] · The user will enter the fol...

Claims

1. An automated analysis system, the automated analysis system comprising: (a) A processing deck for holding analysis components, which provides a generally rectangular surface having a leading edge, a first side edge, a second side edge, and a trailing edge; the processing deck supports: (i) An analysis consumable palletizer centered and protruding cantilevered generally on the leading edge of the processing deck having a plurality of consumable slots sized to hold consumables meeting the specifications for the width and length of a 96-well analysis plate; (ii) A plurality of pipette tip positions for holding pipette tip containers located on the first side of the processing deck; (iii) A plurality of plate oscillator positions located along the trailing edge of the processing deck; (iv) A set of processing positions located generally at the center of the processing deck, between the analysis consumable palletizer and the plurality of plate oscillator positions configured to hold consumables of compliant size; And (v) A barcode scanner located on the first side of the processing deck, behind the plurality of pipette tip positions, the barcode scanner having a scanning surface large enough to scan the bottom surface of consumables having dimensions compliant with ANSI - SLAS; (b) A plate washer located below the processing deck and accessible through a pore in the processing deck between the plurality of pipette tip positions and the set of processing positions; (c) A gantry located above the processing deck, the gantry movably supporting a robotic plate gripper such that the robotic plate gripper can move to access positions (i) - (v) and movably supporting a robotic 8 - channel pipette such that the robotic 8 - channel pipette can access positions (ii) and (iv); (d) An analysis reader adjacent to the first side of the processing deck, located on a platform at a vertical height lower than the processing deck, wherein the highest point on the analysis reader is lower than the lowest point at which the robotic plate gripper can move; and (e) A housing surrounding components (a) - (d), the housing having a temperature controller for maintaining the components under temperature control and having a door that provides the user access to the front side of the processing deck and the analysis consumable palletizer located thereon.

2. An automated analysis system, the automated analysis system comprising: (a) A single robot - controlled 8 - channel pipette, (b) A single robot - controlled analysis plate clamping arm, (c) A single 96 - channel analysis plate washer, (d) A single plate reader, (e) One or more plate oscillators with a total capacity having at least 5 plate oscillation positions, and (f) A processor adapted to perform an analysis process for analyzing a plurality of samples in a 96 - well plate, wherein the following actions of the process are performed in each well of the 96 - well plate: (i) A blocking step, which includes adding a blocking buffer with the single robot - controlled 8 - channel pipette, incubating for a blocking period (b), and washing with the single 96 - channel analysis plate washer, (ii) Sample binding step, which includes adding one of the plurality of samples using the single robot-controlled 8-channel pipette, incubating for a sample incubation period(s), while oscillating at one of the at least 5 plate oscillation positions and washing with the single 96-channel analytical plate washer, (iii) Detection reagent binding step, which includes adding the detection reagent using the single robot-controlled 8-channel pipette, incubating for a detection reagent incubation period (d), while oscillating at one of the at least 5 plate oscillation positions and washing with the single 96-channel analytical plate washer, (iv) Adding the read buffer using the single robot-controlled 8-channel pipette, and (v) Measuring the analytical signal using the single plate reader.

3. An analytical system configured to use analytical consumables in the implementation of an analysis, the analytical consumables including an analytical consumables identifier, the analytical consumables identifier including a data deployment package (DDB) for the analytical consumables, and the analytical system including: (a) A storage medium, the storage medium including a consumables data repository and a data register containing local consumables data; (b) A consumables identifier controller adapted to read and install the DDB to the storage medium; and (c) A consumables data service processor adapted to query the data register and one or more databases of remote consumables data to identify and download the consumables data required for the implementation of the analysis by the analytical system using the analytical consumables.

4. A holder (1200) for an analytical reagent, which includes: A rectangular frame, the rectangular frame forming hollow columns (1203) in a plurality of respective regions on the rectangular frame, wherein at least two of the hollow columns have different respective sizes, and wherein the hollow columns are configured to receive at least two reagent containers (1206, 1208), the at least two reagent containers having different respective container sizes, A rectangular mask, the rectangular mask being configured to cover the rectangular frame, and wherein the rectangular frame forms respective holes or windows (1204) in the plurality of respective regions such that when respective reagent consumables identifiers are located at the respective bottoms of the at least two reagent containers (1206, 1208), the respective reagent consumables identifiers can be observed through at least two of the holes or windows, and wherein the rectangular frame (1201) further includes a ledge (1202), the ledge being configured to be lifted by a clamping pad of a robotic system.

5. A lid configured to cover the top surface of a perforated plate, comprising a serrated edge depending on the top portion of the lid, wherein, The toothed edge is adapted to fit around the outer perimeter of the top surface of the multi-well plate, wherein the size and dimensions of the top surface of the multi-well plate are determined to contact the outer perimeter of the multi-well plate, wherein a plurality of micro-recesses extend from the top portion of the lid towards the multi-well plate.

6. A loading cart adapted to be used with an analytical system, the loading cart including a computer screen and a mobile body including at least one shelf and support for the computer screen, Among them, The at least one shelf includes at least one tray, wherein a plurality of slots are defined in the at least one tray, and wherein the size and dimensions of the plurality of slots are determined to receive a plurality of consumables for performing an analysis. Wherein the computer screen is adapted to display a user interface that shows a first arrangement of the plurality of consumables on the at least one tray.

7. An analytical preparation system for preparing an analytical assembly, the analytical preparation system comprising: (a) An analytical system having a processor that contains information about the analytical components required for performing an analytical run; (b) A loading cart that includes a shelf for assembling components to be used in an analysis and a support for holding a mobile computing device that includes a computer screen; Wherein the mobile computing device includes networking capabilities to access the information on the processor, and a graphical user interface to provide the information to a user on the computer screen and to direct the placement of the analytical components on the loading cart.

8. A method for loading consumables into an analytical system for performing an analysis, the method comprising the steps of: a. Receiving a plurality of consumables; b. Arranging the plurality of consumables on an intermediate consumable loading station according to a first arrangement displayed by a user interface on a screen located at the intermediate consumable loading station; c. Moving the intermediate consumable loading station to the analytical system; d. Transferring the plurality of consumables to the analytical system according to a second arrangement, wherein the first arrangement is substantially the same as the second arrangement.

9. A board, the size and dimensions of the board being set to the size and dimensions of an ANSI-SLAS format analysis board and including an outer rectangular perimeter and at least one support member connecting a first side of the outer rectangular perimeter to a second side of the outer rectangular perimeter, wherein, At least one reference pad is located on a first major surface of the plate and corresponds to the position of at least one hole in the ANSI-SLAS format analytical plate. Wherein, when the plate is positioned in a plate carrier in the analytical system, the position of the at least one reference pad in one dimension of a three-dimensional coordinate system can be measured by a probe of the analytical system.

10. A method for training a robot-controlled probe of an analytical system, the method comprising the steps of: Positioning a training plate sized and dimensioned to the size and dimensions of the analytical plate in a plate carrier inside the analytical system, wherein the position of the training plate is known in a three-dimensional coordinate system; Moving the robot-controlled probe towards a reference pad on the training plate, wherein the reference pad corresponds to a hole in the analytical plate; Obtaining a first position of the reference pad in the three-dimensional coordinate system using a capacitance between the robot-controlled probe and the reference pad; and Assigning the first position as one dimension in the three-dimensional coordinate system for the robot-controlled probe.

11. An analytical consumable storage unit adapted to be attached to a platform in an analytical system, the analytical consumable storage unit comprising a bottom base and a shelving assembly having a plurality of sets of vertically arranged storage units, wherein the size and dimensions of each storage unit are determined to receive consumables for performing an analysis by the analytical system. Among them, The shelving assembly includes a plurality of horizontal members connected by a plurality of upright vertical supports. Wherein, the bottom base is configured to be attached to the platform in a cantilever manner and the rest assembly is movably attached to the bottom base by at least two locating pins and by at least one threaded connector having a finger-actuable head.

12. An analysis system comprising a housing, wherein, The housing includes a continuous glass member, wherein a touch screen for a computer screen is formed by a first portion of the continuous glass member and an array of pressure transducers, and wherein an acoustic emitter is formed by a second portion of the continuous glass member and at least one acoustic actuator.

13. An automated analysis system adapted to receive a consumable in an analysis implementation, the automated analysis system including a robot-controlled pipette and a robot-controlled clamping arm, an analysis reader, a plate washer, and at least one optionally heatable oscillator, at least one heat exchanger, and at least one processor, the processor being adapted to execute at least one instruction to minimize potential errors during loading of the consumable and during running of the analysis. Among them, The consumable includes at least one analysis 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 calibrant, a diluent, and an antibody. Wherein, the at least one instruction includes at least one of the following: Instructions for a user interface to guide a user to load the consumable into the automated analysis system. Instructions for the robot-controlled clamping arm to place a lid on the at least one analysis test plate when the at least one analysis test plate is placed on the at least one optionally heatable oscillator. Instructions for the at least one heat exchanger to maintain a selected temperature within the automated analysis system, and Instructions for running the analysis on the at least one analysis test plate, wherein the at least one analysis test plate includes a plurality of analysis test plates, and wherein each analysis test plate is completed within a generally same period.

14. A method for operating an automated analysis system to minimize potential errors during loading of a consumable for analysis and during running of the analysis. Among them, The automated analysis system includes a robot-controlled pipette and a robot-controlled clamping arm, an analysis reader, a plate washer, and at least one oscillator and incubator, at least one heat exchanger, and at least one processor. Wherein, the automated analysis system is adapted to receive a consumable, the consumable including: at least one analysis 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 calibrant, a control, a diluent, an antibody, a reagent, and a buffer. The method includes at least one of the following steps: Guiding the user to load the consumable into the automated analysis system via a user interface. Instructing the robot-controlled clamping arm to place a lid on the at least one analysis test plate. Instructing the at least one heat exchanger to maintain a selected temperature within the automated analysis system. Direct the at least one processor to run the analysis for the at least one analysis test board, wherein the analysis for each analysis test board is completed within substantially the same period of time.

15. An automated analysis system configured to use analysis consumables in the implementation of an analysis, the automated analysis system including at least one processor and at least one storage medium, Among them, the at least one storage medium storing instructions for the at least one processor to implement the analysis, wherein the instructions are separated into a plurality of components, the plurality of components including: a security component, a user interface component, an instrument control component, and a data service component, wherein each component operates substantially independently of each other and substantially without interaction with each other, wherein the components are connected to a main organizer and the main organizer indicates when each component operates.

16. An analysis system configured to use an analysis consumable in the implementation of a first analysis, wherein, The first analysis includes a unique analysis identifier, and the analysis system includes: a reader adapted to read the unique analysis identifier, and a processor that accesses a general protocol file and an instrument parameter file, wherein the general protocol file contains a general analysis protocol including analysis steps that can be applied to a plurality of analyses including the first analysis, wherein the instrument parameter file contains a plurality of flags in an on or off state, wherein the processor turns on or off the analysis steps in the general analysis protocol according to the flags to implement the first analysis.

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