Automated analysis system and methods for performing analysis in the system

Abstract

The present invention relates to methods, devices and systems for associating consumable data with analytical consumables used 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 specifically for the consumables. Various types of consumable data are described, as well as methods for implementing analysis using the data by an analysis system. The present invention also relates to consumables (e.g., test kits and reagent containers), software, data deployment packages, computer-readable media, loading carts, instruments, systems and methods for performing automated biological analysis.

Description

[0001] This application is a divisional application of the PCT international invention patent application with application number 201680055383.X, application date July 22, 2016, and invention name “Integrated consumables data management system and platform”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 195,956, filed on July 23, 2015, and entitled “Integrated Consumable Data Management System and Platform.”

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

[0005] The present teachings relate to methods, devices and systems for correlating consumable data with analytical consumables used in bioanalysis. It also relates to consumables (e.g., test 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

[0006] Various methods and systems have been developed for implementing analysis. These methods and systems are necessary in a variety of applications, including medical diagnosis, veterinary testing, food and beverage testing, environmental monitoring, manufacturing quality control, drug discovery and basic science 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 to track them. In addition, multiple analytical parameters must be tracked to understand the analytical results of any given analysis, usually requiring the input of multiple parallel tracking systems supplied by manufacturers, consumers or both.

[0007] Automation of immunoassays presents a number of challenges. Repeatability and / or reproducibility remain the goals of all automated assay systems. SUMMARY OF THE INVENTION

[0008] One aspect of the invention is an automated analysis system for performing biological analysis, such as immunoassays and more particularly electrochemiluminescence (ECL) immunoassays. The automated analysis system of the invention is capable of performing analytical runs with reproducible results. Approximate human or machine errors that may occur in the preparation for the analytical run (e.g., sample or calibrant dilution), loading of analytical consumables on the instrument, and during the analytical run have been identified and minimized. Other aspects include consumables, instruments, loading carts, software, data deployment packages, computer readable media, and methods for performing biological analysis.

[0009] The variables that have been minimized in different aspects of the present invention include one or more of the following. The variation of sample concentration between each hole in the porous analysis tray caused by the evaporation of the liquid during incubation is minimized. The position and positioning of the clamping pad and the pipette of the robot system for a specific analysis system are trained by a precision training plate. A heat exchanger is provided to maintain the selected operating temperature in the analysis system. The same analysis operation is generally completed within the expected period to ensure reproducibility. Consumables for specific analysis are provided in the test kit to ensure that appropriate consumables and their amounts can be used for analysis operation. Standardize the loading of consumables in the analysis system to minimize errors. The dedicated analysis consumable storage unit (e.g., plate collector, plate tray, spare pipette tip container tray, slotted tray) on the analysis instrument minimizes loading and analysis execution errors. For example, due to user safety, ergonomics or consumable disposal considerations, the configuration and position of the plate collector minimize loading errors. The user interface guides the user through the selection of the analysis scheme for loading and running of consumables. A loading cart is provided to serve as an intermediate consumable loading station to assist the user in loading consumables appropriately into the analysis system. The operation and performance confirmation of the analysis system of the present invention has been automated and a validation kit is provided to ensure that the confirmation is properly performed and reproducible. The automated analysis steps are performed with tight time arrangement tolerances to ensure reproducibility between runs and between plates. The dedicated plate reader is configured to read the analysis plate in a certain order, and the order minimizes the difference between the time arrangement of adding the reading buffer to the time of reading the signal from one hole and even another hole in a single plate. The noise of multiple background signals in the ECL reader is measured and deviates from the actual ECL reading. The ability of the pipette and plate washer to distribute and / or aspirate is calibrated.

[0010] Other improvements include, but are not limited to, software architectures that minimize revalidation of software systems when they receive software updates, and the creation of general protocols that can be applied to multiple analyses paired with instrument parameter files unique to a particular analysis that turns specific components of the general protocol on or off to customize the protocol for the particular analysis. Providing specialized lids to minimize reagent loss from containers through evaporation while maintaining pipette access to the reagents.

[0011] One embodiment of the present invention is an analysis system configured to use an analysis consumable in the performance of an analysis, the analysis consumable comprising an analysis consumable identifier, the identifier comprising an analysis consumable identifier comprising a data deployment package (DDB) for the analysis consumable, and the analysis system comprising:

[0012] (a) a storage medium comprising a consumable product data repository and a data registry containing local consumable product data;

[0013] (b) a consumable product identifier controller adapted to read and install the DDB to the storage medium; and

[0014] (c) a consumable data service processor adapted to query the data registry and one or more remote consumable data databases to identify and download consumable data required for performance of analysis by an analysis system using the analysis consumable.

[0015] Another embodiment of the present invention is a data deployment package (DDB), which includes one or more data files containing consumable data related to analytical consumables and their use in analytical systems, and the one or more data files include a DDB unique identifier, a DDB version, a DDB xml file, consumable static information, consumable processing information and combinations thereof.

[0016] 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 analysis system, causes the analysis system to perform a method of performing an analysis on the analysis system, wherein the analysis system is configured to use an analysis consumable in the performance of the analysis, the analysis consumable comprising an analysis consumable identifier comprising a DDB as described herein, and the analysis system comprises:

[0017] (a) a storage medium comprising a consumable product data repository and a data registry containing local consumable product data;

[0018] (b) a consumable product identifier controller adapted to read and install the DDB to the storage medium; and

[0019] (c) a consumable data service processor adapted to query the data registry and one or more remote consumable data databases to identify and download consumable data required for performance of an analysis by an analysis system using the analysis consumable;

[0020] The method comprises the following steps:

[0021] (a) reading the DDB from the consumable identifier;

[0022] (b) storing the DDB in the consumables data repository;

[0023] (c) identifying consumable product data from said consumable product data repository and, optionally, downloading the consumable product data from one or more remote consumable product data repositories;

[0024] (d) adjusting one or more operations performed by the system before, during and / or after performing the analysis based on the consumable data; and

[0025] (e) performing the analysis using the analysis consumables in the analysis system.

[0026] Another embodiment relates to a holder for analytical reagents, comprising at least two areas configured to receive at least one or two reagent containers and at least one or two holes or windows configured to view at least one or two consumable identifiers located on the bottom of the reagent containers. The areas can be at least two different sizes to receive at least two analytical containers of different sizes. The areas and the holes or windows can be circular and the diameter of the holes or windows can be smaller than the areas, or the areas and the holes or windows can be linear and the diameter of the holes or windows can be smaller than the areas.

[0027] The holder may include a frame, at least one optional insert, and at least one optional mask. The mask may be attached to the top of the frame, and the insert may be positioned within the frame and below the mask. Two areas of the holder may contain cylindrical holes in the frame or the optional insert, or both. The at least two areas may include holes in the mask. The at least two holes may be clear plastic coated holes in the frame.

[0028] The footprint of the container preferably complies with the ANSI-SLAS dimensions for multiwell plates. The height of the container may also comply with the ANSI-SLAS height for multiwell plates.

[0029] 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 can be positioned between a reagent container and an area larger than the reagent container. The insert can define the cylindrical holes of the analytical reagent container and fill the frame.

[0030] The mask may define a plurality of zones, wherein the number of mask zones may be equal to or less than the number of zones in the container, frame or insert and the mask may limit the number of assay containers received by the assay reagent container. Preferably, the mask contains labels relating to the reagents.

[0031] The holder may have an analytical consumable identifier attached thereto. The analytical consumable identifier is located on the bottom, side or top surface of the container. The holder may also include at least one reagent container. The reagent container contains analytical reagents. The analytical reagents may be reagents for V-PLEX, U-PLEX, immunogenicity (IG), pharmacokinetics (PK) or custom analysis. The label may define analytical reagents for V-PLEX, U-PLEX, immunogenicity (IG), pharmacokinetics (PK) or custom analysis.

[0032] The assay reagent container or the frame may be made of conductive plastic. The holder may have a lid. The lid may be fully or mostly transparent. The assay container may include an assay consumables identifier on its bottom, viewable from the bottom of the container. The area is configured to receive at least one tube and at least one vial.

[0033] The holder may have (a) a frame having a bottom and sides, the bottom being generally rectangular in shape and having dimensions consistent with ANSI-SLAS standards and defining the holder aperture or window, (b) an insert that fits within the frame and has an insert aperture sized to hold a tube or vial and arranged so that the tube or vial matches the holder aperture or window, (c) a mask positioned over the insert and having a mask aperture that matches the insert aperture to allow the tube or vial to be inserted into the insert, the mask also providing identification information about the tube or vial, and (d) optionally, a cap to seal the vial within the holder

[0034] 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 bracket that is inserted into a notch in the bottom of the tube or vial, or printed on a foil disc that is heat-sealed against a notch in the bottom of the tube or vial.

[0035] The assay tubes or vials include tubes or vials having one or more of the following assay reagents: (i) calibration material; (ii) control material; (iii) capture reagent; (iv) detection reagent; (v) diluent or (vi) linking reagent.

[0036] The present invention also relates to an analytical kit comprising any analytical container discussed above in a cardboard container. Preferably, the kit has an analytical consumable identifier on the cardboard container. The kit may also have at least one analytical consumable plate in the cardboard container. The analytical consumable plate may be a multi-well analytical plate and may have an analytical consumable identifier. The kit may also have at least one slot or tube or both.

[0037] The present invention also relates to a lid configured to cover the top surface of a multiwell plate, comprising a toothed edge depending on the top portion of the lid, wherein the toothed edge is adapted to match the outer perimeter of the top surface of the multiwell plate, wherein the top surface of the plate is sized and dimensioned to contact the outer parameters of the multiwell plate, and the lid may also have a plurality of dimples extending from the top portion of the lid toward the multiwell plate. The plurality of dimples may correspond to a plurality of holes in the multiwell plate and be 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.

[0038] The cover may not be made of an integral plastic or elastomeric material, or may be made of a hard plastic or polystyrene.

[0039] The present invention further relates to a lid configured to cover the top surface of a porous plate, comprising a toothed edge depending on the top portion of the lid, wherein the toothed 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 microetched to create a rough surface to trap air so that the bottom surface exhibits Cassie-Baxter behavior as a barrier against moisture.

[0040] Alternatively, the bottom surface may be coated with a hydrophobic coating or a surfactant. The lid may also have a plurality of dimples extending from a top portion of the lid toward the multi-well plate. The plurality of dimples may correspond to a plurality of wells in the multi-well plate, and the plurality of dimples may be configured to extend into the plurality of wells.

[0041] The present invention also relates to a lid configured to be attached to a reagent container and adapted to allow entry and exit of a probe, comprising a top surface, wherein the top surface comprises a cross-sectional pattern that separates the top surface into segments, wherein when the probe enters the reagent container, the segments bend downward and when the probe exits, the segments substantially resume their original orientation. The probe may be at least one pipette tip.

[0042] The cross-sectional pattern may include at least one curve, at least one serpentine line, at least one substantially circular line or parallel straight lines. The cover may be made of a non-elastomeric material or an elastomeric material. The cover may be used to cover a reagent tank.

[0043] The present invention also relates to a loading cart adapted for use with an analytical system, the loading cart comprising a computer screen and a mobile body comprising at least one shelf and support for the computer screen, wherein the shelf comprises at least one tray, wherein a plurality of slots are defined on the tray and wherein the slots are sized and dimensioned to receive a plurality of consumables to perform an analysis. The computer screen is adapted to display a user interface showing a first arrangement of a plurality of consumable containers on the at least one tray.

[0044] The computer screen may be the screen of a tablet computer or connected to a personal computer or laptop. The computer screen may be controlled by a processor on the analysis machine. The computer screen may be connected to the processor on the analysis machine via a WiFi or Bluetooth connection.

[0045] The plurality of slots on the loading cart may be defined on the top surface or on both surfaces of the at least one pallet (ie the pallet is reversible). The slots may be slots of different sizes adapted to receive a variety of consumables of different sizes.

[0046] The support for the computer screen may be an adjustable support. The adjustable support may be rotatable substantially about a vertical axis and / or may be tiltable about an axis substantially orthogonal to the vertical axis. The at least one shelf is a top shelf. The cart may also have a bottom shelf and / or an intermediate shelf. The cart may have a compartment below the at least one tray or the top tray and the compartment may be adapted to store a coolant. The compartment may also have a drain port and the bottom surface of the compartment may be concave. The mobile body of the cart should be supported by at least one castor and the castor may be a hubless castor.

[0047] The loading cart can accommodate a variety of consumables, such as at least one multiwell plate, and the at least one multiwell plate can include at least one analysis plate or at least one dilution plate. The multiple consumables can include at least one container for reagents. The multiple consumables can include at least one tube or at least one slot. An example of the tray is illustrated in Figure 19.

[0048] The present invention also relates to an analytical preparation system for preparing an analytical component, the preparation system comprising:

[0049] (a) an analytical system having a processor containing information about components required to perform an analytical run;

[0050] (b) a cart comprising shelves for assembling components to be used in the analysis and supports for holding the mobile computing device;

[0051] (c) a mobile computing device including a computer screen;

[0052] 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 a computer screen and to guide the placement of an analysis component on the loading vehicle.

[0053] The loading cart may be a loading cart as described above. The loading cart may also include a consumables identifier reader, and the graphical user interface is configured to accept identifier information provided by a user using the reader when the analytical component is placed on the cart and use the information to confirm the validity of the component and transfer the identification information to the processor.

[0054] The present invention also relates to a method of instructing a user to load consumables onto an analytical system, comprising using the loading cart discussed above. The method may comprise arranging a plurality of consumables on the loading station according to a first arrangement displayed by a user interface on a screen.

[0055] The invention further relates to a method for loading consumables into an analytical system for performing an analysis, the method comprising the following steps:

[0056] a. Receive a variety of consumables,

[0057] b. arranging the plurality of consumables on the intermediate consumable loading station according to a first arrangement displayed by a user interface on a screen positioned on the intermediate consumable loading station,

[0058] c. moving the intermediate consumable loading station to the analysis system,

[0059] 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.

[0060] Preferably, the intermediate consumable loading station comprises a mobile cart and the screen is a computer screen. The computer screen may be movably attached to the cart, or may be rotated substantially about a vertical axis and / or may be tilted relative to the vertical axis. The method may also include the step of cooling at least one of the plurality of consumables. Step (b) may include the step of depositing the plurality of consumables into a plurality of slits defined on the top surface of the mobile cart. The plurality of consumables may include at least one multiwell plate, or at least one container for reagents.

[0061] The present invention also relates to a plate that is sized and dimensioned to the size and dimensions of an ANSI-SLAS format analytical plate and comprises 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 hole in the ANSI-SLAS format analytical plate, wherein when the plate is positioned in a plate holder in an 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.

[0062] The probe may measure 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 multi-well plate and the at least one reference pad corresponds to a corner well on the ANSI-SLAS format assay plate.

[0063] The plate may also have at least two opposing clamping areas located on the side connecting the two major surfaces of the plate, wherein the clamping areas 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.

[0064] The plate is preferably made from cast aluminium and / or is machined from cast aluminium.

[0065] Another aspect relates to a plate for teaching or training an automated instrument, the plate being sized and dimensioned to the size and dimensions of an ANSI-SLAS format assay plate and comprising 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 location of at least one well in the ANSI-SLAS format assay plate,

[0066] Wherein when the plate is positioned in a plate holder in the analysis system, the position of the at least one reference pad in one dimension of the three-dimensional coordinate system can be measured by a probe of the analysis system.

[0067] Another aspect relates to a method of training or teaching a robotic gripper or pipette, the method comprising using the plate described above.

[0068] An aspect of the present invention also relates to an analytical consumables storage unit adapted to be attached to a platform in an analytical system, comprising a bottom base and a shelving assembly having a plurality of collections of vertically arranged storage cells, wherein each storage cell is sized and dimensioned to receive consumables for analysis performed by the analytical system,

[0069] wherein the shelving assembly comprises a plurality of horizontal members connected by a plurality of upright vertical supports,

[0070] Wherein the bottom base is attached to the platform in a cantilevered manner and the shelf assembly is movably attached to the bottom base by at least two locating pins and by at least one threaded connection having a finger-actuable head.

[0071] Another aspect relates to 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:

[0072] (a) a storage medium comprising a consumable product data repository and a data registry containing local consumable product data;

[0073] (b) a consumable product identifier controller adapted to read and install the DDB to the storage medium; and

[0074] (c) a consumable data service processor adapted to query the data registry and at least one remote consumable data database to identify and download consumable data required for performance of analysis by an analysis system using the analysis consumable.

[0075] Additional analysis includes an analysis system comprising a housing, wherein the housing comprises 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.

[0076] Other assays include an automated assay system adapted to receive consumables in the performance of an assay, the assay system including a robotically controlled pipette and a robotically controlled clamping arm, an assay reader, a plate washer and at least one optionally heatable shaker, at least one heat exchanger and at least one processor adapted to execute at least one instruction to minimize potential errors in loading of consumables and in running the assay,

[0077] wherein the consumables comprise at least one analytical test plate, at least one dilution plate, at least one collection of pipette tips, at least one sample plate, and a plurality of containers containing at least one of calibrators, diluents, and antibodies,

[0078] The at least one instruction comprises at least one of the following:

[0079] Instructions for the user interface to guide the user in loading consumables into the analytical system,

[0080] instructions for the robotic clamping arm to place a cover on the at least one analytical test plate when the at least one analytical test plate is placed on the shaker,

[0081] instructions to at least one heat exchanger to maintain a selected temperature within the analytical system, and

[0082] Instructions for running an assay for at least one assay test plate, wherein the at least one assay test plate comprises a plurality of assay test plates, wherein each assay test plate was completed within substantially the same period of time.

[0083] Another aspect relates to a method for operating an automated analysis system to minimize potential errors in loading consumables for analysis and running the analysis,

[0084] The analytical system comprises a robotically controlled pipette and a robotically controlled clamping arm, an analytical reader, a plate washer and at least one oscillator and incubator, at least one heat exchanger and at least one processor.

[0085] wherein the analytical system is adapted to receive consumables comprising at least one analytical test plate, at least one dilution plate, at least one collection of pipette tips, at least one sample plate, and a plurality of containers containing at least one of calibrators, controls, diluents, antibodies, reagents, and buffers,

[0086] The method comprises at least one of the following steps:

[0087] Instructional user interface to guide the user in loading consumables into the analytical system,

[0088] instructing the robotic clamping arm to place a cover on the at least one analytical test plate when the at least one analytical test plate is placed on the shaker and incubator,

[0089] instructing at least one heat exchanger to maintain a selected temperature within the analytical system, and

[0090] At least one processor is directed to run an analysis for at least one analytical test plate, wherein the at least one analytical test plate comprises a plurality of analytical test plates, wherein each analytical test plate is completed within substantially the same period of time.

[0091] The present invention also relates to an automated analysis system configured to use an analysis consumable in the performance of an analysis, the analysis system comprising at least one processor and at least one storage medium,

[0092] wherein the storage medium stores instructions for the processor to perform the analysis,

[0093] The instruction is separated into multiple components, including:

[0094] Safe weight,

[0095] User interface components,

[0096] Instrument control components, and

[0097] Data service component,

[0098] wherein the components operate substantially independently of each other and substantially do not interact with each other,

[0099] Wherein the components are connected to a main collator and the main collator instructs each component when to operate.

[0100] The present invention further relates to an analytical system configured to use an analytical consumable in the performance of a first analysis, wherein the first analysis comprises a unique analytical identifier, the analytical system comprising

[0101] a reader adapted to read the unique assay identifier, and

[0102] A processor that accesses general protocol files and instrument parameter files,

[0103] wherein the general protocol file contains a general analysis protocol including analysis steps, wherein the analysis steps are applicable to a plurality of analyses including the first analysis,

[0104] The instrument parameter file contains multiple flags that are turned on or off.

[0105] The processor turns on or off the analysis steps in the general analysis scheme according to the flag to implement the first analysis.

[0106] Additional analysis systems relate to an automated analysis system configured to minimize user, instrument, and analysis method variations, the system comprising at least one of:

[0107] Components for minimizing user errors in system loading

[0108] Widgets for minimizing user errors when selecting automated workflows

[0109] Building blocks for minimizing sample dilution errors

[0110] Components for minimizing system board handling errors

[0111] Building blocks to minimize system pipetting errors

[0112] Components to minimize temperature changes

[0113] Means for minimizing evaporation or condensation within analytical consumables

[0114] means for controlling the oscillation frequency of at least one oscillator, and

[0115] A component used to minimize the complexity of maintenance procedures.

[0116] In another aspect, the automated analysis system is configured to minimize user, instrument, and analysis method variations, the system comprising a robotic clamping arm and a robotic pipette and further comprising software and instrument components for at least one of:

[0117] Perform sample dilution steps;

[0118] Select and execute the correct analysis workflow for a given analysis;

[0119] controlling an air cooling and handling system and thereby maintaining a specified temperature within specified tolerances in an analytical workflow region of said system;

[0120] Maintain consistent timing across runs, plates, and wells; and

[0121] Allows users to execute different analysis workflows without having to reconfigure or revalidate the workflow software.

[0122] Other aspects include an automated analytical system comprising a robotic clamping arm and a robotic pipette, and at least the following additional components: (a) a plate holder, (b) a tip box holder, (c) five optionally heatable oscillators, (d) an air cooling and handling system, (e) an analytical consumable storage unit for analytical reagents, (f) an analytical consumable storage unit for immediate use tips, (g) an analytical consumable storage unit for reserve tips, (h) an analytical consumable storage unit for plates, (i) a location for attaching analytical consumable storage units for tubes and slots, and (j) a platform or table or both; wherein said components (a)-(c) and (e)-(h) are located on the platform or table within the system in substantially the same position relative to each other, as shown in Figures 10(a), (b), (c), (l), (n) or (o), and wherein component (d) is located on the back panel of the instrument, substantially as shown in Figures 10(l), (m) or (n).

[0123] In another aspect, the present invention relates to an automated analysis system comprising

[0124] (a) 8-channel pipette controlled by a single robot

[0125] (b) Single robot-controlled analysis plate clamping arm

[0126] (c) Single 96-channel analysis plate washer

[0127] (d) Single plate reader

[0128] (e) one or more plate shakers having a total capacity of at least 5 plate shaking positions

[0129] (f) a processor adapted to perform an analytical process for analyzing a plurality of samples in a 96-well plate, wherein the following functions of the process are performed in each well of the plate:

[0130] (i) a blocking step comprising adding blocking buffer with the pipette, incubating for the blocking period (b), and washing with the plate washer

[0131] (ii) a sample binding step comprising adding one of the samples with the pipette, incubating for a sample incubation period (s) while shaking at one of the plate shaking positions and washing with the plate washer

[0132] (iii) a detection agent binding step comprising adding the detection agent using the pipette, incubating for a detection agent incubation period (d) while shaking at one of the plate shaking positions and washing with the plate washer

[0133] (iv) Add read buffer using the pipette

[0134] (v) measuring the analytical signal using the reader

[0135] in,

[0136] Up to 5 plates can be processed in one run

[0137] 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), and 17(d)-(h).

[0138] The additional automated analysis system relates to an automated analysis system, which comprises

[0139] (a) a processing deck for holding an analytical component, providing a generally rectangular surface having a leading edge, a first side edge, a second side edge, and a trailing edge; said deck supporting

[0140] (i) An assay consumables plate collector centered approximately on the leading edge of a deck having a plurality of consumable slots sized to hold consumables meeting ANSI-SLAS specifications for the width and length of a 96-well assay plate and extending outwardly from the deck;

[0141] (ii) a plurality of pipette tip locations for holding pipette tip containers located on a first side of the deck

[0142] (iii) Multiple plate shaker locations located along the rear edge of the deck

[0143] (iv) a collection of processing locations located approximately at the center of the deck, between the plate collector and an oscillator configured to hold consumables having dimensions consistent with ANSI-SLAS

[0144] (v) a bar code scanner located on the first side of the deck behind the pipette tip location, the bar code scanner having a scanning surface large enough to scan the bottom surface of a consumable having a size that complies with ANSI-SLAS

[0145] (b) a plate washer located below the deck and accessible through a gap in the deck between the pipetting position and the assay plate handling position

[0146] (c) a gantry located above the deck that movably supports a robotic plate clamp such that the clamp is movable to access positions (i)-(v) and movably supports a robotic 8-channel pipette such that the pipette is accessible to positions (ii) and (iv)

[0147] (d) an analytical reader located adjacent to a first side of the deck and on a platform at a vertical height below the deck, wherein a highest point on the reader is below a lowest point at which the robotic gripper can move

[0148] (e) an enclosure surrounding components (a)-(d) having a temperature controller for maintaining said components under temperature control and having a door providing user access to the front side of said deck and the consumables collector located thereon

[0149] Another aspect relates to an automated analysis system comprising

[0150] (a) 8-channel pipette controlled by a single robot

[0151] (b) Single robot-controlled analysis plate clamping arm

[0152] (c) Single 96-channel analysis plate washer

[0153] (d) Single plate reader

[0154] (d) one or more plate shakers having a total capacity of at least 5 plate shaking positions

[0155] (e) a processor adapted to perform an analytical process for analyzing a plurality of samples in a 96-well plate, wherein the following actions are performed in each well of the plate:

[0156] (i) a blocking step comprising adding blocking buffer with the pipette, incubating for the blocking period (b), and washing with the plate washer

[0157] (ii) a sample binding step comprising adding one of the samples with the pipette, incubating for a sample incubation period (s) while shaking at one of the plate shaking positions and washing with the plate washer

[0158] (iii) a detection agent binding step comprising adding the detection agent using the pipette, incubating for a detection agent incubation period (d) while shaking at one of the plate shaking positions and washing with the plate washer

[0159] (iv) Add read buffer using the pipette

[0160] (v) measuring the analytical signal using the reader

[0161] in,

[0162] Up to 5 plates can be processed in one run. BRIEF DESCRIPTION OF THE DRAWINGS

[0163] Figure 1 Describes the generation and storage of consumables data and the consumables data provided by consumables manufacturers.

[0164] Figure 2 Description In response to a query for consumable product data, consumable product data is assigned to a customer.

[0165] Figure 3 Description The purpose of consumables data is to verify the authorized use of consumables in the analytical system.

[0166] Figure 4 Describes the master repository on the CD server, its contents and / or interfaces with additional vendor directories.

[0167] 5(a)-(d) illustrate an assay reader as described herein.

[0168] 6(a)-(c) illustrate several alternative views of an assay reader described herein.

[0169] Figure 7 Additional views illustrating an assay reader described herein.

[0170] Figure 8 The analysis system described herein is described.

[0171] Figures 9(a)-(c) illustrate an analysis system and 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 access and move one or more consumables (e.g., a multi-well analysis plate) from one subsystem of the analysis system to another subsystem. Figure 9(d) shows the scheduling of operations performed in the system during the performance of the analysis.

[0172] Figures 10(a)-(b) illustrate one embodiment of an analysis system and various subsystems within the system. The analysis system illustrated in Figures 10(a)-(b) is configured to perform all sample processing steps on the plate and all analysis processing steps required in the performance of the analysis, and is also operatively connected to a user interface that is configured to display to the user step-by-step instructions on appropriate sample / reagent preparation steps that should be performed manually before the system performs the analysis.

[0173] Figure 10(c) illustrates another iteration of the analysis system shown in Figures 10(a)-(b). Figure 10(d) shows the top surface of a table supporting the equipment of the analysis system.

[0174] 10(e)-(f) are perspective views of the training board.

[0175] 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).

[0176] Figure 10(i) is a perspective view of a cover and an 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).

[0177] 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) show the cooling mode in the analysis system. Figure 10(p) shows the cooling mode of the electron cover.

[0178] FIG. 10( q ) shows an adjustable hinge of the door of the analytical system having two degrees of freedom.

[0179] FIG. 10( r ) is a top perspective view of the analytical consumables storage unit.

[0180] Figure 10(s)-(t) show the dimensions of the framework of the analysis system.

[0181] Figure 10(u) shows a top view of the platform.

[0182] FIG. 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 Figure 10(y), as shown thereon.

[0183] FIG. 10( z ) is a top view showing the plate bracket ( 1036 ) and the tip bracket ( 1026 ).

[0184] FIG. 11( a) illustrates one specific embodiment of a data association workflow, which is a process in which certain data is associated with a consumable identifier. FIG. 11( b) is a diagram showing the interaction between the computer system of the analysis system and the computer system of a customer. FIG. 11( c) is a diagram of the components of the computer system of the analysis system. FIG. 11( d) is a flow chart of the instrument control portion of the software. FIG. 11( e) is a diagram showing one embodiment of the software architecture.

[0185] 12(a)-(l) illustrate one embodiment of a software architecture for deployment and use of a data deployment package (DDB).

[0186] Figure 12 (Ma, Mb) illustrates a script showing an exemplary general scheme. Figure 12 (Na, Nb), Figure 12 (Oa, Ob), Figure 12P The script of Figure 12(m) is shown, in which selected steps in the scheme are turned off.

[0187] FIG. 12 (qa, qb) shows an exemplary instrument parameter file showing the on / off status of certain steps in the protocol.

[0188] Figure 12 (Ra, Rb) is another example of a general scheme. Figure 12 (Sa, Sb) is the general script with certain steps turned off.

[0189] Figures 13(a)-(c), Figure 13(Da, Db), Figure 13(Ea, Eb) and Figure 13(f) illustrate one embodiment of the use of a data deployment package and consumables / system data for operating an analysis system in the implementation of an analysis.

[0190] Figures 14(a)-(i), Figure 14(Ja, Jb), Figure 14(Ka, Kb), and Figure 14(l) illustrate V-PLEX analysis performed on the analysis system using the software described herein.

[0191] Figures 15(a)-(b), Figure 15(Ca, Cb), Figure 15(Da, Db), Figure 15(Ea, Eb), Figure 15(f), Figure 15(Ga, Gb), and Figure 15(Ha, Hb) illustrate the implementation of U-PLEX analysis on the analysis system using the software described in this article.

[0192] Figure 16(a)-(d) illustrate the preparation, optimization and execution of immunogenicity analysis in the assay system.

[0193] Figures 17(a)-(d), Figure 17(Ea, Eb), Figure 17(Fa, Fb), Figure 17(Ga, Gb), Figure 17(Ha, Hb) and Figure 17(i) illustrate the preparation, optimization and execution of a customized single-plex sandwich immunoassay or pharmacokinetic assay in an analytical system.

[0194] 18(a)-(n) illustrate consumable assay kits that can be used with the assay systems described herein.

[0195] Figures 19(a)-(b) are perspective views of a loading cart of the present invention designed for use with the analytical systems described herein. Figure 19(c) is a top view of the loading cart showing a tray adapted to receive analytical consumables. Figures 19(d)-(h) are exemplary top views of a tray loaded with analytical consumables. Figure 19(i) shows a cooling compartment beneath the tray.

[0196] Figures 20(a)-(e) show exemplary adjustments for pipetting timing and ECL reading mode for use with the analytical system of the present invention.

[0197] As used herein, a sub-section (e.g. Figure 10V-a , 10V-b , 10V-c and 10V-d) and having 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 and without a second suffix in the following description, e.g., Figure 10(v) or 10V.

[0198] Detailed description of various embodiments

[0199] Unless otherwise specified herein, scientific and technical terms used in conjunction with the present invention shall have the meanings commonly understood by those skilled in the art. In addition, unless otherwise required herein, singular terms shall include multiple and plural terms shall include single. The articles "a" and "an" are used herein to refer to one or more than one (i.e., at least one) grammatical object of the article. For example, "an element" means one element or more than one element.

[0200] As used herein, the term "sample" is intended to mean any biological fluid, cell, tissue, organ, or combination or part thereof, which includes or potentially includes a biomarker of a disease of interest. For example, a sample can be a tissue section of a sample obtained by biopsy, or placed in or conditioned to a cell in tissue culture. The sample can further be a subcellular fraction or extract, or a crude substance or substantially pure nucleic acid molecule or protein preparation. In one embodiment, the sample analyzed in the analysis of the present invention is blood, peripheral blood mononuclear cells (PBMC), isolated blood cells, serum, and plasma. Other suitable samples include biopsy tissue, intestinal mucosa, saliva, cerebrospinal fluid, and urine.

[0201] The analysis consumables and system used in the present invention include multiple devices and configurations. In one embodiment, the analysis system used in the present invention includes an analysis reader that can use analysis consumables to implement bioanalysis. The analysis consumables include identifiers (alternatively referred to as identifiers, consumable identifiers or analysis consumable identifiers in this manual) and the analysis system, analysis reader or its components include an identifier controller that interacts with the identifier. As described below, the identifier is associated with information about the analysis consumables, and the information may include but is not limited to how the consumables are manufactured and disposed of before use and how the consumables are used in analysis systems (collectively referred to as "consumable data"). Thus, the analysis system is configured to use analysis consumables in the implementation of the analysis, and the analysis system includes an identifier controller adapted to (i) read consumable data from an analysis consumable identifier associated with the analysis consumable; (ii) access consumable data associated with the analysis consumable, the data being indexed by the analysis consumable identifier, wherein the consumable data is stored locally on the analysis system or analysis reader or remotely on a vendor computing system; and optionally, (iii) eliminate consumable data associated with the analysis consumable identifier; and / or (iv) write consumable data indexed by the consumable identifier to the analysis system and / or remote data table.

[0202] In a specific embodiment, the present invention provides an analysis system configured to use an analysis consumable in the implementation of an analysis, wherein the analysis consumable includes an analysis consumable identifier as described herein and the analysis 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, the storage medium including a consumable data repository containing local consumable data. The local consumable data stored to the analysis system includes consumable identification and / or configuration information and one or more steps of an analysis scheme that can be used by the system to use the consumable in the implementation of the analysis. For example, the analysis 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 that is specific to an individual consumable, and the corresponding local consumable data stored to the analysis system includes information for identifying consumables 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 used by the system once the consumable is identified to use the consumable for the analysis scheme. Additionally, the consumable data (and / or local consumable data) may include one or more analysis tools that can be used by the system to analyze and interpret data generated using the consumables, system and / or consumable technical support information, or a combination thereof. Additionally, the system may 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, analysis protocol information, and one or more of the following: (x) one or more analysis tools that can be used by the system to analyze and interpret results generated during and / or after the performance of the analysis, (y) analysis system maintenance information, (z) system-consumable upgrade information, and (xx) system and / or consumable technical support information.

[0203] One embodiment of the use of the identifier / consumable data in the system is Figure 1-4 This is explained in the. Figure 1The invention shows how consumable data is generated, stored and used by a manufacturer, wholesaler or supplier (referred to herein as a "supplier"). First, the supplier generates consumables and / or a collection or batch of consumables (101) and, with respect to the consumables or batch of consumables, generates consumable data using a consumable data (CD) establishment system (102) and associates it with a consumable identifier (103) indexed into the consumables or batch of consumables (step i). The consumable data is generated by the consumable supplier before, during and / or after individual consumables and / or batches of consumables are made 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 of all consumable data. In addition, the CD establishment system stores information for associating a given consumable identifier with consumable data in the master repository. The CD creation system and / or CD server is located on a remote computing system (i.e., remote from the analysis system and / or the customer or customers' computing systems), such as a site maintained by a supplier. Figure 1 As shown, a supplier generates consumable data about a consumable or batch (a) and associates the information with a consumable identifier (b) indexed into 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.

[0204] Figure 2 A method of distributing consumable data to a customer or a designated user of a customer (collectively referred to herein as a "customer") is described. Upon receipt of an order from a customer or when the consumable or batch is made (step i), the supplier generates, stores and sends a CD database 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 an analysis (step iii), the system 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 stored locally on a local storage medium on the system (in Figure 2The system may include a storage medium (referred to as a "local CD") to identify the consumable data stored in the storage medium and that can be used to perform analysis using a given consumable. If the storage medium includes consumable data about the consumable or batch, then the consumable can be used in the system (step v). If the storage medium does not include consumable data about the specific consumable or batch 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, compressed disk, memory card / stick, flash drive, network data storage service, etc. (step vi). The supplier sends a consumable data binary file (including but not limited to an encrypted XML file) to the customer, such as in the form of an email attachment to a customer's email account, and the customer loads the file attachment to the analysis system and the system software stores the consumable data in a local system consumable data repository. The batch of consumables / consumables can then be used in the instrument (step vii).

[0205] In an alternative embodiment, if the CD server is not available locally on the system, the CD server can 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 a CD database to the CD server for consumable orders and / or batches of consumables, such as Figure 2 As shown and as described above. Thereafter, the customer receives the consumables, order and / or batch and contacts the system with the consumable identifier so that the system can identify the consumables or batch. 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 on the system, the software adjusts the system based on the consumable data if necessary. If the consumable data does not exist in the system consumable data repository, 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 a direct interface with the CD server and store the information locally in the system consumable data repository. Once the consumable data is locally available on the system, the software adjusts the system based on the consumable data and performs analysis if necessary. Once the consumable data is locally available on the system, the consumable or batch can be used in the system to perform 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.

[0206] Additionally, the CD server may periodically send consumable data for new batches / consumable types of consumables to the customer analysis system, e.g., 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 updates of the repository from a remote storage medium, e.g., via email, CD, memory card / stick, flash drive, and / or via a remote interface.

[0207] Figure 3 The results of verifying the consumable data and the program by the system software are described. 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 a 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 the consumable data stored locally 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. However, 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.

[0208] Additionally, the present invention provides a method of controlling customer access to an analytical system and / or analytical consumables by a vendor, wherein the system includes a system identifier, and the method includes receiving the system identifier from a customer, wherein the system identifier is sent to a vendor computing system; authenticating the system identifier by the vendor; and performing operations including:

[0209] (i) enabling full access to the device and / or analytical consumables for use with the device;

[0210] (ii) enabling partial access to the device and / or analytical consumables for use with the device; or

[0211] (iii) denying access to the device and / or analytical consumables for use with the device.

[0212] The system identifier includes information that uniquely identifies the analytical system, such as a serial number or other identification code generated and used by a supplier to identify the analytical 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 a customer.

[0213] In one embodiment, the step of enabling full or partial access includes the step of sending an access code from the supplier to the customer, thereby enabling access to the system. The access code may be a full or partial access code that enables different functions in the system. In one embodiment, the access code is a partial access code that enables the system to operate in a demonstration mode. The partial access code may be time-limited. Alternatively, the access code may be a full access code that enables full operation of the system.

[0214] like Figure 4 As shown, a CD server (401) includes a master repository (402) containing one or more directories of (i) consumable data; (ii) system data; and (iii) customer data. Alternatively or additionally, data contained in one or more of directories (i)-(iii) may be supplied to the master repository by an interface between the CD server and one or more supplemental supplier directories. In one embodiment, the master repository includes (i) a master customer data directory (403); (ii) a master system identifier directory (404); and (iii) a master customer data directory (405). In a preferred embodiment, customer data is supplied to the CD server via an interface with a supplemental supplier-customer directory that maintains customer data. Customer data may be stored in one or more supplemental supplier-customer directories, each of which is connected via an interface with the CD server. The master CD database includes multiple CD directories, each of which is generated for a consumable or batch of consumables. The master system identifier directory includes a unique system identifier for each system manufactured and / or distributed by a supplier. And the main customer directory and / or supplementary supplier-customer directory accessed to the CD server includes information related to each customer of the supplier, such as contact information, billing information, pricing information, shipping information, order history, etc. for the customers and individual customers at the customers.

[0215] In a specific 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 the main system identifier directory or is available via an interface between a supplementary supplier directory and the CD server. If the system is ordered by a customer, then order information (e.g., purchase order, related quotes, pricing, terms and conditions of sale or rental, related service agreements, etc.) and customer information are stored in the main customer directory and / or one or more supplementary supplier-customer directories connected to the CD server. In this regard, the unique system identifier for the system is associated with the customer who has purchased the system in the main repository and any information about the customer's related purchase. Shipping information for the system to the customer is also available in the customer directory and once the system is shipped, the customer will receive 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 is completed, the system software will connect to the CD server via a remote interface between the system and the CD server when needed to enable interaction between the two. The system initially connects to the CD server to confirm that system installation and training are complete and successful, and the CD server records the confirmation. Alternatively, if remote connectivity is not enabled on the system, 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 with the CD server via the confirmation code, system registration, and / or email, thereby providing a customer registration with 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 a portal accessed via a password on a customer access website hosted by the supplier, and / or the customer and the CD server can communicate via an email exchange server, which is configured to send and receive emails between the customer and the CD server (collectively referred to as an "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 a "direct interface") and / or via an indirect interface. As described above, the customer may then purchase a consumable, the system will read the consumable identifier and confirm that the consumable data is stored locally, receiving the consumable data directly or indirectly from the CD server if necessary, and the system will then enable use of the consumable or batch.

[0216] Once customers and suppliers have the means to communicate via a direct or indirect interface, customers and suppliers can interact in a variety of ways and because suppliers have the ability to track customer-specific use information of systems and consumables purchased and / or used by customers, communication between the parties can be more meaningful and productive. For example, customers can browse and / or purchase supplier products, receive customer assistance, schedule service calls, etc. via the direct or indirect interface. Because suppliers are able to track customer activities and purchases very closely via the consumable identifier / CD server, suppliers can tailor their interactions with customers based on the information. For example, because suppliers know the customer's order history, suppliers can send customer upgrade materials for products related to those products that customers have purchased / used in the past. Similarly, because suppliers track information related to customers' systems, suppliers can send customers preventive maintenance tips and reminders, general or specific customer training and seminars based on the unique needs of customers (and informed by the tracking consumable data for the customers), and information about system services, warranties, service contract information and reminders, etc.

[0217] In one embodiment, the supplier tracks and analyzes the use of consumables by customers and the consumable data stored in the analysis system include system-consumable use information. In order to promote the tracking of consumable use, the analysis system is configured to send system-consumable use information to the CD server directly or indirectly. If a direct interface is implemented between the system and the CD server, the system-consumable use information can be automatically sent. However, if a direct interface is not implemented, the system-consumable use 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 use information to the supplier via the indirect interface. The supplier can maintain a directory of customer consumable information to track the use of consumables and use the information from the directory to send consumable data via the direct or indirect interface, and the interface can be related to the customer based on previous consumables and / or system use. If a direct interface is implemented, the analysis system can be configured to receive analysis system maintenance and / or upgrade information from the supplier computing system used by the previous consumables and / or system involving individual customers.

[0218] 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 running diagnostic programs on the system, control charts, periodic maintenance schedules, warranty information about the system and / or its components, or a combination 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, the system may prompt the customer to send a monitoring report to the CD server via an indirect interface. Alternatively or additionally, the system monitoring report may be accessed by a service technician who is tasked with maintaining and / or servicing the system on-site or remotely. In a 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 a service technician based on standard system component life and / or warranty periods. In addition, the CD server may maintain a log of the service history for a given analysis system and schedule service calls by a service technician (which may be performed using a direct or indirect interface). The remote computing system may also send individual analysis system software upgrades via a direct or indirect interface.

[0219] 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 expected motor position during normal usage, position errors for each expected motor position, corrective actions taken by the system in the event of motor positioning errors and / or attempted corrective actions and 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; locking mechanism attempts, retries and failures; bar code identifier controller attempts, retries and failures; 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 / logout, system startup and shutdown, etc. In a particularly preferred embodiment involving a system designed to perform electrochemiluminescence measurements using analytical consumables, the system software can also be programmed to monitor the time and approximate temperature at which the analyzer camera has been powered on, the life cycle of latches within the system, barcode identifier controller attempts, retry attempts 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 timestamps or combinations thereof for each consumable run in the system. In addition, the system software can also monitor experiments performed in the system, such as when, by whom, and the type of consumables used in the experiment. The system-usage monitoring information can be sent to the CD server via a direct and / or indirect interface to enable a vendor to schedule appropriate support, service, and / or maintenance on the system.

[0220] In another embodiment, by the use of the tracking analysis system, the supplier can provide use and / or purchase assistance. For example, the supplier can track the use and purchase history of consumables and based on the consumable data for a given batch or consumables, the supplier can monitor the cut-off data of a given batch or consumables and notify the customer of the approaching deadline for the batch or consumables. The use of the tracking analysis system / consumable type can also enable the supplier to track the relative scheduling / frequency of the use of consumables and notify the customer that the consumable supply of the customer needs to be supplemented. If a direct interface is realized, the system can also be configured to order / reorder consumables and the system can be further configured to track and confirm the consumable order of the supplier. If a direct interface is not realized, the system can monitor the use and inventory of consumables and prompt the customer to replenish the supply of one or more consumables. (In this regard, when the system receives batch information via consumable identifiers and by monitoring consumable usage, it can prompt the customer when the consumable supply available in a given batch has been reduced to a minimum level.) In addition, by tracking the use of consumables, the supplier can send customer information about the customized analysis design service for a specific customized consumable type based on the customer's order / consumable use history. The direct or indirect interface may also provide customer training modules, consulting services, and / or live customer service assistance capabilities to facilitate the customer experience (ie, live chat) (collectively referred to as system and / or consumable technical support information).

[0221] In another embodiment, tracking consumable / system usage enables suppliers to send upgrade materials to customers, such as when new types or batches of consumables historically used by a given end customer appear, the supplier computing system sends consumable data about those new products to the customer. The upgrade materials may also relate to new analytical systems that may be of interest to the customer based on the customer's previous usage. The remote computing system may also send customer literature references that may relate to one or more consumables / systems used by a given customer.

[0222] These and other specific embodiments of consumable data are described in more detail below.

[0223] A. Analysis Systems, Consumables, and Methods of Use

[0224] Any type of diagnosis or analytical method known in the art is implemented using the analytical system encompassed by the present invention. The analytical methods include, but are not limited to, clinical chemistry analysis (e.g., measurement of pH, ions, gases, and metabolites), hematological measurements, nucleic acid amplification analysis (e.g., polymerase chain reaction (PCR) and ligase chain reaction analysis), immunoassays (e.g., direct, sandwich and / or competitive immunoassays and serological analyses), oligonucleotide conjugation analysis, and nucleic acid hybridization analysis. Any biological reagent that may be used in the analytical method 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).

[0225] These systems can be portable (e.g., handheld) and / or operated in a fixed laboratory or field setting, 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 operation 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 for the detection of biological agents. The analytical systems, analytical 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, electromechanical, radio waves, electromagnetics, colorimetry, fluorescence analysis, chemiluminescence, electrochemiluminescence, radiochemistry, nuclear magnetic resonance, enzymes, fluorescence, particle counting and cell counting.

[0226] (i) Specific implementation plan for analyzing consumables

[0227] The analysis consumables include a device in which one or more steps of an analytical method are implemented, and the device may include one or more test sites in which analytical measurements are implemented. In one embodiment, the analysis consumables include at least one analytical test site for analysis. The test site may include a plurality of different analytical domains, at least two of which include reagents for measuring different analytes. In addition, the consumables may include a plurality of test sites for multiple individual analyses. Alternatively, the analysis consumables may be components of reagents or other analytical components provided by the system for implementing analysis. For example, the analysis consumables may be containers with one or more compartments for holding analytical reagents. The analysis consumables (or test sites therein) may be single-use, or they may be reusable. The analysis consumables may be configured to implement a test or multiple tests (sequentially or in parallel).

[0228] As used herein, a test site refers to a consumable area that holds, contacts and / or inquires about a sample. A test site may include a plurality of different analysis domains, at least two of which include reagents for measuring different analytes. Consumables may include a plurality of test sites, which may hold, contact or otherwise inquire about the same sample of different volumes (aliquots) and / or different samples of different volumes. The partitioning of analytical consumables refers to the grouping of two or more test sites of the consumables. Each test site may be used to implement a single measurement or multiple measurements (e.g., measurements of multiple different analytes in a multiple analysis format) of a sample of a certain volume. Depending on the specific needs of the application, a consumable with a plurality of test sites may 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 analytical system, an unused test site is assigned), or a combination of two operating modes may be achieved.

[0229] The analysis consumables may be any structure suitable for diagnostic applications and the structure may be indicated by the specific analysis format or detection method used by the device. Examples of analysis consumables suitable for the present invention include, but are not limited to, test tubes, colorimetric slots, flow cells, analysis cartridges and cassettes (which may include integrated fluidics for analysis and processing), multi-well plates, slides, analysis chips, lateral flow devices (e.g., strip tests), flow devices (e.g., spot blots), pipette tips, solid supports for biological reagents, etc. In certain embodiments, the test sites in the analysis consumables are defined by compartments in the analysis consumables, such as holes, chambers, channels, flow cells, etc. The analysis consumables and / or test sites may include one or more components for analysis and measurement 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, filter matrices, optical windows, sensors (e.g., electrochemical and optical sensors), solid supports for binding reactions (e.g., coated slides, chips, beads, pins, coated filter or lateral flow matrices, tubes, etc.), reagents (dry or in liquid form), electrodes, analyte selective membranes, etc. In one embodiment, the analytical consumable may be a device that incorporates a conventional lateral flow test strip (e.g., an immunoassay test strip) as an analytical medium. In this embodiment, the device is molded to include an identifier or the identifier is attached to the device without any modification to the structure of the device and / or the 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, attached to, 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.

[0230] In another embodiment, the analytical consumables and accompanying analytical system or analytical reader are capable of performing multiplex analysis. Multiplex 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 of each volume of 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 an analyte (i.e., multiple non-identical measurements of the same analyte, such as measurements with different formats or identities of analytical reagents used); and / or (iii) measurements of multiple different analytes. In a specific embodiment, the analytical consumables are configured to perform multiple measurements in one or more test sites, the measurements comprising at least two analyses for two different analytes.

[0231] The present invention is not limited to a specific method for implementing multiplexed measurements in a test site and any of a variety of techniques that have been developed for performing multiplexed measurements may be used. Multiplexed measurements that may be used in the present invention include, but are not limited to, multiplexed measurements that (i) involve the use of multiple sensors; (ii) use individual analytical domains on a surface (e.g., an array) that are distinguishable based on location on the surface; (iii) involve the use of reagents coated on particles that are distinguishable based on particle properties such as size, shape, color, etc.; (iv) produce analytical signals that are distinguishable based on optical properties (e.g., absorbance or emission spectra), (v) based on temporal properties of the analytical signals (e.g., the time, frequency, or phase of the signal), and / or (vi) based on some other analytical feature. Accordingly, interpretation of the results of multiplexed analyses may involve the use of multiplexed information, such as the identity of the analyses performed in each test site and within a test site, for distinguishing the analyses performed in a test site, and / or for making the identity of a specific analysis dependent on any analytical feature of the corresponding analytical signal (the identity of a specific sensor, the location and identity of the analytical domain, etc.).

[0232] In one embodiment, the analytical test site comprises a plurality of different analytical domains and each domain comprises one or more reagents for measuring different analytes. Multiple information (including the location, identity and composition of each analytical domain) is used to identify the analytical signal generated at each domain and to associate it with the determination of the presence or amount of the corresponding analyte (a process that may include the application of additional consumable data such as signal thresholds and / or calibration parameters). The multiple information can be provided in the form of consumable data and / or in association with the consumable identifier.

[0233] The test site can be configured to perform a variety of multiple measurements (e.g., it can include a plurality of different analysis domains, each of which contains reagents for measuring different analytes). In one embodiment, the analysis consumables may include a plurality of test sites. Information about the precise configuration of the one or more test sites, analysis domains, and / or one or more partitions in the consumables may be included in the information saved to the analysis consumables identifier and / or provided in the form of consumables data. This information may include the location and identity of the test site, analysis domain, and / or one or more partitions and multiple information (as described above), including the number, identity, and distinguishing features of individual measurements in a test site, analysis domain, and / or partition (e.g., the specific location, identity, and / or analysis reagents of the analysis domain in each test site). In addition, the use of the test site, analysis domain, and / or partition in the analysis consumables may also be recorded in the identifier to track the use of the consumables in the analysis system. The identifier and / or consumables data may also include information about the analysis format and specific processing steps of the test site, analysis domain, and / or partition intended for analysis of consumables or analysis of consumables. The identifier and / or consumable data may also include information about an analytical method that should be applied by the system once an analysis is performed to analyze the output of an analysis in a given test site, analytical domain and / or partition and optionally provide results combining the output of multiple analyses in the test site, analytical domain and / or partition.

[0234] The test site can be configured in any suitable configuration, depending on the geometry of the consumable and / or the type of analysis implemented with the consumable. In one embodiment, the test site is configured as a hole and / or chamber in the analysis consumable. For example, the analysis consumable of the present invention can be a multi-well plate (e.g., 24-, 96, 384- or 1536-well plate), and the hole of the plate can further include a plurality of (e.g., 2 or more, 4 or more, 7 or more, 25 or more, 64 or more, 100 or more, etc.) different analysis domains. The multi-domain multi-well plate adapted to allow the use of electrode-induced luminescence measurement (e.g., electrochemiluminescence measurement) to implement analysis measurement is described in U.S. Application No. 10 / 238,391, entitled "Methods and Reader for Conducting Multiple Measurements on a Sample" submitted on September 10, 2002, which is incorporated by reference. The precise configuration of the domains, test sites and / or partitions in the analytical consumable and the specific identity of each domain, test site and / or partition and the reagents bound to the domain / test site / partition may be included in the information saved to the analytical consumable identifier and / or provided in the form of consumable data. In addition, the use of a given domain, test site and / or partition in an analytical consumable may also be recorded to the identifier to track the use of the consumable in the analytical system.

[0235] The analysis consumables can be used in multiple different analyses and this heterogeneity causes multiple suitable configurations of related consumables. In a kind of analysis format, the same analyte is measured at different analysis domains in a test site, and the different analysis domains are designed to measure different characteristics or activities of the analyte. Information about the analysis format that can be used for analysis consumables, test sites and / or analysis domains can also be saved to the analysis consumables identifier and / or provided in the form of consumables data. The identifier and / or consumables data can also include information about analytical method, once the analysis is implemented to analyze the output analyzed in a given test site and / or domain and compare the output with the analysis in an independent test site and / or domain, the analytical method should be applied by the system.

[0236] An example of multiplex analysis consumables is described in US2004 / 0022677, which is incorporated herein by reference in its entirety. The analysis consumables include one or more and in one embodiment multiple test sites and / or analysis domains for simultaneously or sequentially implementing one or more analysis measurements. For example, the test site can be configured as a hole and / or chamber. These test sites and / or analysis domains include one or more electrodes for inducing the luminescence of materials in the test site and / or analysis domain. The analysis consumables may further include, for example, an analytical reagent in a liquid or dry form in the test site (e.g., hole or chamber) of the consumables.

[0237] In addition to the test site and the analysis domain, the analysis consumables or porous analysis plates may also include several additional elements, such as plate top, plate bottom, hole, working electrode, counter electrode, reference electrode, dielectric material, electrical connection and analytical reagent. The hole of the plate may be defined by the hole or opening in the plate top, or in the form of a dent or micro-dimple on the surface of the plate. The plate may have a plurality of holes arranged in any size or shape, in any mode or configuration and may be composed of a variety of different materials. The exemplary embodiments that can be used for the consumables of the present invention include industry standard formats for the number, size, shape and configuration of the plate and hole, such as 96-, 384- and 1536-orifice plates, wherein the hole is configured in a two-dimensional array form. Other formats may include single-hole plates, 2-orifice plates, 6-orifice plates, 24-orifice plates and 6144-orifice plates. The porous analysis plate may be used once or may be used repeatedly and is fully suitable for applications in which 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 Figures 11A, 12A, 13A, 13B, 14A, 15 and 16A of U.S. Application No. 2004 / 0022677, each of which is incorporated herein by reference. As stated above, the specific configuration and identity of the analysis test sites, domains and / or partitions of the analysis consumables may be included in the information stored in the analysis consumables identifier and / or provided in the form of consumables data.

[0238] (ii) Specific implementation of the analytical reader

[0239] The analytical consumables can be used in an analytical reader, which can be used to induce and measure luminescence, such as electrode-induced luminescence or electrochemiluminescence, in an analysis performed in or on the analytical consumables (e.g., a multi-well analytical plate). The analytical reader can also induce and / or measure, for example, current and / or voltage at an electrode. The analytical reader can incorporate, for example, one or more photodetectors; a light-tight cover; a mechanism for transferring the analytical plate to and from the analytical reader (and specifically, to and from the light-tight cover); a mechanism for matching the analytical plate with the photodetector and / or with electrical contacts and orienting the analytical plate; an additional mechanism for tracking and identifying the plate (e.g., a barcode identifier controller); a mechanism for making an electrical connection to the plate, one or more electrical energy sources for inducing luminescence, and appropriate devices, electronics, and / or software. The analytical reader can also include a mechanism for storing, stacking, moving, and / or distributing one or more multi-well analytical plates (e.g., a plate stacker and / or a plate conveyor). The assay reader can be configured to measure light from a multi-well assay plate by measuring light sequentially from multiple partitions or regions of the plate (i.e., groupings of multiple adjacent assay domains within a plate) and / or substantially 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 aid in the storage, analysis, and presentation of data. A variety of configurations for suitable assay readers can be used with the present invention, including but not limited to those depicted in Figures 17 to 23 of U.S. Application No. 2004 / 0022677, incorporated herein by reference.

[0240] In a specific embodiment, the analysis reader is a device described and claimed in U.S. application serial number 14 / 147,216 published as US 2014 / 0191109 and WO 2014 / 107576, the disclosure of which is incorporated herein by reference. Specific embodiments of the analysis reader are described in the figures of U.S. serial number 14 / 147,216 and some of those figures are reproduced herein. Figure 5 (a)-(b) respectively shows a front view and a rear view of a device 500 with a stylized cover, and Figure 5 (c)-(d) respectively shows a corresponding front view and a rear view of the device without the cover. As shown in, for example, Figure 5 (c), the device includes a light detection subsystem 510 and a plate handling subsystem 520. A more detailed view is provided in Figure 6 (a)-(b). The board handling subsystem 620 includes a light-tight enclosure 630 that includes a housing 631 having a housing top 632, a bottom 633, a front 634, and a rear 635. The housing also includes a plurality of mating features and is adapted to receive a removable drawer. The removable drawer 640 is located at Figure 76 (a), the housing top 632 also includes one or more plate introduction (and expulsion) apertures 636 and 637, respectively, through which the plate is lowered to the plate translation stage or removed from the plate translation stage (manually or mechanically). Before the luminescence measurement is performed, a sliding light-proof door (shown as 639 in FIG. 6 (c)) is used to seal the plate introduction apertures 636, 637 from ambient light. In addition, the housing top also includes an identifier controller to read and process data associated with the identifier on the board. In one embodiment, the identifier controller is a barcode reader (638) installed in the aperture in the housing top via a light-proof seal, wherein the barcode reader is configured to read a consumables identifier (e.g., a barcode) on a plate on a plate translation stage placed in the housing. In a preferred embodiment, once the plate has been lowered into the drawer, the consumables identifier (e.g., a barcode) on the plate is read. In an alternative or additional embodiment, the identifier controller may be provided separately from the device.

[0241] In another specific embodiment, the analytical reader is a MESO QuickPlex SQ 120, available from MesoScale Discovery, Rockville, MD.

[0242] (iii) Specific implementation scheme of the analysis system

[0243] One embodiment of an analytical system that can be used in the present invention is described in U.S. Application Serial No. 12 / 844,440, published as US 2011 / 0143947, which is hereby incorporated by reference herein. Specifically, Figure 8As shown, the analysis system may include the following components: (i) a sample holder subassembly (810); (ii) a light-tight cover (820); (iii) an auxiliary plate 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 well plate consumables. The device achieves enhanced sensitivity and high sample throughput. It can be adapted to 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 luminescent emissions, such as fluorescence, phosphorescence, chemiluminescence, and electrochemiluminescence (ECL). In a specific embodiment, the device is configured to detect ECL.All biological reagents required for the analysis can be provided in the device, thus minimizing the consumables and reagent requirements of the device. Figure 8 The device depicted in further includes one or more consumable product identifier controllers (not shown) incorporated within the housing of the device and / or positioned external to the housing of the device.

[0244] Another embodiment of the analysis system of the present invention is shown in Figure 9(a). The analysis 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 multi-well analysis plate) from one subsystem of the analysis system to another subsystem. The plurality of subsystems include an analysis reader (903); an analysis consumable storage unit (904); a pipetting subassembly (905) comprising at least one pipetting probe (906) attached to a pipetting head rack (907) that provides X, Y, and Z motion of the probe to and from a pipetting tip wash station (908) and a plate wash subassembly (909); an orbital oscillation subassembly (910); a liquid reagent subassembly (911); and an electronics subassembly, including a computer (912). The computer also includes a user interface (not shown). The analytical system may also include a multi-well plate preparation platform (913) positioned on the table or platform (901) and configured to enable liquid to be pipetted to and / or from one or more wells of a multi-well assay plate positioned on the preparation platform. Optionally, the platform (913) is positioned on a linear track that enables the platform to move to and / or from a pipetting subassembly (905) in a direction parallel to the plane of the table. Alternatively or in addition, the platform and / or one or more subassemblies of the pipetting subassembly are configured to move in an X, Y, and / or Z direction 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 washing subassembly, the track oscillation subassembly, the assay reader, and the consumable storage unit. As shown in Figures 9(b)-(c), the analytical system may further include a cover (914) comprising one or more environmental control units, such as thermoelectric cooling units (915(i) and 915(ii) respectively) disposed within the cover. In one embodiment, the cover is configured to house the analytical system so that the internal temperature within the cover is maintained at approximately 20-30°C.

[0245] The analysis system depicted in Figure 9(a) is configured to process a multi-well analysis plate that has been subjected to an offline 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. In addition, 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 include specific reagents for performing the analysis. In a specific embodiment, samples can be added to the sample plate offline, the system uses one or more diluents and reagents that can be stored in diluent plates and / or reagent plates, respectively, and the analysis can be performed in a test plate (i.e., a plate to which samples and / or reagents are added by the system during one or more processing steps).

[0246] In a specific embodiment, a system processing plate (i.e., all wells of a plate) in batch mode is operated on or processed by the system simultaneously 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 multiwell plate, 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. Figure 9(d) shows the operating sequence of an 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 a storage unit of the analysis system, the set including a sample plate, a diluent plate, and a test plate; (b) removing a diluent and a sample from the diluent and sample plates, respectively, and adding them to the test plate; and (c) moving the test plate to the orbital oscillator assembly and returning the sample and diluent plates to the storage unit. Cycle 1 is completed when the first test plate of the set completes the first incubation. The second system operation cycle (cycle 2) includes the steps of (a) moving the test plate to the plate washing subsystem and washing the test plate; (b) moving the test plate and the detection antibody solution plate to the plate preparation platform; (c) adding the detection antibody solution to the test plate; and (d) moving the test plate to the orbital oscillation subassembly and returning the detection antibody solution plate to the storage unit. When the first test plate has completed the second incubation, cycle 2 is completed. 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 subsystem for up to three minutes (3min / plate).

[0247] In one embodiment, the analytical reader integrated with the analytical system 900 is an analytical reader as described herein, such as the device 500 illustrated in Figures 5-7. In a specific embodiment, the analytical reader is a 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 analytical reader is a MESO QuickPlex SQ 120, available from Meso Scale Discovery, Rockville, MD. Alternatively, the analytical reader is a MESO SECTOR S600, available from Meso Scale Discovery, Rockville, MD.

[0248] The analysis consumable storage unit (904) can be configured to store any type of consumables used in the analysis reader in the implementation of the analysis. In a specific embodiment, the storage unit is a multi-well plate storage unit configured to store a variety of multi-well analysis plates. In one embodiment, the plate storage assembly is configured as a shelving subassembly, which includes a plurality of shelving units, each unit being sized to accommodate a multi-well analysis plate. The shelving subassembly includes a housing, the housing including 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 introduction pore. The shelving subassembly may include an M×N linear array of storage units, wherein M and N are integers, such as a 2×1, 2×2, 3×3, or 4×4 array. In one embodiment, the subassembly includes a 2×1 array of storage units. And in a specific embodiment, the shelving subassembly is a 2×1 array of twenty storage units.

[0249] As described above, the liquid transfer subassembly (alone or in combination with the platform) provides independent X, Y and Z motion of probe to make it close to sample plate, reagent plate and / or test plate (as required). The liquid transfer subassembly may also include suitable pumps and valves (not shown) for controlling the pipette and / or probe. Pump is used to drive fluid through the liquid transfer subassembly. Those skilled in the art should be able to select suitable pumps for the device, including but not limited to diaphragm pumps, peristaltic pumps and injection (or piston) pumps. The pump also includes a multi-port valve to allow the pump to push and pull the fluid from different fluid lines. Alternatively, multiple pumps can be used to independently control the fluid in different fluid lines.

[0250] In one embodiment, the pipetting probe can use a fixed or disposable pipetting tip. In a specific embodiment, the pipetting probe uses a fixed pipetting tip. Alternatively, if a disposable tip is used, the disposable pipetting tip can be stored in a pipetting tip storage / disposal compartment (not shown). The arm / track of the pipette subassembly allows the probe to approach the tip storage / disposal compartment for the tip loading and use of the tip on the pipetting probe. In addition to transferring reagents and samples from one hole to another hole, the fluid line connected to the pipetting probe can also be connected to a working fluid or a diluent so that the probe can be used to deliver these fluids / diluents to the hole. Optionally, the pipetting probe may include a fluid sensing capability, such as using a capacitive sensor to detect when the probe contacts the fluid in a tube or hole. In a specific embodiment, the pipetting probe includes a multichannel pipetting probe that enables multiple holes of a multi-well plate to be transferred fluid simultaneously. For example, the pipetting probe includes a 96-channel pipetting head that can transfer fluid to 96 orifice plates simultaneously. In one embodiment, the pipetting head and corresponding fixed pipetting tips are available from Apricot Designs, Covena, CA. Generally speaking, if a fixed pipetting tip is used, it is supplied by a supplier of a pipetting probe, such as Apricot Designs, Covena, CA. If a disposable pipetting tip is used, the tip can be stored in a tip compartment and disposed of, and the tip compartment includes a housing for one or more individual drawers that can accommodate a standard disposable tip box (available from Axygen, Qiagen or Rainin) and a removable waste container for used pipetting tips. In order to remove the tip, the pipette probe is horizontally translated so that the axis is positioned in the slit and then vertically translated until the pipette tip is pulled off by the carriage. During operation, the specific slit used is selected using a collection mode or a random mode so that the used pipette tip is 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 distributed, and / or the size of the plate in which the tip is placed. In one embodiment, the tip volume is in the range of about 100 μL to 550 μL. In another embodiment, the tip volume is in the range of about 100 μL to 250 μL.

[0251] The plate washing subassembly can be any suitable commercial microtiter plate washing system, such as the plate washing 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. Likewise, the robotic subsystem can be any suitable desktop commercial robotic system, such as the system available from Precise Automation, Inc., Fremont, CA.

[0252] The liquid reagent subassembly comprises a plurality of liquid reagents and waste compartments and is used for one or more steps of the analysis implemented in the device. The reagent / waste compartment comprises a compartment body enclosed in an internal volume and a reagent and waste port for delivering reagents or receiving waste. The volume of the compartment in the subassembly is adjustable so that the relative ratio of the volume of the compartment body occupied by reagents and waste can be adjusted, such as when reagents are consumed in analysis and return to the compartment as waste. The total internal volume of the compartment body can be stored in the volume of the liquid in the body (for example, the volume of the reagent initially provided in the compartment) is low by about 2 times, low by about 1.75 times, low by about 1.5 times or low by about 1.25 times, so as to minimize the space required for waste and reagent storage, and allow 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 a fluid connection with the waste and reagent port, optionally via "one-touch connection" or "quick connection" accessories.

[0253] Optionally, the reagent and / or waste compartment are removable. In one embodiment, the reagent and / or waste compartment are removable and the device further comprises a sensor, such as an optical sensor, to monitor the fluid level in the reagent and / or waste compartment. Or, the liquid reagent subassembly may comprise an electronic scale to monitor the fluid weight in the reagent and waste reservoir, thereby tracking reagent use and availability in real time. Once as detected by the sensor or scale, the reagent and / or waste compartment reach a certain minimum or maximum capacity, and the device will warn the user to take out the reagent or waste compartment to supplement and / or empty the contents. In one embodiment, the motor of the pipetting probe is communicated with the sensor or scale and when the reagent and / or waste compartment reach minimum or maximum capacity, the device fails to operate the pipetting probe motor, for example, the probe sensor relays the information about the capacity of the compartment to the instrument software, and the instrument software then stops further pipetting action.

[0254] The reagent and waste compartment can be provided in the form of a foldable bag located in the subassembly body. One of the reagent and waste compartment can be provided in the form of a foldable bag and another compartment can be provided as a compartment body itself (that is, the volume of the volume defined by any foldable bag in the compartment body is excluded in the compartment body). In addition to the first reagent and the waste compartment, the reagent cartridge can further include one or more additional foldable reagents and / or waste compartments that are connected to one or more additional reagents and / or waste ports. Alternatively, one or the other of the reagent and waste compartments can be constructed by blow-molded plastics. Alternatively or in addition, waste can be pumped to an external drain or container. In one embodiment, the liquid reagent subassembly is also included in the reagent reservoir used during the implementation of the analysis in the device. In a specific embodiment, each reagent compartment is connected to a reagent reservoir via a fluid line, and the reagent reservoir collects a certain volume of reagent used during the analysis. The fluid line is directly guided to the pipette subassembly from the reagent reservoir. In practice, reagent is stored in the reagent compartment and the reagent of predetermined volume is allocated to the reagent reservoir from the reagent compartment. The device draws the fluid for analysis from the reagent reservoir. The reagent compartment and the reagent reservoir can be connected to an independent fluid sensor separately. The fluid sensor in the reservoir monitors the internal volume in the reservoir and if the internal volume is reduced to below a predetermined level, the reagent is allocated to the reservoir from the reagent compartment. Similarly, if the internal volume of the reagent compartment is reduced to below a predetermined level, 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 device is analyzed, because the fluid is replaced in the reagent compartment and the analysis process of the instrument can not be interrupted.

[0255] In one embodiment, the orbital oscillation subassembly (910) is a counter-balanced analytical consumable oscillation device as described and claimed in USSN 62 / 143,557 filed on April 6, 2015, the disclosure of which is hereby incorporated by reference in its entirety. Specifically, the orbital oscillation device includes (a) an orbital oscillator assembly including a horizontal orbiting 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, each of which is sized to accommodate consumables and includes a consumable locking 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 oscillation device further includes a rotation axis extending in a vertical direction from the oscillator assembly to the storage assembly and the counterweight is operatively connected to the rotation axis.

[0256] The analysis system illustrated in FIG. 9 may include a table or platform, such as 901, or the system may be set up and configured on a laboratory bench. In the system depicted in FIG. 9 (a), the analysis system is positioned on a table including one or more shelving units (916 and 917, respectively), which are positioned below the table or platform (901) and are configured to house one or more elements or subsystems of the analysis system. In one embodiment of a system positioned on a laboratory bench, a variety of subsystems may be distributed on the bench in the same XY plane (not shown).

[0257] exist Figures 9(a)-9(d) The analysis system (900) illustrated in (including the orbital oscillator assembly (910)) is described in U.S. Provisional Patent Application Serial No. 62 / 311,752 filed on March 22, 2016 and International Patent Application Serial No. PCT / US 2016 / 026242 filed on April 6, 2016, which are incorporated herein by reference in their entirety.

[0258] Another embodiment of the analysis system of the present invention is shown in Figure 10 and its sub-portions. The analysis system (1000) includes a plurality of subsystems positioned on a table (1001), wherein each subsystem is operatively connected to a robotic subsystem or robotic arm (1002) configured to approach and move one or more consumables (e.g., a multi-well analysis plate) from one subsystem of the analysis system to another subsystem. The robotic subsystem of the instrument depicted in Figure 10 and its sub-portions includes one or more pipetting subassemblies or pipettes (1021), each pipetting subsystem including one or more pipetting tips for dispensing / drawing fluids to / from the holes of the multi-well plate, such as multi-channel pipetting tips. The pipetting subsystems are attached to a gantry (1022) within the robotic system, which enables the pipetting tips to move through the analysis system in the X, Y, and Z directions. The multiple subsystems within the analytical system include an analytical reader (1003); an analytical consumables storage unit (1004); a plate washing subassembly or plate washer (1005); a plate oscillator subassembly or plate oscillator (1006), which includes one or more independent plate oscillating devices (e.g., as described above with reference to element 910 of FIG. 9, except that the orbital oscillator subassembly (910) has its own analytical consumables storage unit and can oscillate and incubate multiple plates simultaneously); a liquid reagent (1007) subassembly; a solid waste storage unit (1008) and a liquid waste storage (1020); and an electronics enclosure (1009) configured to house a system control computer, keyboard, display, wireless router, and power supply (not shown). Electronic components are designated as elements (1010, 1011), which are shown below the reader (1003) in FIG. 10(a), and may also be positioned in the electronics enclosure (1009). The analysis system may also include a platform (1012) positioned on the table (1001) and configured to enable pipetting of liquids to and / or from one or more wells of a multi-well analysis plate positioned on the preparation platform. The robotic subsystem is configured to move one or more plates to and / or from the platform, the plate washing subassembly, the oscillating subassembly, the analysis reader, and the consumable storage unit.The platform includes a consumable identifier controller (e.g., a barcode reader (1013)) configured to read analytical consumable identifiers, such as located on a multi-well plate, such as located on the bottom of a plate or tube placed in a reagent rack or tube holder; a pipette tip storage compartment (1014) configured to store a pipette tip box of variable-sized tips when needed (e.g., 1000 μl and 350 μl tips, respectively, 1015 and 1016); one or more sample / reagent tube racks (1017) and one or more reagent wells (1018) located in one or more corresponding racks. Optionally, the system includes a second consumable identifier controller (1023) located above the platform and configured to read identifiers on the sides of the plate and / or reagent rack; and a third consumable identifier controller (not shown) configured to read identifiers on consumable boxes located outside the system housing (not shown). In one embodiment, the third consumable identifier controller is remote from the analysis system, affixed to the housing of the analysis system, or positioned on a front or side panel of the housing of the analysis system and is configured to enable a user to contact a consumable identifier, such as on a plate or reagent kit, with the third consumable identifier controller before the consumable is used in the system. The analysis system may further include one or more environmental control units, such as thermoelectric cooling units or TECs (1019) disposed within the analysis system. Although the TEC is illustrated with the analysis system (1000), any environmental control system, heat exchanger, or cooling device may be used.

[0259] Different from the analytical system described in Fig. 9 (a), the instrument shown in Fig. 10 and its sub-part is configured to implement all sample processing steps on the plate and all analytical processing steps required in the implementation of the analysis. In addition, the user-interface of the analytical system of Fig. 10 and its sub-part is configured to gradually display to the user the instructions of the appropriate sample / reagent preparation steps that should be manually performed before the system implements the analysis. The sample / reagent preparation steps and the individual analysis steps performed by one or more subsystems of the analytical system can be different between a kind of analytical scheme and another analytical scheme. The detailed embodiment of the multiple analysis performed by the analytical system of Fig. 10 and its sub-part is described below, including but not limited to the implementation of cytokine, V-PLEX, U-PLEX, S-PLEX, pharmacokinetics (PK), immunogenicity (IG) analysis and customized sandwich immunoassay (available from Meso Scale Discovery, Rockville, MD), and the optimization of PK, IG and customized sandwich immunoassay.

[0260] Another iteration of the analytical system (1000) of the present invention is illustrated in FIG. 10(c). Some of the components shown in FIG. 10(a)-(b) are omitted for clarity. This iteration contains one or more grab trays (1024) positioned below the platform (1012) and above the table (1001) to grab and hold liquids that overflow from various reagents, diluents, and buffers during operation of the analytical system (1000). The grab tray (1024) preferably has a flow channel (1025) defined thereon to direct overflow liquid from the tray (1024) toward the solid waste storage unit (1008). Preferably, the flow channel includes a peripheral channel (1025b) to direct liquid away from the edge of the tray (1024), and an internal flow channel (1025a) that directs to the solid waste storage unit (1008). Optionally, the flow channel (1025) has an absorbent material disposed therein to absorb spilled liquid and / or carry the liquid away by capillary action toward a liquid waste reservoir (1020), as best illustrated in Figure 10(d). Alternatively, the flow channel (1025) may be coated with a surfactant to reduce flow resistance.

[0261] Additionally, the platform (1012) also contains additional raised podiums designed to hold additional disposable tips or accommodate additional components, such as individual plate shakers (1006), thereby illustrating the expandable nature of the analytical system (1000). A plurality of wells (1027) are provided on the platform (1012) to receive additional labware or other functional components.

[0262] In one embodiment, the analysis reader for the analysis system 1000 is an analysis reader as described herein, such as the device 500 illustrated in Figures 5-7. In a specific embodiment, the analysis reader is a 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 analysis reader is a MESO QuickPlex SQ 120, available from Meso Scale Discovery, Rockville, MD. Alternatively, the analysis reader is a MESO SECTOR S600, available from Meso Scale Discovery, Rockville, MD.

[0263] The analysis consumables storage unit (1004) can be configured to store any type of consumables used in the analysis reader in the implementation of the analysis. In a specific embodiment, the storage unit is a multi-well plate storage unit configured to store a variety of multi-well analysis plates. In one embodiment, the plate storage assembly is configured as a shelf subassembly, which includes a plurality of shelf units, each unit being sized to accommodate a multi-well analysis plate. The shelf subassembly includes a housing, the housing including a housing top, a housing back, a housing left and right housing wall, and a plurality of storage units disposed within the housing, wherein each storage unit includes a plate introduction pore. The shelf subassembly may include an M×N linear array of storage units, wherein 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 subassembly includes a 2×1 array of storage units. In a specific embodiment, the storage subassembly includes a 2×1 array of twenty storage units.

[0264] In the iteration of Figure 10 (c), the analysis consumable storage unit (1004) is redesigned to have two decorative and functional aspects. In this iteration, the analysis consumable storage unit is a single integral unit with multiple parallel shelving surfaces (1072) connected by multiple vertical supports (1074), as shown in Figure 10 (r). Each storage unit on the top row includes a raised corner (1076), which is sized and dimensioned to retain the reagents illustrated in Figure 18 and the sub-parts below it or the lid of the equipped support when the technician or robot subsystem (1002) places the analysis plate or support thereon. As shown in Figure 10 (c), the bottom horizontal shelf of the analysis consumable storage unit is preferably independently and firmly screwed to the platform (1012) in a cantilevered manner. The upper assembly of the analysis consumable storage unit is fastened to the bottom horizontal shelf, and multiple, preferably two or more matching pins are used to maintain the consistent positioning of the upper assembly. Preferably, the matching pins are located outside the X and / or Y center lines to minimize improper matching of the bottom horizontal shelf and the top assembly. A plurality of, preferably three or more thumb screws are used to fasten the analytical consumable storage unit together. In addition, a plurality of, preferably at least three Z-direction adjustment screws are provided to level the analytical consumable storage unit (1004) when necessary.

[0265] The advantage of having a bottom horizontal shelf mounted independently of the upper assembly is easy removal of the analytical consumables storage unit (1004) for servicing and access to components behind the unit (1004). The matching pins and thumb screws further allow the upper assembly to be easily and accurately reconnected to the bottom horizontal shelf thereafter.

[0266] The pipetting subassembly (1021) is supported on a stand (1022) and is powered by one or more motors to provide independent X, Y and Z motion to a probe (such as one or more pipetting tips) so as to bring it close to a trough, tube and / or plate (when needed). The pipetting subassembly (1021) also includes a suitable pump and valve for controlling the pipette and / or probe, and optionally a pipetting tip washing subassembly (not shown). The pump is used to drive the fluid through the pipetting subassembly. Preferably, each pipette tip can be independently controlled or independently allocated by the control software, controller and motor. In other words, one or more pipette tips can allocate or absorb liquid independently of other pipette tips. In addition, the spacing between adjacent pipette tips can be changed by the control software and motor. These degrees of freedom allow the analyzer (1000) to perform a variety of analyses, calibrations, self-diagnosis, etc. Those skilled in the art should be able to select a suitable pump for the device, including but not limited to a diaphragm pump, a peristaltic pump and an injection (or piston) pump. The pump also includes a multi-port valve to allow the pump to push and pull fluids from different fluid lines. Alternatively, multiple pumps can be used to independently control the fluids in different fluid lines. In a specific embodiment, the liquid transfer subassembly includes an exhaust pipette. Optionally, the liquid transfer probe may include a fluid sensing capability, such as using an ultrasonic capability or a pressure sensor to detect when the probe contacts the fluid in a tube or hole, as a means to minimize the external wetted surface of the probe and detect the presence of liquid in the container.

[0267] In a specific embodiment, the pipetting probe comprises a multichannel pipetting probe, which enables fluid to be transferred to a plurality of holes of a multiwell plate by all pipette tips or by the pipette tips of the selected number that are less than all available pipette tips. For example, the pipetting probe comprises 8 channel pipetting heads, which can simultaneously and independently transfer fluid to one or more channels to enter a multiwell plate or one or more pipes or grooves. Alternatively, the pipetting probe may comprise a 12-, 96- or 384-channel pipetting head. In a specific embodiment, the pipetting subassembly is supplied by Tecan Group LTD, Switzerland.

[0268] In one exemplary embodiment, a capacitive sensor is designed between the pipette tip or pipette and the pipetting deck to detect contact of the disposable tip with the surface of liquid contained in a tube, plate or rack found on the pipetting deck. The pipetting deck is preferably conductive and the pipette tip / pipette is also conductive so that a voltage potential can be applied therebetween.

[0269] A common capacitor is a parallel plate capacitor, which consists of two conductive plates electrically insulated from each other by a dielectric material. In a simple, parallel plate capacitor, the capacitance is inversely proportional to the distance between the two plates. Quantitatively, the capacitance (C) of two overlapping plates in farads is expressed as:

[0270] C=κε o (A / d), where

[0271] κ i is the dielectric constant of the material between the two plates (dimensionless)

[0272] ε o is the electrical constant, which is about 8.854×10 -12 F·m -1 ,

[0273] A is the overlapping area between the two plates in meters, and

[0274] d is the distance in meters between the two plates.

[0275] With respect to capacitive level sensing, the capacitance of the system takes into account the various dielectrics found in succession between the pipette tip and the pipetting deck. Quantitatively, the total capacitance (C) in Farads of two overlapping plates with various dielectrics (e.g., air, liquid, plastic / glass container) in between is expressed as:

[0276] 1 / C=∑1 / C i , where the capacitance of each dielectric is calculated individually as

[0277] C=κ i ε o (A / d i ), and where

[0278] κ i is the dielectric constant of a given substance between the two plates (dimensionless)

[0279] ε o is the electrical constant, which is about 8.854×10 -12 F·m -1 ,

[0280] A is the overlapping area between the two plates in meters, and

[0281] d i is the thickness of a given material between the two plates in meters.

[0282] In a system with multiple dielectrics, the change in capacitance that occurs when the thickness of a single dielectric (e.g., the air between the pipette tip and the liquid in a plate or holder) approaches zero can produce a significant change in capacitance, allowing the system to recognize that the pipette tip is contacting the liquid.

[0283] The inventors have determined that the sensitivity of a particular capacitive sensing system for detecting liquids in conventional tubes and vials can be significantly increased by using a conductive plate or support made of a plastic with a conductive additive such as carbon, metal or metal ions. Using the conductive support, the liquid level maintained in the conventional tubes and vials contained in the support can be determined using the capacitive 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%.

[0284] In one embodiment, the pipetting probe uses a disposable pipetting tip, which is stored in a pipetting tip storage compartment (1014). The disposable pipetting tip 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 tip can be stored in a removable solid waste storage unit (1008) for used pipetting tips. The size of the tip varies according to the size of the pipetting probe, the volume of the sample / reagent assigned, and / or the size of the plate in which the tip is placed. In one embodiment, the tip volume is in the range of about 1000 μL to 50 μL. In another embodiment, the tip volume is in the range of about 1000 μL to 350 μL.

[0285] As stated above, the pipetting subassembly (1021) provides independent X, Y and Z motions to the probe or pipette tip to bring it into proximity with a tank, tube, vial, rack and / or plate. The inventors have invented a training plate designed to initialize the analytical system (1000) periodically before or after first use so 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 subsystem (1002) and its clamping pad (1031) can be pinpoints with higher accuracy and repeatability.

[0286] As best illustrated in FIG. 10( e), a training or teaching board (1035) is positioned on the platform (1012). Preferably, the training board (1035) has dimensions and sizes similar to an industry standard analytical board (ANSI SLAS 1-2004) and is designed to fit into a slot, also referred to as a board bracket (1036), which is designed to receive the analytical board. The training board (1035) can be a solid rectangular prism, or preferably hollow, with a rigid perimeter and internal web designed to provide stiffness and rigidity. The internal web is provided for stiffness and stability and includes a curved rod (1037) and a generally linear element (1038). As shown, the curved rod (1037) has opposite concavities.

[0287] One or more reference points or pads (1040) are defined on the top surface of the training plate (1035). During the initialization procedure for the analysis system (1000), a probe (1042) such as a pipette tip connected to the robotic subsystem (1002) or preferably to the pipetting subassembly or pipette (1021) is brought into close proximity with the reference pad (1040), 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 does not deform or bend due to the contact. The capacitive sensor used for the pipetting subassembly (1021) described above can be used in conjunction with the conductive training plate (1035) in this initialization process to determine the Z-reference point and Z-maximum value of the laboratory vessel without the probe (1042) contacting the reference pad (1040).

[0288] Alternatively, the initialization process may be accomplished with a substrate thinner than about 0.1 mm, which is moved back and forth between the probe (1042) and the reference pad (1040). When the moving substrate is gripped between the probe and the reference pad, a Z-reference point is determined. 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) may be used. Exemplary magnetic proximity sensors include Hall effect sensors.

[0289] 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 the probe (1042) or replaces the probe (1042) and is then used to measure the distance to the reference pad (1040).

[0290] This Z-reference point is selected to be in the middle of a corner well on the XY plane in an industry standard ANSI SLAS1-2004 96-well microplate (8 rows x 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 value or highest height in the vertical direction for all labware. Advantageously, having an accurate Z-maximum value for labware improves the reliability of pipetting and placement and movement of the labware.

[0291] The training plate (1035) may be reversible, i.e., the bottom side has the same features as the top side. In another variation, an X-reference and a Y-reference point are 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 the Cartesian coordinates (x, y, z) are recorded for each reference pad.

[0292] The training plate (1035) can also be used to initialize the position of the clamping pad (1031) or match the clamping pad with the analysis plate on the platform (1012). Precise and consistent matching is preferred to achieve appropriate acquisition (retrieval) and placement (insertion) coordinates for the analysis plate or any other plate, bracket, slot, tube, etc. The clamping area (1044) is provided on the long side and short side of the training plate (1035), as shown in Figure 10 (f) as best as possible. During initialization or matching with the training plate (1035) positioned on the platform (1012), the robot subsystem (1002) positions its clamping pad (1031) on the short side or long side of the training plate (1035). The clamping pad (1031) will be positioned within the clamping area (1044), which is an area defined by a plurality of 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 (rotational coordinates), and the Z-elevation are also known and recorded by the processor controlling the robotic subsystem (1002). This matching information is stored and used to guide the robotic clamping pads (1031) to obtain or place laboratory vessels in the appropriate position.

[0293] As shown in FIG. 10( f ), the first surface (1043) of the reference pad (1040) containing the training plate (1035) has an outer perimeter that is smaller than the outer perimeter of the opposing surface (1045) having a bead line (1041) around the perimeter to provide a larger outer perimeter. When determining the Z-reference point, the opposing surface (1045) with the larger diameter and tighter tolerance is preferably inserted into the nest on the platform (1012). This allows for a sliding fit and more accurate and repeatable positioning of the reference pad (1040). When determining the position of the clamping pad (1031) of the robot arm (1002), the first surface (1043) with the smaller perimeter is preferably inserted into the nest on the platform (1012). This allows the clamping pad (1031) to lift the training plate (1035) without having to exceed any friction caused by contact between the training plate and the nest.

[0294] The training plates (1035) may be individually machined, preferably by a computer numerically controlled (CNC) grinder to achieve tight tolerances. The training plates may be machined to a flatness of 0.5 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 system (1000). The tolerances may be stored in any memory device and used to reconcile possible differences in measured values ​​when different training plates are used to initialize and recalibrate an analyzer.

[0295] Preferably, the training plate (1035) is made of cast aluminum for its stiffness, strength and light weight. The preferred cast aluminum is Aluminum Processing Plate 5 (ATP 5) or a similar metal. For example, a suitable metal should have a hardness of about 2,400 to about 3,000 kg / m 3 The present invention relates to a composite material having a density in the range of about 100 to about 150 HB, a hardness in the range of about 60 to about 80 HB, a tensile strength in the range of about 250 to about 300 MPa, and a yield strength in the range of about 100 to about 150 MPa. Other suitable materials include, but are not limited to, stainless steel, brass, titanium, and hard polymers such as polycarbonate and polystyrene.

[0296] The reference pad (1040) preferably has a diameter of about 1.46 mm ± 10% and the distance from the center of the reference pad (1040) to the side of the training plate (1035) is about 7 mm ± 10%. As shown in Figure 10 (e), the four reference pads (1040) correspond to the centers of the four corner wells in the 96-well microplate discussed above. Preferably, the training plate (1035) is anodized and more preferably gold anodized. Each training plate (1035) has a part number and revision number affixed and preferably bordered thereon, and a serial number affixed thereon.

[0297] In one embodiment, the training plate may have a bar code affixed thereto with its serial number to allow automated access to the sizing information stored for the training plate.

[0298] The plate washing subassembly can be any suitable commercial microtiter plate washing system, such as the plate washing 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. Likewise, the robotic subsystem can be any suitable desktop commercial robotic system, such as the system available from Tecan Group LTD, Switzerland.

[0299] In one embodiment, the plate oscillator subassembly comprises a counter-balanced analytical consumable oscillating device as described and claimed in USSN 62 / 143,557 filed on April 6, 2015 and described herein with reference to FIG. 9( a), the disclosure of which is hereby incorporated herein by reference in its entirety. Specifically, the oscillator subassembly may include a 2×3, 2×4, or 2×6 array of twenty storage cells. Preferably, the plate oscillator (1006) is an individual thermal oscillator having a heater to maintain an elevated temperature for the analytical plate disposed thereon. The thermal oscillator may be purchased from Q.Instruments, Jena, Germany as a BioShake3000-T elm oscillator. In one embodiment, the plate oscillator (1006) may maintain a temperature of about 3°C ​​higher than the operating temperature of the analytical system and up to about 37°C with a tolerance of about ±0.5°C. Samples, buffers, reagents, etc. contained in the wells of the analytical plate may be mixed and incubated on these oscillators.

[0300] The inventors have also discovered that reagents contained in the troughs (1018) and sample / reagent mixtures in the assay plate during incubation and mixing on the plate shaker (1006) undergo evaporation during an assay run. Evaporation of reagents in the troughs (1018) represents a loss, while evaporation of the assay plate on the plate shaker (1006) can cause changes in the concentration of materials contained in the assay plate due to evaporation. According to one aspect of the invention, a lid is designed for use with these containers.

[0301] As illustrated in FIG. 10( g ), an exemplary tank cover ( 1028 ) is illustrated. The cover ( 1028 ) is formed and sized to fit securely on the reagent tank ( 1018 ). The cover ( 1028 ) has a top ( 1029 ) and sidewalls that are sized and sized to fit on the top of the tank ( 1018 ), with a pattern of profiles ( 1030 ) established on the top ( 1029 ), for example, by a laser cutter. The profiles ( 1030 ) are designed to allow the top ( 1029 ) to flex and allow the pipetting subassembly or pipette ( 1021 ) to insert a pipette tip into the reagent tank ( 1018 ) to retrieve the reagent, as shown. When the pipette tip is withdrawn, the profiles ( 1030 ) allow the top to return to its original configuration. Any pattern of cross-sections (1030) may be used, as long as the top (1029) curves to allow the pipette tip to enter and substantially resumes its original configuration when the pipette tip is withdrawn. An exemplary pattern of cross-sections (1030) is shown in FIG. 10( h); however, the present invention is not limited to any particular cross-section pattern.

[0302] The lid (1028) limits the exposure of the reagents contained in the slot (1018) to the interior space in the analytical system (1000) and only to the combined area of ​​the profile. Generally speaking, the open slot may contain a buffer such as tripropylamine (TPA), which can evaporate, resulting in losses. Limiting the exposure will limit evaporation. To further limit the exposure, for example, a second top (1029') having another profile pattern in a relative orientation can be placed on the top or bottom of the top (1029) to establish a tortuous path for the evaporated gas to escape. The lid (1028) can be made of a relatively rigid material or a non-elastomeric material (such as polyester, high-density polyethylene (HDPE) or polycarbonate), and the flexibility of the top (1029) is provided by the profile pattern (1030). Alternatively, the lid (1028) can be made of an elastomeric material (such as neutral or synthetic rubber) to improve flexibility and optionally, the profile is made with a sharp cutting tool instead of a laser cutter to minimize the loss of material and the combined area of ​​the profile. Preferably, the lid (1028) is thermoformed or vacuum formed and the section (1030) is die cut. Thermoforming is a process where a plastic sheet is heated over a mold and formed into its shape using air pressure and vacuum forming is a similar process but uses vacuum instead of air pressure.

[0303] In order to minimize the possibility of the slots (1018) being pulled out of the slotted bracket (not shown in FIG. 10( a) without a reference number), elastomeric blocks may be inserted between the slots. The elastomeric blocks have a body with protrusions on each side facing the adjacent slots. Each block will then have two protrusions, and preferably the protrusions are of different sizes and / or volumes, depending on the amount of clamping required. For example, the protrusions facing the end slots should have a larger volume than the protrusions facing the center slot.

[0304] The plate cover (1032) as illustrated in FIG. 10( i) does not have a cross-sectional pattern because the plate cover (1032) is placed on the analysis plate (1033) after the processing steps are completed and the analysis plate (1033) is incubated and mixed on the plate shaker (1006). As discussed above, the plate shaker (1006) can be heated to an appropriate incubation temperature. High temperatures promote evaporation, especially when exposed to environmental conditions inside the analysis system (1000). The cover (1032) preferably includes a plurality of downwardly facing dimples (1034). Vapor evaporated from the sample / reagent mixture in the wells (1051) in the analysis plate (1033) preferably condenses at the dimples (1034) and the condensate will drip back into the wells (1051). Preferably, one dimple (1034) is positioned above each well (1051) in the analysis plate (1033). For example, with respect to a 96-well assay plate, 96 downward facing dimples are provided on the lid (1032).

[0305] As best shown in Figures 10(j)-(k), the lid (1032) includes a serrated edge (1050) that rests on the top surface. When placed on top of the porous assay plate (1033), the outer periphery of the top surface rests on the outer periphery of the assay plate (1033), thereby establishing a line of contact at (1052). The line of contact (1052) provides a restriction or seal to limit or prevent evaporated gas from leaving the enclosure between the assay plate (1033) and the lid (1032). Preferably, the lid (1032) does not have structural ribs on its bottom surface to interfere with contact at the line of contact (1052).

[0306] In addition, in the embodiment of the lid (1032) shown in Figures 10 (i)-(k), the second contact line (1053) is between the bottom surface of the lid (1032) and the top surface of each hole (1051). These second contact lines (1053) provide another obstacle to hinder the escape of evaporated vapor. The effectiveness of the second contact line (1053) with respect to each hole (1051) depends on the flatness of the lid (1032) and the flatness of the top surface of the analysis plate (1033). The dimples (1034) together with the toothed edge (1050) also help prevent the lid (1032) from sliding off the analysis plate (1033) during oscillation and incubation on the plate shaker (1006). In addition, the dimples (1034) also act as condensation enhancers to promote the condensation of the evaporated vapor back into the hole (1051).

[0307] The plate cover is preferably made of polystyrene, polypropylene or cyclic olefin copolymer (COC) or any other material commonly used in biological research.

[0308] 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.

[0309] 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 micro-topography that acts as an air buffer that prevents liquid from sticking to the surface. This is also known as the "lotus effect" named after the hydrophobic nature of lotus leaves. This effect is also observed on the skin of geckos. The rough micro-topography will not allow water to pool together to prevent widespread distribution. The pooled water will form larger droplets and fall away from the lid, thereby promoting condensation. The micro-etching can be done by a laser source called TresClean ( http: / / cordis.europa.eu / project / rcn / 200832en.html ) is achieved. Hydrophobic surfaces also have antimicrobial properties due to their ability to repel moisture.

[0310] Suitable hydrophobic polymers include, but are not limited to, poly(tetrafluoroethylene), polypropylene, polyamide, polyethylene, polyethylene, polysiloxane, polyvinylidene fluoride, polylactic acid glycolic acid, lyophilized dura mater, silicone, rubber, and / or mixtures thereof.

[0311] Suitable hydrophobic coatings may also include, but are not limited to, polyethylene, paraffin, oils, gels, pastes, greases, waxes, polydimethylsiloxane, poly(tetrafluoroethylene), polyvinylidene fluoride, tetrafluoroethylene-perfluoroalkyl vinyl ether copolymers, fluorinated ethylene propylene, poly(perfluorooctylethylene acrylate), polyphosphazenes, polysiloxanes, silica, carbon black, alumina, titanium dioxide, hydrated silanes, silicones, and / or mixtures thereof. Suitable hydrophobic coatings may also include surfactants such as perfluorooctanoate, perfluorooctane sulfonate, ammonium lauryl sulfate, sodium lauryl ether sulfate, alkylbenzene sulfonates, sulfonated or sulfonated fatty materials, salts of sulfated alkylaryloxypolyalkoxy alcohols, alkylbenzene sulfonates, sodium dodecylbenzene sulfonate, fluorosurfactants, sodium lauryl sulfate, sulfosuccinate mixtures, sodium dioctyl sulfosuccinate, sodium sulfosuccinate, sodium 2-ethylhexyl sulfate, ethoxylated acetylenic alcohols, high ethylene oxide octylphenol, high ethylene oxide nonylphenol, high ethylene oxide linear 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.

[0312] In one variation, the material forming the contact line (1052) on the outer periphery of the top of the plate (1033) resting on the outer periphery of the analytical plate (1033) may be roughened, such as 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 discussed above, thereby exhibiting Cassie-Baxter behavior. It is known that microstructuring a surface will amplify the natural tendency of the surface, and in some cases, if the roughened surface can capture vapors (such as air or other gases), then the hydrophobicity of the surface can be further enhanced (Cassie-Baxter equation). It is also contemplated that the bottom surface of the cover (1032) can be microstructured using methods known in the art, including but not limited to using micromachining, lithography (photolithography, soft lithography (nanoimprint lithography, capillary force lithography, micromolding in capillaries, transfer micromolding), 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 a pattern or texture 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.

[0313] Optionally, a gasket may be placed proximate to the contact line (1052), preferably on the outer periphery of the lid (1032) adjacent to the toothed edge (1050). One or more stacking features (1057) may be positioned around the periphery of the lid (1032) on top thereof so that multiple lids (1032) may be stacked on top of each other without sliding apart.

[0314] Liquid reagent (1007) subassembly comprises a plurality of liquid reagents and waste compartments and is used for one or more steps of the analysis implemented in the device. The reagent / waste compartment comprises a compartment body enclosed in an internal volume and a reagent and waste port for delivering reagents or receiving waste. The volume of the compartment in the subassembly is adjustable so that the relative ratio of the volume of the compartment body occupied by reagents and waste can be adjusted, such as when reagents are consumed in analysis and return to the compartment as waste. The total internal volume of the compartment body can be lower than about 2 times, about 1.75 times, about 1.5 times or about 1.25 times than the volume of the liquid stored in the body (for example, the volume of the reagent initially provided in the compartment), so as to minimize the space required for waste and reagent storage, and allow 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 a fluid connection with the waste and reagent port, optionally via a "one-touch connection" or "quick connection" fittings.

[0315] Optionally, the reagent and / or waste compartment are removable. In one embodiment, the reagent and / or waste compartment are removable and the device further comprises 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 comprise an electronic scale to monitor the fluid weight in the reagent and waste reservoir, thereby tracking reagent use and availability in real time. Once, as detected by the sensor or scale, the reagent and / or waste compartment reaches a certain minimum or maximum capacity, the device will warn the user to take out the reagent or waste compartment to replenish and / or empty the contents. Other liquid level detectors may be used. An exemplary liquid level detector comprises a plurality of thermistors vertically arranged in each compartment, such as, at 1 / 4, 1 / 2, 3 / 4 and full mark. Due to the different heat capacities of liquid and air / steam, the thermistor immersed in the liquid produces an electrical signal that is different from the thermistor located in the air or steam. Another liquid level detector is included in a capacitor having a 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, thereby indicating the amount of liquid contained in the compartment.

[0316] In one embodiment, the pump or motor of the pipetting subassembly (1021) is connected to these sensors or scales and when the reagent and / or waste compartment reaches a minimum or maximum capacity, the device disables the pipetting probe motor operation, for example, the probe sensor relays information about the capacity of the compartment to the instrument software, which then stops further pipetting action.

[0317] The reagent and waste compartment can be provided by the foldable bag in the subassembly body. One of the reagent and waste compartment can be provided by the foldable bag and the other compartment can be provided by the compartment body itself (that is, the volume of the volume defined by any foldable bag in the compartment body is excluded in the compartment body). Or, the reagent and waste compartment can be stored in the same container and separated by flexible, removable or elastic membrane or spacer. Except the first reagent and waste compartment, the reagent cartridge can further include one or more additional foldable reagents and / or waste compartments that are connected to one or more additional reagents and / or waste ports. Or, one or the other of the reagent and waste compartment can be constructed by blow-molded plastics.

[0318] According to another aspect of the present invention, the analysis system (1000) is capable of controlling the internal temperature when its door or panel (1056) is closed. Although its housing and door are not illustrated in Figure 10 (a)-(c) to show the internal components, the analysis system (1000) includes doors and / or panels generally designated as (1056). These doors and panels are closed before the analysis system (1000) performs an operation. Once the system starts running, it is preferred that the internal air temperature in the area above and near the platform where the analysis steps are performed is maintained within a range of about 20°C to about 24°C. Once the operating temperature is selected depending on the specific analysis being run, the selected temperature is preferably maintained within ±1°C. The temperature control area can be defined as from the front of the platform (1012) or the analysis consumable storage unit (1004) to about 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 to the right of the platform (1012), or from position 26 to position 49, as shown in Figure 10 (u), for example to cover the length of all plate shakers (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 the user is notified if the operating temperature is outside the operating range. The temperature of the liquid in the MSD plate with the lid placed on the plate shaker with the shaker temperature control turned off should rise to no more than 2°C above the ambient deck temperature within a two-hour duration.

[0319] The selected operating temperature is maintained, although heat may also be generated by the plate oscillator assembly (1006) of the assay plate incubated at elevated temperature as discussed above, and the assay reader (1003) contains electromechanical components and thermoelectric coolers for heat-generating optical sensors such as charge coupled devices (CCDs) 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 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 plate oscillator (1006). Additionally, some cooling is directed to the electronics (1010, 1011) or electronics housed in an electronics enclosure (1009) discussed below.

[0320] As illustrated in FIG. 10( m ) showing a cross-sectional side view of the analysis system (1000), the TEC (1019) absorbs warm air (1046) near its middle portion (as indicated by the arrows) and produces cold air (1047) at the top and bottom (as indicated by the arrows). The cold air (1047) flows toward the front of the analysis system (1000), thereby cooling the hood, and is turned due to the closed door or panel (1056) and returned as warm air (1046), where the heat is absorbed by the TEC (1019). FIG. 10( n ) shows a top view, in which all six exemplary TECs (1019) are illustrated. The returning warm air is directed toward certain areas closest to the center of the TEC. FIG. 10( o ) is a perspective view showing the flow of warm and cold air and the baffles (1048) in more detail. Each baffle (1048) preferably encloses one or more TECs (1019) as shown, thereby forcing the cool air (1047) to flow upward and downward, as discussed above. The baffles (1048) also bring returning warm air to the sides of the baffles, where heat is exchanged by the TECs. Additional heat exchange occurs on the hot side of the TECs, outside the housing of the analyzer (1000), where heat absorbed from the interior of the analyzer is exchanged by the atmosphere.

[0321] Additionally, the plate shaker (1006) may be raised above the platform (1012) to allow air to flow underneath and cover the top of the shaker to improve convective heat transfer.

[0322] FIG. 10( p) illustrates the cooling of the electronic devices (1010, 1011), which are preferably housed in the electronic enclosure (1009). The cooling of the enclosure (1009) uses the chimney effect by drawing cold air (1047) from the bottom and pulling the air upward to cool the electronic devices (1010, 1011), and expelling warm air (1046) to the exterior of the analyzer (1000) through the cooling channel (1049). 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 cold ambient air and push the air into the electronic enclosure (1009) to cool and expel warm air through the cooling channel (1049).

[0323] Referring back to FIG. 10( l ), ​​at least one computer screen or tablet (1058) is attached to a glass surface (1060) of the analysis system (1000). A pressure transducer, typically used for touch screens, is attached to or adhered directly to the glass surface (1060) and relies on the glass surface (1060) of the analysis system (1000) to transmit pressure applied by a user's fingertips to the transducer to generate a current signal to the CPU of the tablet or computer. At least one acoustic actuator (1062) also relies on the same glass surface (1060) to generate sound waves. The acoustic actuator (1062) is also attached to or adhered to the glass surface (1060). The acoustic actuator (1062) causes the glass surface (1060) to vibrate to cause sound. Both the touch screen and the acoustic actuator can be used in the graphical user interface (GUI) or user interface (UI) described herein.

[0324] In order to minimize or eliminate interference with the pressure transducers of the panel (1058) caused by the vibrations generated by the acoustic actuator (1062), a minimum distance between the actuator and the pressure transducer / touch screen is preferably established. Although human sound frequencies range 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 (7th to 8th octave). Preferably, the pressure transducers in the panel (1058) are designed, selected or adjusted so that they do not respond to the human vocalization range so that the same glass surface (1060) can be shared by visual devices and audio devices.

[0325] In addition, a glass surface (1060) or other surface on the front of the analysis system (1000) may contain lights, such as LED lights or light strings. Preferably, the LED lights are located on the door handle of the analysis system and may also be located on the top of the analysis system. These lights may illuminate different colors, depending on the status of the immunoassay being run. In one embodiment, the lights may convey satisfactory operation by emitting a constant green or blue light when the system is running, a flashing or pulsating green or blue light, emitting yellow or red when an error is detected, and emitting white when the system is completed. The same colors may also be displayed on the flat panel (1058).

[0326] Another aspect of the analysis system (1000) relates to how to support the door or panel (1056) on the frame of the system, which panels and doors can be heavy and bulky. Referring to Figure 10(q), the flange system (1063) includes a main overhang (1066) and a movable bracket (1064) movably mounted on a track (1065) to allow the bracket (1064) to be adjusted up and down in the Z-direction. The main overhang (1066) has a pair of C-shaped openings (1067) adapted to be mounted on supports (1068) on the bracket (1064). Once the vertical position of the door or panel (1056) is satisfactorily established, bolts are screwed into the openings (1069) to secure the vertical position.

[0327] The horizontal position (XY 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 spaced 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 move the main overhang (1066) horizontally in the XY plane. The horizontal movement of the main overhang (1066) is limited by the shape of the opening (1069). In other words, the opening (1069) has a horizontal oval shape, which allows the connecting bolt to move a small amount inside the oval.

[0328] Thus, the flange system (1063) allows the door or panel (1056) to be adjusted in two directions to ensure that the analytical system (1000) can be properly closed. The flange system (1063) can be used on any and all doors and panels on the analytical system.

[0329] Optionally, a camera is positioned within the housing of the analysis system (1000) to record the analysis run and stream the 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.

[0330] The analysis system (1000) is designed to be stable and as shown in Figure 10(s), the table (1001) supporting the platform (1012), all permanent components and laboratory utensils / consumables has a length (L) of 85 inches ± n%, a height (H) of about 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 about 4.5 inches ± n%. The opening (1078) for the plate washer (1005) is about 5.5 inches ± n% by 10 inches ± n%. The opening (1080) for the solid waste storage unit is about 4.5 inches ± n% by 6 inches ± n%. The opening (1082) for the reader (1003) has a length (L direction) of about 16 inches ± n%. The tolerance n% is preferably 10%, more preferably 5% and more preferably 2.5%.

[0331] Referring to FIG. 10( t ), the frame ( 1084 ) has a height (H) of about 52 inches ± n%, a front overhang height (Hfront) of about 30 inches ± n%, a length (L) of about 84.5 inches ± n%, a width at the top (W) of about 34.5 inches ± n%. The bottom support has a long width (W2 bottom) of about 33 inches ± n% and a short width (W1 bottom) of about 18 inches ± n%. The tolerance n% is preferably 10%, more preferably 5% and more preferably 2.5%.

[0332] The reader (1003) is advantageously positioned within the recessed opening (1082) and the plate washer (1005) is positioned within the recessed opening (1078) to provide clearance for movement of the clamping pad (1031) and the pipetting subassembly or pipette (1021) of the robotic subsystem (1002) and to leave room for labware and consumables on the platform (1012). The reader (1003) is also positioned off center, such as on the side of the table (1001), so that the heat it generates is kept away from the center of the assay plate and more easily dissipated. The clamping pad (1031) and the pipetting subassembly or pipette (1021) share the same stand (1022) to save space. The analytical consumable storage unit (1004) is cantilevered to the front edge of the platform (1012) and the plate shaker (1006) is positioned toward the back of the platform (1012), as discussed above, to leave room for labware or consumables on the platform and for a lab technician to load consumables from the front and the clamping pad to remove and place the consumables from the back. The combination of the dimensions of the table (1001) and frame (1084) and the location / elevation of the major components described herein provide stability and space savings for the analytical system (1000).

[0333] The electrical and electronic connections are shown in Figure 10 (v)-(y). Figure 10 (v) shows power and Internet connections. The power supply and Ethernet module (1085) are shown on the left and are connected to UPS (1086). When the power is cut off, UPS (1086) provides emergency power to the analysis system (1000). UPS (1086) is also connected to the processor (1087) for the reader (1003) and the analysis system (1000), and the router (1088). UPS (1086) is also connected to the plate washer (1005) and its pump and is connected to the robot subsystem (1002).

[0334] FIG. 10( w) continues the wiring diagram of FIG. 10( v) and shows the right side of the electrical contacts. FIG. 10( w) shows the UPS connected to another power supply (1089), which is a 300W AC and 24V DC unit. The power supply (1089) supplies a DC power module with a step-down power supply at 24A at 5V DC. This 5V power supply module supplies power to multiple sensors on both sides, such as the waste crusher sensor, plate scrubber sensor, etc. on its left side. On its right side, it supplies power to the panel (1091), which powers the light panel and illuminates the left and right doors (1092). The panel (1091) also supplies power and signals to the sound actuator (1062), the computer screen or tablet (1058) and the bar code reader (1013).

[0335] Figure 10(x) continues the diagram of Figure 10(w) and shows the control and power PCB (1093) connected to the six TECs (1019) and their associated sensors (1094). The control and power PCB (1093) also powers the blower (1095) and the reader (1003).

[0336] Figure 10(y) shows the deck control PCD (1096) which powers the five plate shakers (1006), the bar code reader (1098) and the thermistor sensor (1099) used to monitor the temperature associated with the analytical reader (1000).

[0337] FIG. 10( z ) is a top view showing the plate bracket ( 1036 ) and the tip bracket ( 1026 ).

[0338] In each of the analytical systems depicted in Figures 9-10, additional microprocessors and computers in the analytical system can interact with the identifier by transferring data and commands for / from the analytical consumable identifier through the system to multiple microprocessors / controllers to perform various operations of the components listed above within the analytical system as described below.

[0339] The system can adjust the analysis parameters based on the consumable data stored in the identifier and / or stored or provided as consumable data via a direct or indirect interface before starting the analysis. Thereafter, the system is appropriately electrically connected, fluidically connected and / or optically connected (using electrical connectors, fluid connectors and / or optical connectors on the consumables and the system) to the consumables and uses the consumables to implement the analysis. The sample can be introduced into the consumables before the consumables are inserted into the system. Alternatively, the sample can be introduced by the components of the system after the consumables are inserted into the system. The analysis can also involve adding one or more analysis reagents to the consumables and the instructions for adding those different analysis reagents can be saved to the identifier and / or provided as consumable data and the system adds those reagents to the consumables before or during the analysis according to the instructions saved to the analysis consumables identifier and / or provided as consumable data, as further described below.

[0340] (iv) Analysis cartridge and cartridge reader

[0341] Alternatively, the analytical consumable is a cartridge and the consumable further comprises an element selected from one or more fluid components, one or more detection components, one or more analytical cells, reagents for performing an analysis, working electrodes, counter electrodes, reference electrodes, dielectric materials, electrical connections, dry and / or liquid analytical reagents, or combinations thereof. The cartridge may further comprise at least one analytical cell comprising a plurality of different analytical test sites and / or domains, each of which comprises reagents for measuring a different analyte.

[0342] The example of the analysis consumables cylinder that can be used for the present invention is described in U.S. application number 2004 / 0189311, and the disclosure of the U.S. application is incorporated herein by reference in its entirety. The analysis consumables described therein are analysis cylinders, which are incorporated with one or more fluid components, such as compartments, holes, chambers, fluid conduits, fluid ports / 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 allow optical measurements of the sample in the cylinder, such as absorbance, light scattering, light refraction, light reflection, fluorescence, phosphorescence, chemiluminescence, electrochemiluminescence, etc.) etc. The consumables may also include reagents for analysis, such as binding reagents, detectable labels, sample treatment reagents, washing solutions, buffer solutions, etc. The reagents may exist in liquid form, solid form and / or be fixed on the surface of the solid support present in the cylinder. In this embodiment, the consumables include all components necessary for analysis. Additionally, the analytical consumable is used in conjunction with a consumable analytical reader adapted to receive the consumable and perform some operation on the consumable, such as controlling fluid movement, supplying electrical power, performing physical measurements on the cartridge, and the like.

[0343] More specifically, the analytical consumables cartridge has one or more analytical test sites (e.g., holes, compartments, chambers, conduits, flow cells, etc.), which may include one or more analytical domains for performing a variety of analytical measurements (e.g., individual locations on the surface of the analytical test sites, where analytical reactions occur and / or where analytical dependent signals are induced, such as electrochemical or electrode-induced luminescent signals). In this embodiment, the analytical domain is supported on analytical electrodes (in one embodiment, an array of analytical electrodes, such as a one-dimensional array of analytical electrodes) to allow analysis based on electrochemical or electrode-induced luminescent measurements. The analytical domain is optionally defined by a dielectric layer deposited on the electrode. In addition, the analytical consumables may have one or more attributes that make them suitable for "on-site care" clinical measurements, such as small size, low cost, disposable, multiple detection, easy to use, etc.

[0344] The analysis consumables cartridge may include necessary electronic components and / or active mechanical components for performing analysis and measurement, such as one or more electrical energy sources, ammeters, potentiometers, photodetectors, temperature monitors or controllers, pumps, valves, etc. Alternatively, some or all of the electronic and / or active mechanical components may be arranged in an independent analysis reader. The analysis reader may also have suitable electrical connections, fluid connections, and / or optical connections to analyze using the consumables. Using the arrangement, the analysis consumables may be designed to be low-cost and disposable, and the analysis reader (which has more expensive and complex components) may be reused.

[0345] In one embodiment, a cartridge-based biochemical detection system may include a system housing including an optical detector, wherein the system housing is adapted and configured to receive and position analytical consumables and / or optical detectors for processing. The system may further include a support subsystem, which may include one or more of the following: a storage subsystem for storing analytical reagents / consumables and / or waste; a sample collection / pretreatment / storage subsystem for sample disposal; a fluid handling subsystem for disposing of the reagents, samples, waste, etc. and for providing fluid to the detection chamber via a fluid inlet line; an electrical subsystem for electrically contacting the electrical contacts of the cartridge and supplying electrical energy to the electrodes; and a control subsystem for controlling and coordinating operations of the system and subsystems and for collecting, processing, and storing optical detection signals. Information associated with the analytical consumable identifier and / or provided as consumable data may include information for controlling or adjusting one or more of the analytical system components before and / or during the use of the analytical consumable to perform the analysis.

[0346] Additionally, the analytical consumable may be a container holding one or more analytical reagents, including but not limited to one or more buffers, diluents and / or reagents used by the analytical system to perform the analysis. The analytical consumable identifier may be affixed to the container and / or to packaging for the container.

[0347] B. Analyze consumable identifiers

[0348] In one embodiment, the analysis consumables identifier includes a memory for storing information related to the consumables, its history and / or its use. In one embodiment, the memory is a non-volatile memory. Non-volatile memory is a computer memory that can retain stored information without electricity. Examples of non-volatile memories that can be used for the consumables identifier include, but are not limited to, electronic non-volatile memories (e.g., read-only memories and flash memories), magnetic memories (e.g., hard disks, floppy disk drives, and magnetic tapes), optical memories (CD-ROM drives), and mixtures of these methods (e.g., magneto-optical memories).

[0349] In one embodiment, the analytical consumables identifier comprises 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 consumables identifier comprises an electronic erasable programmable read-only memory (EEPROM), a type of non-volatile electronic memory that can be electrically erased and reprogrammed without exposure to UV light. EEPROM can be written or reprogrammed more than once and can be selectively programmed (customers can change the values ​​of certain cells without erasing the programming of other cells). Therefore, partitions of data can be erased and replaced without changing or reinstalling the rest of the programming of the chip.

[0350] In another embodiment, the analytical consumable identifier comprises 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 EEPROMs 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 EEPROMs when writing large amounts of data.

[0351] In another embodiment, the analytical consumables identifier comprises a smart card, a chip card or an integrated circuit card (ICC) (collectively referred to as "ICC"). These cards are small cards embedded with an integrated circuit 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 read out of the ICC. The ICC electronic components are supported on a card typically made of plastic such as PVC or ABS. The card may include an embedded hologram to avoid counterfeiting. The contact ICC has conductive contact pads. When inserted into the analytical reader, the contact pads on the ICC contact the electrical connector in the identifier controller to allow information to be transferred between the identifier controller and the ICC, such as allowing the identifier controller to read, erase or write information on the ICC.

[0352] Another method of transferring information is via RFID, Radio Frequency Identification, which is similar in theory to barcode identification. When using RFID, electromagnetic or electrostatic coupling in the RF portion of the electromagnetic spectrum is used to transmit signals. An RFID system consists of an antenna and a transceiver, which reads the radio frequency and transfers the information to a processing device, and a transponder or tag, which is an integrated circuit containing the RF circuitry and the information to be transmitted.

[0353] Identification can also be achieved by reading a consumable identifier (e.g., a barcode). One of the key differences between RFID and barcode technology is that RFID eliminates the line-of-sight reading that barcode generation relies on. In addition, RFID scanning can be performed at a distance greater than barcode scanning. High-frequency RFID systems (850MHz to 950MHz and 2.4GHz to 2.5GHz) provide a transmission range of more than 90 feet, but wavelengths in the 2.4GHz range are absorbed by water (the human body) and therefore have limitations.

[0354] In one embodiment, the nonvolatile memory for the present invention comprises EEPROM, flash memory, ICC or a combination thereof. In one embodiment, the nonvolatile memory is EEPROM. In an alternative embodiment, the nonvolatile memory is RFID. In a specific embodiment, the nonvolatile memory is a consumables identifier (e.g., bar code), including but not limited to a one-dimensional or two-dimensional consumables identifier (e.g., bar code), or a combination thereof.

[0355] In an additional alternative embodiment, two or more non-volatile memory components can be used for the present invention. For example, a first analysis consumable comprising a first identifier can be used for the analysis system, and an additional analysis consumable comprising an additional identifier can also be used for the analysis system. Each identifier can include the same or different types of memory. However, for each different form of memory, there will be an independent identifier controller. And some consumable data can be stored on a kind of identifier and other consumable data can be stored on the same or different types of additional identifiers. For example, a kind of analysis consumable for the system can include EEPROM or RFID as an identifier, and the system can also use an additional analysis consumable comprising, for example, a consumable identifier (e.g., a bar code) as an identifier. The analysis system will include an identifier controller that can interface 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 bar code).

[0356] The analysis system of the present invention includes an identifier controller that controls the operation of the non-volatile memory and other components of the analysis system. The identifier controller optionally includes a microcontroller to interface with the non-volatile memory across a communication interface that can be incorporated into conventional interface architectures and schemes, such as I 2 C (a two-wire serial bus scheme). The microcontroller addresses the non-volatile memory and performs write, read and erase operations on the memory.

[0357] The consumables identifier may be located on the consumables or it may be an independent component. In either case, the system may be designed to have a unique identifier for each consumable. Alternatively, the system may be configured so that an independent consumables identifier is used to hold information relevant to a variety of consumables. In one embodiment, each consumable package has a package-specific identifier installed on the package (or alternatively, supplied in the package), which holds information relevant to the multiple consumables in the package. Optionally, each consumable also carries an extra unique consumables-specific identifier attached to the consumables. This consumables-specific identifier is primarily used to uniquely identify the consumables and to correlate it with the information on the package-specific identifier. In this embodiment, batch information content and / or non-editable identifiers may be used, such as consumables identifiers (e.g., barcodes).

[0358] The various components of the analysis system can be stored together in a single unit or can be stored independently. For example, the analysis system may include an analysis reader and an identifier controller as an independent unit. The analysis system provides connectivity (which may be wired or wireless connectivity) directly between the analysis reader and the identifier controller or alternatively, indirectly through the additional components of the analysis system. In an alternative embodiment, the identifier controller is stored in the analysis reader. In the embodiment, the analysis reader can be configured so that the consumables inserted into the analysis reader during the implementation of the analysis also enable the consumables identifier to be connected with the identifier controller (for example, wherein the port into which the consumables are inserted includes a component for processing and / or reading the consumables and also includes a component for establishing connectivity with the consumables identifier, such as an electrical contact or a radio transmitter). In one embodiment, when the consumables are loaded into the analysis system, electrical contact is generated between the controller and the identifier. The controller is then able to read, erase and / or write consumables data from / for the identifier. Alternatively, the analysis reader may have an independent port for processing / reading consumables and for establishing connectivity with the consumables identifier. The customer places the analytical consumable or packaging in or near the controller port so that the controller makes electrical contact with the identifier to enable the controller to read, erase and / or write consumable data.

[0359] In one embodiment, the identifier comprises a non-volatile memory comprising an RFID tag, a consumable identifier (e.g., a barcode), an EPROM, an EEPROM, or a combination thereof. Additionally, the identifier may comprise an EEPROM comprising a flash memory and an ICC. In a specific embodiment, the identifier is a consumable identifier (e.g., a one-dimensional or two-dimensional barcode).

[0360] C. Consumables data

[0361] The identifier is programmed, for example, during the manufacturing process or when the consumable is ready for shipment. The identifier is associated with consumable data, which can be used to control the operation of the analysis system, analysis reader or components of the analysis system before, during or after the step of analysis or multi-step analysis. Alternatively or in addition, some or all of the information required for the use of a given consumable can be provided as consumable data. The term "consumable data" may include any information for uniquely identifying a specific analysis or analysis step, analysis consumable, consumable domain, biological reagent or sample or distinguishing a specific analysis, analysis step, analysis consumable, consumable domain, biological reagent or sample from other analysis consumables, consumable domain, biological reagent or sample. Consumable data may include consumable information, sample information, chain of custody information, consumable / test site information, analysis process information, consumable safety information or a combination thereof. Consumable data may further include information related to one or more analysis tools, which may be used by the system to analyze data generated during and / or after the implementation of the analysis; analysis system maintenance information; system-consumable upgrade information; and / or system and / or consumable technical support information.

[0362] Each type of consumable product data is described in more detail below and it should be understood that each type of consumable product data may be associated with the consumable product identifier and / or provided as consumable product data.

[0363] (i) Consumables identification and configuration information

[0364] Consumable data may include consumable identification and configuration information, including but not limited to batch identification information, batch-specific analytical 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 a product insert that will accompany the analytical consumable, such as the type of analysis, how the analysis is to be performed, instructions for use of the analytical consumable, analytical reagents, or both, etc.), threshold and / or calibration data for one or more reagents used for the analytical consumable or for a step of an analysis or multi-step analysis, and the location of individual analytical reagents and / or samples within one or more test sites of the analytical consumable.

[0365] The consumables data may also include batch identification information, i.e., information used to identify a particular batch of analytical consumables, which is different from batch-specific analytical parameters, including information specific to a given batch that can be used by the system, for example to perform analysis using consumables from that batch or to analyze analytical results derived from consumables from that batch. In one embodiment, if the analytical consumable is a multi-well assay plate or cartridge, then the batch-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 type of consumable; (iii) the date of manufacture; (iv) the batch number; (v) the expiration date; (vi) a crosstalk correction matrix to account for chemical cross-reactivity; (vii) thresholds for the assay 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 positive control samples; (x) software checks and to ensure data integrity; (xi) acceptable ranges for controls in the wells (or test sites); (xii) assay name and / or identifier; (xiii) information about 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 assay calibrators and / or assay calibrator acceptance ranges.

[0366] The consumable data may include sample information, such as 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, and the identity of samples that have been and / or will be analyzed in the analytical consumable.

[0367] Consumables data may also relate to chain of custody, such as information about the control, transfer and / or analysis of the sample and / or analytical consumables. Chain of custody information may be selected from customer identification, sample identification, time and date stamp for analysis, location of the analytical system in the laboratory during the analysis, calibration and quality control (QC) status of the analytical system during the analysis, supervision and / or location information for the analytical consumables before and after the implementation of the analysis, analysis results for a given sample, and free text comment input created by the customer before, during or after the analysis is processed by the system. In addition, chain of custody information may include time, date, manufacturing personnel or processing parameters for one or more steps during the manufacture of the analytical consumables, supervision, location and / or storage conditions for the analytical consumables after manufacture and / or between steps during the manufacture of the analytical consumables.

[0368] The consumable data may also include consumable / test site information, such as consumable type and structure, the location and identity (e.g., structure, composition, sequence, concentration and / or origin) of analytical reagents included in the analytical consumable, and the location and identity of analytical reagents in the analytical test site of the analytical consumable. Consumable data may also be used to distinguish a first test site in the consumable from different test sites in the consumable. In addition, consumable data may include sample information, which includes the location of a sample in at least one test site of the analytical consumable; the 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. In addition, 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 analytical reagents in the analytical test site of the analytical consumable; or a combination thereof.

[0369] In an additional embodiment, the consumables / test site information may include information about the analysis previously performed by the analysis reader or system on one or more test sites of the consumables, and information about the analysis to be performed by the analysis reader on one or more test sites in the consumables. Therefore, once the analysis is implemented by the system, the controller can be used to write the results of the analysis to the identifier. The information includes, but is not limited to, the original or analyzed data collected by the system during the analysis (wherein the analyzed data is data that has been subjected to statistical analysis after collection and the original data is data that has not yet been subjected to the statistical analysis), a list of test sites and / or domains in the analysis consumables used during a given analysis, a scheduling of events to be implemented on the analysis consumables or the test sites and / or domains in the analysis consumables, a list of those test sites and / or domains that have not yet been subjected to analysis, analysis or system errors or combinations thereof generated during a given analysis or analysis step in the analysis device.

[0370] In addition, consumables data can be used as a security mechanism, such as to confirm that the correct analysis consumables are being used for the system (referred to herein as "consumables security information"). Consumables data may include a digital signature to prove that the consumables are manufactured by a specified supplier. In one embodiment, if inappropriate analysis consumables are present in the system, such as counterfeit consumables or consumables that are otherwise incompatible with the analysis system, the controller will malfunction the system, analysis reader or its components. Alternatively or in addition, consumables data can be used to detect the appropriate placement of the analysis consumables in the system, such as the appropriate orientation of the analysis consumables or a part thereof in the analysis system, so that the controller will malfunction the system, analysis reader or its components until the analysis consumables are placed with the correct orientation. In addition, consumables data can also be used to detect defects in the analysis consumables or analysis test sites and / or domains and the controller will malfunction the system, analysis 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 analytical consumable as a whole or instruct the analytical reader not to allow the use of the test sites and / or domains or a collection of test sites and / or domains in the analytical consumable. In one embodiment, the analytical reader may perform a diagnostic analysis on the analytical consumable and / or the test sites and / or domains therein to identify the defect therein and the controller will write the result of the diagnostic analysis to the identifier on the consumable. If the consumable is later used for a different analytical reader, the result of this diagnostic analysis will be read by the controller and used by the analytical reader to adjust the consumable or the use of the test sites and / or domains in the consumable accordingly. In another embodiment, the analytical consumable may be subjected to a quality control process during or after its manufacture and the result of the quality control analysis may be written to the identifier for later use and / or verification by the customer of the analytical consumable in the analytical reader.

[0371] Consumables data can also include authorization information for consumables or its test sites and / or domains or bioreagents, such as whether a specific customer has a valid license to use specific consumables or bioreagents, including the number of times that a customer is allowed to use the specific consumables or bioreagents in a specific analysis and the restriction (if any) about the use, such as whether the license of the customer is only for research purposes. The information can also include verification information about whether a specific consumable or bioreagent has been recalled or has become inappropriate or unauthorized to use in other aspects. Recall information and optional last recall check date and / or timestamp can be written into the identifier and / or provided as consumables data.

[0372] The consumables data may further include information about the origin of the biological reagent used to analyze the consumables, test sites, and / or domains, including, for example, the identification of the original sample from which the biological reagent was produced or the number of generations from which the biological reagent was taken out of the original sample. For example, if the analytical reagent used for analysis is an antibody, the consumables data may include the identification of the hybridoma that produced the antibody, such as the ATCC accession number of the hybridoma.

[0373] According to a plurality of embodiments, the biological sample or reagent provided in the consumables described above or with the consumables can be separately licensed with the system designed to operate on the biological reagent. In a plurality of embodiments, the analytical system, analysis reader or its components are coupled to a network, and the network allows the system to cross public and / or private networks and operate or establish communication on behalf of the computer system of the customer, manufacturer and / or license issuer by the customer, manufacturer and / or license issuer of the biological reagent, consumable or system. In a plurality of embodiments, limited permission can be specified to obtain permission for the purposes of the specific biological analysis of the system only obtained permission. Accordingly, if a specific customer has a valid license, the system can be based on, for example, being contained in the identifier relevant to the specific consumable and / or providing as the digital signature authentication biological reagent, consumable or system of the consumable data. In a plurality of embodiments, the identifier and / or consumable data can also be used to specify a one-time use so that the biological reagent cannot be refilled for the same authentication.

[0374] In certain embodiments, when the identifier is read by a system, analysis reader or its components that can utilize a public or private data network operated by or on behalf of the customer, manufacturer and / or license issuer of the biological reagent, consumable or system, some consumable data can be connected to the analysis system and read, written or erased locally via the identifier / controller on the analysis system. For example, recall and / or license information can be a subset of consumable data that can be obtained via a direct and / or indirect interface, and additional consumable data can be locally stored on the identifier and cannot be obtained via a network connection on the analysis system, such as batch specific information, expiration date, calibration data, consumable specific information, analysis domain information, analysis result information, consumable safety information or a combination thereof. In one embodiment, recall, license and / or consumable safety information can be obtained via a network connection on the analysis system and / or stored as consumable data to the storage medium and the remaining consumable data is locally stored on the identifier. The analysis system or analysis reader includes system hardware, system firmware, system data acquisition and control software, and method or consumable data. In various embodiments, the system hardware includes electronic control and data processing circuits, such as a microprocessor or microcontroller, memory, and non-volatile memory. In various embodiments, the system hardware also includes physical devices to manipulate biological reagents, such as robots and sample pumps. In various embodiments, the system firmware includes low-level, computer-readable instructions for performing basic operations in conjunction with the system hardware. In various embodiments, the system firmware includes microprocessor instructions for initializing operations on a microprocessor in the system hardware.

[0375] The system data acquisition and control software is an advanced software that interfaces with the system firmware to control the system hardware for more specific operations, such as operating a charge coupled device (CCD) to collect visual luminescence information about a specific biological analysis. In multiple embodiments, the data acquisition and control software includes a software-implemented state machine that provides, for example, the following states: (i) idle; (ii) running; (iii) paused; and (iv) error. In multiple embodiments, when the state machine is in an idle state, it can receive instructions from the general machine to perform specific data acquisition or system control operations. In multiple embodiments, the general computer opens a TCP / IP socket connection with the system, determines whether the system is in an idle state and then begins to transmit instructions and / or parameters. In multiple embodiments, an encrypted TCP / IP connection is established using, for example, an SSH scheme. The instructions and / or parameters can be in the form of ASCII-encoded, human-readable consumables and / or method information that defines the behavior of the biological system. In multiple embodiments, the consumables and / or methods are stored in the form of ASCII text files. In multiple embodiments, the general computer transfers the ASCII text file to the system using an FTP scheme. In a number of other embodiments, the method and / or consumables information is stored in and read from the identifier. The method and / or consumables 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.

[0376] According to various embodiments, the consumables, macros, and / or method information include parameters that can be used by the system data acquisition and control software to perform specific data acquisition and system control operations. In various embodiments, the method and / or consumable information contains a sequence of operations to be performed by the system or control parameters used in conjunction with the data acquisition or control software.

[0377] (ii) Analysis process information

[0378] In addition, the consumable data may include analytical process information about individual analytical parameters that should be applied by the system or 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 calibrators that should be used in the analysis) that should be used or added during the analysis or during a specific step of the analysis. The consumable data may also include the type or wavelength of light that should be applied and / or measured by the system or analytical reader during the analysis or a specific step of a multi-step analysis; the temperature that should be applied by the system or analytical reader during the analysis; the incubation time for the analysis; and the statistical or other analysis method that should be used by the system or analytical reader for the raw data collected during the analysis.

[0379] In one embodiment, one or more steps of the analysis scheme can be modified for individual consumables or consumable batches. One or more steps of the scheme can be different between batches of consumables and / or between individual consumables and consumables within a given batch and the consumable data stored to the system include instructions for modifying those steps of the analysis scheme. This type of consumable data can 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. In addition, this type of consumable data can be optionally adjusted by the system user according to the user's judgment. For example, the dilution step in the analysis scheme can be adjusted to illustrate batch to batch or consumable to consumable differences. The amount of the added diluent and / or the property of the diluent can be changed based on the difference. Similarly, the amount of a given reagent that can be added during the implementation of the analysis, the incubation period and / or temperature for one or more steps of the analysis can also depend on batch to batch or consumable to consumable differences. Each of them is a non-limiting example of consumable data that can be saved to the storage medium of the system.

[0380] In addition, the consumable data includes information that directly or indirectly controls components of the analytical system (e.g., one or more light detectors, a light-proof cover); a mechanism for transferring the analytical consumable to and from the analytical reader; a mechanism for matching and orienting the analytical consumable with the one or more light detectors and / or with electrical contacts in the analytical reader; additional mechanisms and / or data storage media for tracking and / or identifying analytical consumables; one or more sources of electrical energy for inducing luminescence; a mechanism for storing, stacking, moving and / or dispensing one or more consumables; a mechanism for measuring light from a consumable during the analysis, the light coming from multiple test sites of the consumable sequentially, substantially simultaneously or simultaneously; or a combination thereof.

[0381] The consumable data may also include analytical process information, which includes analytical parameters to be applied by the analytical reader during the analysis; the sequence of steps to be applied by the analytical reader during the analysis; the identity, concentration and / or amount of analytical reagents to be used or added during the analysis; the type or wavelength of light to be applied and / or measured by the analytical reader during the analysis; the temperature to be applied by the analytical reader during the analysis; the incubation time for analysis; the statistical or analytical method to be used by the analytical reader for the raw data collected during the analysis; or a combination thereof (the analytical process information may optionally be adjusted by the user). In a specific embodiment, the analysis performed with the consumable is a multi-step analysis and the analytical process information relates to one or more steps of the multi-step analysis. In this embodiment, the consumable / test site information includes information about an analysis previously performed by an analytical reader on one or more test sites of the consumable; information about an analysis to be performed by an analytical reader or its components on one or more test sites within the consumable; or a combination thereof.

[0382] The consumable data may additionally include information about the consumable, test site, domain, partition, or biological reagent or sample when individual operations are 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 analysis or step is being performed on the consumable, test site, domain, partition, or biological reagent or sample. For example, if the analysis consumable includes multiple analysis test sites, domains, and / or partitions, the analysis system may perform an analysis or a multi-step analysis step on a single test site, domain, and / or partition of the analysis consumable. Once the analysis or analysis step is completed by the analysis system, the controller will record the results of the analysis to the identifier, such as the original or analyzed data generated during the analysis or analysis step, and / or the controller will record which test site, domain, and / or partition of the analysis consumable was used during the analysis or analysis step, and / or which test site, domain, and / or partition of the analysis consumable has not been used. The analysis consumables may be stored for later use and when a customer is ready to use another test site, domain, and / or partition of the analysis consumables, the controller reads the consumable data stored on the identifier of the analysis consumables to identify which test sites, domains, and / or partitions have been used, have not been used, and / or the results of those analyses. The controller may then instruct the analysis system, analysis reader, or a component thereof to perform an analysis or analysis step on an unused test site, domain, and / or partition.

[0383] In addition, a given analysis scheme may require a collection of specific types of consumables. Therefore, if a customer inputs a specific type of analysis consumable (e.g., a porous analysis plate) for a specific analysis scheme, one or more additional analysis consumables may be required to perform the analysis scheme in the system, such as one or more reagents may be required to be used with the porous analysis plate. Each of the required consumables may include a consumable identifier with information about the consumable demand for the analysis scheme. When one of the required consumables is input into the analysis system and the identifier controller interacts with the consumable identifier for the consumables, the system will obtain the inventory of the components present in the system and compare the result with the consumable demand associated with the consumable identifier and / or stored in the storage medium and / or provided as consumable data. If any required consumables do not exist or exist with insufficient supply, the system will prompt the customer to input the additional required consumables for the analysis scheme based on the information stored on the required consumable identifier. If two or more analysis consumables are used in the system, the instrument will correctly identify the first analysis consumable and any related consumables based on the consumable demand associated with the identifier associated with each consumable. The system will verify that the analysis consumables and related consumables are loaded on the system before the sample runs. In the case where only the first analysis consumable is loaded in the system without corresponding related consumables, if the instrument does not identify the related consumables in the system within a predetermined period, the system will prompt the customer to load the related consumables. The system will notify the customer whether the wrongly matched analysis consumables are loaded on the instrument. If there is no available matching set of analysis consumables (for example, a porous analysis plate and a given reagent for a specific analysis), the system will not run the sample. The system will check the analysis consumables expiration date before the analysis begins and the system will warn the customer and prevent the use of expired consumables. If the consumables have expired before the sample is inhaled, the system will not process the sample. If the partially used analysis consumables are installed in different instruments, the consumables use will automatically start from the next available unused hole.

[0384] The identifier can also be used to track the time when given analysis consumables are present in the analysis system. Therefore, when the analysis consumables are inserted into the analysis system or contacted with the analysis system, the timer in the analysis system is started and the start time is recorded to the identifier. When the analysis is started by the system on the test site, domain and / or partition in the consumables or the consumables, the time is also recorded to the identifier. If the instrument, system or its components are closed (for example, by turning off the power supply), the timer stops and the time is recorded to the identifier so. Therefore, no matter when the timer stops, the time on the board accumulated can be recorded to the identifier.

[0385] (iii) Analytical Tools

[0386] In another embodiment, the consumable data further includes one or more analysis tools that can be used by the system to analyze data generated during and / or after the implementation of the analysis. In addition, the analysis tool may include instructions for the customer and / or the system to generate specific outputs by the system software after the implementation of the analysis, such as data reports and / or formats for the results of the analysis that are trimmed based on the consumable data. Alternatively or in addition, the analysis tool may further include one or more statistical algorithms that can be used by the system for the data. For example, the consumable data may include two or more statistical algorithms that can be used to analyze the data generated due to the use of a given consumable and the customer can optionally select the appropriate algorithm for the required data analysis. The consumable data may also include information that can be used by the customer to select the appropriate algorithm for his or her needs, such as technical notes or literature references related to algorithm selection.

[0387] The analysis tool can be different between consumable batches and / or between individual consumables and consumables in a given batch. In this embodiment, the consumable data is used by the system to adjust the analysis tool used by the system software in the implementation of the analysis or after the analysis is completed and the result is produced and / or displayed. The analysis tool includes but is not limited to analysis thresholds and / or calibration curves, which can be used for one or more steps of the analysis scheme that can also be changed based on consumable differences. In a specific embodiment, for given consumable types and / or required uses, the consumable data may include a project management tool, which uses the given consumables in the system or schedules the implementation of one or more analyses or its steps with the set of consumables. In addition, the analysis tool can be optionally adjusted by the system user according to the judgment of the user. The analysis tool can be sent to the customer via the direct or indirect interface between the system and the customer.

[0388] (iv) Analyze system maintenance information

[0389] The consumables 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, diagnostic program run results on the system, control charts, periodic maintenance schedules, warranty information about the system and / or its components, or a combination thereof. The system software is programmable to monitor the 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, the system may prompt the customer to send a monitoring report to the CD server via an indirect interface. Alternatively or additionally, the system monitoring report may be accessed by a service technician who is tasked with on-site or remote maintenance and / or service of the system. In this embodiment, the service technician may communicate with the customer about the service or assistance of the instrument via a direct or indirect interface. In a 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 a service technician based on standard system component life and / or warranty period. However, the system can be programmed to automatically monitor the information on the system and if the direct interface does not enable a service technician to assess the status of the system and determine if system service or maintenance is required, it can periodically prompt the customer to send the output of the monitoring activities to the CD server via the indirect interface. In addition, the CD server can maintain a log of the service history for a given analytical system and schedule service calls by service technicians (which can be done using either the direct or indirect interface). The remote computing system can also send individual analytical system software upgrades via the direct or indirect interface.

[0390] (v) System-Consumables Upgrade Information

[0391] In another embodiment, the consumables data includes upgrade materials, such as when new types or batches of consumables become available, especially those products used by a given customer in history. The upgrade materials may also relate to new analytical systems, modifications to current systems, and / or optional accessories or improvements to current systems, especially those modifications, attachments or improvements to systems owned or operated by customers, and / or those modifications, attachments or improvements that may cause customer columns based on previous use by customers. This type of consumables 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.

[0392] (vi) Technical support information

[0393] Consumables data also include the technical support information that can assist customers to use consumables or systems, such as product inserts and data booklet information, information related to the relevant products intended to be used together with the consumables, instructions for use, training materials, guides, recommended use and / or storage information, data analysis templates, template reports, calibration curves, batch-specific QC data, quantitative limits and troubleshooting methods and / or algorithms verified. About the consumables that include one or more additional consumables (such as reagents) or provide together with the one or more additional consumables (such as reagents), consumables data also include reagent catalog number, reagent batch-specific information, reagent manufacturing date, reagent expiration date, instructions for use, training materials, guides, recommended use and / or storage etc. Technical support information can also include receiving feedback or assistance via the direct or indirect interface with technical support representatives, such as customer training modules, consulting services and / or real-time customer service assistance capabilities to promote customer experience (that is, real-time chat). It should be understood that technical support information can relate to consumables, systems or both.

[0394] In one particular embodiment, Table 1 includes a list of consumable data that may be associated with a consumable identifier and / or exchanged between a CD server and a system via a direct or indirect interface.

[0395] Table 1.

[0396]

[0397] D. Specific implementation plan of data association workflow

[0398] A specific embodiment of a data association workflow (a process in which certain data is associated with and stored in 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. 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), which are configured to process data queries, extract data from one or more databases or data tables within the central database, and generate, generate and / or store data sets in response to data queries. An order (1102) has a unique identifier associated with it, 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, shipping addresses, etc. for one or more individuals or organizations associated with the customer. For example, if the customer is a company with multiple locations, the customer may be uniquely identified by a single customer number, each customer number being associated with multiple locations of the company in the customer data table, 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), the customer data table may also include one or more sub-directories or data tables for internal departments when requesting replenishment of consumable inventory. 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 its order (e.g., Customer X-Order Number Y).

[0399] The order is received by a manufacturing technician and a unique consumable identifier is created for the specific consumable (e.g., as described above, a consumable identifier (e.g., a barcode)) and the consumable identifier is stored in a consumable identifier data table (1107). Therefore, 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 associated with the product (e.g., quality-related data or manufacturing-related data) may be stored in individual data-specific data tables and each entry is indexed by the consumable identifier. Therefore, 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 about the consumable is needed, 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 about the consumable. The system also includes a customer number-order number-consumable identifier association data table (1108) such that for each customer, order and consumable, there is a unique association between customer X, order number Y and consumable identifier Z (customer number X-order number Y-consumable identifier Z), which is stored in the data table. Additional unique identifiers may also be associated with an order, such as a catalog number, salesperson number, order subcomponents, etc. Each association with the order number may 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 required for the manufacture of the consumable or the fulfillment of the order (consumable specification data table (1109)). The data is associated with the consumable identifier, 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. The consumable data associated with the consumable or batch so far in the manufacturing process is saved to the consumable identifier data table. The manufacturing process may also include a quality control system, wherein the product is subjected to one or more quality control steps. Unique data from each quality control step performed on the consumable or batch is associated with the consumable identifier and the consumable identifier data table and / or the quality data specific data table are updated to include this data. The consumable or batch (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 the shipping specific data table are updated accordingly.

[0400] 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 kit including multiple components, etc. For example, if the consumable is a kit containing multiple components, then when the order is transferred to manufacturing and the manufacturing technician queries the consumable specification data sheet for data on how to manufacture the kit, the consumable specification data sheet will provide a list of the components of the kit and each component of the kit will include a unique component identifier that is correlated to the kit identifier in the system.

[0401] 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 are 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 a 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 made (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 (in Figure 2The system may include a storage medium (referred to as a "local CD") to identify the consumable data stored in the storage medium and that can be used to perform analysis using a given consumable. If the storage medium includes consumable data about the consumable or batch, then the consumable can be used in the system (step v). If the storage medium does not include consumable data about the specific consumable or batch 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, compressed disk, memory card / stick, flash drive, network data storage service, etc. (step vi). The supplier sends a consumable data binary file (including but not limited to an encrypted XML file) to the customer, such as in the form of an email attachment to a customer's email account, and the customer loads the file attachment to the analysis system and the system software stores the consumable data in a local system consumable data repository. The batch of consumables / consumables can then be used in the instrument (step vii).

[0402] In an alternative embodiment, if the CD server is not available locally on the system, the CD server can 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 a CD database to the CD server for consumable orders and / or batches of consumables, such as Figure 2 As shown and as described above. Thereafter, the customer receives the consumables, order and / or batch and contacts the system with the consumable identifier so that the system can identify the consumables or batch. 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 on the system, the software adjusts the system based on the consumable data if necessary. If the consumable data does not exist in the system consumable data repository, 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 a direct interface with the CD server and store the information locally in the system consumable data repository. Once the consumable data is locally available on the system, the software adjusts the system based on the consumable data and performs analysis if necessary. Once the consumable data is locally available on the system, the consumable or batch can be used in the system to perform 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.

[0403] As described above, consumables and / or instrument data can be sent to the data bus via the software so that suppliers can collect data related to the customer, instrument, consumables and / or suppliers. 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 when the instrument is installed. In one embodiment, the following consumables data are collected by the instrument and sent to the data bus: the specific consumables identifier used on the instrument at the customer's location and the analysis layout for the experiment performed using one or more specific consumables. About the instrument installed on the networked system (that is, a computer network maintained by a customer with two or more instruments), the software can collect the following consumables data: consumables statistics, such as detection signal, CV, mean value, image center; the performance of controls and calibrants, such as % recovery, detection signal data; the identity of the consumables identifier uploaded to one or more instruments connected to the network; audit log; and / or instrument log.

[0404] In another embodiment, an exemplary system (also referred to as a laboratory information management system (LIMS)) that coordinates the communication between the processors present in the analysis system (1000) and the computers located at the user's facility is shown in Figure 11 (b). The LIMS (1120) is connected to the multiple processors in the analysis system (1000) through a data integration agent (DIA) (1122). The DIA (1122) is preferably an application programming interface (API) and is the interface between the LIMS (1120) and the workbench software (1124) (such as a user interface (UI) and a database (DB) (1126)).

[0405] To initiate an analysis run, the LIMS (1120) sends a request to the DIA (1122) (arrow 1). The DIA (1122) then forwards and / or translates the request (arrow 1) to the DB (1126). The workbench (1124) connects to the DB (1126), guides the user / laboratory technician through the analysis protocol using the UI, and the analysis system (1000) or another analysis system (900) runs the 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 ECL data with analysis (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 about the status of the analysis run to the DIA (1122) via a connection (arrow 4).

[0406] Figure 11 (c) illustrates the relationship between the workbench / UI (1124) and the processor in other systems and analysis system (1000). The workbench / UI (1124) is connected to a component with its own processor, such as a robot subsystem (1002) including a pipette (1021) and a clamping pad (1031). The workbench / UI (1124) is also wirelessly connected to the processor of the flat plate (1058) and reader (1003) that actually displays the UI by a line or preferably by a router (1130). As discussed above, the workbench / UI (1124) is also connected to the LIMS (1120). A barcode reader (1013) or a customer ID controller will read a consumable identifier (e.g., a barcode) or a unique ID from any laboratory utensil or analysis kit. As further discussed below, the consumable identifier (e.g., a barcode) or a unique ID will notify the workbench / UI of the type of laboratory utensil or analysis to be run from the test kit. If any additional information or data is required, it may be downloaded from an external server or cloud.

[0407] The software that runs the analysis system (1000) comprises three main components:

[0408] (i) A user interface (UI) that guides the user through the process of selecting, loading, and running an immunoassay as described herein

[0409] (ii) an instrument control system that controls the operation of the robotic subsystem (1002) and confirms said operation and performance, as well as reporting errors, and

[0410] (iii) The data service described above in conjunction with Figure 11(b), which stores ECL results and user preferences.

[0411] Referring to Figure 11(d), the workbench / UI will send a request 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 validation of the analysis system before use and during periodic maintenance, which are described below in conjunction with the operation and performance validation system. The command listener (1134) listens for requests instructing the robotic system (including the pipette (1021) and the robotic clamping pad (1031)) to perform steps of the immunoassay. The error response listener (1136) listens for error code broadcasts from multiple components of the analysis system (1000).

[0412] Errors are classified into three types: (i) unrecoverable errors that result in data loss, such as a connectivity error 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 a single sample not detected, and (iii) interactively recoverable errors, such as a door to the analysis system (1000) not being properly closed. Preferably, errors will be flagged in the generated files and a visual or audio warning will be generated. In the event of a power loss, the instrument control portion of the software will control the shutdown of the instrument using a universal power supply system (UPS), which should be stored in the instrument.

[0413] According to another aspect of the invention, the UI portion of the software is built using plug-ins (also referred to as applications or applets). Once an analytical system is verified or validated, an operator generally does not want to re-verify or re-validate the system due to a software upgrade. Re-validation is necessary when the components of a software system are interconnected. In other words, when a component depends on input or instructions from other components to function, the components are interconnected. Therefore, the inventive feature of the UI or workbench is 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.

[0414] Referring to Figure 11 (e), the main collator (labeled as OSGI) (1140) is connected to the components of the UI platform. In this embodiment, the main collator (1140) is shown in the form of a bus or message bus and is connected to multiple components, such as the security / login / logout component (1142), UI (1144), application framework (1146) and event framework (1148). Other components can be connected to the main collator (1140), such as the instrument control component and data service component discussed above.

[0415] The master collator (1140) operates similarly to a traffic controller and sends start or shutdown requests to the components when it is necessary to operate or shut down each component. The communication between the components is implemented through the master collator bus, except that the master collator (1140) can instruct the components to send information or data to each other. For example, in Figure 11 (e), when directed or requested by the master collator (1140), the event framework (1148) that establishes and maintains a log file of events during the analysis run can publish or notify significant events, such as the reading of the analysis board, to the application framework (1146). In the absence of the master collator (1140), the publication or notification will not exist.

[0416] 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 master collation (1140) may also act as a conduit to pass data from one component to another.

[0417] An application may be built by an application implementation (1150) that obtains code from a storage medium, such as a base application (1152) that may be present in an application framework (1146). The base application (1152) stores code that may be accessed by the application implementation (1150) for use by the UI during an analysis run. When the main finisher (1140) directs the shutdown framework (1142) to shut down, the application built by the application implementation (1150) may remain or be removed, as illustrated in FIG. 11( e). The application implementation (1150) is displayed external to the UI platform and may be another software component connected to the main finisher bus.

[0418] Due to this decoupled architecture, if a component requires a software upgrade, then that component should be revalidated rather than the entire software system.

[0419] In another embodiment, other major components may have similar architectures. For example, the instrument control component may have its own internal master organizer to control the amount of communication between its internal components having processors, such as the robotic subsystem (1002), pipette (1021), robotic grippers, plate washer (1005), plate (1058), 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).

[0420] The main software components (ie, the Workbench / UI, the Instrument Control and the Data Services) may also be connected to the host organizer and share the same software architecture.

[0421] An example of a UI is shown below.

[0422]

[0423]

[0424] The main components of the UI are shown in the left column, and the steps within each component are shown in the right column. The UI walks the user through these steps to perform the analysis.

[0425] 12( a)-(l) illustrate an exemplary software framework for the collection, deployment, and location of global product data (GPD) for multi-well assay kits and plates available from Meso Scale Discovery, Rockville, Md. Although the following description and figures specifically relate to plates and kits, it should be understood that the software framework and methods described herein are also applicable to assay systems, instruments, and additional assay consumables other than plates and kits.

[0426] The GPD is associated with a consumable identifier, such as a global product identifier (GPI). A GPD is a flexible data container containing a collection of consumable data as described herein, which may include the following non-limiting list of data for a given consumable (e.g., a plate, an assay reagent container (reagent rack), or an assay kit):

[0427] Physical consumable characteristics, e.g. board characteristics such as board type, geometry, graphics

[0428] Image processing parameters

[0429] Detection parameters

[0430] Plate coating, analysis and evaluation

[0431] Partial board information

[0432] Recommended sample layout

[0433] Analysis plan

[0434] GPI-related analysis workflows or scripts and instrument parameters

[0435] Contents of the test kit, such as product inserts, reagents

[0436] Recommended analysis information, such as fitting curves

[0437] Recommended reports

[0438] Customer order information, such as consumables deadlines, consumables batch information, etc.

[0439] As shown in Figure 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). DDBs are assembled by suppliers and deployed to supplier software products. DDBs provide a framework for deploying new information or data to customers, such as software packages that operate on customer analysis systems. GPD is an instance of a DDB. Some additional instances of DDBs include, but are not limited to, new analyses, new plate types, new consumable types, etc. Different types of products (e.g., consumables and instruments or analysis systems) are each associated with a different DDB. For example, an analysis system includes a unique identifier as described above, and the identifier is associated with a 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:

[0440] Physical system characteristics, such as system components, configuration, etc.

[0441] Subsystem characteristics, configuration, etc.

[0442] Related consumable types

[0443] Workflow wizards to guide users through the use of the system

[0444] Customer order information, such as system manufacturing information, etc.

[0445] Each DDB has a DDB identifier (UID), a version number, and a deployment package description file. The UID and version number together uniquely identify the DDB. The description file 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 distributing GPDs. The data contained in the DDB can be in an independent file structure or in a file structure. The format of the file can be XML, key-value pairs, etc. The DDB can be distributed via a variety of forms, such as a supplier e-commerce site or an email attachment.

[0446] As shown in Figure 12 (b), in order to install the DDB, the file is placed locally on the analysis system in a specified directory. Using a plug-and-play framework, the local software system detects the package and processes it for incorporation into the software. The local software contains a registry, which is a directory that lists information about services and data available on the software. The DDB registers what data is available from the registry itself and the DDB instructs the local software how it should be processed. The DDB also includes a filtering processor that controls the data exposed in the registry and the characteristics of the exposed data, for example, in order to resolve or remove data conflicts that may occur between one DDB and another DDB, such as between one board and another board.

[0447] The DDB includes a unique DDB UID and version. As shown in Figure 12 (c), the DDB may include data that will persist to the local data storage, such as the DDB UID and version. Data is persisted so that if the DDB includes a large data set, the data type required during system operation is effectively accessed. 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 type. In one embodiment, the complete content of the DDB is persisted, that is, locally restructured in an independent data set. In a specific embodiment, the DDB UID, version, board static data (data about board type) and / or board processing data (data for processing and / or running boards) are persisted. In another specific embodiment, the DDB UID, version and board static data are persisted. During the DDB installation, the software determines whether the DDB has data persistence and whether the data has been persisted by using the DDB UID and version. After the DDB data that needs to persist to the data storage is persisted, the DDB UID and version are saved to track those that have been stored. This eliminates unnecessary data storage operations to the same DDB by detecting that the data has been stored.

[0448] 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 that are used together 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 the previous data format version and the software is backward compatible with older DDB versions. Similarly, DDB can provide downgrades to previous data format versions. By providing downgrades, the DDB can be backward compatible with previous software versions. Therefore, in the framework illustrated in Figure 12 (d), DDB does not need to be released again to cooperate with new software versions and a DDB acting on multiple versions of software can be established. DDB files are upgraded and / or downgraded when needed, one or more files are locally stored and / or sustained, and the DDB processor (agent factory) converts the original category data into a data type or format that can be used by the software to perform analysis or analysis steps on the analysis system.

[0449] As shown in Figure 12(e), a typical DDB for a board may include the following consumables data:

[0450] The board static data contains data about the board type. These are properties that relate to the physical board, regardless of the type of instrument that will be used to process the board. Some example properties:

[0451] ○Number of columns / rows of holes

[0452] ○ Number of spots per well

[0453] The plate processing data contains data used to process / run a plate. The plate processing data is typically instrument specific. Some example features:

[0454] ○Number of zones / circuits

[0455] ○ Used to read the detection parameters of the board, such as camera binning, waveform, etc.

[0456] ○Image processing features used to produce ECL results

[0457] ○Board Type Gain

[0458] ○Spot Gain

[0459] ○Optical crosstalk matrix

[0460] The kit contains data (such as analysis), and kit information. Some example data would be:

[0461] ○Analysis of spot assignment

[0462] ○Analysis plan

[0463] ○Data analysis parameters

[0464] ○Product Insert

[0465] • The batch contains specific data about the test kit or panel built for the order.

[0466] FIG. 12( f) illustrates an embodiment of how to deploy a GPD DDB and FIG. 12( g) is an example of a DDB xml and a diagram of files within a GPD DDB. As illustrated in FIG. 12( g), the DDB xml describes the data within the DDB and how to process the data, 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 associated GPI. In addition, FIG. 12( g) shows that other data may also be contained within the DDB.

[0467] 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, the GPD service queries the master repository for the required data and downloads the data locally. Most searches use the UID as a search criterion and the UID can be obtained from the GPI to GPD mapping. The GPD agent factory obtains the UID and receives the GPD data from the appropriate data store for the system software (in the embodiment illustrated in Figure 12(h), Client 1 is, for example, analysis system software, and Client 2 is, for example, a related independent software system that provides the user-interface functionality of the software in Client 1, for example, at a remote laptop or desktop computer). The following are two possible options for how the data search may occur:

[0468] (a) The DDB registers all the data it provides. The GPD service queries the registry for matches. Some aspects of this search method include, but are not limited to:

[0469] The register contains multiple entries and all data is directly accessible through the register.

[0470] • Searches may be slow, depending on the registry implementation.

[0471] (b) The DDB only directly registers a select 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 searches provided by the DDB by searching the registry. Aspects of this search method include, but are not limited to:

[0472] The DDB manages the data it provides, hiding or filtering details that it does not need to expose.

[0473] Less information is published to the register, making it smaller.

[0474] • This approach is well suited for agent factories and resource-constrained systems.

[0475] These search options are not mutually exclusive. A GPD service implementation may support both and expose each DDB definition.

[0476] 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 internally uses a registry 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.

[0477] For example, a supplier manufactures a batch of consumables, such as boards, each board having a GPI. There will be a DDB for the batch of consumables and the DDB has a single UID and all GPIs within the batch (no matter 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, the GPD service queries the master 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 it locally installs the required GPD, which can be used immediately to process the individual board or if another board from the same batch is processed by the system, it can be used at a later time.

[0478] As shown in Figure 12(j)-(l), GPD searches for different stages in its life cycle from installation to data retrieval. These stages include but are not limited to:

[0479] • All data for the DDB is collected and packaged in one DDB file for deployment.

[0480] The DDB file is delivered to the software in an agreed directory.

[0481] The DDB instructs the software what to do. It controls how it should proceed.

[0482] • 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.

[0483] • Some GPD data will be extracted to the file system where appropriate and the location of the data is saved in the database.

[0484] • The remainder of the data is placed in a database.

[0485] • 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 an archive / backup directory.

[0486] • Software clients use the GPD service to receive GPD data.

[0487] - Using the GPI to GPD mapping, the software can determine which GPD data should be used with a given board.

[0488] - After reading, the software board data memory will contain a read-only copy of the data from the GPD for that board and the data generated by processing it.

[0489] Examples of interactions between GPD-DDB and GPI are discussed below.

[0490] The GPD may include a general analysis protocol (e.g., steps in an analysis) containing all steps for a variety of analyses preferably within one analysis type (e.g., immunoassays, which include pharmacokinetic analysis, immunogenicity analysis, U-PLEX, V-PLEX analysis, and other analysis types). Certain specific analysis protocols within one analysis type may not require all 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 instrument parameter files associated with the GPI for the specific analysis.

[0491] As shown in Figure 12 (m), the scheme or script of streptavidin plate, indirect analysis is shown. This scheme or script contains multiple steps, including but not limited to diluting the sample for plate 1-5, blocking plate, coating plate, incubating sample, preparing the first detection incubation, preparing the second detection incubation and reading the analysis plate. About another analysis in this analysis type, the second detection step is not started, as shown in Figure 12 (n). Another analysis may not need the coating plate step, as shown in Figure 12 (o), and another analysis in this analysis type may not need the coating plate step and does not need the second detection step, as shown in Figure 12 (p). The following table summarizes the analysis scheme in Figure 12 (m)-(p).

[0492]

[0493]

[0494] Assay 1: Custom Assay, Streptavidin Plate, Indirect Assay

[0495] Assay 2: Custom Assay, Streptavidin Plate, Direct Assay

[0496] Assay 3: Custom assay, uncoated plate, indirect assay, offline coating

[0497] Analysis 4: Custom analysis of uncoated plates, direct analysis, offline coating

[0498] In this embodiment, since all steps in analysis 1 are performed, this scheme may serve as a general scheme for customized sandwich immunoassays, including pharmacokinetic analysis. The general scheme is preferably a part of the GPD. Accompanying the GPD is an instrument parameter file related to the GPI unique to analysis 1. The instrument parameter file will include multiple flags or switches. Each flag or switch will be turned on ("1" or "true") or off ("0" or "false"). With respect to analysis 1, all flags in the instrument parameter file will be turned on. With respect to analysis 2, the flag associated with the second detection agent will be turned off, and the remaining flags will be turned on. With respect to analysis 3, the flag associated with the coating of the plate will be turned off, and the remaining flags will be turned on. With respect to analysis 4, the flag associated with the coating of the plate and the second detection agent will be turned off, and the remaining flags will be turned on.

[0499] The general protocol will be the same for all of these exemplary analyses 1-4 and other compatible analyses in this analysis type, but the instrument parameter files for analyses 1-4 are files of much smaller size than the general protocol and are different. An exemplary instrument parameter file is illustrated in FIG. 12 (q), which is a computer readable file in text format. Multiple flags are located at the bottom of this text file. Some flags are turned on or true and some are turned off or false. Analyses 1-4 include pharmacokinetic analyses.

[0500] In this embodiment, before running a specific analysis, the GPI for this specific analysis, such as the consumables identifier (e.g., barcode) on the outer box of a kit (such as an analysis kit available from Meso Scale Diagnostics) containing laboratory utensils and consumables for this specific analysis, is read by a barcode reader or other processor. The GPI is mapped to its associated GPD by the processor of the analysis system. This processor will then determine whether the general protocol or script is included in the processor / memory of the analysis system and whether the instrument parameter file associated with the GPI has been stored in the memory of the system. If not, the processor can download the general protocol and the instrument parameter file, which is preferably stored in binary format to minimize its size, and the instrument parameter file can be stored in text format from an external system or server or from the cloud.

[0501] Another table below illustrates another example of a general protocol or script for bridging immunogenicity analysis, and a specific instrument parameter file associated with a GPI for analysis of IG with acid treatment, and another specific instrument parameter file associated with a BPI for analysis of IG without acid treatment.

[0502]

[0503]

[0504] Using a general protocol for multiple analyses in which individual instrument parameter files have on / off flags uniquely associated with the GPI of a specific assay would provide improvements to specific computer techniques used with immunoassays and more particularly with immunoassays using ECL and with automated immunoassays.

[0505] The embodiments of the protocols or scripts shown in conjunction with Figures 12(m)-(s) may represent best practices 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 prior to the start of the 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 the following non-limiting options.

[0506] Analysis type: direct or indirect

[0507] Board Type

[0508] ·Standard curve settings, including the number of points on the curve, dilution factor, etc.

[0509] Control setup, including the number of controls on each plate, the dilution factor for each control

[0510] Sample setup, including the number of duplicates for each unknown and the dilution factor for each

[0511] Washing board: Y / N

[0512] Blocking: Y / N, including blocking volume, incubation time, and subsequent plate washing

[0513] Coating: Y / N, including coating volume, online / offline incubation, incubation time, subsequent plate washing (Y / N)

[0514] Sample incubation, including sample volume, online / offline incubation, incubation time, subsequent plate wash (Y / N)

[0515] For indirect analysis: Unlabeled / biotinylated test substance incubation: test substance volume, online / offline incubation, incubation time, subsequent plate washing (Y / N)

[0516] STAG-labeled test substance incubation: test substance volume, online / offline incubation, incubation time, subsequent plate washing (Y / N)

[0517] Read buffer incubation: on / off, incubation time

[0518] Regarding the Bridging Immunogenicity Assay, the following are some user-selectable options.

[0519] Board Type

[0520] ·Standard curve settings, including the number of points on the curve and dilution factor, etc.

[0521] Control setup, including the number of controls on each plate, the dilution factor for each control

[0522] Sample setup, including the number of duplicates for each unknown and the dilution factor for each

[0523] Acid treatment (Y / N), including the ratio of acid to diluted sample and incubation time

[0524] Sample incubation time, including the ratio of master mix to sample

[0525] Wash shortly before start (Y / N)

[0526] Blocking Y / N, including blocking volume and subsequent plate washing (Y / N)

[0527] Incubation of samples on the plate, including sample volume, online / offline incubation, incubation time, subsequent washing of the plate (Y / N)

[0528] Read buffer incubation: on / off, incubation time

[0529] One embodiment of an analysis performed in the analysis system described in Figure 10 and its subsections is shown in Figures 13(a)-(f). Figure 13(a) shows a schematic diagram of certain subsystems of the analysis system (1300) involved in the performance of the analysis positioned on a table or platform (1301), wherein each subsystem is operatively connected to a robotic system (not shown). The multiple subsystems include an assay reader (1302); an assay consumable storage unit (1303); a plate wash 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, such as positioned on a multi-well plate; a pipette tip storage compartment (1307) configured to house a pipette tip box of variable size tips when needed (e.g., 1308 and 1309, 1000 μl and 350 μl tips, respectively) and further includes a pipette tip disposal chute (1310) connected to a waste compartment (not shown); and one or more sample / reagent tube racks (1311).

[0530] As shown in FIG. 13( b), when an analytical consumable (e.g., a multiwell plate) is inserted into the analytical system (1300), a barcode reader (1306) reads a consumable identifier (1313) on the consumable and downloads 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), including but not limited to components, calibrant values, control values, receiving customer numbers, order numbers, catalog numbers, associated analytical protocols for the consumables, and the like. The analytical protocol (1315) includes one or more steps performed by a user and / or by a component of the analytical system during the implementation of the analysis. With respect to those steps performed by the user (1316), the software displays those steps to the user via a user-interface of the analytical system (1317). All manual steps may be displayed on the user-interface at the same time or each manual step may be displayed individually on the user-interface and the software will prompt the user to confirm the completion of the step on the user-interface before displaying the next manual step. Once the manual step is completed, the software will continue to the next step in the analysis scheme. Each step in the analysis scheme that should be performed by the analysis subsystem may include one or more sub-steps (1318 and 1319, respectively), and each sub-step may include one or more analysis subsystem operations (e.g., 1320-1322, respectively). For example, if one step of the analysis scheme is to incubate a test plate in a plate oscillation subsystem, the step may include at least the following sub-steps: (a) moving the test plate to the plate oscillation subsystem and (b) starting the plate oscillation 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-steps, such as moving the test plate to the plate oscillation subsystem requires the software to command one or more motors in the robot subsystem to move to the test plate and collect the test plate and move the test plate to a specified position in the plate oscillation subsystem. Each of the subsystem operations is identified in a scenario script in the software.

[0531] The analysis system should then be prepared for the implementation of the analysis before the manual analysis step can be completed (if any). For example, the software may instruct the analysis reader to evaluate the demonstration multi-hole analysis plate to ensure the appropriate performance of the analysis reader. Washing buffer can be filled or supplemented (manually) when necessary, and waste containers or reservoirs can be emptied (manually) when necessary. The software may also instruct the plate washing subsystem to execute a maintenance script when necessary and start the washing 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 implementation of the analysis on a remote, networked computer or directly on the analysis system user interface. The consumables (e.g., test kit) 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 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 the specified experiment to the system software. As described above, the software will prompt the user to complete any manual steps when necessary and follow any software prompts to prepare the system for implementation of the analysis. The user starts the analysis run on the user-interface, locks the system, and starts the software script for the protocol.

[0532] In one embodiment of a V-PLEX (e.g., cytokine) assay performed on the assay system of FIG. 13( b ), the following manual steps are required and the software displays each step on a user-interface, optionally requiring the user to confirm via the user-interface that each step has been completed:

[0533] a) Unpack the consumables test kit;

[0534] b) Thaw the reagents according to the consumables instructions;

[0535] c) Dilute the ECL read buffer 2-fold with deionized water;

[0536] d) Dilute the washing buffer by 1-fold with deionized water;

[0537] e) Reconstitute the lyophilized calibrant by adding 1000 uL of Diluent A and mix thoroughly by vortexing;

[0538] f) Reconstitute the lyophilized control by adding 250 uL of Diluent A to the vial and mix thoroughly by vortexing.

[0539] A calibrator is a sample of an analyte relevant to the assay with a known concentration that is used to determine if the fitted curve is appropriate for an unknown sample. Calibrators are generally provided in high concentrations and are diluted to prepare solutions of lower concentrations. Typically, up to eight (8) points are used to prepare the fitted curve. A control is also a sample of an analyte relevant to the assay with a known concentration that is 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.

[0540] Appropriate consumables and reagents are loaded into the analysis system, as depicted in Figure 13 (c). Briefly, disposable pipetting tips are loaded onto the platform, empty dilution plates, empty test plates, and preloaded sample plates are loaded onto the platform, slots are filled with ECL reading buffer and sample diluent and loaded into the slotted bracket on the platform, and reagent racks are loaded with empty antibody mixture tubes, control vials, calibrant vials, detection antibody tubes, and antibody diluent tubes. The software can display the subsystem layout depicted in Figure 13 (c) on the user-interface, highlighting each subsystem to help each consumable or reagent be properly placed in the subsystem. Once the loading step is completed, the software prompts the user to close the door of the analysis system, the software locks the door of the system and starts a loading confirmation script, which is configured to confirm that each consumable and reagent has been properly loaded in the instrument in the correct position and orientation. If any consumables or reagents have been improperly loaded, the system door will unlock and the software will display a warning on the user-interface, instructing the improperly loaded consumables or reagents to be manually adjusted afterwards.

[0541] The scheme for the implementation of V-PLEX (e.g., cytokine) analysis on the analysis system is shown in Figure 13 (d). As described above with reference to Figure 13 (b), each step of the scheme corresponds to one or more sub-steps and subsystem operations, and the software includes the required scripts and the sub-scripts required for the execution of each step, sub-step and operation required for the system to complete the analysis. The sequence of steps in the analysis scheme and the time arrangement of events are shown in Figure 13 (e) and an overview of the steps is provided in Figure 13 (f).

[0542] Figure 14 (a)-(i) illustrate the implementation of a V-PLEX analysis for the analysis system depicted in Figure 14. The V-PLEX analysis is available from Meso Scale Discovery, LLC. (Rockville, MD). As in Figure 13 (a), Figure 14 (a) illustrates the layout of various subsystems in the analysis system. Figure 14 (b) shows the configuration of the plate storage subassembly for implementing one or more V-PLEX analyses in the analysis system and similarly, Figure 14 (c) shows the orientation of reagent tubes and slots in the tube rack (panel (i)), the slot rack (panel (ii)) and the reagent rack (panel (iii)). Figure 14 (d)-(i) shows various analysis protocols for the V-PLEX kit, and as described above, the protocol that should be used with a given item number or catalog number is the consumables data associated with the consumables identifiers of the kit and kit subassemblies. Figures 14(Ja, Jb) (relating to "V-PLEX stepwise analysis, 5 plate run") and 14(Ka, Kb) (relating to "V-PLEX homogenous analysis, 5 plate run") show two exemplary time scheduling sequences or scripts for the V-PLEX protocol. Figure 14(l) shows an upgraded protocol for the Sthe V-PLEX stepwise protocol sequence shown in Figure 14(d).

[0543] Analysis system and software as described herein can be configured to implement multiple different types of analysis and based on the type of analysis and scheme, and the user-interface is configured to progressively display to the user the command for the appropriate preparation of the sample and / or reagent for the analysis system. For example, in addition to the V-PLEX analysis described in detail above, the analysis system and software are also configured to implement U-PLEX and S-PLEX analysis (available from Meso Scale Discovery, Rockville, MD). U-PLEX and S-PLEX analysis all require a certain number of preparations and optional optimization steps, and the software is configured to display to the user the individualized step-by-step scheme for those preparations and optimization steps. For example, the U-PLEX scheme needs to prepare one or more reagents according to a specific reagent preparation scheme and display those steps to the user via the user-interface before implementing the analysis on the analysis system. Figure 15 (a)-(b) illustrates the analysis scheme as implemented on the analysis system for single plate U-PLEX analysis, and Figure 15 (c)-(f) illustrates the analysis scheme as implemented on the analysis system for multi-plate U-PLEX analysis. FIG. 15 (Ga, Gb) (relating to "U-PLEX Singleplex, 5-plate run (same as custom singleplex, streptavidin plates, direct analysis)") and FIG. 15 (Ha, Hb) (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 analysis protocols identified above, the analysis system may also be configured to perform the following types of analysis and the software configured to guide the user through the sample / reagent preparation steps via the user-interface:

[0544] Pharmacokinetic analysis, preparation, optimization and analytical execution

[0545] Immunogenicity analysis, preparation, optimization and analytical execution

[0546] Customized sandwich immunoassays: preparation, optimization and assay execution

[0547] Kinetic measurements

[0548] ·Analysis development panel

[0549] Antibody screening

[0550] Calibration curve titration

[0551] Manually read prepared consumable test panels

[0552] Plate incubation

[0553] IQ / OQ / PQ (Installation Qualification (IQ); Operation Qualification (OQ); Performance Qualification (PQ))

[0554] U-PLEX and V-PLEX analysis, when automated to run in an analysis system such as analysis system (1000) or (900), may have the following steps:

[0555] Automated analysis sequence

[0556] 1 Stock Board

[0557] 2 Start the scrubber

[0558] 3. Coupling the Antibody to the U-PLEX Linker

[0559] 4. Incubate the capture antibody with the linker

[0560] 5. Add stop solution to the coupled antibody linker solution

[0561] 6 Incubation with stop solution

[0562] 7. Preparation of capture antibody mixture

[0563] 8. Prepare capture antibody dilution

[0564] 9. Apply capture antibody mixture to MSD plate

[0565] 10. Perform the coating incubation

[0566] 11. Apply blocking agent to MSD plate

[0567] 12 Apply sample diluent to the MSD plate

[0568] 13 Perform blocking incubation

[0569] 14 Apply diluent to the dilution plate

[0570] 15 Generate calibration curve

[0571] 16 Dilution Control Vials

[0572] 17. Establish control dilution

[0573] 18. Create sample dilutions

[0574] 19 Washing the MSD analysis plate

[0575] 20 Apply dilution to MSD analysis plate

[0576] 21 Perform the sample incubation

[0577] 22 Preparation of detection antibody mixture

[0578] 23. Prepare the detection antibody mixture with blocking agent

[0579] 24 Apply the detection antibody cocktail to the MSD plate

[0580] 25 Perform the assay incubation

[0581] 26 Apply detection antibody and diluent to MSD plate

[0582] 27. Perform V-PLEX analysis of homogenized incubations

[0583] 28 Apply read buffer to plate

[0584] 29 Read the plate on the ECL reader

[0585] 30 Cleaning process

[0586] (i) Immunogenicity assay preparation, optimization and execution

[0587] Immunogenicity is the property or degree to which a substance has the ability to elicit an immune response by producing anti-drug antibodies. Bridging IG analysis is 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 immunogenicity of a drug substance in a sample of ... or The complex used for bridging immunogenicity (IG) analysis on the Meso Scale Discovery platform (available from Meso Scale Discovery, LLC., Rockville, MD). To form the complex, biotinylated drug, SULFO-TAG TM The labeled (STAG) drug and the anti-drug antibody (ADA) are incubated together and the biotin-labeled drug and STAG drug are each bound to different partitions of the ADA. The drug / ADA complex is incubated on an MSD test plate containing spots of streptavidin or avidin and the biotin-labeled drug is bound to streptavidin or avidin in the plate spots (Figure 16 (a)). A block diagram of a standard IG analysis protocol is shown in Figure 16 (b). Figure 16 (d) illustrates an exemplary deck layout intended for a bridging IG analysis that does not include acid treatment performed on an analysis system (1000).

[0588] The IG analysis is preferably optimized prior to implementation in the laboratory. The standard IG protocol includes multiple 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 analytical 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.

[0589] To optimize the IG analysis on the analysis system shown in FIG. 10 and its subsections, 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 cover, reagent tubes, and a collection of kits that may include the following components:

[0590] Table 1.

[0591]

[0592] The development kit itself and the components within it include consumable identifiers (e.g., barcodes) 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 processing information, and combinations thereof. For example, if the component includes a multi-well analysis plate, the consumable type information includes the number of columns of wells; the number of rows of wells; the number of binding domains per well; and combinations thereof; and the consumable processing information includes data used by the analysis system in the implementation of the analysis using the plate and / or the processing of analysis data caused by the implementation of the analysis using the plate. In a specific embodiment, the consumable processing information includes the number of partitions per plate, the number of circuits per plate, detection parameters used by the analysis system to read the plate; image processing characteristics for generating ECL results; plate type gain; binding domain gain; optical crosstalk matrix; and combinations thereof.

[0593] 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 consumables, 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 implementation 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 drugs and STAG-labeled drugs; (iii) performing a sample matrix tolerance assessment; and / or (iv) performing a free drug tolerance assessment. At each step, the user can also evaluate whether to use an acid dissociation protocol as part of the final protocol; in addition, the user can evaluate multiple analytical plate types (e.g., 96-well Streptavidin GOLD TM Board pair 96-well high binding avidin gold plate). The user can 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 to be generated in the skipped steps, such as drug concentrations.

[0594] 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 of this embodiment of the IG optimization workflow is ADA selection, and the system prompts the user in the design of an experiment performed by the system to determine the appropriate ADA as a control for the analysis. The user-interface will prompt the user to enter the following data about the anti-drug antibody to be tested:

[0595] The number of dilutions of each ADA tested (8 or 12 dilutions)

[0596] Number of ADA tested (2-6 different ADA per plate, depending on the number of dilutions chosen)

[0597] The name of each ADA tested (for tracking purposes)

[0598] · The user will choose whether to include zero dilution

[0599] Concentration of the dilution tested

[0600] The user-interface will also prompt the user to (i) select the length of incubation (30 min 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 varying types of plates 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.

[0601] 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 analysis (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:

[0602] Enter the following data about the test substance to be tested:

[0603] Number of test substance dilutions (4 concentrations of biotin-labeled drug and 4 concentrations of STAG-labeled drug per plate)

[0604] Dilution factor for each test substance

[0605] · The user will choose whether to include zero dilution

[0606] Enter the following data about the ADA sample to be tested:

[0607] Number of ADA dilutions (up to 3 dilutions per plate)

[0608] Concentration of ADA dilution

[0609] • Select the length of incubation (30 min to 4 hours on the instrument or user determined length of time off the instrument).

[0610] Choose whether to include an acid dissociation step.

[0611] Added different types of boards.

[0612] • Select whether to apply the same reagents (ie, same reagent source) to all plates.

[0613] 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.

[0614] 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 signal generated by the analysis in the presence of different sample matrix concentrations. The user interface prompts the user to make the following selections regarding the MDR optimization experiment:

[0615] Enter the following data about the ADA sample to be tested:

[0616] The number of ADA dilutions tested (8 or 12 dilutions per plate)

[0617] Concentration of ADA dilution

[0618] · The user will choose whether to include zero dilution

[0619] Enter the following data about the sample matrix to be tested:

[0620] Number of matrix dilutions (2-6 dilutions per plate, depending on the number of ADA dilutions being tested.)

[0621] Dilution factor for each dilution

[0622] · The user will choose whether to include zero dilution

[0623] User can use different sample matrices for each plate (e.g. serum, citrated plasma, EDTA plasma, etc.)

[0624] • Select the length of incubation (30 min to 4 hours on the instrument or user determined length of time off the instrument).

[0625] Choose whether to include an acid dissociation step.

[0626] • Add plates of varying types, assuming appropriate capacity exists in the run.

[0627] • Select whether to apply the same reagents (ie, same reagent source) to all plates.

[0628] 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.

[0629] Finally, the user-interface prompts the user to perform a fourth free drug tolerance assessment experiment to determine the impact of free drug on the assay and whether it is necessary to use acid dissociation to improve the free drug tolerance of the assay. With respect to the free drug tolerance assessment, the user has the option of performing the protocol with or without acid dissociation and / or performing a comparison between untreated and acid treated plates. The user interface prompts the user to make the following selections with respect to the free drug tolerance assessment experiment:

[0630] Enter the following data about the ADA sample to be tested:

[0631] The number of ADA dilutions tested (8 or 12 dilutions per plate)

[0632] Concentration of ADA dilution

[0633] · The user will choose whether to include zero dilution

[0634] Enter the following data about the free drug to be tested:

[0635] Number of free drug dilutions (2-6 dilutions per plate, depending on the number of ADA dilutions being tested.)

[0636] · Dilution factor for each dilution.

[0637] The user will choose whether to include zero dilution.

[0638] • Select the length of incubation (30 min to 4 hours on the instrument or user determined length of time off the instrument).

[0639] • Choose whether to use acid dissociation and / or whether to perform a comparison between acid-treated and untreated plates.

[0640] • Add plates of varying types, assuming appropriate capacity exists in the run.

[0641] • Select whether to apply the same reagents (ie, same reagent source) to all plates.

[0642] 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 a user-interface.

[0643] The immunogenicity (IG) assay, when automated to be run in an assay system such as assay system (1000) or (900), may have the following steps:

[0644] Automated analysis sequences

[0645] 1 Stock Board

[0646] 2 Start the scrubber

[0647] 3. Create a drug mixture

[0648] 4. Apply the drug mixture to the sample incubation plate

[0649] 5 Apply diluent to the dilution plate

[0650] 6. Generate a standard curve

[0651] 7. Establish control dilution

[0652] 8. Create sample dilutions

[0653] 9. Apply blocking agent to MSD plate

[0654] 10. Perform blocking incubation

[0655] 11 Apply diluent to the sample incubation plate

[0656] 12 Perform sample incubation

[0657] 13. Washing the MSD test plate

[0658] 14 Apply the incubated sample to the MSD test plate

[0659] 15 Perform MSD test plate incubation

[0660] 16 Apply read buffer to plate

[0661] 17 Read the plate on the ECL reader

[0662] 18 Cleaning process

[0663] (ii) Preparation, optimization and execution of pharmacokinetic assays

[0664] 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. or The standard PK analysis implemented on the platform is shown in Figure 17 (a). First, the MSD plate is coated with a capture substance. The capture substance is fixed to the MSD plate and can be an antibody, protein, antigen, carbohydrate, lysate, etc. The detection substance and analyte are applied to the coated MSD test plate. The detection substance may include a single STAG-labeled antibody (direct format), a STAG-labeled streptavidin and a biotin-labeled detection antibody (indirect format), a STAG-labeled anti-substance antibody and an unlabeled detection antibody, etc. (indirect format). The detection substance may be premixed with the analyte or it may be directly applied to the test plate. The block diagram for the implementation of direct PK analysis and two different types of indirect PK analysis is shown in Figure 17 (b) (respectively panel (i)-(iii)).

[0665] Figure 17(d) (referred to as "Customized Sandwich Immunoassays") shows the general protocol sequence for customized sandwich immunoassays. Figures 17(e)-(h) show the protocol and labeled reagent racks, and Figure 17(i) shows the deck layout for these assays. Figure 17(e)-a and 17(e)-b Relates to "Protocols for direct assays, streptavidin or avidin plates and reagent holders". Figure 17(f)-a and 17(f)-b Relates to "Protocols for direct assays, uncoated plates and reagent holders". Figure 17(g)-a and 17(g)-b Relating to "Protocols for indirect assays, streptavidin or avidin plates and reagent holders". Figure 17(h)-a and 17(h)-b Relates to "Protocols for indirect assays, uncoated plates and reagent holders".

[0666] The standard PK protocol includes multiple parameters that can be optimized, including but not limited to:

[0667] Duration of incubation (1 hour to overnight)

[0668] Board Type

[0669] Type and / or concentration of captured substances

[0670] Type and / or concentration of blocking agent

[0671] Concentration of unlabeled / biotinylated test substance (indirect analysis only)

[0672] Concentration of STAG-labeled detection substance

[0673] Assess analytical sensitivity by varying known concentrations of drug in samples

[0674] To optimize PK analysis on the analytical system shown in FIG. 10 and its subsections, a system development kit is provided to the user that includes a sample dilution plate (1.1 mL), a plate cover, reagent tubes, and a collection of kits that may include the following components:

[0675] Table 2.

[0676]

[0677] The development kit itself and the components within it include consumable identifiers (e.g., barcodes) 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 processing information, and combinations thereof. For example, if the component includes a multi-well analysis plate, the consumable type information includes the number of columns of wells; the number of rows of wells; the number of binding domains per well; and combinations thereof; and the consumable processing information includes data used by the analysis system in the implementation of the analysis using the plate and / or the processing of analysis data caused by the implementation of the analysis using the plate. In a specific embodiment, the consumable processing information includes the number of partitions per plate, the number of circuits per plate, detection parameters used by the analysis system to read the plate; image processing characteristics for generating ECL results; plate type gain; binding domain gain; optical crosstalk matrix; and combinations thereof.

[0678] The system barcode reader reads the consumable identifier (e.g., barcode) and downloads the appropriate protocol and optimized 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 type and / or concentration of the blocking agent; (iii) optimizing the concentration of the detection substance; and / or (iv) evaluating the sensitivity of the analysis. The user can make a 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 the parameters / data that will be generated in the skipped steps.

[0679] The suggested sequence of assay optimization experiments for indirect assays is as follows:

[0680] Step 1: Optimize capture species type and / or concentration

[0681] Step 2: Optimize blocking agent type and / or concentration

[0682] Step 3A: Optimize the concentrations of biotinylated / unlabeled detection substances and sulfo-tag-labeled detection substances

[0683] Step 4: Test drug sensitivity

[0684] The suggested sequence of an assay optimization experiment for direct analysis is as follows:

[0685] Step 1: Optimize capture species type and / or concentration

[0686] Step 2: Optimize blocking agent type and / or concentration

[0687] Step 3B: Optimize the concentration of the sulfo-tagged detection substance

[0688] Step 4: Test drug sensitivity

[0689] To optimize the capture process, the software will prompt the user to enter the following data in preparation for the experiment:

[0690] The user will enter the following data about the sample to be tested:

[0691] Number of sample dilutions (8 or 12 dilutions per plate)

[0692] Dilution factor for the sample

[0693] · The user will choose whether to include zero dilution

[0694] The user will enter the following data regarding the capture substance to be tested:

[0695] Number of capture substance types and / or dilutions (up to 6 per plate, depending on the number of sample dilutions being tested)

[0696] Dilution factor for each type of capture material (if more than one dilution per type is used)

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

[0698] • The user will select the length of incubation (1 hour to 4 hours on the instrument or a user determined length of time off the instrument).

[0699] • The user can add plates of varying types, assuming appropriate capacity exists in the run.

[0700] • The user will choose whether to apply the same reagents (ie, same reagent source) to all plates.

[0701] The experiment can be performed on up to 5 plates. The system then performs the experiment and displays the results of the experiment on a user-interface.

[0702] To optimize the blocking process, the software will prompt the user to enter the following data in preparation for the experiment:

[0703] The user will enter the following data about the sample to be tested:

[0704] Number of sample dilutions (8 or 12 dilutions per plate)

[0705] Dilution factor for the sample

[0706] · The user will choose whether to include zero dilution

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

[0708] Number of blocking agent types and / or dilutions (up to 6 per plate, depending on the number of sample dilutions being tested)

[0709] Dilution factors for each type of blocking agent (if more than one dilution of each type is used)

[0710] • The user will select the length of incubation (1 hour to 4 hours on the instrument or a user determined length of time off the instrument).

[0711] • The user can add pla...

Claims

1. An automated analysis system, comprising: robotic clamping arms and robotic pipettes; at least one of a plate carrier or a tip box carrier; multiple plate shakers; an analytical consumable storage unit for analytical reagents; an analytical consumables storage unit for the plates; as well as At least one of a platform or a table, wherein the analytical consumables storage unit for the plates is attached to the front edge of the table or platform in a cantilevered manner, wherein the plate carrier or tip cartridge carrier is located behind an analytical consumables storage unit for the plates, and Wherein, the plurality of plate oscillators are positioned toward the rear of the platform.

2. The automated analysis system of claim 1, further comprising an air cooling and handling system, wherein: The air cooling and handling system is located on the rear panel of the automated analysis system.

3. The automated analysis system of claim 1, further comprising at least one of an analysis consumables storage unit for immediate use of the tip or an analysis consumables storage unit for reserving the tip.

4. The automated analysis system according to claim 1, wherein: The automated analysis system has locations for attaching analysis consumable storage units for tubes and tanks.

5. The automated analysis system of claim 1, further comprising a plate washer located below the platform or table, wherein: The platform or table has an opening for accessing the plate scrubber.

6. The automated analysis system of claim 5, further comprising one or more containers for wash buffer and liquid waste below the plate washer.

7. The automated analysis system according to claim 1, wherein: The automated analysis system includes a platform and a table, and wherein the platform is attached to and supported by the table.

8. The automated analysis system of claim 1, further comprising an analysis reader.

9. The automated analysis system according to claim 8, wherein: The assay reader is located beneath the platform or table.

10. The automated analysis system according to claim 1, wherein: The platform or table has a waste opening for disposal of waste.

11. The automated analysis system of claim 10, further comprising a chute for solid waste extending from above the waste opening, through the waste opening, and to below the waste opening.

12. The automated analysis system of claim 1, further comprising at least one waste container located beneath the platform or table.

13. The automated analysis system of claim 1, further comprising a laptop computer for controlling the robotic clamping arm and the robotic pipette.

14. The automated analysis system of claim 1, further comprising a universal power supply system (UPS) under the platform or table.

15. The automated analysis system according to claim 1, wherein: The robotic pipette includes a capacitive sensor configured to detect the presence of liquid in a container.

16. The automated analysis system according to claim 15, wherein: The capacitive sensor includes a conductive stack formed of a plastic material coated with metal.

17. The automated analysis system according to claim 1, wherein: The plurality of plate shakers are raised above the platform to allow air to flow underneath and cover the tops of the plurality of plate shakers.

18. The automated analysis system according to any one of claims 6, 9, 12 and 14, wherein: The platform or table underneath is divided into compartments.

19. The automated analysis system according to claim 1, wherein: An analytical consumables storage unit for storing analytical reagents and a pipette tip storage compartment for storing pipette tips are located on the platform behind the analytical consumables storage unit for plates.

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