Consumables data management

Abstract

To provide a method, a device, and a system for associating assay consumables and consumables data used in a biological assay.SOLUTION: In a consumables data (CD) creation system 102, a method includes: a step (i) in which a supplier (a vendor) generates consumables data about consumables or a lot 101 of the consumables and stores that information in a consumables identifier 103 associated with the consumables or the lot of the consumables; a step (ii) in which a CD database is generated; a step (iii) in which the consumables data is stored in the CD database; and a step (iv) in which the CD database including a master repository of all consumables data is transmitted to a CD server 104.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application Nos. 61 / 400,441, filed July 27, 2010, and 61 / 462,024, filed January 27, 2011, the entire contents of each of which are incorporated herein by reference.

[0002] FIELD OF THEINVENTION The present teachings relate to methods, devices and systems for associating consumable data with assay consumables used in biological assays. [Background technology]

[0003] 2. Background of the Invention Numerous methods and systems have been developed for performing assays. These methods and systems are necessary in a variety of applications including medical diagnostics, veterinary testing, food and beverage testing, environmental monitoring, manufacturing quality control, drug discovery, and basic scientific research. During the manufacture and use of reagents and other consumables used in biological assays, the reagents and consumables are typically coded and labeled by the manufacturer in order to track them. Furthermore, a myriad of analytical parameters must be tracked to understand the analytical results of any given assay, often requiring input from a variety of parallel tracking systems supplied by the manufacturer, the customer, or both. Summary of the Invention [Means for solving the problem]

[0004] Summary of the Invention The present invention provides an assay system configured to use an assay consumable in performing an assay, the assay consumable comprising an assay consumable identifier, and the assay system comprising: (a) a storage medium including a consumable data repository comprising local consumable data; and (b) a reader adapted to read the consumable data from the consumable identifier, wherein the consumable data and the local consumable data comprise (i) consumable identification and / or configuration information, and (ii) one or more steps of an assay protocol that may be applied by the system in performing an assay using the consumable, and the system is configured to receive updates to the repository, the updates including additional consumable data, and: (x) one or more analytical tools that can be applied by the system to analyze data generated during and / or after the performance of the assay; (y) assay system maintenance information; (z) System - Consumables sales promotion information; (xx) Technical support information for systems and / or consumables; or (yy) combinations of these The at least one consumable data type comprises:

[0005] In one embodiment, an assay system of the invention includes an interface configured to transmit and / or receive consumable data to and / or from a vendor computer system.

[0006] The invention also provides a method of using an assay system configured to use an assay consumable in performing an assay, the assay consumable comprising an assay consumable identifier, and the assay system comprising: (a) a storage medium including a consumable data repository comprising local consumable data; and (b) a reader adapted to read the consumable data from the consumable identifier, wherein the consumable data and the local consumable data comprise (i) consumable identification and / or configuration information, and (ii) one or more steps of an assay protocol that may be applied by the system in performing an assay using the consumable, and the system is configured to receive updates to the repository, the updates comprising additional consumable data, and at least one consumable data type comprising (x) one or more analytical tools that may be applied by the system to analyze data generated during and / or after the performance of the assay, (y) assay system maintenance information, (z) system-consumable promotion information, (xx) system and / or consumable technical support information, or (yy) a combination thereof; This method involves the following: (a) reading consumable data from a consumable identifier; (b) adjusting one or more operations performed by the system before, during, and / or after performance of the assay by the system based on the consumable data; (c) performing an assay in an assay system using the assay consumable; and (d) receiving update information for the repository The present invention relates to a method for producing a semiconductor device comprising the steps of:

[0007] Also contemplated is a method for enabling use of an assay system by a system / consumable vendor, the assay system being configured to use an assay consumable comprising an assay consumable identifier in performing an assay, the assay system comprising: (a) a storage medium comprising local consumable data; and (b) a reader adapted to read the consumable data from the consumable identifier, wherein the system / consumable vendor maintains a master consumable data repository comprising the consumable data; The method comprises providing the consumable data from a master consumable data repository to a customer for enabling use of the consumable data in the system.

[0008] Still further, the present invention encompasses an assay system configured to use an assay consumable in performing an assay, the assay consumable comprising an assay consumable identifier, and the assay system comprising: (a) an interface configured to transmit and / or receive consumable data to and / or from a vendor computer system, (b) a storage medium comprising local consumable data, and (c) a reader adapted to read the consumable data from the consumable identifier, wherein the consumable data comprises: (i) consumable identification and / or configuration information; and (ii) one or more steps of an assay protocol that can be applied by the system in performing an assay that uses the consumable The present invention relates to a method for producing a semiconductor device comprising the steps of:

[0009] Another embodiment of the invention is a method of tracking usage of an assay consumable in an assay system, the assay consumable comprising an assay consumable identifier, and the assay system comprising: (a) an interface configured to transmit and / or receive consumable data to and / or from a vendor computer system; (b) a storage medium comprising local consumable data; and (c) a reader adapted to read information from the consumable identifier, where the consumable data and the local consumable data comprise (i) consumable identification and / or configuration information, and (ii) one or more steps of an assay protocol that may be applied by the system in performing an assay using the consumable, the method comprising: (a) reading consumable data from a consumable identifier; (b) using the consumable data to configure the assay system for use of the assay consumables in performing an assay in the system; (c) performing the assay in the assay system using the assay consumable; (d) storing the system-consumable usage information in a storage medium; and (e) transmitting the system-consumable usage information to a vendor computer system via an interface; The present invention relates to a method for producing a semiconductor device comprising the steps of:

[0010] Also included is a method of controlling customer access to an assay system by a system vendor, where the system comprises a system identifier, the method comprising the steps of: (a) receiving a system identifier from a customer, wherein the system identifier is transmitted to a vendor computer system; (b) identifying a system identifier by the vendor; and (c) (i) allow full access to the Equipment and / or Consumables used in the Equipment; (ii) allowing partial access to the Equipment and / or consumables used in the Equipment; or (iii) Denying access to the Equipment and / or any consumables used in the Equipment; performing one or more operations selected from The present invention relates to a method for producing a semiconductor device comprising the steps of:

[0011] A further embodiment of the present invention is a method of generating and maintaining consumable data and consumable data for a consumable, the method comprising: (a) manufacturing consumables for use in performing the assays; (b) generating a database comprising consumable data relating to the consumables, wherein the database comprises information used to associate the consumable data with the consumables; and (c) Maintaining the database on the server The present invention relates to a method for producing a semiconductor device comprising the steps of:

[0012] The present invention further encompasses a method of providing consumable data for a consumable to a customer, the method comprising: (a) receiving queries from customers regarding consumables data relating to the consumables; and (b) transmitting consumable data about a consumable by any medium including email attachments, compact discs, memory cards / sticks, flash drives, web data storage services, or any combination thereof; The present invention relates to a method for producing a semiconductor device comprising the steps of:

[0013] Still further, the present invention provides a method for providing consumable data for a consumable to a customer, the method comprising: (a) receiving a query from a customer system via a direct interface for consumable data related to the consumable, where the direct interface comprises an Internet connection between the customer system and a vendor server; and (b) transmitting consumable data about the consumables to the customer system via the interface; The present invention relates to a method for producing a semiconductor device comprising the steps of:

[0014] Also contemplated is a computer readable medium having a computer program stored thereon which, when executed by a computer system operatively connected to an assay system, causes the assay system to perform a method of performing an assay in an assay system, where the assay system is configured to use an assay consumable in performing the assay, and where the assay system comprises: (a) a storage medium including a consumable data repository comprising local consumable data; and (b) a reader adapted to read the consumable data from the consumable identifier; the method comprising: (a) reading consumable data from a consumable identifier associated with an assay consumable, where the consumable data and the local consumable data comprise: (i) consumable identification and / or configuration information, and (ii) one or more steps of an assay protocol that can be applied by the system in performing an assay using the consumable; (b) adjusting one or more operations performed by the system before, during, and / or after performance of the assay based on the consumable data; (c) performing an assay in an assay system using the assay consumable; and (d) receiving updates to the repository, the updates comprising additional consumable data and at least one consumable data type comprising: (x) one or more analytical tools that may be applied by the system to analyze data generated during and / or after the execution of the assay; (y) assay system maintenance information; (z) system-consumable promotional information; (xx) system and / or consumable technical support information; or (yy) a combination thereof. The present invention relates to a method for producing a semiconductor device comprising the steps of:

[0015] In a further embodiment, the present invention provides a computer readable medium having a computer program stored thereon which, when executed by a computer system, causes the computer system to perform a method of enabling use of an assay system by a system / consumable vendor, the assay system being operatively connected to the computer system and configured to use an assay consumable comprising an assay consumable identifier in performing an assay, and the assay system comprising: (a) a storage medium comprising local consumable data; and (b) a reader adapted to read the consumable data from the consumable identifier, wherein the system / consumable vendor maintains a master consumable data repository comprising the consumable data; the method comprising a step of receiving the consumable data from the master consumable data repository to enable use of the consumable in the system.

[0016] In certain embodiments, a computer readable medium having a computer program stored thereon is provided which, when executed by a computer system, causes the computer system to perform a method of tracking usage of assay consumables in an assay system operatively connected to the computer system, the assay consumables comprising an assay consumable identifier, and the assay system comprising: (a) an interface configured to transmit and / or receive consumable data to and / or from a vendor computer system; (b) a storage medium comprising local consumable data; and (c) a reader adapted to read information from the consumable identifier, the method comprising: (a) reading consumable data from a consumable identifier, where the consumable data and local consumable data comprises (i) consumable identification and / or configuration information, and (ii) one or more steps of an assay protocol that can be applied by the system in performing an assay using the consumable; (b) using the consumable data to configure the assay system for use of the assay consumables in performing an assay in the system; (c) performing the assay in the assay system using the assay consumable; (d) storing the system-consumable usage information in a storage medium; and (e) transmitting the system-consumable usage information to a vendor computer system via an interface; The present invention relates to a method for producing a semiconductor device comprising the steps of:

[0017] The invention further encompasses a computer readable medium having stored thereon a computer program which, when executed by a computer system, causes the computer system to perform a method of controlling customer access to an assay system by a system vendor, wherein the system comprises a system identifier, the method comprising: (a) receiving a system identifier from a customer, wherein the system identifier is transmitted to a vendor computer system; (b) identifying a system identifier by a vendor; and (c) (i) allow full access to the Equipment and / or Consumables used in the Equipment; (ii) allowing partial access to the Equipment and / or consumables used in the Equipment; or (iii) Denying access to the Equipment and / or any consumables used in the Equipment; performing one or more operations selected from The present invention relates to a method for producing a semiconductor device comprising the steps of:

[0018] Still further, the invention encompasses a computer readable medium having stored thereon a computer program which, when executed by a computer system, causes the computer system to perform a method for generating and maintaining consumable data and consumable data for a consumable, the method comprising: (a) generating a database comprising consumable data relating to the consumables, wherein the database comprises information used to associate the consumable data with the consumables; and (b) Maintaining the database on the server The present invention relates to a method for producing a semiconductor device comprising the steps of:

[0019] Also contemplated is a computer readable medium having stored thereon a computer program which, when executed by a computer system, causes the computer system to perform a method of providing consumable data to a customer about a consumable, the method comprising: (a) receiving queries from customers regarding consumables data relating to the consumables; and (b) transmitting consumable data about a consumable by any medium including email attachments, compact discs, memory cards / sticks, flash drives, web data storage services, or any combination thereof; The present invention relates to a method for producing a semiconductor device comprising the steps of:

[0020] The invention further encompasses a computer readable medium having stored thereon a computer program which, when executed by a computer system, causes the computer system to perform a method of providing consumable data about a consumable to a customer, the method comprising: (a) receiving a query from a customer system via a direct interface for consumable data related to the consumable, where the direct interface comprises an Internet connection between the customer system and a vendor server; and (b) transmitting consumable data about the consumables to the customer system via the interface; The present invention relates to a method for producing a semiconductor device comprising the steps of:

[0021] In a preferred embodiment, the assay consumable comprises at least one assay test site for an assay, and preferably the test site comprises a plurality of separate assay domains, at least two of which comprise reagents for measuring different analytes. The test site may be a well and / or a chamber in the assay consumable. In one particular embodiment, the assay consumable comprises a plurality of wells, and the consumable further comprises at least one element comprising a plate top, a plate bottom, a working electrode, a counter electrode, a reference electrode, a dielectric material, an electrical connection, a dry assay reagent and / or a liquid assay reagent, or a combination thereof. Alternatively, or in addition, the assay consumable comprises a flow cell, and the consumable may be a cartridge further comprising at least one element comprising one or more fluidic components, one or more detection components, one or more assay cells, reagents for performing the assay, a working electrode, a counter electrode, a reference electrode, a dielectric material, an electrical connection, a dry assay reagent and / or a liquid assay reagent, or a combination thereof. In this embodiment, the cartridge comprises at least one assay cell that includes a plurality of distinct assay domains, at least two of which comprise reagents for measuring different analytes. Still further, the assay consumable may be a container adapted to contain one or more assay reagents.

[0022] The present invention provides systems, methods, and computer readable media configured to transmit, receive, and utilize consumable data associated with a consumable in an assay system. In one embodiment, the consumable data comprises information used to identify at least one element including: (i) an assay consumable, (ii) one or more test sites within the consumable, (iii) reagents and / or samples that have been or will be used in the consumable, or (iv) a combination thereof. Still further, the consumable data is used to distinguish a first test site within the consumable from a different test site within the consumable.

[0023] Additionally, the consumable data may be consumable information comprising lot identification information, lot-specific analytical parameters, manufacturing process information, raw material information, expiration date, calibration data, threshold information, location of individual assay reagents and / or samples within one or more test sites of the assay consumable, Material Safety Data Sheet (MSDS) information, or combinations thereof.

[0024] Still further, the consumable data includes sample information comprising the location of the sample within at least one test site of the assay consumable, assay results obtained with the assay consumable for the sample, the identity of the sample being assayed and / or to be assayed in the assay consumable, or combinations thereof. Additionally, the consumable data also includes chain of custody information including, but not limited to, information regarding the custody, transport, analysis, or combinations thereof of the sample. Additionally, the chain of custody information also includes customer identification, time and date stamp for the assay, location of the assay system during the assay, calibration and QC status of the assay system during the assay, custody and / or location information for the assay consumable before and after the performance of the assay, assay results for the sample; times, dates, manufacturing personnel or processing parameters for one or more steps during the manufacture of the assay consumable; storage, location and / or storage conditions for the assay consumable after and / or between steps during the manufacture of the assay consumable; or combinations thereof.

[0025] Still further, the consumable data includes consumable / test site information comprising the type and configuration of the consumable, the location and identity of assay reagents included with the assay consumable, the location and identity of assay reagents within the assay test site of the assay consumable, or a combination thereof.

[0026] Also contemplated is consumable data that includes assay process information comprising assay parameters to be applied by the reader during the assay, the order of steps to be applied by the reader during the assay, the identity, concentration and / or amount of assay reagents to be used or added during the assay, the type or wavelength of light to be applied and / or measured by the reader during the assay, the temperature to be applied by the reader during the assay, the incubation time for the assay, statistical or analytical methods to be applied by the reader to the raw data collected during the assay, or combinations thereof. In certain embodiments, the assay performed in the system is a multi-step assay, and the assay process information relates to one or more steps of the multi-step assay. Thus, the consumable / test site information comprises information regarding an assay previously performed by the reader at one or more test sites of the consumable; information regarding an assay to be performed by the assay reader or components thereof at one or more test sites within the consumable; or a combination thereof.

[0027] Additionally, the consumable data also includes consumable security information comprising: information regarding assay consumable authentication; information regarding the proper placement and / or orientation of the assay consumable in the system; information regarding defects in the assay consumable and / or its test site; or any combination thereof.

[0028] The consumable data may be used by the system to coordinate the operation of at least one component of the assay system comprising one or more sensors; a mechanism for transporting assay consumables into and out of the system; a mechanism for aligning and orienting assay consumables with one or more sensors and / or electrical, mechanical or fluidic interfaces in the system; a mechanism, electronics or software for tracking and / or identifying assay consumables; a mechanism for storing, stacking, moving and / or dispensing one or more consumables; or a combination thereof. [Brief description of the drawings]

[0029] [Figure 1] 1 illustrates generation and storage of consumable data by consumable manufacturers. [Diagram 2] 1 illustrates distribution of consumable data to customers in response to a query for the consumable data. [Diagram 3] 1 illustrates the use of consumable data to verify authorized use of consumables in an assay system. [Figure 4] It represents the master repository on the CD server, its contents, and / or an interface to further vendor directories. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS Unless otherwise defined herein, scientific and technical terms used in connection with the present invention shall have the meanings commonly understood by those skilled in the art. Further, unless otherwise required by context, singular terms shall include the plural and plural terms shall include the singular. The articles "a" and "an" are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, "an element" means one element or more than one element.

[0031] The assay consumables and systems used in the present invention include a variety of devices and configurations. In one embodiment, the assay system used in the present invention includes an assay reader capable of performing a biological assay using the assay consumable. The assay consumable comprises an identifier (alternatively referred to throughout the specification as an identifier, consumable identifier, or assay consumable identifier), and the assay system, reader, or components thereof, comprises an identifier controller that interacts with the identifier. As described herein below, the identifier comprises information about the assay consumable, which may include, but is not limited to, how the consumable was manufactured and handled prior to use, and how the consumable is used in the assay system (collectively referred to as "consumable data"). Thus, the assay system is configured to use the assay consumable in performing an assay, and the assay system includes a reader adapted to (i) read information from the assay consumable identifier associated with the assay consumable; and optionally (ii) erase information from the assay consumable identifier; and / or (iii) write information to the assay consumable identifier.

[0032] In certain embodiments, the invention provides an assay system configured to use an assay consumable in performing an assay, wherein the assay consumable comprises an assay consumable identifier as described herein, and the assay system comprises: (a) a storage medium comprising a consumable data repository; and (b) a reader adapted to read information from the consumable identifier. In one embodiment, the system comprises a storage medium comprising a consumable data repository comprising local consumable data. The local consumable data stored in the assay system includes consumable identification and / or configuration information, as well as one or more steps of an assay protocol that can be applied by the system in performing an assay using the consumable. For example, the assay consumable identifier includes information that can be used to identify a particular consumable, such as lot-specific information for a given lot of consumables and / or information specific to an individual consumable, and the corresponding local consumable data stored in the assay system includes information used to identify a consumable associated with the system, such as as a member of a given lot or as an individual consumable within a lot, including information used by the system to perform an assay protocol using the consumable once the consumable is identified. Still further, the consumable data (and / or local consumable data) may include one or more analytical tools that may be applied by the system to analyze data generated using the consumable, system and / or consumable technical support information, or combinations thereof. Additionally, the system may also be configured to receive updates from the remote storage medium to the consumable data repository, where these updates include additional consumable data, including, but not limited to, additional consumable identification and / or configuration information, assay protocol information, and one or more of the following: (x) one or more analytical tools that may be applied by the system to analyze data generated during and / or after the execution of an assay, (y) assay system maintenance information, (z) system-consumable promotion information, and (xx) system and / or consumable technical support information.

[0033] The use of identifiers / consumable data in the system is illustrated in Figures 1-4. Figure 1 shows how consumable data is generated, stored, and used by a manufacturer, distributor, or supplier (referred to herein as a "vendor"). First, the vendor generates a consumable and / or a set of consumables or consumable lots (101) and for that consumable or consumable lot, generates consumable data using a consumable data (CD) production system (102) and stores it in a consumable identifier (103) associated with the consumable or consumable lot (step i). The consumable data is generated by the consumable vendor before, during, and / or after the manufacture and / or distribution of the individual consumable and / or consumable lot. The CD production system creates a database of CD information for that consumable or lot, i.e., the CD database, in which the consumable data is stored. The CD database is sent to a CD server (104) that contains the master repository of all consumable data. Additionally, the CD production system stores information used to associate a given consumable identifier with the consumable data in the master repository. The CD production system and / or CD server are located on a remote computer system, i.e., an assay system and / or a computer system that is remote from the customer or the customer, e.g., a site maintained by the vendor. Thus, as shown in Figure 1, the vendor generates consumable data for a consumable or lot (a) and stores that information in a consumable identifier (b) associated with that consumable or lot. The CD system also (step ii) generates a CD database; (step iii) stores the consumable data in the CD database; and (step iv) transmits the CD database to the CD server (c), which contains the master repository of all consumable data.

[0034] FIG. 2 illustrates one method of distributing consumable data to customers or designated users of a customer (collectively referred to herein as "customers"). Upon receiving an order from a customer or when a consumable or lot is manufactured (step i), the vendor generates, stores, and transmits a CD database to the CD server (201) (step ii). The CD database may include order fulfillment information, i.e., a summary of the components of an order for a given customer that allows the system to verify that all components of an order for a given customer have been supplied to the customer. The customer receives a consumable (202) including a consumable identifier (203) and contacts the consumable with an assay (204) in preparation for the execution of an assay (step iii), the system reads the information stored in the assay 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 to the system in a local storage medium (referred to as "local CD" in FIG. 2) to verify that the consumable data stored in the storage medium can be used for the execution of an assay using the given consumable. If the storage medium contains consumable data for that consumable or lot, those consumables can be used in the system (step v). If the storage medium does not contain consumable data for that particular consumable or lot of consumables, the system can query the customer for the consumable data, and the customer can contact the vendor to receive the required consumable data, for example, via email, compact diskette, memory card / stick, flash drive, web data storage service, etc. (step vi). The vendor sends a binary file (including, but not limited to, an encrypted XML file) of the consumable data to the customer, for example, as an email attachment to the customer's email account, the customer loads the file attachment into the assay system, and the system software stores the consumable data in a local system consumable data repository. The consumable / lot of consumables can then be used in the instrument (step vii).

[0035] In an alternative embodiment, the CD server may be connected to the system via a direct interface that can automatically obtain consumable data from the CD server if it is not available locally on the system. In this embodiment, as shown in FIG. 2 and described above, the vendor generates, stores, and transmits a CD database for consumable orders and / or consumable lots to the CD server. The customer then receives the consumable, order, and / or lot and contacts the system with a consumable identifier so that the system can identify the consumable or lot. The system software queries the system's consumable data repository for the consumable data associated with that consumable identifier, and if the consumable data is available locally on the system, the software adjusts the system based on the consumable data, if necessary. If the consumable data is not present in the system consumable data repository, the system (i) prompts the customer to manually obtain the consumable data from the vendor, or (ii) automatically obtains the consumable data from the CD server via a direct interface with the CD server and stores the information locally in the system consumable data repository. Once the consumable data is available locally on the system, the software adjusts the system based on the consumable data, if necessary, and runs the assay. Once the consumable data is available locally on the system, the consumable or lot can be used in the system to run the assay and present the assay results to the customer. In certain embodiments, the system software adjusts the output to the customer based on the consumable data.

[0036] Additionally, the CD Server may periodically transmit consumable data for new consumable lots / consumable types to the customer's assay 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 comprises a consumable data repository containing the consumable data, and the assay system is configured to receive updates to the repository from the remote storage medium, e.g., via email, CD, memory card / stick, flash drive, and / or via a remote interface.

[0037] Figure 3 illustrates the matching of consumable data by the system software and the results of that procedure. Initially, a customer inserts a consumable (301) with a consumable identifier (302) into the system (303) (or otherwise places the consumable identifier in contact with a controller on the system), and the system software identifies the consumable via the consumable identifier (302). The system attempts to associate that identifier with consumable data stored locally in the system repository. If the consumable data is verified and valid, the system processes the consumable and presents the results of the processing step to the customer. However, if the consumable data is invalid or cannot be verified, the consumable is processed by the system, but the analysis results are not presented or otherwise made available to the customer until the consumable data has been verified by the system software.

[0038] The present invention further provides a method of controlling customer access to an assay system and / or assay consumables by a vendor, the system comprising a system identifier, the method comprising: receiving the system identifier from the customer, wherein the system identifier is transmitted to a vendor computer system; identifying the system identifier by the vendor; and (i) allowing full access to the device and / or assay consumables used in the device; (ii) allowing partial access to the device and / or assay consumables used in the device; or (iii) Denying access to the device and / or assay consumables used in the device; The method includes performing an operation comprising:

[0039] The system identifier includes information that uniquely identifies the assay system, such as a serial number or other identification code that is generated and used by the vendor to identify the assay system. The system identifier is generated by the vendor during or after the manufacturing process and / or when preparing for shipment or transport to a customer.

[0040] In one embodiment, enabling either full or partial access includes transmitting an access code from the vendor to the customer, thereby enabling access to the system. The access code may be a full or partial access code that enables various features 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 the system to be fully operational.

[0041] As shown in FIG. 4, the CD Server (401) includes a master repository (402) that includes one or more directories: (i) consumable data; (ii) system data; and (iii) customer data. Additionally or alternatively, data contained in or more of the directories (i)-(iii) may be provided to the master repository by an interface between the CD Server and one or more supplemental vendor directories. In one embodiment, the master repository includes (i) a master customer data directory (403); (ii) a master system identifier directory (404); and (iii) a master customer data directory (405). In a preferred embodiment, the customer data is provided to the CD Server via an interface to a supplemental vendor-customer directory that holds the customer data. The customer data may be stored in one or more supplemental vendor-customer directories, each of which is connected to the CD Server via an interface. The master CD database includes a plurality of CD directories, each of which is generated for a consumable or a lot of consumables. The master system identifier directory includes a system identifier that is unique to each system manufactured and / or distributed by the vendor. And a master customer directory and / or a supplemental vendor-customer directory in conjunction with the CD Server contains information about each of the vendor's customers, such as contact information, billing information, pricing information, shipping information, order history, etc., for the customer and each individual customer within that customer.

[0042] In certain embodiments, when a system is manufactured and / or prepared for delivery, the vendor generates a system identifier for that system. The system identifier is stored in a master system identifier directory or is available via an interface to the CD Server with a supplemental vendor directory. When a system is ordered by a customer, the order information, such as the purchase order, associated quotes, pricing, terms of sale or rental, associated service agreements, etc., and customer information are stored in a master customer directory and / or one or more supplemental vendor-customer directories in conjunction with the CD Server. In this regard, the system identifier unique to that system is associated in the master repository with the customer who purchased the system, and also with information regarding the associated purchase by that customer. Delivery information for the system to the customer is also available in the customer directory(s), and once the system is delivered to the customer, a delivery confirmation is received and a copy of which is also stored in the customer directory. Once the customer receives the system, and in a preferred embodiment, installation and training on the system is complete, if necessary, the system software connects to the CD Server via a remote interface between the system and the CD Server, enabling interaction between the two. The system first connects to the CD server to confirm that the system installation and training have been successfully completed, and the CD server records the confirmation. Alternatively, if remote connections are not enabled on the system, once the system is installed and training is completed, the customer receives a confirmation code, system login, and / or email address from the system, and the customer can log into the CD server via the confirmation code, system login, and / or email, thereby providing the customer with a login to the CD server, which provides a separate vendor-customer interface without a direct connection between the system and the CD server.This separate vendor-customer interface may be a portal on a vendor-provided website accessible to the customer via a password, and / or the customer and the CD server may communicate via an email exchange server configured to send and receive email between the customer and the CD server (collectively referred to as an "indirect interface" between the customer and the CD server). Thus, the vendor may communicate with the customer via a direct system-CD interface (referred to as a "direct interface") and / or via an indirect interface. As above, the customer may then purchase a consumable, the system reads the consumable identifier and ensures that the consumable data is stored locally, and if necessary, receives the consumable data directly or indirectly from the CD server, and the system may then use that consumable or lot.

[0043] Once a customer and a vendor have the means to communicate through a direct or indirect interface, the customer and vendor can interact in a variety of ways, and the communications between the parties can be more meaningful and productive because the vendor has the ability to track customer-specific usage information about the systems and consumables purchased and / or used by the customer. For example, a customer can view and / or purchase the vendor's products, receive customer assistance, schedule service calls, etc., through a direct or indirect interface. Because the vendor can track customer activities and purchases very closely through the consumable identifier / CD server, the vendor can tailor its interactions with the customer based on that information. For example, because the vendor knows the customer's order history, the vendor can send promotional materials to the customer about products related to products the customer has purchased / used in the past. Similarly, because the vendor can track information related to the customer's system, the vendor can send the customer preventative maintenance advice and reminders, general or specific customer training and seminars based on the customer's unique needs (and informed by tracking consumables data for that customer), as well as information regarding system service, warranty repairs, service contract information and reminders, and the like.

[0044] In one embodiment, the vendor tracks the use of consumables by assay customers, and the consumable data stored in the assay system includes system-consumable usage information. To facilitate tracking of consumable usage, the assay system is configured to transmit the system-consumable usage information to the CD server, directly or indirectly. If a direct interface is available between the system and the CD server, the system-consumable usage information may be transmitted automatically. However, if a direct interface is not available, the system-consumable usage information may be provided indirectly from the customer to the CD server. In this embodiment, the system periodically prompts the customer to provide the system-consumable usage information to the vendor via the indirect interface. The vendor may maintain a directory of customer consumable information to track consumable usage, and information from the directory is used to transmit consumable data that may be associated with the customer based on previous consumable and / or system usage, via the direct or indirect interface. If a direct interface is available, the assay system may be configured to receive assay system maintenance and / or promotional information related to an individual customer's previous consumable and / or system usage from the vendor computer system.

[0045] The vendor may also monitor, for example, system and / or system component utilization, service history, system troubleshooting information, results of diagnostics performed on the system, control charting, routine maintenance schedules, warranty information regarding the system and / or its components, or a combination thereof, to track and / or communicate system maintenance information to the customer. The system software may be programmed to monitor various components of the system and automatically or when instructed to send monitoring reports to a remote computer system and / or service technician. If a direct interface is not available, the system may instruct the customer to send the monitoring reports to the CD Server via an indirect interface. Additionally or alternatively, such system monitoring reports may be accessed by service technicians tasked with maintaining and / or servicing the system, either on-site or remotely. In certain embodiments where a direct interface is available, the CD Server monitors utilization and / or warranty information of the system components and schedules periodic system / component maintenance and / or upgrades by service technicians based on standard system component life spans and / or warranty periods. Additionally, the CD server may maintain a log of the service history for a given assay system and may schedule a service call by a service technician (which may be done using either the direct or indirect interface). The remote computer system may also transmit individual assay system software upgrades via the direct or indirect interface.

[0046] Additionally, 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 positions during normal usage, position errors for each expected motor position, corrective actions taken and / or attempted corrective actions by the system in the event of a motor positioning error, and error frequency; amount of usage of a component, e.g., the approximate time a component has been operational in the system, and in a preferred embodiment, the system also tracks the relative life of that component under normal use conditions; locking mechanism attempts, retries, and failures; bar code reader attempts, retries, and failures; approximate temperature of one or more components in the system, error warnings, database performance and capacity, device hard disk capacity, software and firmware versions and patches, customer login / logout, system startup and shutdown, etc. In particularly preferred embodiments involving systems designed to perform electrochemiluminescence measurements using assay consumables, the system software may also be programmed to monitor the time and approximate temperature the camera has been in operation, the cycles of use of latches in the system, barcode reader attempts, retries, and failures, consumable lock and unlock events, ECL waveform voltages and integrated currents, image processing analysis accuracy and failures, consumable type, kit, owner, barcode, and timestamp of each consumable in the system, or combinations thereof. Still further, the system software may also monitor experiments performed in the system, such as when, by whom, and what type(s) of consumable(s) were used in the experiment. Such system-usage monitoring information may be transmitted to the CD Server via direct and / or indirect interfaces to enable the vendor to determine appropriate support, service, and / or maintenance schedules on the system.

[0047] In another embodiment, tracking the usage of the assay system allows the vendor to provide usage and / or purchasing assistance. For example, the vendor can track the usage and purchase history of the consumable, and based on the consumable data for a given lot or consumable, the vendor can monitor the expiration data of a given lot or consumable and notify the customer of the approaching expiration date for the lot or consumable. Tracking the usage of the assay system / consumable type also allows the vendor to track the relative schedule / frequency of the use of the consumable and notify the customer that the customer's consumable stock needs to be replenished. If a direct interface is available, the system can also be configured to order / reorder the consumable, and the system can further be configured to track and confirm the order of the consumable from the vendor. If a direct interface is not available, the system can monitor the usage and inventory of the consumable, and can prompt the customer to replenish their stock of one or more consumables. (In this regard, the system can receive lot size information via the consumable identifier and monitor consumable usage to indicate to the customer when the available reserves of consumables for a given lot have decreased to a minimum level.) Additionally, by tracking consumable usage, the customer can be sent information regarding custom assay design services for a particular custom consumable type based on the customer's order / consumable usage history. The direct or indirect interface can also provide the customer with training modules, consulting services, and / or live customer service assistance capabilities (i.e., live-chatting) to facilitate the customer's experience (collectively referred to as technical support information for the system and / or consumables).

[0048] In another embodiment, tracking the use of consumables / systems allows the vendor to send promotional materials to the customer, for example, in the case of a new model or lot of a consumable that has been historically used by a given end-customer, the vendor computer system sends the customer consumable data relating to those new products. Such promotional materials may also be related to new assay systems that the customer may be interested in based on that customer's previous usage. The remote computer system may also send the customer literature references that may be related to one or more consumables / systems used by a given customer.

[0049] These and other specific examples of consumable data are described in more detail herein below.

[0050] Assay Systems, Consumables, and Methods of Use The assay systems contemplated by the present invention may be used to perform any type of diagnostic or analytical method known in the art. Such analytical methods include, but are not limited to, clinical chemistry assays (e.g., pH, ion, gas, and metabolite measurements), hematology measurements, nucleic acid amplification assays (e.g., polymerase chain reaction (PCR) and ligase chain reaction assays), immunoassays (e.g., direct, sandwich, and / or competitive immunoassays, and serological assays), oligonucleotide ligation assays, and nucleic acid hybridization assays. Any biological reagent that may be used in such analytical methods may 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 such as drugs or prodrugs, streptavidin, avidin, and biotin.

[0051] These systems may be portable, e.g., alone or in combination with one or more additional components, assay devices or systems, handheld and / or operated in a fixed laboratory or field environment. These systems may be used in a variety of applications from field operations to laboratory environments, including, but not limited to, medical, clinical, forensic, pharmaceutical, environmental, veterinary, biological, chemical, agricultural, waste management, hazardous chemical, drug testing, in a wide variety of industries, and in defense applications, e.g., for detection of biological warfare agents. The assay systems and consumables used in the present invention may detect the analyte of interest by any suitable method, including, but not limited to, optical, electromechanical, radio wave, electromagnetic, colorimetric, fluorometric, chemiluminescent, electrochemiluminescent, radiochemical, nuclear magnetic resonance, enzymatic, fluorescent, particle counting, and cell counting based detection.

[0052] Assay consumables include devices in which one or more steps of an assay process are performed, and such devices may include one or more test sites in which an assay measurement is performed. In one embodiment, an assay consumable includes at least one assay test site for an assay. The test site may include multiple separate assay domains, at least two of the domains including reagents for measuring different analytes. Still further, the consumable may include multiple test sites for multiple individual assays. Alternatively, an assay consumable may be a component that provides reagents or other assay components used by the system to perform an assay. For example, an assay consumable may be a container having one or more compartments for holding assay reagents. An assay consumable (or the test sites therein) may be single-use or reusable. An assay consumable may be configured to perform a single test or multiple tests (series or parallel).

[0053] A test site, as used herein, refers to an area of ​​a consumable that holds, contacts, and / or interrogates a sample. A test site may include multiple separate assay domains, with at least two such domains containing reagents for measuring different analytes. A consumable may include multiple test sites that can hold, contact, or otherwise interrogate separate volumes (aliquots) of the same sample and / or separate volumes of different samples. A sector of an assay consumable refers to a population of two or more test sites of that consumable. Each test site may be used to perform a single measurement or multiple measurements (e.g., measurements of multiple different analytes in a multiplexed assay format) of a volume of sample. Depending on the specific requirements of the application, a consumable with multiple test sites may be configured to use all of its test sites in parallel, to use its test sites at different times (e.g., to assign unused test sites to use when new samples are delivered to the assay system), or a combination of both modes of operation may be enabled.

[0054] The assay consumables may be any structure useful in diagnostic applications, and the structure may depend on the particular assay format or detection method used by the device. Examples of assay consumables suitable for use in the present invention include, but are not limited to, test tubes, cuvettes, flow cells, assay cartridges and cassettes (which may include integrated fluidics for assay processing), multi-well plates, slides, assay chips, lateral flow devices (e.g., strip tests), flow-through devices (e.g., dot blots), pipette tips, solid supports for biological reagents, and the like. In certain embodiments, the test sites in the assay consumables are defined by compartments in the assay consumables, such as wells, chambers, channels, flow cells, and the like. The assay consumables and / or test sites may include one or more components used to perform assay measurements according to one or more particular detection methodologies. Depending on the function of the consumable and the detection modality used by the assay system, examples of such components may include, but are not limited to, lateral flow matrices, filtration matrices, optical windows, sensors (e.g., electrochemical and optical sensors), solid supports for binding reactions (e.g., coated slides, chips, beads, pins, coated filtration or lateral flow matrices, tubes, etc.), reagents (in dry or liquid form), electrodes, analyte selection membranes, etc.

[0055] In one embodiment, the assay consumable may be a device incorporating a conventional lateral flow test strip, e.g., an immunoassay test strip, as the assay medium. In this example, the device is molded to include an identifier or an identifier is attached to the device without modifying the structure of the device and / or the assay medium. In one embodiment, the device is placed in an analytical system, i.e., an assay system, for analysis before, during, and after performing an assay, and an identifier controller in, attached to, or associated with the assay system reads the data contained in the identifier and uses the data in the assay or after the assay is completed by the system.

[0056] In another embodiment, the assay consumable and associated assay system or reader are capable of performing multiplex assays. A multiplex assay is a type of assay in which multiple measurements are performed on a single sample, for example by distributing the sample across multiple test sites, and / or by performing multiple measurements on a large number of samples at individual test sites. Multiplex measurements can include, but are not limited to, (i) multiple repetitions of a measurement for an analyte; (ii) multiple measurements of a particular analyte (i.e., multiple non-identical measurements for the same analyte, e.g., measurements that differ in format or identity of assay reagents used); and / or (iii) measurements of multiple different analytes. In one particular embodiment, the assay consumable is configured to perform multiplex measurements, including at least two assays for two different analytes at one or more test sites.

[0057] The present invention is not limited to a particular approach for performing multiplexed measurements at a test site, and may use any of the numerous techniques developed for performing multiplexed measurements. Multiplexed measurements that may be used with the present invention include, but are not limited to, (i) multiplexed measurements involving the use of multiple sensors; (ii) multiplexed measurements using separate assay domains on a surface (e.g., an array) that are distinguishable based on their location on the surface; (iii) multiplexed measurements involving the use of reagents coated on particles that are distinguishable based on particle characteristics, such as size, shape, color, etc.; (iv) multiplexed measurements that produce distinguishable assay signals based on optical properties (e.g., absorbance or emission spectra); (v) multiplexed measurements based on temporal characteristics of the assay signal (e.g., time, frequency, or phase of the signal), and / or (vi) multiplexed measurements based on some other assay feature. Thus, interpretation of multiplexed assay results may include the use of multiplexed information, such as the identity of the assays performed at and within each test site, assay features (such as the identity, location, and identity of the assay domain of a particular sensor) that are used to distinguish assays performed at a test site and / or that are used to associate a particular assay identity with a corresponding assay signal.

[0058] In one embodiment, an assay test site comprises multiple separate assay domains, and each domain comprises one or more reagents for measuring a different analyte. Multiplexing information, including the location, identity, and composition of each assay domain, is used to identify the assay signal generated in each domain and relate it to a determination of the presence or amount of the corresponding analyte (a process that may include application of additional consumable data such as signal thresholds and / or calibration parameters). Such multiplexing information may be provided as consumable data and / or stored in a consumable identifier.

[0059] A test site may be configured to perform multiple multiplexed measurements (e.g., may include multiple separate assay domains, each domain comprising reagents for measuring a different analyte). In one embodiment, an assay consumable may include multiple test sites. Information regarding the exact configuration of one or more test sites, assay domains, and / or one or more sectors in the consumable may be included in the information stored in the assay consumable identifier and / or provided as consumable data. This information may include multiplexing information (as described above) including the location and identity of the test site, assay domain, and / or one or more sectors, as well as the number, identity and differentiating characteristics of the individual measurements within the test site, assay domain, and / or sector (e.g., the specific location, identity, and / or assay reagents of the assay domains within each test site). Furthermore, the use of the test sites, assay domains, and / or sectors in the assay consumable may also be recorded in the identifier to track the use of the consumable in the assay system. The identifier and / or consumable data may also include information regarding the assay format and specific processing steps to be used for the assay consumable or the test sites, assay domains, and / or sectors of the assay consumable. The identifier and / or consumable data may also include information regarding the analytical method to be applied by the system when the assay is performed to analyze the output of the assays at a given test site, assay domain and / or sector, and optionally to provide a result that combines the output from multiple assays at a test site, assay domain and / or sector.

[0060] The test sites may be configured in any suitable configuration depending on the shape of the consumable and / or the type of assay to be performed with the consumable. In one embodiment, the test sites are configured as wells and / or chambers in the assay consumable. For example, the assay consumable of the present invention may be a multi-well plate (e.g., a 24-well, 96-well, 384-well, or 1536-well plate), and the wells of the plate may further include a plurality (e.g., 2 or more, 4 or more, 7 or more, 25 or more, 64 or more, 100 or more, etc.) of separate assay domains. A multi-domain multi-well plate adapted to enable assay measurements to be performed using electrode-induced luminescence measurements (e.g., electrochemiluminescence measurements) is described in U.S. Application Serial No. 10 / 238,391 (entitled "Methods and Reader for Conducting Multiple Measurements on a Sample," filed September 10, 2002, which is incorporated herein by reference). The exact configuration of domains, test sites and / or sectors in an assay consumable, as well as the specific identity of each domain, test site and / or sector and the reagents associated with that domain / test site / sector, may be included in the information stored in the assay consumable identifier and / or provided as consumable data. Additionally, the use of a given domain, test site and / or sector in an assay consumable may also be recorded in the identifier to track the use of the consumable in the assay system.

[0061] Assay consumables can be used in many different assays, and this variety results in a variety of suitable configurations of related consumables. In one assay format, the same analyte is measured in different assay domains within a test site, and these different assay domains are designed to measure different properties or activities of the analyte. Information regarding the assay format that may be used in the assay consumable, test site and / or assay domain may also be stored in the assay consumable identifier and / or provided as consumable data. The identifier and / or consumable data may also include instructions regarding the analytical method to be applied by the system when performing the assay to analyze the output of the assay at a given test site and / or domain and compare the output to an assay at another test site and / or domain.

[0062] An example of a multiplex assay consumable and reader is described in US2004 / 0022677, the disclosure of which is incorporated herein by reference in its entirety. Such assay consumables include one or more, and in one embodiment multiple, test sites and / or assay domains for performing one or more assay measurements simultaneously or sequentially. For example, the test sites may be configured as wells and / or chambers. These test sites and / or assay domains comprise one or more electrodes for inducing luminescence from materials at the test sites and / or assay domains. The assay consumables may further include assay reagents in liquid or dry form, e.g., at the test sites, e.g., at the wells or chambers, of the consumable.

[0063] In addition to the test sites and assay domains, an assay consumable or multi-well assay plate may include several additional elements, such as a plate top, a plate bottom, wells, working electrodes, counter electrodes, reference electrodes, dielectric materials, electrical connections, and assay reagents. The wells of the plate may be defined by holes or openings in the plate top, or as depressions or indentations on the surface of the plate. The plate may have any number of wells of any size or shape arranged in any pattern or configuration, and may be composed of a variety of different materials. Exemplary embodiments of consumables that may be used in the present invention include industry standard formats for the number, size, shape, and configuration of plates and wells, such as 96-well, 384-well, and 1536-well plates with wells configured in a two-dimensional array. Other formats may include single-well plates, 2-well plates, 6-well plates, 24-well plates, and 6144-well plates. Multi-well assay plates may be used once or multiple times, and are well suited for applications in which the plates are disposable. A variety of configurations for suitable assay plates may be used in the present invention, including, but not limited to, those shown in Figures 11A, 12A, 13A, 13B, 14A, 15 and 16A of U.S. Application No. 2004 / 0022677, each of which is incorporated herein by reference. As noted above, the specific configuration and identity of the assay test sites, domains and / or sectors of the assay consumable may be included in the information stored in the assay consumable identifier and / or provided as consumable data.

[0064] In this embodiment, the assay consumable may be used in a reader (e.g., electrodes) that may be used to induce and measure luminescence, such as electrode-induced luminescence or electrochemiluminescence, in the assay consumable (e.g., multi-well assay plate) or in an assay performed on the assay consumable. The associated assay system may also induce and / or measure current and / or voltage, for example, at the electrodes. The assay system may incorporate, for example, one or more photodetectors; a light-tight housing; mechanisms for transporting the assay plate into and out of the reader (and in particular into and out of the light-tight housing); mechanisms for aligning and orienting the assay plate with the photodetector and / or with the electrical contacts; additional mechanisms for tracking and identifying the plate (e.g., a barcode reader); mechanisms for generating electrical connections to the plate, one or more sources of electrical energy for inducing luminescence, and appropriate devices, electronics, and / or software. The assay reader may also include mechanisms (e.g., plate stackers and / or conveyors) for storing, stacking, moving, and / or dispensing one or more multi-well assay plates. The assay system may be configured to measure light from a multi-well assay plate by measuring light sequentially from multiple sectors or regions of the plate (i.e., a population of multiple adjacent assay domains within the plate) and / or substantially simultaneously or simultaneously from the entire plate. The assay system may also incorporate additional microprocessors and computers to control certain functions within the system and to assist in the storage, analysis and presentation of data. A variety of configurations for suitable assay systems may be used in the present invention, including, but not limited to, those shown in Figures 17-23 of U.S. Application No. 2004 / 0022677, each of which is incorporated herein by reference.

[0065] Additional microprocessors and computers in the assay system may also interact with the assay consumable identifier microprocessor or controller by transferring data and commands to / from the identifier to the various microprocessors / controllers throughout the system to perform various operations of the components listed above within the assay system.

[0066] The system may adjust assay parameters prior to starting the assay based on the consumable data stored in the identifier and / or stored or provided as consumable data via a direct or indirect interface. The system then creates the appropriate electrical, fluidic and / or optical connections to the consumable (utilizing electrical, fluidic and / or optical connectors on the consumable and the system) and runs the assay using the consumable. The sample may be introduced into the consumable prior to inserting the consumable into the system. Alternatively, the sample is introduced by a component of the system after the consumable is inserted into the system. The assay may also include adding one or more assay reagents to the consumable, and instructions for adding the various assay reagents may be stored in the identifier and / or provided as consumable data, and the system adds those reagents to the consumable prior to or during the assay according to the instructions stored in the assay consumable identifier and / or provided as consumable data.

[0067] Alternatively, the assay consumable is a cartridge, and the consumable further comprises elements selected from one or more fluidic components, one or more detection components, one or more assay cells, reagents for performing the assay, working electrodes, counter electrodes, reference electrodes, dielectric materials, electrical connections, dry assay reagents and / or liquid assay reagents, or combinations thereof. The cartridge may further comprise at least one assay cell comprising a plurality of separate assay test sites and / or domains, each of which comprises a reagent for measuring a different analyte.

[0068] Examples of assay consumable cartridges that may be used in the present invention are described in U.S. Application No. 2004 / 0189311, the disclosure of which is hereby incorporated by reference in its entirety. The assay consumables described therein are assay cartridges that incorporate one or more fluidic components (e.g., compartments, wells, chambers, fluid conduits, fluidic ports / vents, valves, etc.) and / or one or more detection components (e.g., electrodes, electrode contacts, sensors (e.g., electrochemical sensors, fluidic sensors, mass sensors, optical sensors, capacitive sensors, impedance sensors, optical waveguides, etc.), detection windows (e.g., windows configured to allow optical measurements on samples in the cartridge, such as measurements of absorbance, light scattering, light refraction, light reflectance, fluorescence, phosphorescence, chemiluminescence, electrochemiluminescence, etc.), etc.). Such consumables may also include reagents for performing the assay, such as binding reagents, detectable labels, sample processing reagents, wash solutions, buffers, etc. These reagents may be present in liquid form, solid form, and / or immobilized on the surface of a solid support present in the cartridge. In this embodiment, the consumable contains all the components necessary to perform the assay. Additionally, the assay consumable is used in conjunction with a consumable reader adapted to accept the consumable and perform a specific operation on the consumable, such as controlling fluid movement, providing power, performing physical measurements on the cartridge, etc.

[0069] More specifically, such assay consumable cartridges have one or more assay test sites (e.g., wells, compartments, chambers, conduits, flow cells, etc.) that may include one or more assay domains (e.g., discrete locations on the assay test site surface where an assay reaction occurs and / or an assay-dependent signal, such as an electrochemiluminescence or electrode-induced luminescence signal, is induced) for performing multiple assay measurements. In this embodiment, the assay domains are supported on assay electrodes (in one embodiment, an array of assay electrodes, e.g., a one-dimensional array of assay electrodes) to enable performance of an assay based on the measurement of electrochemiluminescence or electrode-induced luminescence. The assay domains are optionally defined by a dielectric layer deposited on the electrodes. Additionally, the assay consumables may have one or more properties that make them suitable for use in "point of care" clinical measurements, such as small size, low cost, disposability, multiplexed detection, ease of use, etc.

[0070] The assay consumable cartridge may contain the electronic and / or active mechanical components necessary to perform the assay 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 are located in a separate assay reader. The reader will also have the appropriate electrical, fluidic and / or optical connections to the assay consumables for performing an assay using the consumables. Using such an arrangement, the assay consumables can be designed to be low cost and disposable, while the reader (which holds the more expensive and complex components) is reusable.

[0071] In one embodiment, the cartridge-based biochemical detection system may include a system housing including an optical detector, where the system housing is adapted and configured to receive and position the assay consumables and / or the optical detector for processing. The system may further include a support subsystem, which may include one or more of the following: a storage subsystem for storing assay reagents / assay consumables and / or waste; a sample acquisition / pretreatment / storage subsystem for handling samples; a fluid handling subsystem for handling reagents, samples, waste, etc., and for providing fluids to the detection chambers via fluid inlet lines; an electrical subsystem for electrically contacting electrical contacts of the cartridge and providing electrical energy to the electrodes; and a control subsystem for controlling and coordinating the operation of the system and subsystems, and for acquiring, processing and storing optical detection signals. Information stored in the assay consumable identifier and / or provided as consumable data may include information used to control or regulate one or more assay system components before and / or during the performance of an assay using the assay consumable.

[0072] Still further, an assay consumable may be a container that holds one or more assay reagents, including, but not limited to, one or more buffers, diluents, and / or reagents used by the assay system in performing an assay. An assay consumable identifier may be attached to the container and / or to the packaging of the container.

[0073] Assay Consumable Identifier In one embodiment, the assay consumable identifier comprises a memory for storing information about the consumable, 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 even in the absence of power. Examples of non-volatile memory that can be used in the consumable identifier include, but are not limited to, electronic non-volatile memory (e.g., read-only memory and flash memory), magnetic memory (e.g., hard disk, floppy disk drive, and magnetic tape), optical memory (optical disk drive), and a mixture of these approaches (e.g., magneto-optical memory).

[0074] In one embodiment, the assay consumable identifier comprises an EPROM (erasable programmable read-only memory), a type of programmable read-only memory that can be erased by exposure to ultraviolet light. Once erased, it can be reprogrammed with new or modified data. In another embodiment, the assay consumable identifier comprises an EEPROM (electronically erasable programmable read-only memory), a class of non-volatile electronic memory that can be erased electrically and reprogrammed without exposure to UV light. EEPROMs can be written or programmed more than once, and can be selectively programmed (a customer can change the value of a particular cell without erasing the programming of other cells). Thus, sections of data can be erased and replaced without having to change or reinstall the rest of the chip's programming.

[0075] In another embodiment, the assay consumable identifier comprises flash memory, a particular type of EEPROM that is erased and programmed in large blocks. Although flash memory is technically a type of EEPROM, the term "EEPROM" is generally used to refer specifically to non-flash EEPROM that is erasable in small blocks, typically bytes. Because erase cycles are slow, the large block size used in erasing flash memory provides a significant speed advantage over conventional EEPROM when writing large amounts of data.

[0076] In another embodiment, the assay consumable identifier comprises a smart card, chip card, or integrated circuit card (ICC) (collectively referred to as "ICCs"). These are small cards with embedded integrated circuits capable of processing and storing data. There are two broad categories of ICCs; i) "memory cards" which contain a non-volatile memory storage component and possibly some specific security logic, but no microprocessor, and Ii) "microprocessor cards" which combine a non-volatile memory component and a microprocessor component to allow processing of information read to or from the ICC. The ICC electronics are supported on a card, which is typically made from a plastic such as PVC or ABS. The card may contain an embedded hologram to prevent counterfeiting. Contact ICCs have conductive contact pads. When inserted into a reader, the contact pads on the ICC contact the electrical connectors of the reader, allowing the transfer of information between the reader and the ICC, for example allowing the reader to read, erase or write information on the ICC.

[0077] Another way to transfer information is through RFID, or radio frequency identification, which is similar in theory to barcode identification. In RFID, electromagnetic or capacitive coupling in the RF portion of the electromagnetic spectrum is used to transmit signals. An RFID system consists of an antenna and a transceiver (which reads the radio waves and transfers the information to a processing device), and a transponder, or tag (which is an integrated circuit that contains the RF circuitry and the information to be transmitted).

[0078] Identification can also be achieved by reading a barcode. One important difference between RFID and barcode technology is that RFID does not require line-of-sight reading that barcoding relies on. RFID scanning can also occur at greater distances than barcode scanning. High frequency RFID systems (850 MHz to 950 MHz and 2.4 GHz to 2.5 GHz) offer transmission distances greater than 90 feet, but wavelengths in the 2.4 GHz range are absorbed by water (and the human body) and therefore have limitations.

[0079] In one embodiment, the non-volatile memory used in the present invention comprises EEPROM, flash memory, ICC or a combination thereof. In one embodiment, the non-volatile memory is EEPROM. In an alternative embodiment, the non-volatile memory is RFID.

[0080] In further alternative embodiments, two or more non-volatile memory components may be used in the present invention. For example, a first assay consumable comprising a first identifier may be used in the assay system, and a further assay consumable comprising a further identifier may also be used in the assay system. Each identifier may comprise the same or a different type of memory. However, for each different form of memory, there will be a separate identifier controller. And certain consumable data may be stored in one identifier, and other consumable data may be stored in the same or different type of further identifier. For example, one assay consumable used in the system may comprise an EEPROM or RFID as an identifier, while the system may use a further assay consumable comprising, for example, a barcode as an identifier. The assay system will comprise an identifier controller capable of interfacing with the first identifier, i.e., the EEPROM or RFID, and the system will further comprise a further controller interfacing with the barcode.

[0081] The assay system of the present invention includes an identifier controller that controls the operation of the non-volatile memory and other components of the assay system. The identifier controller optionally includes a microcontroller connected to the non-volatile memory by a communication interface, which may include a conventional interface architecture and an I / O interface. 2 It may incorporate protocols such as the C, 2-line serial bus protocol. The microcontroller addresses the non-volatile memory and performs write, read and erase operations on the memory.

[0082] The consumable identifier may be located on the consumable or may be a separate component. In either case, the system may be designed to have a unique identifier for each consumable. Alternatively, the system may be configured such that one separate consumable identifier is used to hold information related to multiple consumables. In one example, each package of consumables has a package unique identifier attached to (or provided in) the package that holds information about the multiple consumables in the package. Optionally, each consumable also has an additional unique consumable unique identifier attached to the consumable. This consumable unique identifier is primarily used to uniquely identify the consumable and associate it with the information on the package unique identifier. In this embodiment, non-editable identifiers such as lot information content and / or barcodes may be used.

[0083] The various components of the assay system may be housed together in a single unit or housed separately. For example, the assay system may include an assay reader and an identifier controller as separate units. The assay system provides communication (which may be wired or wireless) between the assay reader and the identifier controller directly or alternatively indirectly through further components of the assay system. In an alternative embodiment, the identifier controller is housed within the assay reader. In such an embodiment, the assay reader may be configured such that insertion of a consumable into the reader during the execution of an assay also allows communication between the consumable identifier and the identifier controller (e.g., the port into which the consumable is inserted includes components to process and / or read the consumable, and also includes components such as electrical contacts or wireless transmitters to communicate with the consumable identifier). In one example, when the consumable is loaded into the assay system, electrical contact is made between the controller and the identifier (e.g., non-volatile memory). As a result, the controller can read, erase and / or write consumable data to the identifier. Alternatively, the assay reader may have separate ports for processing / reading the cartridge and for communicating with the consumable identifier. The user places the assay consumable or package at or near the controller port such that the controller makes electrical contact with the identifier, allowing the controller to read, erase and / or write consumable data to the non-volatile memory.

[0084] In one embodiment, the identifier comprises a non-volatile memory comprising an RFID tag, a barcode, an EPROM, and an EEPROM. Still further, the identifier may comprise an EEPROM comprising a flash memory and an ICC.

[0085] The methodologies of the present disclosure may be provided on and / or implemented in one or more processors, and may also be provided via, for example, a web-based and / or cloud computing framework.

[0086] A computer readable medium may include tangible devices that can store computer code or instructions that can be read and executed by a computer or machine. Examples of computer readable media may include, but are not limited to, hard disks, diskettes, random access memories (RAM), read-only memories (ROM), storage devices such as optical storage devices, and other recording or storage media.

[0087] Consumables Data The identifier may be programmed, for example, during the manufacturing process or when preparing the consumable for delivery. The identifier may be programmed with consumable data that may be used before, during, or after an assay or step of a multi-step assay to control the operation of the assay system, the reader, or a component of the assay system. Additionally or alternatively, some or all of the information required for use of a given consumable may be provided as consumable data. The term "consumable data" may include any information used to uniquely identify a particular assay or assay step, assay consumable, consumable domain, biological reagent or sample, or to distinguish a particular assay, assay step, assay consumable, consumable domain, biological reagent or sample from other assay consumables, consumable domains, biological reagents or samples. Consumable data may include consumable information, sample information, chain of custody information, consumable / test site information, assay process information, consumable security information, or a combination thereof. The consumable data may further include information related to one or more analytical tools that may be applied by the system to analyze data generated during and / or after the performance of an assay, assay system maintenance information, system-consumable promotional information, and / or technical support information for the system and / or consumables.

[0088] Each type of consumable data is described in more detail below, and it will be appreciated that each type of consumable data may be stored in a consumable identifier and / or provided as consumable data.

[0089] Consumables Identification and Configuration Information The consumable data may include consumable identification and configuration information, including, but not limited to, lot identification information, lot-specific analytical parameters, manufacturing process information, raw material information, expiration date, Material Safety Data Sheet (MSDS) information, product insert information (i.e., any information that may be contained or written in a product insert that would accompany the assay consumable, such as the type of assay, how the assay is performed, instructions for use of the assay consumable, assay reagents, or both, etc.), threshold and / or calibration data for one or more reagents used in the assay consumable or in the steps of an assay or multi-step assay, and the location of individual assay reagents and / or samples within one or more test sites of the assay consumable.

[0090] The consumable data may also include lot identification information, i.e., information used to identify a particular lot of assay consumables, which is distinct from lot-specific analytical parameters and includes that information specific to a given lot that can be used by the system, for example, to perform an assay using consumables from that lot or to analyze assay results generated from consumables from that lot. In one embodiment, where the assay consumable is a multi-well assay plate or cartridge, the lot-specific analytical parameters may include, but are not limited to, (i) revision level, which determines the schema used to interpret the information; (ii) type of consumable; (iii) date of manufacture; (iv) lot number; (v) expiration date; (vi) crosstalk correction matrix to account for chemical cross-reactivity; (vii) threshold values ​​for the assays and each internal negative control to be run in the consumable; (viii) ranges for each internal positive control; (ix) ranges of positive control samples for each assay to be run in the cartridge; (x) software checksums to ensure data integrity; (xi) in-well (or in-test site) control tolerances; (xii) assay name and / or identifier; (xiii) information regarding assay quality controls, including negative and positive quality control materials used to verify the operation of the reader and the consumable; (xiv) calibration information, such as a master calibration curve; and (xv) number and names of assay recalibrators and / or assay calibrator tolerances.

[0091] The consumable data may include sample information, such as the location of the sample within at least one test site of the assay consumable, assay results obtained in the assay consumable for the sample, and the identity of the sample that has been assayed and / or will be assayed in the assay consumable.

[0092] Consumable data may also be related to the chain of custody, such as information regarding the care, transport and / or analysis of samples and / or assay consumables. Chain of custody information may be selected from customer identification, sample identification, time and date stamp for the assay, location of the assay system in the assay laboratory, calibration and QC (quality control) status of the assay system during the assay, care and / or location information for the assay consumables before and after the assay is performed, the assay results for a given sample, and even free text commentary input made by the customer before, during or after the assay is processed by the system. Still further, chain of custody information may include times, dates, manufacturing personnel or processing parameters for one or more steps during the manufacture of the assay consumables, care, location and / or storage conditions for the assay consumables after manufacture and / or between steps during manufacture of the assay consumables.

[0093] The consumable data may also include consumable / test site information, such as the type and structure of the consumable, the location and identity (e.g., structure, composition, sequence, concentration and / or origin) of the assay reagents contained within the assay consumable, and the location and identity of the assay reagents within the assay test sites of the assay consumable. The consumable data may be used to distinguish a first test site within the consumable from different test sites within the consumable. Still further, the consumable data may include sample information comprising: the location of a sample within at least one test site of the assay consumable; an assay result obtained with the assay consumable for the sample; the identity of the sample being assayed and / or to be assayed in the assay consumable; or a combination thereof. Additionally, the consumable data is consumable / test site information comprising: the type and structure of the consumable; the location and identity of the assay reagents contained with the assay consumable; the location and identity of the assay reagents within the assay test sites of the assay consumable; or a combination thereof.

[0094] In further embodiments, the consumable / test site information may include information regarding assays previously performed by the reader at one or more test sites in the consumable, and information regarding assays to be performed by the reader at one or more test sites in the consumable. Thus, once an assay has been performed by the system, the controller may be used to write the results of the assay to the identifier. Such information may include, but is not limited to, raw or analyzed data collected by the system during an assay (where analyzed data is data that has been subjected to statistical analysis after collection, and raw data is data that has not been subjected to such statistical analysis), a list of test sites and / or domains within the assay consumable used during a given assay, a schedule of events to be performed on the assay consumable or on the test sites and / or domains within the assay consumable, a list of test sites and / or domains of the assay device that have not been subjected to an assay, assay errors or system errors that occurred during a given assay or assay step, or combinations thereof.

[0095] Still further, the consumable data may be used as a security mechanism, for example to verify that the correct assay consumable is being used in the system (referred to herein as "consumable security information"). The consumable data may include a digital signature to verify that the consumable was manufactured by a designated vendor. In one embodiment, if an improper assay consumable is present in the system (e.g., a counterfeit consumable or a consumable that is otherwise incompatible with the assay system), the controller will disable the system, reader, or components thereof. Additionally or alternatively, the consumable data may be used to detect the proper placement of the assay consumable in the system, for example, the proper orientation of the assay consumable or a portion thereof in the assay system, such that the controller will disable the system, reader, or components thereof until the assay consumable is placed in the correct orientation. Still further, the consumable data may also be used to detect defects in the assay consumable or assay test sites and / or domains, and the controller will disable the system, reader, or components thereof accordingly. For example, depending on the nature of the defect in the assay consumable or domain, the controller may reject the use of the assay consumable in its entirety or may instruct the reader to reject the use of a test site and / or domain, or a set of test sites and / or domains, in the assay consumable. In one embodiment, the reader may perform a diagnostic analysis on the assay consumable and / or the test sites and / or domains therein to identify defects therein, and the controller writes the results of the diagnostic analysis into the consumable's identifier. If the consumable is later used with a different reader, the results of this diagnostic analysis are read by the controller and used by the reader to adjust the use of the consumable or the test sites and / or domains in the consumable accordingly. In a further embodiment, the assay consumable may be subjected to a quality control process during or after its manufacture, and the results of the quality control analysis may be written into the identifier for later use and / or verification by the customer of the assay consumable at the assay reader.

[0096] The consumable data may also include authorization information for the consumable or its test site and / or domain or biological reagent, such as the number of times a customer is authorized to use a particular consumable or biological reagent in a particular assay, and any limitations on its use, such as whether a particular customer has valid authorization to use a particular consumable or biological reagent, including whether the customer's authorization is for research purposes only. Such information may also include verification information regarding whether a particular consumable or biological reagent has been recalled or has otherwise become unsuitable for use or unauthorized. The recall information and the date and / or timestamp of any last recall check may be written to the identifier and / or provided as the consumable data.

[0097] The consumable data may further include information regarding the origin of the assay consumable, biological reagent used in the test site and / or domain, including, for example, the identity of the original sample it was derived from or the number of generations removed from the original sample. For example, if the assay reagent used in the assay is an antibody, the consumable data may include the identity of the hybridoma from which the antibody was derived, for example the ATCC accession number for that hybridoma.

[0098] According to various embodiments, the biological samples or reagents provided in or with the consumables described above can be licensed separately from the system designed to function on the biological reagents. In various embodiments, the assay system, reader or components thereof are connected to a network that allows the system to communicate over public and / or private networks with computer systems operated by or on behalf of the customers, manufacturers and / or licensors of the biological reagents, consumables or systems. In various embodiments, a limited license can be given for the use of the licensed biological reagents, consumables or systems for a particular biological analysis only with the licensed system. Thus, the system can certify the biological reagents, consumables or systems based on a digital signature included in an identifier associated with a particular consumable and / or provided as consumable data, for example, if a particular customer has a valid license. In various embodiments, the identifier and / or consumable data can also be used to provide one-time use so that the biological reagents cannot be refilled for use with the same certification.

[0099] In certain embodiments, when the identifier is read by a system, reader or components thereof having access to a public or private data network operated by or on behalf of the customer, manufacturer and / or licensor of the biological reagent, consumable or system, certain consumable data may be communicated to the assay system and may be read, written or erased locally via the identifier / controller on the assay system. For example, recall and / or license information may be a subset of the consumable data available via a direct and / or indirect interface, while additional consumable data, such as lot specific information, expiration date, calibration data, consumable specific information, assay domain information, assay result information, consumable security information, or combinations thereof, may be stored locally on the identifier and not otherwise available via a network connection at the assay system. In one embodiment, recall, license and / or consumable security information may be available via a network connection at the assay system and / or may be stored in a storage medium as consumable data, and the remaining consumable data is stored locally on the identifier. The assay system or reader includes system hardware, system firmware, system data acquisition and control software, and method or consumable data. In various embodiments, the system hardware includes electronic control and data processing circuitry, such as a microprocessor or microcontroller, memory, and non-volatile storage. In various embodiments, the system hardware also includes physical devices for manipulating the biological reagents, such as robots and sample pumps. In various embodiments, the system firmware includes subordinate computer readable instructions for performing basic operations in conjunction with the system hardware. In various embodiments, the system firmware includes microprocessor instructions for initiating operations on the microprocessor in the system hardware.

[0100] The system data collection and control software is a higher level software that interacts with the system firmware to control the system hardware for more detailed operations, such as operating a charge-coupled device (CCD) to obtain visible luminescence information for a particular biological analysis. In various embodiments, the data collection and control software includes a software-implemented state machine that provides, for example, the following states: (i) wait; (ii) run; (iii) pause; and (iv) error. In various embodiments, when the state machine is in a wait state, it can receive commands from a general purpose machine tool to perform a particular data collection or system control operation. In various embodiments, the general purpose computer opens a TCP / IP socket connection to the system, determines whether the system is in a wait state, and then begins sending commands and / or parameters. In various embodiments, an encrypted TCP / IP connection is established, for example, using the SSH protocol. The commands and / or parameters can be in the form of ASCII-encoded human-readable consumable and / or method information that defines the operation of the biological system. In various embodiments, the consumable and / or method are stored in the form of an ASCII text file. In various embodiments, the general purpose computer transfers the ASCII text file to the system using the FTP protocol. In various other embodiments, the method and / or consumable information is stored in and read from the identifier. The method and / or consumable information may be stored in the identifier in the form of an ASCII text file, although it will be understood that the information may be represented in other data formats without departing from the present teachings.

[0101] According to various embodiments, the consumable, macro and / or method information includes parameters that can be used by the system data collection and control software to perform specific data collection and system control operations. In various embodiments, the method and / or consumable information includes sequences of operations to be performed by the system or control parameters for use in conjunction with the data collection or control software.

[0102] (ii) Assay process information Additionally, consumable data may include assay process information regarding individual assay parameters to be applied by the system or reader during an assay. For example, such consumable data may include the order of steps of a given assay, the identity, concentration, and / or amount of assay reagents (e.g., buffers, diluents, and / or calibrators to be used in the assay) to be used or added during an assay or during a particular step of an assay. Consumable data may also include the type or wavelength of light to be applied and / or measured by the system or reader during a particular step of an assay or multi-step assay; the temperature to be applied by the system or reader during the assay; incubation times for the assay; and statistical or other analytical methods to be applied by the system or reader to raw data collected during the assay.

[0103] In one embodiment, one or more steps of an assay protocol may be adjusted for an individual consumable or lot of consumable. One or more steps of the protocol may vary from lot to lot and / or for individual consumables within a given lot, and the consumable data stored in the system includes instructions to adjust those steps of the assay protocol. Such consumable data may be used by the system to adjust one or more operations performed by the system before, during, and / or after the system runs an assay. Furthermore, such consumable data may be adjusted by a system user at the discretion of the user. For example, a dilution step in an assay protocol may be adjusted to account for lot-to-lot or consumable differences. The amount of diluent added and / or the nature of the diluent may be altered based on such differences. Similarly, the amount of a given reagent that may be added during the run of an assay, the incubation time and / or temperature for one or more steps of the assay may also depend on lot-to-lot or consumable differences. Each of these are non-limiting examples of consumable data that may be stored in the system's storage medium.

[0104] Additionally, the consumable data may include information that directly or indirectly controls components of the assay system, such as one or more photodetectors, a light-tight housing; mechanisms for transporting the assay consumables into and out of the reader; mechanisms for aligning and orienting the assay consumables with one or more photodetectors and / or electrical contacts in the reader; further mechanisms and / or data storage media for tracking and / or identifying the assay consumables; one or more sources of electrical energy for inducing light emission; mechanisms for storing, stacking, moving and / or dispensing one or more consumables; mechanisms for measuring light from the consumables sequentially, substantially simultaneously, or simultaneously from multiple test sites on the consumable during the assay; or combinations thereof.

[0105] The consumable data may also include assay process information comprising: assay parameters to be applied by the reader during the assay; the sequence of steps to be applied by the reader during the assay; the identity, concentration and / or amount of assay reagents to be used or added during the assay; the type or wavelength of light to be applied and / or measured by the reader during the assay; the temperature to be applied by the reader during the assay; the incubation time for the assay; statistical or analytical methods to be applied by the reader to the raw data collected during the assay; or a combination thereof (such assay process information may be optionally adjusted by the user). In one particular embodiment, the assay performed with the consumable is a multi-step assay, and the assay process information relates to a step or steps of the multi-step assay. In this embodiment, the consumable / test site information comprises information regarding an assay previously performed by the reader at one or more test sites of the consumable; information regarding an assay to be performed by the assay reader or a component thereof at one or more test sites within the consumable; or a combination thereof.

[0106] When a particular operation is performed on a consumable, test site, domain, sector or biological reagent or sample, such as during the manufacture of the consumable, test site, domain, sector or biological reagent, or while an assay or process is being performed on the consumable, test site, domain, sector or biological reagent or sample, the consumable data may further include information about that consumable, test site, domain, sector or biological reagent. For example, if an assay consumable includes multiple assay test sites, domains and / or sectors, the assay system may perform an assay or a process of a multi-step assay on a single test site, domain and / or sector of the assay consumable. Once the assay or assay process is completed by the assay system, the controller records the results of the assay in the identifier, such as raw data or analyzed data generated during the assay or assay process, and / or the controller records which test sites, domains and / or sectors of the assay consumable have been used during the assay or assay process, and / or which test sites, domains and / or sectors of the assay consumable have not yet been used. The assay consumables may be stored for later use and when the customer is ready to use another test site, domain, and / or sector of the assay consumable, the controller reads the consumable data stored in the assay consumable's identifier to identify which test sites, domains, and / or sectors have been used and which have not yet been used, and / or the results of those assays, and the controller may then instruct the assay system, reader, or components thereof, to perform an assay or assay step at the unused test site, domain, and / or sector.

[0107] Additionally, a given assay protocol may require a set of consumables of a particular type. Thus, if a customer inputs a particular type of assay consumable for use in a particular assay protocol, e.g., a multi-well assay plate, one or more additional assay consumables may be required to perform that assay protocol in the system, e.g., one or more reagents may be required for use with the multi-well assay plate. Each of the required consumables may include a consumable identifier that has information about the consumable requirements for the assay protocol. When one of the required consumables is loaded into the assay system and the identifier controller interacts with the consumable identifier for that consumable, the system takes an inventory of the components present in the system and compares the results to the consumable requirements stored in the consumable identifier and / or stored in the storage medium and / or provided as consumable data. If any of the required consumables are not present or are present in insufficient supply, the system prompts the customer to load additional required consumables for that assay protocol based on the information stored in the required consumable identifier. When two or more assay consumables are used in the system, the instrument accurately identifies a first assay consumable and any associated consumables based on the consumable requirements stored in the identifier associated with each consumable. The system verifies that the assay consumable and associated consumables are loaded into the system before processing a sample. If only a first assay consumable is loaded into the system without a corresponding associated consumable, the system prompts the customer to load the associated consumable if the instrument does not identify the associated consumable in the system within a predetermined time. If an incompatible assay consumable is loaded into the instrument, the system notifies the customer. If there is not a compatible set of assay consumables available (e.g., a multi-well assay plate and a predetermined reagent for a particular assay), the system will not process the sample. The system checks for assay consumable expiration before the start of an assay and warns the customer to prevent the use of expired consumables. If a consumable has expired prior to sample aspiration, the system will not process the sample.When a partially used assay consumable is placed into a different instrument, consumable usage automatically begins with the next available unused well.

[0108] The identifier may also be used to track the time that a given assay consumable has been in the assay system. Thus, when the assay consumable is inserted into or contacted with the assay system, a timer is started in the assay system and the start time is recorded in the identifier. When an assay is started by the system on the consumable or a test site, domain and / or sector within the consumable, the time is also recorded in the identifier. If the instrument, system or a component thereof is shut down (e.g., by being turned off), the timer stops and the time is recorded in the identifier. Thus, whenever the timer stops, the accumulated onboard time is recorded in the identifier.

[0109] (iii) Analytical tools In another embodiment, the consumable data further includes one or more analytical tools that can be applied to the system to analyze data generated during and / or after the execution of the assay. Moreover, such analytical tools can include instructions that cause the customer and / or the system to generate a particular output by the system software after the execution of the assay (e.g., a data report or format tailored to the analytical results based on the consumable data). Alternatively, or in addition, the analytical tools can further include one or more statistical algorithms that can be applied by the system to the data. For example, the consumable data can include a selection of two or more statistical algorithms that can be used to analyze data generated by the use of a given consumable, and the customer can optionally select the appropriate algorithm for the desired data analysis. The consumable data can also include information that can be used by the customer to select the appropriate algorithm for the customer's needs, such as technical notes or literature references regarding the algorithm selection.

[0110] The analytical tools may vary for each lot of consumables and / or for each individual consumable within a given lot. In this embodiment, the consumable data is used by the system to adjust analytical processing tools applied by the system software during the execution of the assay and / or after the assay is completed, and the results are generated and / or displayed. Such analytical processing tools include, but are not limited to, assay thresholds and / or calibration curves that may be applied to one or more steps of the assay protocol (which may also be modified based on consumable differences). In certain embodiments, for a given consumable type and / or desired use, the consumable data may include project management tools that use a given consumable in the system or schedule the execution of one or more assays or steps thereof with a set of consumables. Still further, such analytical processing tools may optionally be adjusted by the system user at the user's discretion. The analytical tools may be transmitted to the customer via a direct or indirect interface between the system and the customer.

[0111] (iv) Assay system maintenance information The consumable data may further include system maintenance information to the customer, including, but not limited to, system monitoring reports, system component usage, service history, system troubleshooting information, results of diagnostics performed on the system, control charts, routine maintenance schedules, warranty information regarding the system and / or its components, or combinations thereof. The system software may be programmed to monitor various components of the system and automatically or when instructed to send monitoring reports to a remote monitoring system and / or a service technician. If a direct interface is not available, the system may instruct the customer to send the monitoring reports to the CD Server via an indirect interface. Additionally or alternatively, such system monitoring reports may be accessed by a service technician tasked with maintaining and / or servicing the system, either on-site or remotely. In this embodiment, the service technician may communicate with the customer regarding equipment service or assistance via a direct or indirect interface. In certain embodiments where a direct interface is available, 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 spans and / or warranty periods. However, the system may be programmed to automatically monitor such information on the system and may periodically prompt the customer to send the output of such monitoring activity to the CD Server via an indirect interface if a direct interface is not available so that a service technician can assess the status of the system and determine whether system service or maintenance is required. Additionally, the CD Server may maintain a log of the service history for a given assay system and may schedule a service call by a service technician (which may be done using either the direct or indirect interface).The remote computer system can also transmit individual assay system software upgrades via a direct or indirect interface.

[0112] (v) System - Consumables Sales Promotion Information In another embodiment, the consumable data includes promotional materials, for example, when a new model or lot of a consumable becomes available, particularly for products that have been used historically by a given customer. Such promotional materials may also be related to new assay systems, modifications to current systems, and / or any accessories or improvements to current systems, particularly modifications, accessories, or improvements that are specifically related to systems owned or operated by the customer, and / or modifications, accessories, or improvements that the customer may be interested in based on that customer's previous use. This type of consumable data may also include literature references, catalogs, product inserts, technical and application notes, technical expressions, conference information, and promotional seminars, particularly those that may be related to one or more consumables / systems used by a given customer. Such promotional information may be provided to the customer through a direct or indirect interface between the customer and the vendor.

[0113] (vi) Technical support information The consumable data also includes technical support information that may assist the customer in using the consumable or system, such as product insert and data sheet information, information about related products intended to be used with the consumable, instructions for use, training materials, tutorials, recommended use and / or storage information, data analysis templates, template reports, calibration curves, lot-specific QC data, validated quantification limits, and troubleshooting methods and / or algorithms. For consumables that include or are provided with one or more additional consumables (e.g., reagents), the consumable data may also include reagent catalog numbers, reagent lot-specific information, reagent manufacturing dates, reagent expiration dates, instructions for use, training materials, tutorials, recommended use and / or storage, and the like. The technical support information may also include receiving feedback or assistance through direct or indirect interfaces with technical support personnel, such as customer training modules, consulting services, and / or live customer service assistance features (i.e., live chat) to facilitate the customer's experience. Of course, the technical support information may relate to the consumable, the system, or both.

[0114] In certain embodiments, Table 1 includes a list of consumable data that may be stored in a consumable identifier and / or exchanged between the CD Server and the system via a direct or indirect interface.

[0115] [Table 1]

[0116] The present invention is not limited in scope by the specific embodiments described herein. Indeed, various modifications of the present invention in addition to those described herein will become apparent to those skilled in the art from the foregoing description and accompanying drawings. Such modifications are intended to fall within the scope of the appended claims. Various publications are cited herein, including U.S. Application No. 12 / 844,345 (filed July 27, 2010), the disclosures of which are incorporated by reference in their entireties.

Claims

1. A non-transitory computer-readable medium storing executable instructions that, when executed by a controller of an assay system, receiving a consumable identifier from the consumable; attempting to validate consumable data on the assay system using the consumable identifier; controlling access to the assay system based on the outcome of the attempted validation; A non-transitory computer-readable medium that causes the controller to execute.

2. A non-transitory computer-readable medium as described in claim 1, wherein the instructions, when executed, cause the controller to process the consumable in response to a successful verification attempt.

3. The non-transitory computer-readable medium of claim 2, wherein, when the instructions are executed, the controller outputs the results of the processing to a display device.

4. The non-transitory computer-readable medium of claim 1, wherein the instructions, when executed, cause the controller to process the consumable in response to a failed verification attempt.

5. The non-transitory computer-readable medium of claim 4, wherein, when the instructions are executed, the controller suspends outputting processing results to a display device.

6. When the instruction is executed, suspending output of the processing result to the display device until the verification of the consumable data is successful; outputting a processing result on the display device when the verification of the consumable data is successful; causing the controller to execute The non-transitory computer-readable medium of claim 5.

7. The non-transitory computer-readable medium of claim 1, wherein, when the instructions are executed, the controller identifies the consumable using the consumable identifier.

8. The non-transitory computer-readable medium of claim 7, wherein the instructions, when executed, cause the controller to process the consumable using an identification.

9. A non-transitory computer-readable medium storing executable instructions that, when executed by a controller of an assay system, receiving a consumable identifier from the consumable; attempting to validate consumable data on the assay system using the consumable identifier; in response to the verification attempt being successful, processing the consumable and outputting a result of the processing on a display device; in response to the verification attempt being unsuccessful, withholding processing the consumable and outputting results of the processing to the display device; A non-transitory computer-readable medium that causes the controller to execute.

10. A non-transitory computer-readable medium as described in claim 9, wherein when the instructions are executed, the controller, in response to a failed verification attempt, causes the controller to refrain from outputting the results of the processing to the display device until verification of the consumable data is successful, and to output the results of the processing to the display device when the verification attempt of the consumable data is successful.

11. The non-transitory computer-readable medium of claim 9, wherein, when the instructions are executed, the controller identifies the consumable using the consumable identifier.

12. The non-transitory computer-readable medium of claim 11, wherein the instructions, when executed, cause the controller to process the consumable with an identification in response to a successful verification attempt.

13. A method for controlling access to an assay system, the method comprising: receiving a consumable identifier from the consumable; attempting to validate consumable data on the assay system using the consumable identifier; controlling access to the assay system based on the outcome of the attempted validation; A method comprising:

14. The method of claim 13, further comprising processing the consumable in response to the verification attempt being successful.

15. The method of claim 14, further comprising outputting results of the processing to a display device.

16. The method of claim 13, further comprising processing the consumable in response to a failed verification attempt.

17. The method of claim 16, further comprising withholding output of the results of the processing to a display device.

18. Continuing to withhold output of the processing result to the display device until the verification of the consumable data is successful; outputting a processing result on the display device when the verification of the consumable data is successful; 20. The method of claim 17, further comprising:

19. The method of claim 13, further comprising identifying the consumable using the consumable identifier.

20. The method of claim 19, further comprising processing the consumable using the identification.

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