Consumables Data Management

Abstract

This invention provides a method, device, and system for associating assay consumables used in biological assays with consumable data. [Solution] The method is as follows: When an order is received from a customer or when consumables or lots are manufactured (step i), the vendor generates, saves, and sends a CD database to the CD server 201 (step ii). The customer receives consumables 202 containing a consumable identifier 203 and brings the consumables into contact with the assay 204 in preparation for performing the assay (step iii). The system reads the information stored in the assay consumable identifier and uses it to identify the consumables (step iv). The consumable data stored on the local CD is reviewed to confirm that the consumable data stored on the storage medium is used for performing the assay using the specified consumables, and if it includes consumable data about the consumables or lots, those consumables are used (step v).

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Application Nos. 61 / 400,441, filed Jul. 27, 2010, and 61 / 462,024, filed Jan. 27, 2011. The entire contents of each of these applications are hereby incorporated by reference.

[0002] Field of the Invention The present teachings relate to methods, devices, and systems for associating assay consumables and consumable data used in biological assays.

Background Art

[0003] Background of the Invention A number of methods and systems for performing assays have been developed. These methods and systems are required in a variety of applications including medical diagnosis, veterinary testing, food and beverage testing, environmental monitoring, manufacturing quality control, drug discovery, and basic scientific research. During the manufacture and use of reagents and other consumables used in biological assays, the reagents and consumables are typically coded and labeled by the manufacturer to track them. Further, numerous assay parameters must be tracked to understand the results of any given assay, often requiring input from various parallel tracking systems supplied by the manufacturer, the customer, or both.

Summary of the Invention

Means for Solving the Problems

[0004] Gist of the Invention The present invention provides an assay system configured to use assay consumables in the execution of an assay, wherein the assay consumables comprise an assay consumable identifier, and the assay system comprises: (a) a storage medium comprising a consumable data repository comprising local consumable data; and (b) a reader adapted to read consumable data from a consumable identifier, wherein the consumable data and 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 the execution of an assay using the consumables, wherein the system is configured to receive update information for the repository, which includes 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 assay, (y) Assay system maintenance information, (z) System - Consumables Sales Promotion Information, (xx) Technical support information for the system and / or consumables, or (yy) combinations of those It includes at least one consumable data type which includes

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

[0006] The present invention also provides a method for using an assay system configured to use assay consumables in the execution of an assay, wherein the assay consumables comprise an assay consumable identifier, and the assay system comprises: (a) a storage medium comprising a consumable data repository comprising local consumable data; and (b) a reader adapted to read consumable data from a consumable identifier, wherein the consumable data and 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 the execution of an assay using the consumables, wherein the system is configured to receive repository update information, which comprises additional consumable data, and at least one consumable data type comprising (x) one or more analytical tools that can 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-consumer sales promotion information, (xx) system and / or consumable technical support information, or (yy) a combination thereof. This method is as follows: (a) A process of reading consumable data from a consumable identifier; (b) A process of adjusting one or more operations performed by the system before, during, and / or after the execution of an assay by the system based on consumable data; (c) The step of performing an assay in an assay system using assay consumables; and (d) process of receiving repository update information It consists of including.

[0007] Furthermore, a method for enabling system / consumable vendors to use the assay system has also been considered, which is configured to use assay consumables comprising assay consumable identifiers in the execution of the assay, and the assay system comprises (a) a storage medium comprising local consumable data; and (b) a reader adapted to read consumable data from consumable identifiers, wherein the system / consumable vendor maintains a master consumable data repository comprising consumable data; This method includes the step of providing consumable data from a master consumable data repository to the customer in order to enable its use in the system.

[0008] Furthermore, the present invention encompasses an assay system configured to use assay consumables in the execution of an assay, wherein the assay consumables include an assay consumable identifier, and the assay system includes: (a) an interface configured to transmit and / or receive consumable data to and / or from a vendor computer system, (b) a storage medium containing local consumable data, and (c) a reader adapted to read consumable data from a consumable identifier, wherein the consumable data is (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 the execution of an assay using consumables It consists of including.

[0009] Another embodiment of the present invention is a method for tracking the use of assay consumables in an assay system, wherein the assay consumables include an assay consumable identifier, and the assay system includes (a) an interface configured to transmit and / or receive consumable data to and / or from a vendor computer system, (b) a storage medium including local consumable data, and (c) a reader adapted to read information from the consumable identifier, wherein the consumable data and local consumable data include (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, and this method is as follows: (a) A process of reading consumable data from a consumable identifier; (b) The process of configuring the assay system for the use of assay consumables in the execution of assays in the system using consumable data; (c) The step of performing an assay in an assay system using assay consumables; (d) A process of storing system consumable usage information in a storage medium; and (e) System - Process of transmitting consumable usage information to the vendor computer system via an interface. It consists of including.

[0010] The method also includes a way for the system vendor to control customer access to the assay system, where the system includes a system identifier, and this method involves the following steps: (a) The process of receiving a system identifier from the customer [where the system identifier is sent to the vendor computer system]; (b) the step of the vendor identifying a system identifier; and (c) (i) To enable full access to the device and / or consumables used in the device; (ii) To enable partial access to the apparatus and / or consumables used in the apparatus; or (iii) Denying access to the device and / or consumables used in the device Performing one or more operations selected from comprising.

[0011] A further embodiment of the present invention is a method for generating and maintaining consumable data and consumable data about consumables, the method comprising: (a) Manufacturing consumables used in the execution of assays; (b) Generating a database comprising consumable data related to the consumables [where the database comprises information used to associate consumable data with the consumables]; and (c) Maintaining the database on a server comprising.

[0012] Furthermore, the present invention encompasses a method for providing consumable data about consumables to a customer, the method comprising: (a) Receiving a query from the customer about consumable data related to the consumables; and (b) Transmitting the consumable data about the consumables by a medium comprising an email attachment file, a compact disc, a memory card / stick, a flash drive, a web data storage service, or a combination thereof comprising.

[0013] Still further, the present invention provides a method for providing consumable data about consumables to a customer, the method comprising (a) Receiving a query from the customer system via a direct interface about consumable data related to the consumables [where the direct interface comprises an Internet connection between the customer system and the vendor server]; and (b) Transmitting the consumable data about the consumables to the customer system via the interface comprising.

[0014] Computer-readable media storing a computer program are also contemplated, where the computer program, 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 the assay system, where the assay system is configured to use assay consumables 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 consumable data from a consumable identifier; the method comprising the following: (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 based on the consumable data before, during, and / or after performance of the assay; (c) performing an assay in the assay system using the assay consumable; and (d) receiving update information for the repository, the update information comprising at least one consumable data type comprising additional consumable data and one or more analysis tools that can be applied by the system to analyze data generated during and / or after performance of the assay, (y) assay system maintenance information, (z) system-consumable sales promotion information, (xx) system and / or consumable technical support information, or (yy) a combination thereof; comprising.

[0015] In a further embodiment, the present invention provides a computer-readable medium on which a computer program is stored, which, when executed by a computer system, causes the computer system to perform a method that enables a system / consumables vendor to use an assay system, the assay system being functionally connected to the computer system and configured to use assay consumables, which include assay consumable identifiers, in the execution of an assay, the assay system comprising (a) a storage medium containing local consumables data; and (b) a reader adapted to read consumables data from consumable identifiers, wherein the system / consumables vendor maintains a master consumables data repository containing consumables data; and the method comprising the step of receiving consumables data from the master consumables data repository to enable the use of consumables in the system.

[0016] In a particular embodiment, a computer-readable medium is provided on which a computer program is stored, which, when executed by a computer system, causes the computer system to perform a method for tracking the use of assay consumables in an assay system functionally connected to the computer system, wherein the assay consumables include assay consumable identifiers, and the assay system includes: (a) an interface configured to transmit and / or receive consumable data to and / or from a vendor computer system, (b) a storage medium containing local consumable data, and (c) a reader adapted to read information from consumable identifiers, wherein this method is as follows: (a) A step of reading consumable data from a consumable identifier [wherein the consumable data and local consumable data include (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) The process of configuring the assay system for the use of assay consumables in the execution of assays in the system using consumable data; (c) The step of performing an assay in an assay system using assay consumables; (d) A process of storing system consumable usage information in a storage medium; and (e) System - Process of transmitting consumable usage information to the vendor computer system via an interface. It consists of including.

[0017] Furthermore, the present invention includes a computer-readable medium on which a computer program is stored, which, when executed by a computer system, causes the computer system to perform a method by which a system vendor controls customer access to an assay system, wherein the system includes a system identifier, and this method is as follows: (a) The process of receiving a system identifier from the customer [where the system identifier is sent to the vendor computer system]; (b) the process of vendors identifying a system identifier; and (c) (i) To enable full access to the device and / or consumables used in the device; (ii) To enable partial access to the apparatus and / or consumables used in the apparatus; or (iii) Denying access to the device and / or consumables used in the device. A process of performing one or more operations selected from the following: It consists of including.

[0018] Furthermore, the present invention includes a computer-readable medium on which a computer program is stored, and this computer program, when executed by a computer system, causes the computer system to perform a method for generating and maintaining consumable data and consumable data about consumables, and this method (a) to generate a database which includes consumable data related to consumables [wherein the database which includes information used to associate the consumable data with consumables]; and (b) Maintaining the database on a server. It consists of including.

[0019] A computer-readable medium on which a computer program is stored is also considered, and this computer program causes the computer system to provide the customer with consumable data about consumables when executed by the computer system, and this method is: (a) receiving queries from customers regarding consumable data related to consumables; and (b) Transmitting consumable data about consumables by means of a medium including email attachments, compact discs, memory cards / sticks, flash drives, web data storage services, or a combination thereof. It consists of including.

[0020] Furthermore, the present invention includes a computer-readable medium on which a computer program is stored, which, when executed by a computer system, causes the computer system to perform a method of providing consumable data about consumables to a customer, and this method is: (a) Receiving queries from customer systems via a direct interface regarding consumable data related to consumables [where the direct interface includes an Internet connection between the customer system and the vendor server]; and (b) Send consumable data about consumables to the customer system via the interface. It consists of including.

[0021] In a preferred embodiment, the assay consumable comprises at least one assay test site for the assay, and preferably, the test site comprises a plurality of distinct assay domains, of which at least two contain reagents for measuring different subjects. The test site may be wells and / or chambers 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, electrical connections, a dry assay reagent and / or a liquid assay reagent, or a combination thereof. Alternatively, the assay consumable may further comprise a flow cell, and the consumable may be a cartridge further comprising at least one element comprising one or more fluid components, one or more detection components, one or more assay cells, reagents for performing the assay, a working electrode, a counter electrode, a reference electrode, a dielectric material, electrical connections, 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 containing a plurality of distinct assay domains, at least two of which contain reagents for measuring different subjects. Furthermore, the assay consumable may be a container adapted to hold one or more assay reagents.

[0022] The present invention provides a system, method, and computer-readable medium configured to transmit, receive, and utilize consumable data related to consumables in an assay system. In one embodiment, the consumable data includes 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 used or to be used in the consumable, or (iv) a combination thereof. Furthermore, the consumable data is used to distinguish a first test site within the consumable from other test sites within the consumable.

[0023] Furthermore, consumable data may include lot identification information, lot-specific analytical parameters, manufacturing process information, raw material information, expiration date, calibration data, threshold information, the 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 a combination thereof.

[0024] Furthermore, the consumable data includes sample information, which includes the location of the sample within at least one test site of the assay consumable, the assay results obtained with the assay consumable for the sample, the identity of the sample being assayed and / or to be assayed with the assay consumable, or a combination thereof. Furthermore, the consumable data also includes chain of custody information, which includes, but is not limited to, information regarding the handling, transport, analysis, or a combination thereof of the sample. Furthermore, the chain of custody information also includes customer identification, time and date stamps 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 assay, assay results for the sample; time, date, manufacturing personnel or processing parameters for one or more processes in the manufacture of the assay consumable; storage, location and / or storage conditions for the assay consumable after and / or between processes in the manufacture of the assay consumable; or a combination thereof.

[0025] Furthermore, the consumable data includes consumable / test site information, which includes the type and structure of the consumable, the location and identity of the assay reagent included with the assay consumable, the location and identity of the assay reagent within the assay test site of the assay consumable, or a combination thereof.

[0026] Consumable data is also considered, including assay process information, which includes 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, the statistics or analytical methods to be applied by the reader to the raw data collected during the assay, or a combination thereof. In certain embodiments, the assay performed in the system is a multi-step assay, and the assay process information pertains to one or more steps of the multi-step assay. Accordingly, consumable / test site information includes information about assays pre-performed by the reader at one or more test sites of the consumable; information about assays to be performed by the assay reader or its components at one or more test sites within the consumable; or a combination thereof.

[0027] Furthermore, the consumable data also includes consumable security information, which comprises information regarding assay consumable certification; information regarding the proper placement and / or orientation of assay consumables in the system; information regarding defects in assay consumables and / or their test sites; or a combination thereof.

[0028] Consumable data may be used by the system to coordinate the operation of at least one component of an assay system, which includes 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 fluid interfaces in the system; a mechanism, electronic equipment or software for tracking and / or identifying assay consumables; a mechanism for storing, stacking, moving and / or distributing one or more consumables; or a combination thereof. [Brief explanation of the drawing]

[0029] [Figure 1] This document describes the generation and storage of consumable data by consumable manufacturers. [Figure 2] This shows how consumables data is distributed to customers in response to queries about consumables data. [Figure 3] This demonstrates the use of consumable data to verify the authorized use of consumables in the assay system. [Figure 4] This shows the master repository on the CD server, its contents, and / or interfaces with further vendor directories. [Modes for carrying out the invention]

[0030] Detailed description of various embodiments Unless otherwise defined herein, scientific and technical terms used in connection with the present invention shall have meanings generally understood by those skilled in the art. Furthermore, unless otherwise required by context, singular terms shall include plurals and plural terms shall include singulars. The articles “a” and “an” refer herein to one or more (i.e., at least one) grammatical objects of the article. For example, “an element” means one or more elements.

[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 assay consumables. The assay consumables comprise identifiers (or referred to throughout this specification as identifiers, consumable identifiers, or assay consumable identifiers), and the assay system, reader, or its components comprise identifier controllers that interact with the identifiers. As described below in this specification, the identifiers comprise information about the assay consumables, which may include, but are not limited to, how the consumables were manufactured and handled before use, and how the consumables are used in the assay system (collectively referred to as “consumable data”). Accordingly, the assay system is configured to use assay consumables in the performance of an assay, and the assay system comprises a reader adapted to (i) read information from the assay consumables and the associated assay consumable identifiers; and optionally, (ii) erase information from the assay consumable identifiers; and / or (iii) write information to the assay consumable identifiers.

[0032] In certain embodiments, the present invention provides an assay system configured to use assay consumables in the execution of an assay, wherein the assay consumables include assay consumable identifiers as described herein, and the assay system includes (a) a storage medium comprising a consumable data repository; and (b) a reader adapted to read information from consumable identifiers. 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 a (cancan) assay protocol that can be applied by the system in the execution of an assay using the consumables. For example, the assay consumable identifier includes information that can be used to identify a particular consumable, e.g., lot-specific information for a given lot of consumables and / or information specific to individual consumables, and the corresponding local consumable data stored in the assay system includes information used to identify consumables associated with the system, e.g., as members of a given lot or as individual consumables within a lot, and this also includes information used by the system to perform an assay protocol using the consumable once it has been identified. Furthermore, consumable data (and / or local consumable data) may include one or more analytical tools that the system can apply to analyze data generated using the consumable, system and / or consumable technical support information, or a combination thereof. In addition, the system may also be configured to receive updates to the consumable data repository from a remote storage medium, where these updates include additional consumable data, which includes, but is 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 the system can apply to analyze data generated during and / or after the execution of an assay, (y) assay system maintenance information, (z) system-consumer sales 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 manufacturers, distributors, or suppliers (hereinafter referred to as "vendors"). First, the vendor generates consumables and / or a set of consumables or lots of consumables (101), and for that consumable or lot of consumables, generates consumable data using a consumable data (CD) generation system (102) and stores it in a consumable identifier (103) associated with the consumable or lot of consumables (step i). Consumable data is generated by the consumable vendor before, during, and after the manufacture and / or distribution of individual consumables and / or lots of consumables. The CD generation system creates a database of CD information for that consumable or lot, i.e., the CD database, where the consumable data is stored. The CD database is transmitted to a CD server (104) which contains a master repository of all consumable data. Furthermore, the CD production system stores information used to associate predetermined consumable identifiers with consumable data in the master repository. The CD production system and / or CD server are located on a remote computer system, i.e., the assay system and / or a computer system located away from the customer, for example, at 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 this 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] Figure 2 illustrates one method for distributing consumable data to a customer or a designated user of a customer (collectively referred to herein as “customer”). When an order is received from a customer, or when a consumable or lot is manufactured (step i), the vendor generates, stores, and transmits a CD database to a CD server (201) (step ii). The CD database may include order fulfillment information, i.e., a summary of the components of an order for a given customer, so that the system can confirm that all components of an order for a given customer have been supplied to the customer. The customer receives a consumable (202) containing a consumable identifier (203) and brings the consumable into contact with an assay (204) in preparation for performing the assay (step iii). The system reads the information stored in the assay consumable identifier (203), and this information is used by the system to identify the consumable (202) (step iv). The system reviews the consumable data stored locally in the system on a local storage medium (referred to as “local CD” in Figure 2) to confirm that the consumable data stored on the storage medium can be used for performing an assay using a given consumable. If the storage medium contains consumable data for its consumables or lot, those consumables can be used in the system (step v). If the storage medium does not contain consumable data for its particular consumable or lot, the system can inquire with the customer about that consumable data, and the customer can contact the vendor to receive the necessary 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 of the consumable data (including, but not limited to, encrypted XML files) 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 the local system's consumable data repository. The consumables / lots 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, which can automatically retrieve consumable data from the CD server if it is not locally available on the system. In this embodiment, as shown in Figure 2 and described above, the vendor generates, stores, and transmits a CD database for consumable orders and / or lots of consumables to the CD server. The customer then receives the consumables, orders, and / or lots and contacts the system with the consumable identifier so that the system can identify the consumables or lots. 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 locally available 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's consumable data repository, the system (i) instructs the customer to manually obtain the consumable data from the vendor, or (ii) automatically retrieves the consumable data from the CD server via the direct interface with the CD server and stores the information locally in the system's consumable data repository. Once consumable data is available locally on the system, the software adjusts the system based on the consumable data if necessary and then runs the assay. Once consumable data is available locally on the system, the consumables or lots 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] Furthermore, the CD server may periodically transmit consumable data about new consumable lots / types to the customer's assay system via, for example, 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 update information from the remote storage medium to the repository via, for example, email, CD, memory card / stick, flash drive, and / or via a remote interface.

[0037] Figure 3 shows the matching of consumable data by the system software and the results of the procedure. First, the customer inserts a consumable (301) with a consumable identifier (302) into the system (303) (or otherwise contacts the consumable identifier with a controller on the system), and the system software identifies the consumable via the consumable identifier (302). The system attempts to associate that identifier with consumable data stored locally in the system repository. If the consumable data is verified and valid, the system processes the consumable and presents the results of the processing 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 they are not available to the customer until the consumable data is verified by the system software.

[0038] Furthermore, the present invention provides a method by which a vendor controls customer access to an assay system and / or assay consumables, the system comprising a system identifier, and the method includes receiving the system identifier from the customer [wherein the system identifier is transmitted to the vendor computer system]; identifying the system identifier by the vendor; and (i) To enable full access to the apparatus and / or assay consumables used in the apparatus; (ii) To enable partial access to the apparatus and / or assay consumables used in the apparatus; or (iii) Denying access to the apparatus and / or assay consumables used in the apparatus. This includes performing an operation that includes the following:

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

[0040] In one embodiment, the process of enabling either full or partial access includes the process of the vendor sending an access code to the customer, thereby enabling access to the system. This access code may be a full access code or a partial access code that enables various functions in the system. In one embodiment, the access code is a partial access code that enables the system to operate in demonstration mode. The partial access code may be for a limited time. Alternatively, the access code may be a full access code that enables the system to be fully operational.

[0041] As shown in Figure 4, the CD server (401) includes a master repository (402) comprising one or more directories of (i) consumable data; (ii) system data; and (iii) customer data. Furthermore, or otherwise, data contained in or more of directories (i) to (iii) may be supplied to the master repository via an interface between the CD server and one or more supplemental vendor directories. In one embodiment, the master repository comprises (i) a master customer data directory (403); (ii) a master system identifier directory (404); and (iii) a master customer data directory (405). In a preferred embodiment, customer data is supplied to the CD server via an interface to supplemental vendor-customer directories holding the customer data. Customer data may be stored in one or more supplemental vendor-customer directories, each connected to the CD server via an interface. The master CD database comprises a plurality of CD directories, each generated for a consumable or lot of consumables. The master system identifier directory contains system identifiers unique to each system manufactured and / or distributed by the vendor. The master customer directory and / or supplemental vendor-customer directory, linked to the CD server, include information about each of the vendor's customers, such as contact information for the customer and its individual customers, billing information, pricing information, shipping information, and order history.

[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 supplemental vendor directories. When a system is ordered by a customer, order information, such as purchase orders, associated quotes, pricing, terms of sale or lease, and agreements on associated services, as well as customer information, are stored in a master customer directory and / or one or more supplemental vendor-customer directories linked to 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 further associated with information on related purchases 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 thereof is also stored in the customer directory. Once the customer receives the system, and in a preferred embodiment, after installation and training on the system are completed, the system software, if necessary, 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 verify that its installation and training have been successfully completed, and the CD server records this verification. Alternatively, if remote access is not available on the system, once the system is installed and training is complete, the customer receives a verification code, system login, and / or email address from the system, and the customer can log in to the CD server via the verification code, system login, and / or email, thereby providing the customer with access to the CD server, resulting in a separate vendor-customer interface without a direct connection between the system and the CD server.This separate vendor-customer interface could be a portal on a vendor-provided website accessible to the customer via a password, and / or the customer and CD server could communicate via an email exchange server configured to send and receive emails between the customer and the CD server (collectively referred to as the “indirect interface” between the customer and the CD server). Thus, the vendor can communicate with the customer via the direct system-CD interface (referred to as the “direct interface”) and / or via the indirect interface. As described above, the customer can then purchase consumables, the system 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 can then use that consumable or lot.

[0043] When customers and vendors have means of communicating through direct or indirect interfaces, they can interact in various ways, and the communication between the parties can become more meaningful and productive, as vendors have the ability to track customer-specific usage information about systems and consumables purchased and / or used by the customer. For example, customers can browse and / or purchase vendor products, receive customer support, and schedule service calls through direct or indirect interfaces. Vendors can track customer activity and purchases very closely through consumable identifier / CD servers, and can tailor their interactions with customers based on that information. For example, since vendors are aware of a customer's order history, they can send promotional materials to customers about products related to products they have previously purchased / used. Similarly, because vendors can track information related to customer systems, they can send customers preventative maintenance advice and reminders, general or specific customer training and seminars based on the customer's unique needs (and which can be informed by tracking consumable data for that customer), as well as information on system services, warranty repairs, service contract information and reminders.

[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 system-consumable usage information directly or indirectly to a CD server. If a direct interface is available between the system and the CD server, system-consumable usage information may be transmitted automatically. However, if a direct interface is not available, system-consumable usage information may be provided indirectly by the customer to the CD server. In this embodiment, the system periodically instructs the customer to provide system-consumable usage information to the vendor via an indirect interface. The vendor may maintain a directory of customer consumable information to track consumable usage, and information from that directory is used to transmit consumable data that may be relevant to the customer based on previous consumable and / or system usage, via a direct or indirect interface. If a direct interface is available, the assay system may be configured to receive assay system maintenance and / or sales promotion information related to the individual customer's previous consumable and / or system usage from the vendor computer system.

[0045] The vendor can also track and / or communicate system maintenance information to the customer by monitoring, for example, the usage of the system and / or system components, service history, system troubleshooting information, the results of diagnostics performed on the system, control charting, periodic maintenance schedules, warranty information for the system and / or its components, or a combination thereof. System software may be programmed to monitor various components of the system and, automatically or as instructed, 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 monitoring reports to the CD server via an indirect interface. Furthermore, or / or, such system monitoring reports may be accessed by service technicians responsible for maintaining and / or servicing the system, either on-site or remotely. In certain embodiments where a direct interface is available, the CD server monitors the usage and / or warranty information of system components and, based on the standard lifespan and / or warranty period of system components, schedules for periodic system / component maintenance and / or upgrades by service technicians. Furthermore, the CD server may maintain a log of service history for a given assay system and schedule service calls by service technicians (this may be done using either a direct or indirect interface). The remote computer system may also transmit individual assay system software upgrades via a direct or indirect interface.

[0046] Furthermore, one or more of the following system components and / or actions may be monitored by the system software, including, but not limited to, the expected motor position during normal use, the positional error for each expected motor position, corrective actions taken and / or attempted by the system in the event of a motor positioning error, and the frequency of errors; the utilization of a component, such as the approximate time a component has been operating in the system; and in a preferred embodiment, the system may also track the relative lifespan of that component under normal operating conditions; attempts, retries, and failures of locking mechanisms; attempts, retries, and failures of barcode readers; the approximate temperature of one or more components in the system, error warnings, database performance and capacity, equipment hard disk capacity, software and firmware versions and patches, customer login / logout, system startup and shutdown, etc. In a particularly preferred embodiment, including a system designed to perform electrochemiluminescence measurements using assay consumables, the system software may also be programmed to monitor the time the camera was in operation and its approximate temperature, the usage cycle of latches in the system, barcode reader attempts, retries, and failures, consumable lock and unlock events, ECL waveform voltage and integrated current, image processing analysis accuracy and failures, consumable type, kit, owner, barcode, and timestamp of each consumable in the system, or a combination thereof. Furthermore, the system software may also monitor experiments performed in the system, for example, when, by whom, and which type of consumable(s) was used in that experiment. Such system-usage monitoring information may be transmitted to a CD server via direct and / or indirect interfaces to enable the vendor to determine appropriate support, service, and / or maintenance schedules for the system.

[0047] In another embodiment, by tracking the use of assay systems, vendors can provide assistance with use and / or purchase. For example, vendors can track the history of use and purchase of consumables, and based on consumable data for a given lot or consumable, the vendor can monitor expiration data for a given lot or consumable and notify the customer of the approaching expiration date for a lot or consumable. By tracking the use of assay systems / consumable types, vendors can also track the relative schedule / frequency of consumable use and notify customers when they need to replenish their consumable stocks. If a direct interface is available, the system can also be configured to order / reorder consumables, and the system can further be configured to track and confirm consumable orders from vendors. If a direct interface is not available, the system can monitor consumable use and inventory and instruct customers to replenish their stocks of one or more consumables. (In this regard, the system receives lot size information via consumable identifiers and, by monitoring consumable usage, can notify the customer when the stock of available consumables in a given lot falls to a minimum level.) Furthermore, by tracking consumable usage, the system can send customers information about custom assay design services for specific custom consumable types based on their order / consumable usage history. Direct or indirect interfaces can also provide customers with training modules, consulting services, and / or live customer service support features (i.e., live-chatting) to facilitate the customer experience (collectively referred to as system and / or consumable technical support information).

[0048] In another embodiment, tracking the use of consumables / systems enables a vendor to send promotional materials to customers. For example, in the case of a new type or lot of a consumable historically used by a given end-customer, the vendor computer system sends consumable data about those new products to the customer. Such promotional materials may also relate to new assay systems that the customer might be interested in based on their previous use. The remote computer system may also send the customer literature references that may be related to one or more consumables / systems used by the given customer.

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

[0050] Assay system, consumables, and method of use The assay systems considered in the present invention are used to perform any type of diagnostic or analytical method known in the art. Such analytical methods include, but are not limited to, clinical chemical assays (e.g., measurement of pH, ions, gases and metabolites), hematological measurements, nucleic acid amplification assays (e.g., polymerase chain reaction (PCR) and ligase chain reaction assays), immunoassays (e.g., direct, sandwich, and / or competitive immunoassays, as well as serological assays), oligonucleotide ligation assays, and nucleic acid hybridization assays. Any biological reagents that may be used in such analytical methods may be used in the above systems, and these include, but are not limited to, nucleic acids, nucleotides, oligonucleotides, DNA, RNA, PNA, primers, probes, antibodies or their fragments, antigens, small molecules such as drugs or prodrugs, streptavidin, avidin, and biotin.

[0051] These systems may be portable and, for example, can be operated by hand and / or in a fixed laboratory or field environment, either alone or in combination with one or more further components, assay devices, or systems. These systems may be used in a wide range of applications, from field work to laboratory environments, in various industries, and in defense applications, such as for the detection of biological weapons agents, including, but not limited to, medical, clinical, forensic, pharmaceutical, environmental, veterinary, biological, chemical, agricultural, waste management, hazardous chemicals, and drug testing. The assay systems and consumables used in the present invention may detect the subject of interest by any suitable method, including but not limited to optical, electromechanical, radio wave, electromagnetic, colorimetric, fluorescence analysis, chemiluminescence, electrochemiluminescence, radiochemical, nuclear magnetic resonance, enzymatic, fluorescence, particle counting, and cell counting-based detection.

[0052] Assay consumables include a device on which one or more steps of the assay process are performed, and such a device may include one or more test sites on which the assay measurement is performed. In one embodiment, the assay consumables include at least one assay test site for the assay. The test site may include several separate assay domains, at least two of which contain reagents for measuring different subjects. Furthermore, the consumables may include multiple test sites for several individual assays. Alternatively, the assay consumables may be components that provide reagents or other assay components used by the system to perform the assay. For example, the assay consumables may be a container having one or more compartments for holding assay reagents. The assay consumables (or the test sites therein) may be single-use or reusable. The assay consumables may be configured to perform one or more tests (sequentially or in parallel).

[0053] As used herein, a test site refers to an area of ​​a consumable that holds, contacts, and / or examines a sample. A test site may include multiple distinct assay domains, at least two of which contain reagents for measuring different subjects. A consumable may include a number of test sites capable of holding, contacting, or otherwise examining the same sample in separate volumes (aliquots) and / or different samples in separate volumes. A sector of an assay consumable refers to a group of two or more test sites within that consumable. Each test site may be used to perform a single measurement or multiple measurements of a certain volume of sample (e.g., measurement of multiple different subjects in a multiplexed assay). Depending on the specific requirements of the application, a consumable with a number of test sites may be configured to use all of its test sites in parallel, or to use the test sites at different points in time (e.g., assigning unused test sites to be used when a new sample is delivered to the assay system), or a combination of both modes of operation may be possible.

[0054] Assay consumables may be any structure useful in diagnostic applications, and their structure may depend on the specific 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), multiwell plates, slides, assay tips, lateral flow devices (e.g., strip tests), flow-through devices (e.g., dot blots), pipette tips, and solid-phase supports for biological reagents. In certain embodiments, the test site in the assay consumable is defined by a compartment in the assay consumable, such as a well, chamber, channel, or flow cell. The assay consumable and / or test site may include one or more components used to perform assay measurements according to one or more specific detection methodologies. Depending on the function of the consumables and the detection mode used by the assay system, examples of such components may include, but are not limited to, lateral flow matrices, filtration matrices, light windows, sensors (e.g., electrochemical sensors and optical sensors), solid-phase supports for binding reactions (e.g., coated slides, tips, beads, pins, coated filtration matrices or lateral flow matrices, tubes, etc.), reagents (in dry or liquid form), electrodes, and subject selection membranes.

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

[0056] In another embodiment, the assay consumables and associated assay system or reader can perform multiple assays. A multiple assay is a type of assay in which multiple measurements are performed on a single sample, for example by distributing the sample across multiple test sites, and / or by performing multiple measurements on a large amount of sample at individual test sites. Multiple measurements may include, but are not limited to, (i) multiple repetitions of a measurement for a given subject; (ii) multiple measurements of a particular subject (i.e., multiple non-identical measurements of the same subject, e.g., measurements with different forms or identities of assay reagents used); and / or (iii) measurements of a large number of different subjects. In one particular embodiment, the assay consumables are configured to perform multiple measurements, including at least two assays for two different subjects at one or more test sites.

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

[0058] In one embodiment, an assay site comprises a plurality of distinct assay domains, each domain comprising one or more reagents for measuring different subjects. Multiplexing information, including the location, identity, and configuration of each assay domain, is used to identify the assay signal generated in each domain and to associate it with the determination of the presence or quantity of the corresponding subject (a process which may include the application of further 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 (for example, it may include multiple separate assay domains, each containing reagents for measuring different subjects). 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 stored in the assay consumable identifier and / or included in the information provided as consumable data. This information may include the location and identity of the test sites, assay domains, and / or one or more sectors, as well as multiplexed information (as described above) including the number, identity, and differentiating features of individual measurements within the test sites, assay domains, and / or sectors (for example, the specific location, identity, and / or assay reagents of the assay domains within each test site). Furthermore, the use of test sites, assay domains, and / or sectors in the assay consumable may also be recorded in the identifier to track the use of the consumable in the assay system. The identifier and / or consumable data may also include information regarding the assay format and specific processing steps to be used with respect to the assay consumable or the test sites, assay domains, and / or sectors of the assay consumable. Identifiers and / or consumable data may also include information about analytical methods to be applied by the system at the time the assay is performed and the assay output at a given test site, assay domain, and / or sector is analyzed, and optionally provides results combining the outputs from multiple assays at the test site, assay domain, and / or sector.

[0060] The test site may consist of any suitable configuration depending on the shape of the consumable and / or the type of assay performed using the consumable. In one embodiment, the test site consists of wells and / or chambers in the assay consumable. For example, the assay consumable of the present invention may be a multiwell plate (e.g., a 24-well, 96-well, 384-well, or 1536-well plate), and the wells of the plate may further contain a plurality of separate assay domains (e.g., 2 or more, 4 or more, 7 or more, 25 or more, 64 or more, 100 or more, etc.). A multi-domain multiwell plate adapted to enable assay measurements to be performed using electrode-induced emission measurements (e.g., electrochemiluminescence measurements) is described in U.S. Patent Application No. 10 / 238,391 (titled "Methods and Reader for Conducting Multiple Measurements on a Sample," filed September 10, 2002, incorporated herein by reference). The precise configuration of domains, test sites, and / or sectors within 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. Furthermore, 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 a wide variety of assays, and this variety leads to various appropriate configurations of the relevant consumables. In a single assay format, the same subject 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 subject. Information about the assay formats that can be used in assay consumables, test sites, and / or assay domains can also be stored in the assay consumable identifier and / or provided as consumable data. The identifier and / or consumable data may also include a method for the analytical method to be applied by the system when performing an assay, analyzing the assay output at a given test site and / or domain, and comparing that output with 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 thereof is incorporated herein by reference in its entirety). Such an assay consumable comprises 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 material in the test sites and / or assay domains. The assay consumable may further comprise assay reagents in liquid or dry form in, for example, the test sites, for example, wells or chambers of the consumable.

[0063] In addition to the test site and assay domain, assay consumables or multiwell assay plates may include several further elements, such as the top of the plate, the bottom of the plate, wells, working electrode, counter electrode, reference electrode, dielectric material, electrical connections, and assay reagents. The wells of the plate may be defined by holes or openings in the top of the plate, or by 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. Examples of consumable embodiments that may be used in the present invention include industry standard forms of the number, size, shape and configuration of plates and wells, such as 96-well, 384-well, and 1536-well plates with wells arranged in a two-dimensional array. Other forms may include single-well plates, 2-well plates, 6-well plates, 24-well plates, and 6144-well plates. Multiwell assay plates may be used once or multiple times and are well suited to applications where the plate is disposable. Various configurations for appropriate assay plates may be used in the present invention, including, but are not limited to, those shown in Figures 11A, 12A, 13A, 13B, 14A, 15 and 16A of U.S. Patent Application No. 2004 / 0022677 (each incorporated herein by reference). As described above, the specific configuration and identity of the assay test sites, domains, and / or sectors of the assay consumable may be contained in the information stored in the assay consumable identifier and / or provided as consumable data.

[0064] In this embodiment, assay consumables may be used in a reader (e.g., an electrode) which can be used to induce and measure luminescence, such as electrode-induced luminescence or electrochemiluminescence, in the assay consumable (e.g., a multiwell assay plate) or in an assay performed on the assay consumable. The accompanying assay system may also induce and / or measure current and / or voltage, for example, in the electrode. The assay system may incorporate, for example, one or more photodetectors; a light-blocking housing; a mechanism for transporting assay plates into and out of the reader (and in particular, into and out of the light-blocking housing); a mechanism for aligning and orienting assay plates with the photodetector and / or electrical contacts; further mechanisms for tracking and identifying plates (e.g., a barcode reader); a mechanism for generating plates, one or more electrical energy sources for inducing luminescence, and electrical connections to appropriate devices, electronic equipment and / or software. The assay reader may also include a mechanism for storing, stacking, moving and / or distributing one or more multiwell assay plates (e.g., a plate stacker and / or conveyor). The assay system may be configured to measure light from a multiwell assay plate by measuring light sequentially from multiple sectors or regions of the plate (i.e., a group of multiple adjacent assay domains within the plate) and / or substantially simultaneously from the entire plate, or simultaneously. The assay system may also incorporate further microprocessors and computers to control specific functions within the system and to assist in data storage, analysis, and presentation. Various configurations for a suitable assay system may be used in the present invention, including, but are not limited to, those shown in Figures 17–23 of U.S. Patent Application No. 2004 / 0022677 (each incorporated herein by reference).

[0065] Further microprocessors and computers in the assay system may also interact with the assay consumable identifier microprocessor or controller by transferring data and commands through the system to / from the identifier to various microprocessors / controllers, thereby performing various operations on the components listed above within the assay system.

[0066] The system may adjust assay parameters before starting the assay based on consumable data stored in an identifier and / or stored or provided as consumable data via a direct or indirect interface. The system then generates appropriate electrical, fluid, and / or optical connections to the consumable (utilizing electrical, fluid, and / or optical connectors on the consumable and the system) and performs the assay using the consumable. A sample may be introduced into the consumable before it is inserted into the system, or the sample may be introduced by a component of the system after the consumable has been inserted into the system. The assay may also include adding one or more assay reagents to the consumable, and instructions for adding these various assay reagents may be stored in an identifier and / or provided as consumable data, and the system adds these reagents to the consumable before or during the assay according to the instructions stored in the assay consumable identifier and / or provided as consumable data.

[0067] Alternatively, the assay consumable is a cartridge, which further comprises one or more fluid components, one or more detection components, one or more assay cells, reagents for performing the assay, a working electrode, a counter electrode, a reference electrode, a dielectric material, electrical connections, dry assay reagents and / or liquid assay reagents, or a combination thereof. 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 subject.

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

[0069] More specifically, such an assay consumable cartridge may have one or more assay sites (e.g., wells, compartments, chambers, conduits, flow cells, etc.) which may include one or more assay domains (e.g., separate locations on the assay site surface where 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 the execution of assays based on electrochemiluminescence or electrode-induced luminescence measurements. The assay domains are optionally defined by a dielectric layer attached to the electrodes. Furthermore, the assay consumables may have one or more characteristics that make them suitable for use in "point of care" clinical measurements, such as small size, low cost, disposability, multiple detection, and ease of use.

[0070] Assay consumable cartridges may include electronic and / or active mechanical components necessary for performing assay measurements, such as one or more electrical energy sources, ammeters, potentiometers, photodetectors, temperature monitors or controllers, pumps, valves, etc. Alternatively, some or all of the electronic and / or active mechanical components may be housed in a separate assay reader. The reader would also have electrical, fluid, and / or optical connections to the assay consumables, suitable for performing assays using the consumables. Using such an arrangement, the reader (holding the more expensive and complex components) can be designed to be reusable while the assay consumables are low-cost and disposable.

[0071] In one embodiment, a cartridge-based biochemical detection system may include a system housing containing an optical detector, which is adapted and configured to receive and position assay consumables and / or the optical detector for processing. The system may further include one or more support subsystems, which may include: 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 supplying fluid to the detection chamber via a fluid inlet line; an electrical subsystem for electrically bringing the electrical contacts of the cartridge into contact and supplying 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 an assay consumable identifier and / or provided as consumable data may include information used to control or adjust one or more assay system components before and / or during the execution of an assay using the assay consumable.

[0072] Furthermore, assay consumables may also be containers holding one or more assay reagents, which may include, but are not limited to, one or more buffers, diluents, and / or reagents used by the assay system in performing the assay. Assay consumable identifiers 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 includes a memory for storing information about the consumable, its history, and / or its use. In one embodiment, the memory is non-volatile memory. Non-volatile memory is computer memory that can retain stored information even without power. Examples of non-volatile memory that may 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 disks, flexible disk drives, and magnetic tapes), optical memory (optical disk drives), and a combination 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 electrically erased and reprogrammed without exposure to UV light. The EEPROM can be written to or programmed more than once and can be selectively programmed (the customer can change the value of a specific cell without erasing the programming of other cells). Thus, sections of data can be erased and replaced without having to change or reinstall the rest of the chip's programming.

[0075] In another embodiment, the assay consumable identifier comprises flash memory, which is a specific type of EEPROM that is erased and programmed in large blocks. While flash memory is technically a type of EEPROM, the term “EEPROM” is generally used to refer specifically to non-flash EEPROM that can be erased in small blocks, typically a few bytes at a time. Because the erase cycle is slow, the large block size used for 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 embedded with integrated circuits capable of processing and storing data. There are two broad categories of ICCs: i) “memory cards” that include non-volatile memory storage components and, optionally, some specific security logic, but do not include a microprocessor; and i) “microprocessor cards” that combine non-volatile memory components and microprocessor components to enable processing of information read to or from the ICC. The ICC electronic components are supported on a card typically made from a plastic such as PVC or ABS. The card may include an embedded hologram to prevent counterfeiting. Contact ICCs have conductive contact pads. When inserted into a reader, the contact pads on the ICC make contact with the reader's electrical connector, enabling 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 method of transferring information is via RFID, or radio frequency identification, which is theoretically similar to barcode identification. In RFID, electromagnetic or electrostatic coupling in the RF portion of the electromagnetic spectrum is used to transmit signals. An RFID system consists of an antenna and transceivers (which read radio signals and transfer the information to a processing device), as well as a transponder or tag (which is an integrated circuit containing the RF circuitry and the information to be transmitted).

[0078] Identification can also be achieved by reading barcodes. One key difference between RFID and barcode technology is that RFID does not require line-of-sight reading, on which barcodes depend. Also, RFID scanning can be performed at longer distances than barcode scanning. High-frequency RFID systems (850MHz-950MHz and 2.4GHz-2.5GHz) offer transmission distances greater than 90 feet, but wavelengths in the 2.4GHz range are absorbed by water (the human body), thus having 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 containing a first identifier may be used in the assay system, and further assay consumables containing further identifiers may also be used in the assay system. Each identifier may contain the same or different types of memory. However, there will be separate identifier controllers for each different form of memory. Certain consumable data may be stored in one identifier, and other consumable data may be stored in the same or different types of further identifiers. For example, one assay consumable used in the system may contain an EEPROM or RFID as an identifier, while the system may use further assay consumables containing, for example, a barcode as an identifier. The assay system may include an identifier controller that can interface with the first identifier, i.e., the EEPROM or RFID, and the system may further include a further controller that interfaces with the barcode.

[0081] The assay system of the present invention includes an identifier controller that controls the operation of non-volatile memory and other components of the assay system. The identifier controller optionally includes a microcontroller connected to the non-volatile memory via a communication interface, which is a conventional interface architecture and I 2 A protocol such as C, 2-line serial bus protocol may be incorporated. 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 it 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 so that one separate consumable identifier is used to hold information related to multiple consumables. In one example, each package of consumables has a package-specific identifier attached to (or supplied in) the package that holds information about multiple consumables in the package. Optionally, each consumable also has a further unique consumable-specific identifier attached to the consumable. This consumable-specific identifier is primarily used to uniquely identify the consumable and associate it with the information on the package-specific identifier. In this embodiment, non-editable identifiers such as lot information and / or barcodes may be used.

[0083] The various components of an assay system may be housed together in a single unit or separately. For example, an assay system may include an assay reader and an identifier controller as separate units. The assay system provides communication (either wired or wireless) between the assay reader and the identifier controller, either directly or 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 also be configured to enable communication between the consumable identifier and the identifier controller upon insertion of consumables into the reader during assay execution (e.g., the port into which the consumables are inserted includes a component that processes and / or reads the consumables, and also includes a component such as an electrical contact or wireless transmitter for communicating with the consumable identifier). In one example, when consumables are loaded into the assay system, an electrical contact is created 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 cartridges and for communicating with the consumable identifier. The user places the assay consumable or package on or near the controller port so that the controller makes electrical contact with the identifier, allowing the controller to read, erase, and / or write consumable data to non-volatile memory.

[0084] In one embodiment, the identifier includes a non-volatile memory comprising an RFID tag, a barcode, an EPROM, and an EEPROM. Furthermore, the identifier may also include an EEPROM comprising flash memory and an ICC.

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

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

[0087] Consumables data Identifiers are programmed, for example, during the manufacturing process or when preparing for the delivery of consumables. Identifiers may be programmed using consumable data that can be used before, during, or after a step in an assay or multi-step assay to control the operation of an assay system, reader, or components of an assay system. Furthermore, some or all of the information necessary for the 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, control chain information, consumable / test site information, assay process information, consumable security information, or a combination thereof. Consumables data may further include information related to one or more analytical tools that the system may apply to analyze data generated during and / or after the assay, assay system maintenance information, system-consumables sales promotion 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 naturally, each type of consumable data may be stored in a consumable identifier and / or provided as consumable data.

[0089] Consumables identification and configuration information Consumable data may include, but is 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 included in or described in product inserts that will be attached to assay consumables, such as the type of assay, how the assay is performed, and a description of the use of assay consumables, assay reagents, or both), threshold and / or calibration data for one or more reagents used in assay consumables or in 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 assay consumables.

[0090] 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 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 derived from consumables from that lot. In one embodiment, if the assay consumable is a multiwell assay plate or cartridge, the lot-specific analytical parameters may include, but are not limited to, the following: (i) revision level that determines the schema used to interpret the information; (ii) type of consumable; (iii) manufacturing date; (iv) lot number; (v) expiration date; (vi) crosstalk correction matrix to account for chemical cross-reactivity; (vii) thresholds for the assay to be performed on the consumable and each internal negative control; (viii) range of each internal positive control; (ix) range of positive control samples for each assay to be performed on the cartridge; (x) software checksum to ensure data integrity; (xi) in-well (or in-test site) control tolerance; (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 consumable; (xiv) calibration information such as a master calibration curve; and (xv) number and name of assay recalibrators and / or assay calibrator tolerance.

[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, the assay results obtained with the assay consumable for the sample, and the identity of the sample that is and / or will be assayed with the assay consumable.

[0092] Consumable data may also include information related to distribution process management, such as the management, transport, and / or analysis of samples and / or assay consumables. Chain of management information may be selected from customer identification, sample identification, timestamps and date stamps for assays, the location of the assay system in the laboratory, the calibration and QC (quality control) status of the assay system during the assay, management and / or location information for assay consumables before and after the assay, assay results for a given sample, and free text comments entered by the customer before, during, or after the assay is processed by the system. Furthermore, chain of management information may include time, date, manufacturing personnel, or processing parameters for one or more steps in the manufacturing of assay consumables, and management, location, and / or storage conditions for assay consumables after and / or between steps in the manufacturing process.

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

[0094] In further embodiments, the consumable / test site information may include information about assays previously performed by the reader at one or more test sites within the consumable, and information about assays to be performed by the reader at one or more test sites within the consumable. Thus, once the assay is performed by the system, the controller can be used to write the assay results to an identifier. Such information may include, but is not limited to, raw or analyzed data collected by the system during the 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 in a given assay, a schedule of events to be performed on the assay consumable or at test sites and / or domains within the assay consumable, a list of test sites and / or domains of assay devices that have not been subjected to the assay, assay errors or system errors that occurred during a given assay or assay process, or a combination thereof.

[0095] Furthermore, consumable data may be used as a security mechanism to verify, for example, that the correct assay consumables are being used in the system (referred to herein as “consumable security information”). Consumable data may include a digital signature to prove that the consumable was manufactured by a designated vendor. In one embodiment, if an inappropriate assay consumable is present in the system (e.g., a counterfeit consumable or a consumable that is otherwise incompatible with the assay system), the controller disables the system, reader, or its components. Furthermore, consumable data may also be used to detect the proper placement of assay consumables in the system, for example, the proper orientation of an assay consumable or part thereof in the assay system, and as a result the controller will disable the system, reader, or its components until the assay consumable is placed in the correct orientation. Furthermore, consumable data may also be used to detect defects in assay consumables or assay test sites and / or domains, and the controller will disable the system, reader, or its components accordingly. For example, depending on the nature of the defect in the assay consumable or domain, the controller may instruct the reader to refuse to use the entire assay consumable, or to refuse to use 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 to the identifier of the consumable. 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 therein 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 to the identifier by the customer of the assay consumable at the assay reader for later use and / or verification.

[0096] Consumable data may also include approval 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 restrictions on such use, such as whether the customer's authorization is for research purposes only, and information regarding whether a particular customer has valid authorization to use a particular consumable or biological reagent. Such information may also include verification information regarding whether a particular consumable or biological reagent has been recalled or is otherwise unsuitable for use or unauthorized. Recall information and any date and / or timestamp of the last recall check may be written to the identifier and / or provided as consumable data.

[0097] Consumable data may further include information about the origin of assay consumables, biological reagents used in the test site and / or domain, including, for example, the identification of the original sample from which it originates or the number of generations taken from the original sample. For example, if the assay reagent used in the assay is an antibody, the consumable data may include the identification of the hybridoma from which the antibody originates, for example, the ATCC acceptance number for that hybridoma.

[0098] In various embodiments, the biological samples or reagents provided in or with the consumables described above may be licensed separately from the system designed to function with the biological reagents. In various embodiments, the assay system, reader, or its components are connected to a network that enables the system to communicate with a computer system operated by or on behalf of the customer, manufacturer, and / or licensor of the biological reagent, consumable, or system, over a public and / or private network. In various embodiments, a license may be granted that is limited to the use of the licensed biological reagent, consumable, or system for specific biological analyses only on the licensed system. Thus, the system may certify the biological reagent, consumable, or system based on a digital signature contained 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 may also be used to provide single-use so that the biological reagent cannot be replenished for use in the same certification.

[0099] In certain embodiments, when an identifier is read by a system, reader, or component thereof having access to a public or private data network operated by, or on behalf of, a customer, manufacturer, and / or licensor of a biological reagent, consumable, or system, certain consumable data may be communicated with the assay system and may be read, written, or erased locally via an identifier / controller on the assay system. For example, recall and / or license information may be a subset of consumable data available via direct and / or indirect interfaces, while further consumable data, such as lot-specific information, expiration dates, calibration data, consumable-specific information, assay domain information, assay result information, consumable security information, or a combination thereof, may be stored locally in an identifier and otherwise not available via a network connection in the assay system. In one embodiment, recall, license, and / or consumable security information may be available via a network connection in the assay system and / or stored as consumable data on a storage medium, and the remaining consumable data may be stored locally in an 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 circuits, such as a microprocessor or microcontroller, memory, and non-volatile storage devices. In various embodiments, the system hardware also includes physical devices for operating biological reagents, such as robots and sample pumps. In various embodiments, the system firmware includes instructions readable by a lower-level computer 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] System data acquisition and control software is higher-level software that interacts with the system firmware to control the system hardware for more detailed operations (e.g., operating a charge-coupled device (CCD) to acquire visible light emission information for a specific biological analysis). In various embodiments, the data acquisition and control software includes a software-executable state machine that results in, for example, the following states: (i) standby; (ii) running; (iii) paused; and (iv) error. In various embodiments, when the state machine is in the standby state, it can receive commands from a general-purpose machine tool to perform specific data acquisition or system control operations. In various embodiments, a general-purpose computer opens a TCP / IP socket connection to the system, determines whether the system is in the standby state, and then begins sending commands and / or parameters. In various embodiments, an encrypted TCP / IP connection is established using, for example, the SSH protocol. The commands and / or parameters may be in the form of ASCII-encoded, human-readable information about consumables and / or methods that define the operation of a biological system. In various embodiments, consumables and / or methods are stored in the form of an ASCII text file. In various embodiments, a general-purpose computer transfers the ASCII text file to the system using the FTP protocol. In various other embodiments, method and / or consumable information is stored in and read from an identifier. While method and / or consumable information may be stored in an identifier in the form of an ASCII text file, it is understood that the information can be represented in other data formats without departing from this teaching.

[0101] In various embodiments, the consumables, macros, and / or method information includes parameters that can be used by system data acquisition and control software to perform specific data acquisition and system control operations. In various embodiments, the method and / or consumable information includes the sequence of operations to be performed by the system, or control parameters for use in relation to data acquisition or control software.

[0102] (ii) Assay process information Furthermore, consumable data may include assay process information relating to individual assay parameters to be applied by the system or reader during the assay. For example, such consumable data may include the sequence of steps in a given assay, the identity, concentration, and / or quantity of assay reagents to be used or added during or at any particular step of the assay (e.g., buffers, diluents, and / or test substances to be used in that assay). Consumable data may also include the type or wavelength of light to be applied and / or measured by the system or reader during any particular step of the assay or multi-step assay; the temperature to be applied by the system or reader during the assay; the incubation time for the assay; and statistical or other analytical methods to be applied by the system or reader to the raw data collected during the assay.

[0103] In one embodiment, one or more steps of an assay protocol may be adjusted for individual consumables or lots of consumables. One or more steps of the protocol may differ from lot to lot and / or from individual consumables within a given lot, and consumable data stored in the system may include instructions for adjusting those steps of the assay protocol. This type of consumable data may be used by the system to adjust one or more operations performed by the system before, during, and / or after the execution of an assay. Furthermore, this type of consumable data may be adjusted by the system user at the user's discretion. For example, a dilution step in an assay protocol may be adjusted to account for lot-to-lot or lot-to-lot differences. The amount of diluent added and / or the properties of the diluent may be changed based on such differences. Similarly, the amount of a given reagent that may be added during the execution 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 lot-to-lot differences. These are each non-limiting examples of consumable data that may be stored in the system's storage medium.

[0104] Furthermore, the consumable data includes information that directly or indirectly controls the components of the assay system, such as one or more photodetectors, light-blocking housings; mechanisms for transporting assay consumables into and out of the reader; mechanisms for aligning and orienting 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 assay consumables; one or more electrical energy sources for inducing luminescence; mechanisms for storing, stacking, moving and / or distributing one or more consumables; mechanisms for measuring light from consumables continuously, substantially simultaneously, or simultaneously from multiple test sites on the consumables during the assay; or a combination thereof.

[0105] Consumable data may also include assay process information, which may include 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 quantity 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; statistics 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 adjusted by the user as appropriate). In a particular embodiment, the assay performed using the consumable is a multi-step assay, and the assay process information relates to one or more steps of the multi-step assay. In this embodiment, the consumable / test site information may include information about assays previously performed by the reader at one or more test sites of the consumable; information about assays to be performed by the assay reader or its components at one or more test sites within the consumable; or a combination thereof.

[0106] When individual operations are performed on consumables, test sites, domains, sectors, or biological reagents or samples, for example during the manufacture of consumables, test sites, domains, sectors, or biological reagents, or while an assay or process is being performed on a 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 or sample. For example, if an assay consumable includes multiple assay test sites, domains, and / or sectors, the assay system may perform the assay or multi-step assay process 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 assay results, for example, raw data or analyzed data generated during the assay or assay process, in an identifier, and / or the controller records which test sites, domains, and / or sectors of the assay consumable were 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. Assay consumables may be stored for later use and when the customer is ready to use other test sites, domains, and / or sectors of the assay consumables, and the controller reads the consumable data stored in the assay consumable identifier, and / or the results of those assays, to identify which test sites, domains, and / or sectors have been used and which have not yet been used. The controller may then instruct the assay system, reader, or its components to run the assay or assay process with the unused test sites, domains, and / or sectors.

[0107] Furthermore, a given assay protocol may require a specific set of consumables. Therefore, if a customer inputs a specific type of assay consumable, such as a multiwell assay plate, for use in a particular assay protocol, the system may require one or more additional assay consumables to perform that assay protocol, for example, one or more reagents may be required for use with the multiwell assay plate. Each required consumable may include a consumable identifier containing information about the consumable requirements for the assay protocol. When one of the required consumables is input into the assay system and the identifier controller interacts with the consumable identifier for that consumable, the system creates an inventory of the components present in the system and compares the results with the consumable requirements stored in the consumable identifier and / or stored on a storage medium and / or provided as consumable data. If any of the required consumables are missing or present in insufficient quantities, the system instructs the customer to input the 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 the primary 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 the sample. If only the primary assay consumable is loaded into the system without its corresponding associated consumable, the system will instruct the customer to load the associated consumable if the instrument does not detect the associated consumable in the system within a specified time. If an incompatible assay consumable is loaded into the instrument, the system will notify the customer. If there is no available compatible set of assay consumables (e.g., a multiwell assay plate and the specified reagents for a particular assay), the system will not process the sample. The system checks for expiration of assay consumables before starting the assay and warns the customer to prevent the use of expired consumables. If a consumable has expired before sample aspiration, the system will not process the sample.If partially used assay consumables are installed in different instruments, use of the consumables will automatically begin in the next available unused well.

[0108] The identifier can also be used to track the time a given assay consumable is present in the assay system. Therefore, when an assay consumable is inserted into or comes into contact with the assay system, a timer is activated in the assay system, and the start time is recorded in the identifier. When the assay is started by the system on the consumable or on a test site, domain, and / or sector within the consumable, the time is also recorded in the identifier. If the instrument, system, or its components are shut down (e.g., by turning off the power), the timer stops, and that time is recorded in the identifier. Therefore, whenever the timer stops, the accumulated onboard time is recorded in the identifier.

[0109] (iii) Analysis tools In another embodiment, the consumables 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 an assay. Furthermore, such analytical tools may include instructions that cause the customer and / or the system to generate specific outputs (e.g., data reports or formats tailored to the analysis results based on the consumables data) by the system software after the execution of the assay. Alternatively, the analytical tools may further include one or more statistical algorithms that can be applied by the system to the data. For example, the consumables data may include a selection of two or more statistical algorithms that can be used to analyze data resulting from the use of a given consumable, and the customer may optionally select the appropriate algorithm for the desired data analysis. The consumables data may also include information that the customer can use to select an appropriate algorithm for their needs, e.g., technical notes or literature references regarding algorithm selection.

[0110] The analytical tools may differ for each lot of consumables and / or for each individual consumable within a given lot. In this embodiment, consumable data is used by the system to adjust analytical processing tools applied by the system software during 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 can be applied to one or more steps of an assay protocol (which may also be modified based on consumable differences). In a particular embodiment, for a given type of consumable and / or desired use, the consumable data may include a project management tool that schedules the execution of one or more assays or steps using a given consumable or a set of consumables in the system. Furthermore, such analytical processing tools may 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 Consumable data may further include system maintenance information for the customer, including, but not limited to, system monitoring reports, system component usage, service history, system troubleshooting information, results of diagnostics performed on the system, control charts, periodic maintenance schedules, warranty information for the system and / or its components, or a combination thereof. System software may be programmed to monitor various components of the system and, automatically or as instructed, send monitoring reports to a remote monitoring system and / or service technician. If a direct interface is not available, the system may instruct the customer to send monitoring reports to the CD server via an indirect interface. Furthermore, or / or, such system monitoring reports may be accessed by service technicians responsible for maintaining and / or servicing the system, either on-site or remotely. In this embodiment, service technicians may communicate with the customer via a direct or indirect interface regarding the service or assistance of the equipment. In certain embodiments where a direct interface is available, the CD server monitors system component usage and / or warranty information and, based on the lifespan and / or warranty period of standard system components, determines the schedule for periodic system / component maintenance and / or upgrades by the service technician. However, the system may be programmed to automatically monitor such information on the system, and the customer may be periodically instructed to send the output of such monitoring activities to the CD server via an indirect interface if a direct interface is unavailable, so that service technicians can assess the system's condition and determine whether system service or maintenance is required. Furthermore, the CD server may maintain a log of service history for a given assay system and schedule service calls by service technicians (this may be done using either a direct or indirect interface).The remote computer system can also transmit individual assay system software upgrades via direct or indirect interfaces.

[0112] (v) System - Consumables Sales Promotion Information In another embodiment, consumable data may include promotional materials, for example, when a new type or lot of a consumable becomes available (particularly for products historically used by a given customer). Such promotional materials may also relate to new assay systems, modifications to the current system, and / or any accessories or improvements to the current system, particularly modifications, accessories or improvements 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 their previous use. This type of consumable data may also include literature references, catalogs, product inserts, technical and application notes, technical statements, conference information, and promotional seminars, particularly those relating 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 Consumable data also includes technical support information that can assist customers in the use of consumables or systems, such as product inserts and datasheet information, information on related products intended for use with the consumable, usage instructions, training materials, tutorials, recommended use and / or storage information, data analysis templates, template reports, calibration curves, lot-specific QC data, validated limits of quantification, and troubleshooting methods and / or algorithms. For consumables that include or are provided with one or more additional consumables (e.g., reagents), consumable data may also include reagent catalog numbers, reagent lot-specific information, reagent manufacturing date, reagent expiration date, usage instructions, training materials, tutorials, recommended use and / or storage, etc. 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 support features (i.e., live chat) to facilitate the customer experience. Naturally, technical support information may relate to consumables, systems, or both.

[0114] In a particular embodiment, 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 to the scope of the specific embodiments described herein. In fact, various modifications of the present invention, in addition to those described herein, will be apparent to those skilled in the art from the foregoing description and the accompanying drawings. Such modifications are intended to fall within the scope of the claims. Various publications, including U.S. Application No. 12 / 844,345 (filed July 27, 2010), are referenced herein, and their disclosures are joined by reference in their entirety.

Claims

1. An assay system configured to use assay consumables in the execution of an assay, wherein the assay consumables include assay consumable identifiers, and the assay system includes: (a) a storage medium including a consumable data repository including local consumable data; and (b) a reader adapted to read consumable data from the consumable identifier, wherein the consumable data and local consumable data are (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 the execution of an assay using the consumables. It includes, The system is configured to receive update information for the repository, which includes additional consumable data, as well as: (x) One or more analytical tools that can 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 - Information on sales promotion of consumables, (xx) System and / or consumables technical support information, or (yy) combinations of those The assay system comprising at least one consumable data type comprising the following:

2. The assay system according to claim 1, further comprising an interface configured to transmit and / or receive consumable data to and / or from a vendor computer system, the system receiving update information via the interface.

3. The assay system according to claim 2, wherein the interface comprises a direct interface, an indirect interface, or a combination thereof.

4. The assay system according to claim 1, wherein the system is configured to receive the update information from a remote storage medium including a compact disk, a memory card / stick, a flash drive, or a web data storage service.

5. The assay system according to claim 2, wherein the remote computer system is a consumables vendor computer system.

6. The assay system according to claim 1, wherein the assay consumable comprises at least one assay test site for the assay.

7. The assay system according to claim 6, wherein the test site comprises a plurality of separate assay domains, and at least two of the domains comprises reagents for measuring different subjects.

8. The assay system according to claim 6, wherein the test site is a well and / or chamber in the assay consumable.

9. The assay system according to claim 8, wherein 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.

10. The assay system according to claim 6, wherein the assay consumables include a flow cell.

11. The assay system according to claim 10, wherein the assay consumable is a cartridge, and the consumable further comprises at least one element including one or more fluid components, one or more detection components, one or more assay cells, reagents for performing the assay, a working electrode, a counter electrode, a reference electrode, a dielectric material, an electrical connection, a dry assay reagent and / or a liquid assay reagent, or a combination thereof.

12. The assay system according to claim 11, wherein the cartridge comprises at least one assay cell containing a plurality of distinct assay domains, and at least two of the domains contain reagents for measuring different subjects.

13. The assay system according to claim 1, wherein the assay consumable is a container adapted to accept one or more assay reagents.

14. The assay system according to claim 1, wherein the consumable data includes information used to identify at least one element, including (i) the assay consumable, (ii) one or more test sites within the consumable, (iii) reagents and / or samples used or to be used in the consumable, or (iv) a combination thereof.

15. The assay system according to claim 1, wherein the consumable data is used to distinguish a first test site within the consumable from other test sites within the consumable.

16. The assay system according to claim 1, wherein the consumable data is consumable information comprising lot identification information, lot-specific analytical parameters, manufacturing process information, raw material information, expiration date, calibration data, threshold information, the location of individual assay reagents and / or samples within one or more test sites of the assay consumables, material safety data sheet (MSDS) information, or a combination thereof.

17. The assay system according to claim 1, wherein the consumable data is sample information comprising the location of a sample within the at least one test site of the assay consumable, the 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.

18. The assay system according to claim 1, wherein the consumable data is management chain information.

19. The assay system according to claim 18, wherein the management chain information includes information regarding the management, transfer, analysis, or combination thereof of the sample.

20. The assay system according to claim 18, wherein the management chain information relates to the management, transfer, manufacture, or combination thereof of the assay consumables.

21. The assay system according to claim 18, wherein the management chain information includes customer identification, time and date stamps for the assay, location of the assay system during the assay, calibration and QC status of the assay system during the assay, management and / or location information for the assay consumables before and after the assay; assay results for the sample, or a combination thereof.

22. The assay system according to claim 18, wherein the control chain information includes time, date, manufacturing personnel, or processing parameters for one or more steps in the manufacture of the assay consumable; storage, location, and / or storage conditions for the assay consumable after and / or between steps in the manufacture of the assay consumable; or a combination thereof.

23. The assay system according to claim 1, wherein the consumable data is consumable / test site information comprising the type and structure of the consumable, the location and identity of the assay reagent included with the assay consumable, the location and identity of the assay reagent within the assay test site of the assay consumable, or a combination thereof.

24. The assay system according to claim 1, wherein the consumable data is 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, the statistical or analytical method to be applied by the reader to the raw data collected during the assay, or a combination thereof.

25. The assay system according to claim 1, wherein the assay is a multi-step assay, and the assay process information relates to one or more steps of the multi-step assay.

26. The assay system according to claim 23, wherein the consumable / test site information includes information relating to an assay previously performed by a reader at one or more test sites of the consumable; information relating to an assay to be performed by an assay reader or its components at one or more test sites within the consumable; or a combination thereof.

27. The assay system according to claim 1, wherein the consumable data is consumable security information comprising: information relating to assay consumable authentication; information relating to the appropriate placement and / or orientation of the assay consumable in the system; information relating to defects in the assay consumable and / or its test site; or a combination thereof.

28. The assay system according to claim 1, wherein the consumable data is used by the system to coordinate the operation of at least one component of the assay system, which includes 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 the one or more sensors and / or electrical, mechanical or fluid interfaces in the system; a mechanism, electronic equipment or software for tracking and / or identifying assay consumables; a mechanism for storing, stacking, moving and / or distributing one or more consumables; or a combination thereof.

29. A method of using an assay system configured to use assay consumables in the execution of an assay, wherein the assay consumables include assay consumable identifiers, and the assay system includes: (a) a storage medium including a consumable data repository including local consumable data; and (b) a reader adapted to read consumable data from the consumable identifier, wherein the consumable data and local consumable data are (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 the execution of an assay using the consumables. It includes, The system is configured to receive update information for the repository, and the update information includes additional consumable data, and at least one consumable data type comprising (x) one or more analytical tools that can 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 sales promotion information, (xx) technical support information for the system and / or consumables, or (yy) a combination thereof. (a) A step of reading consumable data from the consumable identifier; (b) A step of adjusting one or more operations performed by the system before, during, and / or after the execution of the assay by the system, based on the consumable data; (c) the step of performing an assay in the assay system using the assay consumables; and (d) Step of receiving update information for the repository The above method comprising the above.

30. The method according to claim 29, wherein the system is configured to receive update information from a remote storage medium comprising a compact disk, a memory card / stick, a flash drive, or a web data storage service, and further comprises the step of updating the repository via the remote storage medium.

31. The method according to claim 29, wherein the assay system includes an interface comprising a direct interface, an indirect interface, or a combination thereof, and further comprises the step of receiving update information from a remote computer system to the repository via the interface.

32. The method according to claim 31, wherein the interface is configured to transmit and / or receive consumable data to and / or from a vendor computer system, and the method further includes the step of receiving update information for the repository from the vendor computer system.

33. The method according to claim 29, wherein the consumable data further includes assay system maintenance information, and further includes the step of adjusting one or more components of the assay system based on the maintenance information.

34. The method according to claim 29, wherein the consumable data further comprises technical support information for the system and / or consumables, and further comprises the step of adjusting one or more steps of the assay based on the technical support information for the system and / or consumables.

35. A method for enabling a system / consumables vendor to use an assay system, wherein the assay system is configured to use assay consumables, each comprising an assay consumable identifier, in the execution of an assay, and the assay system comprises (a) a storage medium comprising local consumables data; and (b) a reader adapted to read consumables data from the consumables identifier, wherein the system / consumables vendor maintains a master consumables data repository comprising consumables data; The method, comprising the step of providing consumable data to a customer from the master consumable data repository in order to enable the use of the consumable data in the system.

36. The method according to claim 35, wherein the step of providing includes transmitting the consumable data via a remote storage medium.

37. The method according to claim 36, wherein the remote storage medium comprises a compact disk, a memory card / stick, a flash drive, or a web data storage service, and further comprises the step of updating the repository via the remote storage medium.

38. The method according to claim 35, wherein the assay system includes an interface comprising a direct interface, an indirect interface, or a combination thereof, and further comprises the step of transmitting update information from a vendor computer system to the interface.

39. The method according to claim 38, wherein the update information is automatically transmitted to the interface.

40. An assay system configured to use assay consumables in the execution of an assay, wherein the assay consumables include an assay consumable identifier, and the assay system includes: (a) an interface configured to transmit and / or receive consumable data to and / or from a vendor computer system, (b) a storage medium containing local consumable data, and (c) a reader adapted to read consumable data from the consumable identifier, wherein the consumable data is (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 the execution of an assay using the consumables. The assay system comprising the above.

41. The assay system according to claim 40, wherein the system is configured to transmit system-consumable usage information to a vendor computer system via the interface.

42. The assay system according to claim 40, wherein the system is configured to receive sales promotion information from a vendor computer system via the interface.

43. The assay system according to claim 42, wherein the vendor computer system is a computer system of a consumables manufacturer.

44. The assay system according to claim 42, wherein the interface includes a direct interface, an indirect interface, or a combination thereof.

45. A method for tracking the use of assay consumables in an assay system, wherein the assay consumables include an assay consumable identifier, and the assay system includes (a) an interface configured to transmit and / or receive consumable data to and / or from a vendor computer system, (b) a storage medium containing local consumable data, and (c) a reader adapted to read information from the consumable identifier, wherein the consumable data and local consumable data are (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 the execution of an assay using the consumables. It includes, below: (a) A step of reading consumable data from the consumable identifier; (b) The step of configuring the assay system to use the assay consumables in the execution of the assay of the system using the consumable data; (c) The step of performing an assay in the assay system using the assay consumables; (d) The step of storing consumable usage information in the storage medium; and (e) The system – the step of transmitting consumable usage information to the vendor computer system via the interface. The above method comprising the above.

46. The method according to claim 45, wherein the vendor computer system is a consumables manufacturing computer system.

47. The method according to claim 45, further comprising the step (f) of receiving additional consumable data via the interface, wherein the additional consumable data includes assay system maintenance information, system-consumable sales promotion information, system and / or consumable technical support information, or a combination thereof.

48. A method by which a system vendor controls customer access to an assay system, the system comprising a system identifier, the following: (a) The step of receiving the system identifier from the customer [where the system identifier is transmitted to the vendor computer system]; (b) the step of the vendor identifying the system identifier; and (c) (i) An operation that enables full access to the apparatus and / or consumables used in the apparatus; (ii) an operation that enables partial access to the apparatus and / or consumables used in the apparatus; or (iii) An operation that denies access to the device and / or consumables used in the device. A step of performing one or more operations selected from the following: The above method comprising the above.

49. The method according to claim 48, wherein the system further includes a remote interface comprising a direct interface, an indirect interface, or a combination thereof, and the receiving step (a) comprises receiving the system identifier via the remote interface.

50. The method according to claim 48, wherein the vendor receives the system identifier from the vendor computer system via the interface.

51. The method according to claim 48, wherein the enabling step (c)(i) further comprises the vendor sending a full access code to the customer, thereby enabling full access to the system.

52. The method according to claim 48, wherein the enabling step (c)(ii) further comprises the vendor transmitting a partial access code to the customer, thereby enabling partial access to the system.

53. The method according to claim 48, wherein the partial access code enables the use of the system in demonstration mode.

54. The method according to claim 48, wherein the vendor is a system manufacturer.

55. The method according to claim 48, wherein the vendor is a system distributor.

56. The method according to claim 48, wherein the assay system is configured to use assay consumables in the execution of the assay, and the vendor is a consumables manufacturer.

57. The method according to claim 48, wherein the assay system is configured to use assay consumables in the execution of the assay, and the vendor is a consumables distributor.

58. A method for generating and maintaining consumable data and consumable data about consumables: (a) A step of manufacturing consumables used in the execution of an assay; (b) The step of generating a database which includes consumable data associated with the consumable [wherein the database which includes information used to associate the consumable data with respect to the consumable]; and (c) The step of maintaining the database on a server, The above method comprising the above.

59. The method according to claim 58, wherein the server includes a master repository which includes a directory comprising a master consumables data directory, a master system identifier directory, a customer data directory, or a combination thereof.

60. The method according to claim 58, wherein the master repository includes an interface to one or more supplemental vendor directories, each comprising a master consumables data directory and a master system identifier directory, a customer data directory, or a combination thereof.

61. A method of providing customers with consumable data about consumables: (a) the step of receiving a query from the customer regarding consumable data associated with the consumable; and (b) The step of transmitting consumable data for the consumables by means of a medium including an email attachment, a compact disc, a memory card / stick, a flash drive, a web data storage service, or a combination thereof, The above method comprising the above.

62. A method for providing customers with consumable data about consumables, (a) the step of receiving queries from a customer system via a direct interface regarding consumable data associated with the consumable [where the direct interface includes an Internet connection between the customer system and the vendor server]; and (b) A step of transmitting consumable data for the consumable to the customer system via the interface, The above method comprising the above.

63. A computer-readable medium containing a computer program that, when executed on a computer system functionally connected to the assay system, causes the assay system to perform an assay on the assay system, wherein the assay system is configured to use assay consumables in the execution of the assay, and the assay system comprises: (a) a storage medium containing a consumable data repository containing local consumable data; and (b) a reader adapted to read consumable data from a consumable identifier; the method is as follows: (a) A step of reading consumable data from a consumable identifier associated with the assay consumable [wherein the consumable data and local consumable data include: (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 the execution of the assay using the consumable]; (b) A step of adjusting one or more operations performed by the system before, during, and / or after the assay based on the consumable data; (c) the step of performing the assay in the assay system using the assay consumables; and (d) A step of receiving update information for the repository [the update information includes additional consumable data, and at least one consumable data type comprising (x) one or more analytical tools that can 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 sales promotion information, (xx) technical support information for the system and / or consumables, or (yy) a combination thereof]. A computer-readable medium comprising the above.

64. The computer-readable medium according to claim 63, wherein the system is configured to receive update information from a remote storage medium comprising a compact disk, a memory card / stick, a flash drive, or a web data storage service, and the method further comprises the step of updating the repository via the remote storage medium.

65. The computer-readable medium according to claim 64, wherein the assay system includes an interface comprising a direct interface, an indirect interface, or a combination thereof, and the method further comprises the step of receiving update information from the remote computer system to the repository via the interface.

66. The computer-readable medium according to claim 65, wherein the interface is configured to transmit and / or receive consumable data to and / or from a vendor computer system, and the method includes the step of receiving update information for the repository from the vendor computer system.

67. The computer-readable medium according to claim 63, wherein the consumable data further includes assay system maintenance information, and the method further includes the step of adjusting one or more components of the assay system based on the maintenance information.

68. The computer-readable medium according to claim 63, wherein the consumable data further comprises technical support information for the system and / or consumables, and the method further comprises the step of adjusting one or more steps of the assay based on the technical support information for the system and / or consumables.

69. A computer-readable medium containing a computer program that, when executed on a computer system, causes the computer system to perform a method that enables the system / consumables vendor to use the assay system, wherein the assay system is functionally connected to the computer system and configured to use assay consumables, which include assay consumable identifiers, in the execution of the assay, and the assay system includes (a) a storage medium containing local consumable data; and (b) a reader adapted to read consumable data from the consumable identifier, wherein the system / consumables vendor maintains a master consumable data repository containing consumable data; The method comprises the step of receiving consumable data from a master consumable data repository to enable the use of the consumable in the system, on a computer-readable medium.

70. The computer-readable medium according to claim 69, wherein the receiving step includes receiving the consumable data via a remote storage medium.

71. The computer-readable medium according to claim 70, wherein the remote storage medium comprises a compact disk, a memory card / stick, a flash drive, or a web data storage service, and the method further comprises the step of updating the repository via the remote storage medium.

72. The computer-readable medium according to claim 69, wherein the assay system includes an interface comprising a direct interface, an indirect interface, or a combination thereof, and the method further comprises the step of receiving update information from a vendor computer system to the interface.

73. The computer-readable medium according to claim 72, wherein the update information is automatically transmitted to the interface.

74. A computer-readable medium containing a computer program that, when executed by a computer system, causes the computer system to perform a method for tracking the use of assay consumables in an assay system functionally connected to the computer system, wherein the assay consumables include assay consumable identifiers, and the assay system includes: (a) an interface configured to transmit and / or receive consumable data to and / or from a vendor computer system, (b) a storage medium containing local consumable data, and (c) a reader adapted to read information from the consumable identifiers. The method is as follows: (a) A step of reading consumable data from the consumable identifier [wherein the consumable data and local consumable data include (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, configure the assay system to use the assay consumable in running the assay of the system; (c) The step of performing an assay in the assay system using the assay consumables; (d) The step of storing consumable usage information in the storage medium; and (e) System – Step of transmitting consumable usage information to the vendor computer system via the interface. A computer-readable medium comprising the above.

75. A computer-readable medium according to claim 74, wherein the vendor computer system is a consumables manufacturing computer system.

76. The computer-readable medium according to claim 74, further comprising step (f) receiving additional consumable data via the interface, wherein the additional consumable data includes assay system maintenance information, system-consumable sales promotion information, system and / or consumable technical support information, or a combination thereof.

77. A computer-readable medium containing a computer program that, when executed by a computer system, causes the computer system to perform a method by which a system vendor controls customer access to an assay system, wherein the system includes a system identifier, and the method is as follows: (a) The step of receiving the system identifier from the customer [where the system identifier is transmitted to the vendor computer system]; (b) the step of the vendor identifying the system identifier; and (c) (i) An operation that enables full access to the apparatus and / or consumables used in the apparatus; (ii) an operation that enables partial access to the apparatus and / or consumables used in the apparatus; or (iii) An operation that denies access to the device and / or consumables used in the device. A step of performing one or more operations selected from: A computer-readable medium comprising the above.

78. The computer-readable medium according to claim 77, wherein the system further includes a remote interface comprising a direct interface, an indirect interface, or a combination thereof, and the receiving step (a) comprises receiving the system identifier via the remote interface.

79. The computer-readable medium according to claim 77, wherein the vendor receives the system identifier from the vendor computer system via the interface.

80. The computer-readable medium according to claim 77, wherein the enabling step (c)(i) further comprises the vendor transmitting a full access code to the customer, thereby enabling full access to the system.

81. The computer-readable medium according to claim 77, wherein the enabling step (c)(ii) further comprises the vendor transmitting a partial access code to the customer, thereby enabling partial access to the system.

82. The computer-readable medium according to claim 81, wherein the partial access code enables the use of the system in demonstration mode.

83. The computer-readable medium according to claim 77, wherein the vendor is a system manufacturer.

84. The computer-readable medium according to claim 77, wherein the vendor is a system distributor.

85. The computer-readable medium according to claim 77, wherein the assay system is configured to use assay consumables in the execution of the assay, and the vendor is a consumables manufacturer.

86. The computer-readable medium according to claim 77, wherein the assay system is configured to use assay consumables in the execution of the assay, and the vendor is a consumables distributor.

87. A computer-readable medium on which a computer program is stored causes the computer system to perform a method of generating and maintaining consumable data and consumable data about consumables when executed by the computer system, wherein the method is (a) the step of generating a database which includes consumable data associated with the consumable [wherein the database which includes information used to associate the consumable data with the consumable]; and (b) the step of maintaining the database on a server, A computer-readable medium comprising the above.

88. The computer-readable medium according to claim 87, wherein the server includes a master repository containing a directory comprising a master consumables data directory, a master system identifier directory, a customer data directory, or a combination thereof.

89. The computer-readable medium according to claim 88, wherein the master repository includes an interface to one or more supplemental vendor directories, each comprising a master consumables data directory and a master system identifier directory, a customer data directory, or a combination thereof.

90. A computer-readable medium containing a computer program that, when executed by a computer system, causes the computer system to perform a method of providing consumable data about consumables to a customer, wherein the method is: (a) the step of receiving a query from the customer regarding consumable data associated with the consumable; and (b) The step of transmitting consumable data for the consumable by means of a medium including an email attachment, a compact disc, a memory card / stick, a flash drive, a web data storage service, or a combination thereof, A computer-readable medium comprising the above.

91. A computer-readable medium containing a computer program that, when executed by a computer system, causes the computer system to perform a method of providing consumable data about consumables to a customer, wherein the method is: (a) receiving queries from a customer system via a direct interface regarding consumable data associated with the consumable [wherein the direct interface includes an Internet connection between the customer system and the vendor server]; and (b) A step of transmitting consumable data for the consumable to the customer system via the interface, A computer-readable medium comprising the above.

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