# US 8,770,471 B2 · Consumable data management > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,770,471 B2 - Document ID: US8770471B2 - Status: Granted - Kind: B2 - Application number: 13/191,000 - Filed: 2011-07-26 - Published: 2012-06-14 - Granted: 2014-07-08 - Earliest claimed: 2010-07-27 - Assignees: Meso Scale Technologies, LLC. - Applicants: Xinri Cong; Jerome Jackson; Carl Stevens; Michael Vock; Jacob N. Wohlstadter - Inventors: Xinri Cong; Jerome Jackson; Carl Stevens; Michael Vock; Jacob N. Wohlstadter - Web page: https://patentgrep.com/patent/US8770471B2 ## CPC - G06Q 30/0201: Market modelling; Market analysis; Collecting market data - G01N 35/00871: {Communications between instruments or with remote terminals} - G01N 35/0099: {comprising robots or similar manipulators (robots per se B25J)} - G01N 35/04: Details of the conveyor system {(G01N35/021 - G01N35/028 take precedence)} - G01N 35/1002: {Reagent dispensers} - G06F 16/21: Design, administration or maintenance of databases - G06F 16/951: Indexing; Web crawling techniques - G06Q 10/06: Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling - G06Q 10/10: Office automation; Time management - G06Q 30/0625: {by formulating product or service queries, e.g. using keywords or predefined options} - G07C 9/27: with central registration - G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis - G16Z 99/00: Subject matter not provided for in other main groups of this subclass - G01N 2035/00881: {network configurations} - G01N 2035/0425: {Stacks, magazines or elevators for plates} - G01N 2035/0475: {electric, e.g. stepper motor, solenoid} - G16B 50/00: ICT programming tools or database systems specially adapted for bioinformatics - Y02P 90/80: Management or planning - G06Q: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N) - G07C: TIME OR ATTENDANCE REGISTERS; REGISTERING OR INDICATING THE WORKING OF MACHINES; GENERATING RANDOM NUMBERS; VOTING OR LOTTERY APPARATUS; ARRANGEMENTS, SYSTEMS OR APPARATUS FOR CHECKING NOT PROVIDED FOR ELSEWHERE - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA - G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR - G16B: BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY - Y02P: CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS ## Abstract The present invention relates to methods, devices and systems for associating consumable data with an assay consumable used in a biological assay. Provided are assay systems and associated consumables, wherein the assay system adjusts one or more steps of an assay protocol based on consumable data specific for that consumable. Various types of consumable data are described, as well as methods of using such information in the conduct of an assay by an assay system. ## Claims ### Claim 1 An assay system configured to use an assay consumable in the conduct of an assay, said assay consumable comprising an assay consumable identifier and said assay system comprising: (a) a storage medium including a consumable data repository comprising local consumable data; (b) a reader adapted to read consumable data from said consumable identifier; and (c) an interface configured to send and/or receive consumable data to and/or from a remote computing system, wherein said consumable data and local consumable data comprises (i) consumable identification and/or configuration information, and (ii) one or more steps of an assay protocol that can be applied by said system in the conduct of an assay using said consumable, wherein said system is configured to receive updates of said repository via said interface, said updates comprising additional consumable data and at least one consumable data type comprising: (x) one or more analytical tools that can be applied by said system to analyze data generated during and/or after the conduct of an assay, (y) assay system maintenance information, (z) system-consumable promotional information, (xx) system and/or consumable technical support information, or (yy) combinations thereof. ### Claim 2 (depends on 1) The assay system of claim 1 wherein said interface comprises a direct interface, an indirect interface, or combinations thereof. ### Claim 3 (depends on 1) The assay system of claim 1 wherein said system is further configured to receive updates from a remote storage medium comprising a compact disc, a memory card/stick, a flash drive, or a web data storage service. ### Claim 4 (depends on 1) The assay system of claim 1 wherein said remote computing system is a consumable vendor computing system. ### Claim 5 (depends on 1) The assay system of claim 1 wherein said assay consumable comprises at least one assay test site for said assay. ### Claim 6 (depends on 5) The assay system of claim 5 wherein said test site comprises a plurality of distinct assay domains, at least two of said domains comprising reagents for measuring different analytes. ### Claim 7 (depends on 5) The assay system of claim 5 wherein said test sites are wells and/or chambers in said assay consumable. ### Claim 8 (depends on 7) The assay system of claim 7 wherein said assay consumable comprises a plurality of wells and said consumable further includes at least one element comprising a plate top, plate bottom, working electrodes, counter electrodes, reference electrodes, dielectric materials, electrical connections, dried and/or liquid assay reagents, or combinations thereof. ### Claim 9 (depends on 5) The assay system of claim 5 wherein said assay consumable comprises a flow cell. ### Claim 10 (depends on 9) The assay system of claim 9 wherein said assay consumable is a cartridge and said consumable further comprises at least one element including one or more fluidic components, one or more detection components, one or more assay cells, reagents for carrying out an assay, working electrodes, counter electrodes, reference electrodes, dielectric materials, electrical connections, dried and/or liquid assay reagents, or combinations thereof. ### Claim 11 (depends on 10) The assay system of claim 10 wherein said cartridge comprises at least one assay cell that includes a plurality of distinct assay domains, at least two of said domains comprising reagents for measuring different analytes. ### Claim 12 (depends on 1) The assay system of claim 1 wherein said assay consumable is a container adapted to receive one or more assay reagents. ### Claim 13 (depends on 1) The assay system of claim 1 wherein said consumable data comprises information used to identify at least one element including (i) said assay consumable, (ii) one or more test sites within said consumable, (iii) a reagent and/or sample that has been or will be used in said consumable, or (iv) combinations thereof. ### Claim 14 (depends on 1) The assay system of claim 1 wherein said consumable data is used to distinguish a first test site within said consumable from a different test site within said consumable. ### Claim 15 (depends on 1) The assay system of claim 1 wherein said consumable data is consumable information comprising lot identification information, lot specific analysis parameters, manufacturing process information, raw materials 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 combinations thereof. ### Claim 16 (depends on 1) The assay system of claim 1 wherein said consumable data is sample information comprising the location of samples within said at least one test sites of the assay consumable, assay results obtained on said assay consumable for said sample, identity of samples that have been and/or will be assayed in said assay consumable, or combinations thereof. ### Claim 17 (depends on 1) The assay system of claim 1 wherein said consumable data is chain of custody information. ### Claim 18 (depends on 17) The assay system of claim 17, wherein said chain of custody information includes information regarding the control, transfer, analysis of said sample, or combinations thereof. ### Claim 19 (depends on 17) The assay system of claim 17 wherein said chain of custody information regarding the control, transfer, manufacture of said assay consumable, or combinations thereof. ### Claim 20 (depends on 17) The assay system of claim 17, wherein said chain of custody information comprises customer identification, time and date stamp for said assay, location of said assay system during said assay, calibration and QC status of said assay system during said assay, custody and/or location information for said assay consumable before and after the conduct of said assay, assay results for said sample, or combinations thereof. ### Claim 21 (depends on 17) The assay system of claim 17, wherein said chain of custody information comprises time, date, manufacturing personnel or processing parameters for one or more steps during the manufacture of said assay consumable; custody, location and or storage conditions for said assay consumable following manufacture and/or between steps during the manufacture of said assay consumable; or combinations thereof. ### Claim 22 (depends on 1) The assay system of claim 1 wherein said consumable data is consumable/test site information comprising consumable type and structure, location and identity of assay reagents included with said assay consumable, location and identity of assay reagents within an assay test site of said assay consumable, or combinations thereof. ### Claim 23 (depends on 22) The assay system of claim 22 wherein said consumable/test site information comprises information concerning assays previously performed by a reader on one or more test sites of said consumable; information concerning assays to be performed by an assay reader or a component thereof on one or more test sites within said consumable; or combinations thereof. ### Claim 24 (depends on 1) The assay system of claim 1 wherein said consumable data is assay process information comprising assay parameters to be applied by said reader during the assay, a sequence of steps to be applied by said reader during said assay, the identity, concentration, and/or quantity of assay reagents to be used or added during said assay, the type or wavelength of light to be applied and/or measured by the reader during said assay, the temperature to be applied by the reader during said assay, an incubation time for said assay, statistical or analytical methods to be applied by the reader to raw data collected during said assay, or combinations thereof. ### Claim 25 (depends on 1) The assay system of claim 1 wherein said assay is a multi-step assay and said assay process information relates to a step or step(s) of said multi-step assay. ### Claim 26 (depends on 1) The assay system of claim 1 wherein said consumable data is consumable security information comprising information concerning assay consumable authentication; information concerning appropriate placement and/or orientation of said assay consumable in said system; information concerning defects in said assay consumable and/or a test site thereof; or combinations thereof. ### Claim 27 (depends on 1) The assay system of claim 1 wherein said consumable data is used by said system to adjust the operation of at least one component of said assay system comprising one or more sensors; mechanisms to transport the assay consumables into and out of the system; mechanisms to align and orient the assay consumables with said one or more sensors and/or with electrical, mechanical or fluidic interfaces in said system; mechanisms, electronics or software to track and/or identify assay consumables; mechanisms to store, stack, move and/or distribute one or more consumables; or combinations thereof. ### Claim 28 A method of using an assay system configured to use an assay consumable in the conduct of an assay, said assay consumable comprising an assay consumable identifier and said assay system comprising: (a) a storage medium including a consumable data repository comprising local consumable data; (b) a reader adapted to read consumable data from said consumable identifier; and (c) an interface configured to send and/or receive consumable data to and/or from a remote computing system, wherein said consumable data and local consumable data comprises (i) consumable identification and/or configuration information, and (ii) one or more steps of an assay protocol that can be applied by said system in the conduct of an assay using said consumable, wherein said system is configured to receive updates of said repository via said interface, said updates comprising additional consumable data and at least one consumable data type comprising (x) one or more analytical tools that can be applied by said system to analyze data generated during and/or after the conduct of an assay, (y) assay system maintenance information, (z) system-consumable promotional information, (xx) system and/or consumable technical support information, or (yy) combinations thereof, said method comprising the steps of: (a) reading consumable data from said consumable identifier; (b) adjusting one or more operations performed by said system before, during, and/or after the conduct of said assay by said system based on said consumable data; (c) conducting an assay in said assay system using said assay consumable; and (d) receiving said updates of said repository. ### Claim 29 (depends on 28) The method of claim 28 wherein said system is further configured to receive updates from a remote storage medium comprising a compact disc, a memory card/stick, a flash drive, or a web data storage service, and said method further comprises the step of updating said repository via said remote storage medium. ### Claim 30 (depends on 28) The method of claim 28 wherein said interface comprises a direct interface, an indirect interface, or combinations thereof, and said method further comprises the step of receiving updates to said repository via said interface from said remote computing system. ### Claim 31 (depends on 30) The method of claim 30 wherein said interface is configured to send and/or receive consumable data to and/or from a vendor computing system and said method comprises receiving updates of said repository from said vendor computing system. ### Claim 32 (depends on 28) The method of claim 28 wherein said consumable data further comprises assay system maintenance information and said method further comprises the step of adjusting one or more components of said assay system based on said maintenance information. ### Claim 33 (depends on 28) The method of claim 28 wherein said consumable data further comprises system and/or consumable technical support information and said method further comprises the step of adjusting one or more steps of said assay based on said system and/or consumable technical support information. ### Claim 34 A method of enabling use of an assay system by a system/consumable vendor, said assay system being configured to use an assay consumable in the conduct of an assay comprising an assay consumable identifier and said assay system comprising (a) a storage medium comprising local consumable data; and (b) a reader adapted to read consumable data from said consumable identifier, wherein said system/consumable vendor maintains a master consumable data repository comprising consumable data; said method comprising the step of providing consumable data to a customer from said master consumable data repository to enable use in said system of said consumable data. ### Claim 35 (depends on 34) The method of claim 34 wherein said providing step comprises sending said consumable data via a remote storage medium. ### Claim 36 (depends on 35) The method of claim 35 wherein said remote storage medium comprises a compact disc, a memory card/stick, a flash drive, or a web data storage service, and said method further comprises the step of updating said repository via said remote storage medium. ### Claim 37 (depends on 34) The method of claim 34 wherein said assay system comprises an interface comprising a direct interface, an indirect interface, or combinations thereof, and said method further comprises the step of sending updates to said interface from a vendor computing system. ### Claim 38 (depends on 37) The method of claim 37 wherein said updates are automatically sent to said interface. ### Claim 39 An assay system configured to use an assay consumable in the conduct of an assay, said assay consumable comprising an assay consumable identifier and said assay system comprising: (a) an interface configured to send and/or receive consumable data to and/or from a vendor computing system, (b) a storage medium comprising local consumable data, and (c) a reader adapted to read consumable data from said consumable identifier, wherein said consumable data comprises (i) consumable identification and/or configuration information, and (ii) one or more steps of an assay protocol that can be applied by said system in the conduct of an assay using said consumable. ### Claim 40 (depends on 39) The assay system of claim 39 wherein said system is configured to send system-consumable use information via said interface to a vendor computing system. ### Claim 41 (depends on 39) The assay system of claim 39 wherein said system is configured to receive promotional information via said interface from a vendor computing system. ### Claim 42 (depends on 41) The assay system of claim 41 wherein said vendor computing system is a consumable manufacturer computing system. ### Claim 43 (depends on 41) The assay system of claim 41 wherein said interface comprises a direct interface, an indirect interface, or combinations thereof. ### Claim 44 A method of tracking use of assay consumables in an assay system, said assay consumable comprising an assay consumable identifier and said assay system comprising (a) an interface configured to send and/or receive consumable data to and/or from a vendor computing system, (b) a storage medium comprising local consumable data, and (c) a reader adapted to read information from said consumable identifier, wherein said consumable data and local consumable data comprises (i) consumable identification and/or configuration information, and (ii) one or more steps of an assay protocol that can be applied by said system in the conduct of an assay using said consumable, said method comprising the steps of: (a) reading consumable data from said consumable identifier; (b) configuring said assay system for use of said assay consumable in the conduct of an assay in said system using said consumable data; (c) conducting an assay in said assay system using said assay consumable; (d) storing system-consumable use information to said storage medium; and (e) sending system-consumable use information to said vendor computing system via said interface. ### Claim 45 (depends on 44) The method of claim 44 wherein said vendor computing system is a consumable manufacturing computer system. ### Claim 46 (depends on 44) The method of claim 44 further comprising the step of (f) receiving additional consumable data via said interface, said additional consumable data comprises assay system maintenance information, system-consumable promotional information, system and/or consumable technical support information, or combinations thereof. ### Claim 47 A non-transitory computer readable medium having stored thereon a computer program which, when executed by a computer system operatively connected to an assay system, causes the assay system to perform a method of conducting an assay on said assay system, wherein said assay system is configured to use an assay consumable in the conduct of said assay and said assay system comprises: (a) a storage medium including a consumable data repository comprising local consumable data; (b) a reader adapted to read consumable data from said consumable identifier; and (c) an interface configured to send and/or receive consumable data to and/or from a remote computing system; said method comprising the steps of: (a) reading consumable data from a consumable identifier associated with said assay consumable, wherein said consumable data and local consumable data comprises: (i) consumable identification and/or configuration information, and (ii) one or more steps of an assay protocol that can be applied by said system in the conduct of said assay using said consumable; (b) adjusting one or more operations performed by said system before, during and/or after the conduct of said assay based on said consumable data; (c) conducting said assay in said assay system using said assay consumable; and (d) receiving updates of said repository via said interface, said updates comprising additional consumable data and at least one consumable data type comprising (x) one or more analytical tools that can be applied by said system to analyze data generated during and/or after the conduct of an assay, (y) assay system maintenance information, (z) system-consumable promotional information, (xx) system and/or consumable technical support information, or (yy) combinations thereof. ### Claim 48 (depends on 47) The non-transitory computer readable medium of claim 47 wherein said system is further configured to receive updates from a remote storage medium comprising a compact disc, a memory card/stick, a flash drive, or a web data storage service, and said method further comprises the step of updating said repository via said remote storage medium. ### Claim 49 (depends on 48) The non-transitory computer readable medium of claim 48 wherein said interface comprises a direct interface, an indirect interface, or combinations thereof, and said method further comprises the step of receiving updates to said repository via said interface from said remote computing system. ### Claim 50 (depends on 49) The non-transitory computer readable medium of claim 49 wherein said interface is further configured to send and/or receive consumable data to and/or from a vendor computing system and said method comprises receiving updates of said repository from said vendor computing system. ### Claim 51 (depends on 47) The non-transitory computer readable medium of claim 47 wherein said consumable data further comprises assay system maintenance information and said method further comprises the step of adjusting one or more components of said assay system based on said maintenance information. ### Claim 52 (depends on 47) The non-transitory computer readable medium of claim 47 wherein said consumable data further comprises system and/or consumable technical support information and said method further comprises the step of adjusting one or more steps of said assay based on said system and/or consumable technical support information. ### Claim 53 A non-transitory computer readable medium having stored thereon a computer program which, when executed by a computer system, causes the computer system to perform a method of enabling use of an assay system by a system/consumable vendor, said assay system being operatively connected to said computer system and configured to use an assay consumable in the conduct of an assay comprising an assay consumable identifier and said assay system comprising (a) a storage medium comprising local consumable data; and (b) a reader adapted to read consumable data from said consumable identifier, wherein said system/consumable vendor maintains a master consumable data repository comprising consumable data; said method comprising the step of receiving consumable data from said master consumable data repository to enable use of said consumable in said system. ### Claim 54 (depends on 53) The non-transitory computer readable medium of claim 53 wherein said receiving step comprises receiving said consumable data via a remote storage medium. ### Claim 55 (depends on 54) The non-transitory computer readable medium of claim 54 wherein said remote storage medium comprises a compact disc, a memory card/stick, a flash drive, or a web data storage service, and said method further comprises the step of updating said repository via said remote storage medium. ### Claim 56 (depends on 53) The non-transitory computer readable medium of claim 53 wherein said assay system comprises an interface comprising a direct interface, an indirect interface, or combinations thereof, and said method further comprises the step of receiving updates to said interface from a vendor computing system. ### Claim 57 (depends on 26) The non-transitory computer readable medium of claim 26 wherein said updates are automatically sent to said interface. ### Claim 58 A non-transitory computer readable medium having stored thereon a computer program which, when executed by a computer system, causes the computer system to perform a method of tracking use of assay consumables in an assay system operatively connected to said computer system, said assay consumable comprising an assay consumable identifier and said assay system comprising: (a) an interface configured to send and/or receive consumable data to and/or from a vendor computing system, (b) a storage medium comprising local consumable data, and (c) a reader adapted to read information from said consumable identifier, said method comprising the steps of: (a) reading consumable data from said consumable identifier, wherein said consumable data and local consumable data comprises (i) consumable identification and/or configuration information, and (ii) one or more steps of an assay protocol that can be applied by said system in the conduct of an assay using said consumable; (b) configuring said assay system for use of said assay consumable in the conduct of an assay in said system using said consumable data; (c) conducting an assay in said assay system using said assay consumable; (d) storing system-consumable use information to said storage medium; and (e) sending system-consumable use information to said vendor computing system via said interface. ### Claim 59 (depends on 58) The non-transitory computer readable medium of claim 58 wherein said vendor computing system is a consumable manufacturing computer system. ### Claim 60 (depends on 58) The non-transitory computer readable medium of claim 58 further comprising the step of (f) receiving additional consumable data via said interface, said additional consumable data comprising assay system maintenance information, system-consumable promotional information, system and/or consumable technical support information, or combinations thereof.