Assay information management methods and devices

Abstract

The present invention relates to methods, devices and systems for associating assay information with an assay consumable used in a biological assay. Provided are assay systems and associated consumables, wherein the assay system includes a reader adapted to read/erase/write information from/to an assay consumable identifier associated with the assay consumable. Various types of assay information are described, as well as methods of using such information in the conduct of an assay by an assay system.

1 .- 88 . (canceled) 
     
     
         89 . An assay system configured to use an assay consumable in the conduct of an assay, said assay system comprising a reader adapted to perform the following operations:
 (i) reading lot identification information from a first consumable identifier associated with said assay consumable;   (ii) reading lot specific parameters from an additional consumable identifier; and   (iii) using said lot identification information and said lot specific parameters to adjust one or more operations performed by said assay system before, during and/or after the conduct of an assay by said system.   
     
     
         90 . The assay system of  claim 89 , wherein said assay consumable is a multi-well assay plate or a cartridge. 
     
     
         91 . The assay system of  claim 89 , wherein said first consumable identifier comprises non-volatile memory. 
     
     
         92 . The assay system of  claim 91 , wherein said non-volatile memory is selected from the group consisting of an RFID tag, a bar code, ICC, an EPROM, and EEPROM. 
     
     
         93 . The assay system of  claim 92 , wherein said non-volatile memory is a bar code. 
     
     
         94 . The assay system of  claim 89 , wherein said additional consumable identifier comprises non-volatile memory. 
     
     
         95 . The assay system of  claim 94 , wherein said non-volatile memory is selected from the group consisting of an RFID tag, a bar code, ICC, an EPROM, and EEPROM. 
     
     
         96 . The assay system of  claim 95 , wherein said non-volatile memory is an ICC. 
     
     
         97 . The assay system of  claim 96 , wherein said ICC is a memory card. 
     
     
         98 .- 106 . (canceled) 
     
     
         107 . The assay system of  claim 89 , wherein the first consumable identifier further comprises origin information regarding the origin of a biological reagent used in the assay consumable, the origin information comprising identification of an original sample from which it was derived and the number of generations removed it is from an original sample. 
     
     
         108 . The assay system of  claim 90 , wherein said lot specific parameters are selected from the group consisting of (i) a revision level that determines schema used to interpret assay results and/or assay information; (ii) cartridge type; (iii) year of cartridge manufacture; (iv) cartridge lot number; (v) expiration date of cartridge and/or reagents used in said assay; (vi) a cross-talk correction matrix to account for chemical cross-reactivity; (vi) threshold values for assays to be conducted in said cartridge; (vii) a range for internal positive control(s) used in said assay; (viii) a ranges for each assay to be conducted in said cartridge for a positive control sample; and (ix) a software checksum. 
     
     
         109 . The assay system of  claim 90 , wherein said cartridge comprises a flow cell having an assay chamber, and further comprising an inlet, an outlet or a detection chamber, said inlet, detection chamber, or outlet defining a flow path through said flow cell. 
     
     
         110 . The assay system of  claim 90 , wherein said assay consumable is a multi-well assay plate, and the assay system is configured to use the multi-well assay plate, an additional multi-well assay plate, and one or more sample tube racks in the conduct of an assay, wherein the reader is configured to perform the following operations (i) reading tube position information from a first consumable identifier associated with said one or more sample tube racks; (ii) reading assay information and lot specific parameters from an additional consumable identifier associated with said additional multi-well assay plate; (iii) using position information and said lot specific parameters to adjust one or more operations performed by said assay system before, during and/or after the conduct of an assay on said multi-well assay plate by said system; (iv) erasing information from said additional consumable identifier; and (v) writing information to said additional consumable identifier. 
     
     
         111 . The assay system of clam  90  wherein said assay information is selected from the group consisting of (i) a digital signature to verify manufacturer identify; (ii) lot code of said multi-well assay plate; (iii) expiration date of said multi-well assay plate; (iv) type of multi-well assay plate; (v) serialized identification for said additional multi-well assay plate; and (vi) lot specific parameters for said multi-well assay plate. 
     
     
         112 . The assay system of  claim 111 , wherein said lot specific parameters for said multi-well assay plate are selected from the group consisting of (i) in-well control acceptance ranges; (ii) assay names; (iii) assay identifiers; (iv) assay thresholds; (v) number and identity of assay quality controls; (vi) assay quality control acceptance ranges; (vii) calibration information; (viii) number and identity of assay calibrators; (ix) assay calibrator acceptance ranges; (x) chemical cross-talk matrix for said multi-well assay plate; and (xi) combinations thereof. 
     
     
         113 . The assay system of  claim 89 , wherein the assay system further comprises an auxiliary assay plate, wherein said auxiliary assay plate comprises an auxiliary assay consumable identifier, wherein said reader is adapted to perform an operation of reading information from said auxiliary assay consumable identifier. 
     
     
         114 . The assay system of  claim 113 , wherein said auxiliary assay consumable identifier comprises information identifying the auxiliary assay plate. 
     
     
         115 . The assay system of  claim 114 , wherein said auxiliary assay consumable identifier is a barcode. 
     
     
         116 . The assay system of  claim 89 , wherein said reader is configured to perform an operation selected from the group consisting of (i) read information from said consumable identifier; (ii) erase information from said consumable identifier; (iii) write information to said consumable identifier; and (iv) combinations thereof, wherein said read information, erase information, and/or write information comprises:
 authorization information for said consumable or a test site thereof or a domain thereof, said authorization information comprising whether a user has a valid license to use said consumable, the number of times the user is permitted to use said consumable, or the limitations on said use of the consumable by the user, if any, and at least one of the following (a)-(c);   (a) a digital signature indicating the consumable was manufactured by a designated vendor;   (b) data regarding how one or more steps in an assay protocol may be adjusted to account for lot to lot or consumable to consumable differences; or   (c) lot-specific analysis parameters comprising the revision level that determines the schema used to interpret the assay results, a cross-talk correction matrix to account for chemical cross-reactivity, a threshold for assays to be conducted in the consumable and each internal negative control, a range for each internal positive control, ranges for each assay to be conducted for the positive control sample, a software checksum to ensure integrity of the data, in-well or in-test site control acceptance ranges, negative and positive quality control materials that are used to verify the operation of said consumable, master calibration curve information, or assay calibrator acceptance ranges.   
     
     
         117 . The assay system of  claim 116 , wherein said read information, erase information, and/or write information further comprises:
 lot-specific analysis parameters comprising the revision level that determines the schema used to interpret the assay results, a cross-talk correction matrix to account for chemical cross-reactivity, a threshold for assays to be conducted in the consumable and each internal negative control, a range for each internal positive control, ranges for each assay to be conducted for the positive control sample, a software checksum to ensure integrity of the data, in-well or in-test site control acceptance ranges, negative and positive quality control materials that are used to verify the operation of said consumable, master calibration curve information, or assay calibrator acceptance ranges.