Assay information management methods and devices

• US 10,446,263 B2
• Filed: 09/23/2015
• Issued: 10/15/2019
• Est. Priority Date: 07/27/2009
• Status: Active Grant

• Current Assignee: Meso Scale Technologies, LLC
• Original Assignee: Meso Scale Technologies, LLC
• Inventors: Clinton, Charles M., Cong, Xinri, Glezer, Eli N., Kumar, Sudeep, Stevens, Carl, Vock, Michael, Willoughby, Jon S.
• Primary Examiner(s): Mui, Christine T
• Application Number:
  US14/862,298
• Publication Number:
  US 20160012208A1
• Time in Patent Office: 1,483 Days
• Field of Search: 436 50, 436 43
• CPC Class Codes: B01L 2300/02 Identification, exchange or storage of information
• CPC Class Codes: B01L 3/54 Labware with identification means identification of carriers, materials or components in automatic analysers G01N35/00732
• CPC Class Codes: G01N 2035/00633 logging process history of individual samples
• CPC Class Codes: G01N 2035/00851 process control parameters
• CPC Class Codes: G01N 33/54306 Solid-phase reaction mechanisms
• CPC Class Codes: G01N 35/00663 of consumables
• CPC Class Codes: G16C 20/20 Identification of molecular entities, parts thereof or of chemical compositions
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis

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.

Claims

1. A method of using an assay consumable in an assay system, wherein said assay consumable comprises a consumable identifier on a first assay consumable and a plurality of test sites and said assay system comprises a reader adapted 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 the read information, erase information, and/or write information comprises calibration data and-multiplexing information to identify at least one assay test site and a component thereof in said plurality of test sites, wherein the multiplexing information further comprises at least one of (A) the configuration of the plurality of test sites, (B) assay format, (C) specific processing steps and (D) analytical methods that should be applied by the system once an assay is conducted to analyze the output of an assay in a given test site, said method comprising the steps of (a) reading information from said consumable identifier, wherein the information comprises identification information of one or more other consumables associated with the first assay consumable, and wherein the assay system determines the presence of consumable identifiers of the one or more other consumables in the assay system;

(b) conducting an assay in said assay system using said assay consumable;

(c) writing information resulting from said assay conducted in step (b) to said consumable identifier; and

(d) tracking use of said assay consumable, 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 (i)-(iii);

(i) a digital signature indicating the consumable was manufactured by a designated vendor;

(ii) 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

(iii) 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,

wherein said assay consumable is a multi-well plate or a cartridge, and wherein said consumable identifier is not a radio frequency identification (RFID) tag.

19. The method of claim 1, wherein said information read from said consumable identifier comprises a digital signature.

21. The method of claim 1, wherein said information read from said consumable identifier is origin information of a biological reagent of the assay consumable.

22. The method of claim 21, wherein said origin information is identification information of an original sample of the biological reagent.

24. The method of claim 1, further comprising 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.

25. The method of claim 24, wherein said consumable identifier comprises information identifying the auxiliary assay plate.

26. The method of claim 24, wherein said auxiliary assay consumable identifier is a barcode.

27. The method of claim 1, wherein said assay consumable is inside a container, and wherein said consumable identifier is affixed to the container.

33. The method of claim 1, wherein the assay consumable identifier further comprises origin information regarding the origin of a biological reagent used in an assay consumable, test site and/or domain, 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.

2. A method of tracking use of an assay consumable comprising an assay consumable identifier and a plurality of test sites, said method comprising (a) reading test site usage information from said assay consumable identifier, wherein the information comprises identification information of one or more other consumables associated with the first assay consumable, and wherein the test site usage information comprises calibration data and multiplexing information to identify at least one assay test site and a component thereof in said plurality of test sites, wherein the multiplexing information further comprises at least one of (A) the configuration of the plurality of test sites, (B) assay format, (C) specific processing steps and (D) analytical methods that should be applied by the system once an assay is conducted to analyze the output of an assay in a given test site, and wherein the assay system determines the presence of consumable identifiers of the one or more other consumables in the assay system;

(b) identifying, based on said test site usage information, an available test site on said consumable;

(c) carrying out an assay using said available test site; and

(d) writing updated test site usage information to said assay identifier, wherein said assay consumable identifier 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 (i)-(iii);

(i) a digital signature indicating the consumable was manufactured by a designated vendor;

(ii) 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

(iii) 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,

wherein said assay consumable is a multi-well plate or a cartridge, and wherein said consumable identifier is not a radio frequency identification (RFID) tag.

3. The method of claim 2, wherein said information is selected from the group consisting of chain of custody information;

assay results obtained on said assay consumable or one or more test site(s); and

identity of samples that have been and/or will be assayed in said assay consumable or a portion thereof.

4. The method of claim 3, wherein said information is chain of custody information comprising information regarding the control, transfer, and/or analysis of said sample.

5. The method of claim 3, wherein said information is chain of custody information comprising information regarding the control, transfer, and/or manufacture of said assay consumable.

6. The method of claim 3, wherein said chain of custody information is selected from the group consisting of user identification;

time and date stamp for said assay;

location of said assay system during said assay;

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; and

combinations thereof.

7. The method of claim 3, wherein said information is chain of custody information selected from the group consisting of 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; and

combinations thereof.

23. The method of claim 2, wherein an assay was previously carried out with the assay consumable and step (a) of reading the test site usage information from said assay consumable identifier determines which of the plurality of test sites are available for carrying out another assay in step (c).

28. The method of claim 2, wherein said assay consumable is inside a container, and wherein said assay consumable identifier is affixed to the container.

34. The method of claim 2, wherein the assay consumable identifier further comprises origin information regarding the origin of a biological reagent used in an assay consumable, test site and/or domain, 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.

8. A method of tracking the manufacture of an assay consumable, wherein said assay consumable comprises an identifier and a plurality of test sites and one or more component parts and said manufacturing process includes one or more operations conducted by one or more manufacturing consumables each comprising a reader adapted to perform an operation of (i) reading manufacturing information from said identifier, wherein the information comprises identification information of one or more other consumables associated with the first assay consumable and wherein the manufacturing information comprises calibration data and multiplexing information to identify at least one assay test site and a component thereof in said plurality of test sites, wherein the multiplexing information further comprises at least one of (A) the configuration of the plurality of test sites, (B) assay format, (C) specific processing steps and (D) analytical methods that should be applied by the system once an assay is conducted to analyze the output of an assay in a given test site, and wherein the assay system determines the presence of consumable identifiers of the one or more other consumables in the assay system;

and optionally an operation selected from the group consisting of (ii) erasing manufacturing information from said identifier;

(iii) writing manufacturing information to said identifier; and

(iv) combinations thereof;

said method comprising (a) affixing said identifier to a first component of said consumable;

(b) performing an operation of said manufacturing process;

(c) writing manufacturing information to said identifier, wherein said manufacturing information comprises information related to the operation performed in step (b);

(d) performing an additional step in said manufacturing process; and

(e) writing manufacturing information to said identifier, wherein said manufacturing information comprises information related to the operation performed in step (d), wherein said reading manufacturing information, erasing manufacturing information, and/or writing manufacturing 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 (i)-(ii);

(i) a digital signature indicating the consumable was manufactured by a designated vendor;

(ii) 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

(iii) 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,

wherein said assay consumable is a multi-well plate or a cartridge, and wherein said consumable identifier is not a radio frequency identification (RFID) tag.

9. The method of claim 8, wherein said manufacturing information is selected from the group consisting of lot-specific information;

reagent expiration date;

threshold information;

the location of individual reagents within a test site of the assay consumable;

chain of custody information; and

combinations thereof.

29. The method of claim 8, wherein said assay consumable is inside a container, and wherein said consumable identifier is affixed to the container.

35. The method of claim 8, wherein the assay consumable identifier further comprises origin information regarding the origin of a biological reagent used in an assay consumable, test site and/or domain, 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.

10. A method of using an assay consumable in an assay system, wherein said assay consumable comprises a consumable identifier and a plurality of test sites and said assay system comprises a reader adapted 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 the read information, erase information, and/or write information comprises calibration data and multiplexing information to identify at least one assay test site and a component thereof in said plurality of test sites, wherein the multiplexing information further comprises at least one of (A) the configuration of the plurality of test sites, (B) assay format, (C) specific processing steps and (D) analytical methods that should be applied by the system once an assay is conducted to analyze the output of an assay in a given test site, said method comprising the steps of (a) reading information from said consumable identifier, wherein said assay system determines whether the first assay consumable is a correct assay consumable by confirming the presence or absence of at least one of a digital signature of the first assay consumable, a placement of the first assay consumable in the assay system, and a defect in the first assay consumable;

(b) conducting an assay in said assay system using said assay consumable;

(c) writing information resulting from said assay conducted in step (b) to said consumable identifier; and

(d) tracking use of said assay consumable, 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 (i)-(iii);

(i) a digital signature indicating the consumable was manufactured by a designated vendor;

(ii) 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

(iii) 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,

wherein said assay consumable is a multi-well plate or a cartridge, and wherein said consumable identifier is an electronically erasable programmable read-only memory (EEPROM).

12. The method of claim 10, wherein said information is selected from the group consisting of chain of custody information;

assay results obtained on said assay consumable or one or more test site(s); and

identity of samples that have been and/or will be assayed in said assay consumable or a portion thereof.

13. The method of claim 12, wherein said information is chain of custody information comprising information regarding the control, transfer, and/or analysis of said sample.

14. The method of claim 12, wherein said information is chain of custody information comprising information regarding the control, transfer, and/or manufacture of said assay consumable.

15. The method of claim 12, wherein said chain of custody information is selected from the group consisting of user identification;

time and date stamp for said assay;

location of said assay system during said assay;

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; and

combinations thereof.

16. The method of claim 12, wherein said information is chain of custody information selected from the group consisting of 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; and

combinations thereof.

30. The method of claim 10, wherein said assay consumable is inside a container, and wherein said consumable identifier is affixed to the container.

36. The method of claim 10, wherein the assay consumable identifier further comprises origin information regarding the origin of a biological reagent used in an assay consumable, test site and/or domain, 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.

11. A method of tracking use of an assay consumable comprising an assay consumable identifier and a plurality of test sites, said method comprising (a) reading test site usage information from said assay consumable identifier, wherein said assay system determines whether the first assay consumable is a correct assay consumable by confirming the presence or absence of at least one of a digital signature of the first assay consumable, a placement of the first assay consumable in the assay system, and a defect in the first assay consumable, and wherein the test site usage information comprises calibration data and multiplexing information to identify at least one assay test site and a component thereof in said plurality of test sites, wherein the multiplexing information further comprises at least one of (A) the configuration of the plurality of test sites, (B) assay format, (C) specific processing steps and (D) analytical methods that should be applied by the system once an assay is conducted to analyze the output of an assay in a given test site;

(b) identifying, based on said test site usage information, an available test site on said consumable;

(c) carrying out an assay using said available test site; and

(d) writing updated test site usage information to said assay identifier, wherein said assay consumable identifier 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 (i)-(iii);

(i) a digital signature indicating the consumable was manufactured by a designated vendor;

(ii) 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

(iii) 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,

wherein said assay consumable is a multi-well plate or a cartridge, and wherein said consumable identifier is an electronically erasable programmable read-only memory (EEPROM).

31. The method of claim 11, wherein said assay consumable is inside a container, and wherein said assay consumable identifier is affixed to the container.

37. The method of claim 11, wherein the assay consumable identifier further comprises origin information regarding the origin of a biological reagent used in an assay consumable, test site and/or domain, 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.

17. A method of tracking the manufacture of an assay consumable, wherein said assay consumable comprises an identifier and a plurality of test sites and one or more component parts and said manufacturing process includes one or more operations conducted by one or more manufacturing consumables each comprising a reader adapted to perform an operation of (i) reading manufacturing information from said identifier, wherein said assay system determines whether the first assay consumable is a correct assay consumable by confirming the presence or absence of at least one of a digital signature of the first assay consumable and wherein the manufacturing information comprises calibration data and multiplexing information to identify at least one assay test site and a component thereof in said plurality of test sites, wherein the multiplexing information further comprises at least one of (A) the configuration of the plurality of test sites, (B) assay format, (C) specific processing steps and (D) analytical methods that should be applied by the system once an assay is conducted to analyze the output of an assay in a given test site, a placement of the first assay consumable in the assay system, and a defect in the first assay consumable;

and optionally an operation selected from the group consisting of (ii) erasing manufacturing information from said identifier;

(iii) writing manufacturing information to said identifier; and

(iv) combinations thereof;

said method comprising (a) affixing said identifier to a first component of said consumable;

(b) performing an operation of said manufacturing process;

(c) writing manufacturing information to said identifier, wherein said manufacturing information comprises information related to the operation performed in step (b);

(d) performing an additional step in said manufacturing process; and

(e) writing manufacturing information to said identifier, wherein said manufacturing information comprises information related to the operation performed in step (d), wherein said reading manufacturing information, erasing manufacturing information, and/or writing manufacturing 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 (i)-(iii);

(i) a digital signature indicating the consumable was manufactured by a designated vendor;

(ii) 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

(iii) 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,

wherein said assay consumable is a multi-well plate or a cartridge, and wherein said consumable identifier is an electronically erasable programmable read-only memory (EEPROM).

18. The method of claim 17, wherein said manufacturing information is selected from the group consisting of lot-specific information;

reagent expiration date;

threshold information;

the location of individual reagents within a test site of the assay consumable;

chain of custody information; and

combinations thereof.

20. The method of claim 17, wherein said number of times the particular user can conduct the assay is limited.

32. The method of claim 17, wherein said assay consumable is inside a container, and wherein said consumable identifier is affixed to the container.

38. The method of claim 17, wherein the assay consumable identifier further comprises origin information regarding the origin of a biological reagent used in an assay consumable, test site and/or domain, 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.