Assay information management methods and devices

Patent metadata

Field	Value
Publication number	US-11315662-B2
Application number	US-201916594301-A
Country	US
Kind code	B2
Filing date	Oct 7, 2019
Priority date	Jul 27, 2009
Publication date	Apr 26, 2022
Grant date	Apr 26, 2022

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.

First claim

What is claimed is:

1. A method of using an assay cartridge, in the conduct of an assay, with an assay system, said assay system comprising a reader, the method comprising:
(i) reading cartridge lot identification information from a first consumable identifier associated with an assay consumable;
(ii) reading lot specific parameters from an additional consumable identifier;
(iii) performing 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, and

(iv) 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.

2. The method of claim 1 , 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.

3. The method of claim 1 , wherein said first consumable identifier comprises non-volatile memory.

4. The method of claim 3 , wherein said non-volatile memory is selected from the group consisting of an RFID tag, a bar code, ICC, an EPROM, and EEPROM.

5. The method of claim 4 , wherein said non-volatile memory is a bar code.

6. The method of claim 1 , wherein said additional consumable identifier comprises non-volatile memory.

7. The method of claim 6 , wherein said non-volatile memory is selected from the group consisting of an RFID tag, a bar code, ICC, an EPROM, and EEPROM.

8. The method of claim 7 , wherein said non-volatile memory is an ICC.

9. The method of claim 8 , wherein said ICC is a memory card.

10. A computer readable medium having stored thereon a computer program which, when executed by a computer system, causes the computer system to perform a method of using an assay cartridge, in the conduct of an assay, with an assay system, said assay system comprising a reader, the method comprising:
(i) reading cartridge lot identification information from a first consumable identifier associated with an assay consumable;
(ii) reading lot specific parameters from an additional consumable identifier;
(iii) performing 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, and

(iv) 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 assay system.

11. The computer readable medium of claim 10 , 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.

12. The computer readable medium of claim 10 , wherein said first consumable identifier comprises non-volatile memory.

13. The computer readable medium of claim 12 , wherein said non-volatile memory is selected from the group consisting of an RFID tag, a bar code, ICC, an EPROM, and EEPROM.

14. The computer readable medium of claim 13 , wherein said non-volatile memory is a bar code.

15. The computer readable medium of claim 10 , wherein said additional consumable identifier comprises non-volatile memory.

16. The computer readable medium of claim 15 , wherein said non-volatile memory is selected from the group consisting of an RFID tag, a bar code, ICC, an EPROM, and EEPROM.

17. The computer readable medium of claim 16 , wherein said non-volatile memory is an ICC.

18. The computer readable medium of claim

Assignees

• Meso Scale Technologies Llc

Inventors

• Clinton Charles M
• Cong Xinri
• Glezer Eli N
• Kumar Sudeep
• Stevens Carl
• Vock Michael
• Willoughby Jon S

Classifications

• B01L3/54 Primary

  Labware with identification means · CPC title

• G01N35/00663

  of consumables · CPC title

• G01N33/54306

  Solid-phase reaction mechanisms · CPC title

• G01N2035/00633

  logging process history of individual samples · CPC title

• B01L2300/02

  Identification, exchange or storage of information · CPC title