Assay information management methods and devices

Patent metadata

Field	Value
Publication number	US-10446263-B2
Application number	US-201514862298-A
Country	US
Kind code	B2
Filing date	Sep 23, 2015
Priority date	Jul 27, 2009
Publication date	Oct 15, 2019
Grant date	Oct 15, 2019

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 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.

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.

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 manufactur

Assignees

• Meso Scale Technologies Llc

Inventors

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

Classifications

• G01N2035/00851

  process control parameters · CPC title

• G01N2035/00633

  logging process history of individual samples · CPC title

• G01N35/00663

  of consumables · CPC title

• G01N33/54306

  Solid-phase reaction mechanisms · CPC title

• B01L2300/02

  Identification, exchange or storage of information · CPC title