ASSAY INFORMATION MANAGEMENT METHODS AND DEVICES

• US 20160012208A1
• Filed: 09/23/2015
• Published: 01/14/2016
• 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.
• Granted Patent: US 10,446,263 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 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, said method comprising the steps of (a) reading information from said consumable identifier;

(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.

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;

(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.

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);

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 assay system 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 assay system 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;

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; and

combinations thereof.

7. The assay system 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 betweens 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 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 selected from the group consisting of (i) reading manufacturing information from said identifier;

(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).

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

reagent expiration date;

calibration data;

threshold information;

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

chain of custody information; and

combinations thereof.