Monitoring an immunoassay

• US 9,360,478 B2
• Filed: 06/19/2008
• Issued: 06/07/2016
• Est. Priority Date: 06/20/2007
• Status: Active Grant

• Current Assignee: Alere Toxicology Plc (Abbott Laboratories Incorporated)
• Original Assignee: Cozart Bioscience Limited (Abbott Laboratories Incorporated)
• Inventors: Abbott, Timothy John, Brookes, David Patrick Edward
• Primary Examiner(s): FITZGERALD, JOHN P
• Application Number:
  US12/665,501
• Publication Number:
  US 20100206055A1
• Time in Patent Office: 2,910 Days
• Field of Search: 73/530.1, 731/47
• US Class Current: 1/1
• CPC Class Codes: G01N 11/02 by measuring flow of the material
• CPC Class Codes: G01N 33/54306 Solid-phase reaction mechanisms
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387

Abstract

A method of monitoring an immunoassay comprises determining the position of the flow edge of fluid across an immunoassay region. This allows, for example, early detection of possible errors in the test. For example the speed of the movement of the fluid flow edge may be determined from measurements of the position of the fluid flow edge at times throughout the test, and the determined speed may be compared with one or more thresholds to determine whether the test is proceeding correctly. A further method of monitoring an immunoassay comprising monitoring the variation with time of a reference zone of an immunoassay region. This can provide the user with early information as to whether the test is proceeding correctly. The above methods may also be used to provide methods to improve the run conditions of a test during its development. The method may be applied to a competitive assay.

Claims

1. A method of monitoring the quality of an immunoassay, the method comprising:

determining, using an image processing device configured to determine positions of flow edges of fluid across immunoassay regions, a position of a flow edge of fluid across an immunoassay region;

obtaining a value of a parameter representing variation with time of the position of the flow edge of fluid across the immunoassay region;

determining information about the quality of the immunoassay from the value of the parameter; and

applying a correction for performing of a test from the obtained value of the parameter.

2. A method as claimed in claim 1 and comprising applying the correction using a look-up table.

3. A method as claimed in claim 1 wherein the parameter is selected from the group consisting of:

a time before movement of the flow edge of fluid is detected, a speed of movement of the fluid flow edge, a change in speed of movement of the fluid flow edge and a time for the fluid flow edge to cross the immunoassay region.

4. A method as claimed in claim 1 and further including a step of determining when the flow edge of fluid reaches a boundary of an active area of the immunoassay region.

5. A method as claimed in claim 1 and further comprising monitoring a shape of the flow edge of fluid.

6. A method as claimed in claim 1 and comprising monitoring a variation with time of an area of the immunoassay region containing fluid.

7. A method as claimed in claim 1 and comprising a step of determining a start of movement of the flow edge of fluid across the immunoassay region.

8. A method as claimed in claim 7 and comprising taking an observed time for the fluid flow edge to reach the boundary into account in a determination of an incubation period for the immunoassay.

9. A method as claimed in claim 1 and further comprising determining a position of another flow edge of fluid across another immunoassay region.

10. A method as claimed in claim 9 and comprising comparing a speed of movement of the fluid flow edge across the immunoassay region with a speed of movement of the fluid flow edge across the another immunoassay region.

11. A method as claimed in claim 9 and comprising comparing the travel time of the fluid flow edge across the immunoassay region with the travel time of the another fluid flow edge across the another immunoassay region.

12. A method as claimed in claim 1 and comprising comparing the obtained value of the parameter with a reference.

13. A method as claimed in claim 12 and comprising taking at least one environmental factor into account in the step of comparing the obtained value of the parameter with the reference.

14. A method as claimed in claim 13 wherein the at least one environmental factor comprises an ambient temperature.

15. A method as claimed in claim 13 wherein the at least one environmental factor comprises an ambient humidity.

16. A method as claimed in claim 13, wherein the at least one environmental factor comprises a tilt of the immunoassay region.

17. An immunoassay reader device having a processor configured to:

determine a position of a flow edge of fluid across an immunoassay region;

obtain a value of a parameter representing variation with time of the position of the flow edge of fluid across the immunoassay region;

determine information about the quality of the immunoassay from the value of the parameter; and

apply a correction for performing of a test from the obtained value of the parameter.