Monitoring an immunoassay

• US 10,473,572 B2
• Filed: 05/10/2016
• Issued: 11/12/2019
• Est. Priority Date: 06/20/2007
• Status: Active Grant

• Current Assignee: Alere Toxicology Plc (Abbott Laboratories Incorporated)
• Original Assignee: Alere Toxicology Plc (Abbott Laboratories Incorporated)
• Inventors: Abbott, Timothy John, Brookes, David Patrick Edward
• Primary Examiner(s): Fitzgerald, John
• Application Number:
  US15/150,791
• Publication Number:
  US 20160252441A1
• Time in Patent Office: 1,281 Days
• 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 shape of the flow edge of fluid across an immunoassay region. This allows, for example, early detection of possible errors in the test. 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 test while the test is being carried out, the method comprising:

disposing an immunoassay fluid sample on an upstream region of an immunoassay test strip;

monitoring the shape of a flow edge of fluid by using an image processing device to acquire images at successive times as the fluid is passing across the active area of the immunoassay test strip and to determine shapes of flow edges of fluid by subtracting one image from a subsequent image;

obtaining, by a controller of the image processing device, information about the presence of error in the immunoassay by comparing a determined shape of a flow edge of fluid with a reference shape; and

applying a correction for performing the test from the obtained information about the quality of the immunoassay test.

2. The method as claimed in claim 1 wherein the controller of the image processing device outputs a report to a user that an error in the immunoassay test may have occurred.

3. The method as claimed in claim 1 wherein the immunoassay fluid sample flows on the immunoassay test strip by capillary action.

4. The method as claimed in claim 1 wherein monitoring the shape of the flow edge of fluid comprises monitoring the shape of the flow edge of fluid as the flow edge of fluid passes along an immunoassay region.

5. The method as claimed in claim 4 and further comprising monitoring the shape of the flow edge of fluid as the flow edge of fluid passes along another immunoassay region.

6. The method as claimed in claim 4 wherein the immunoassay region contains a drug derivative protein conjugate specific to a drug that is being tested for.