Assay test strips with multiple labels and reading same

• US 10,041,941 B2
• Filed: 03/24/2009
• Issued: 08/07/2018
• Est. Priority Date: 04/22/2005
• Status: Active Grant

• Current Assignee: Alverix, Inc. (Becton, Dickinson & Co)
• Original Assignee: Alverix, Inc. (Becton, Dickinson & Co)
• Inventors: Petruno, Patrick T., Petrilla, John F., Brosnan, Michael J., Zhou, Rong, Roitman, Daniel B.
• Primary Examiner(s): White, Dennis
• Assistant Examiner(s): KILPATRICK, BRYAN T
• Application Number:
  US12/410,178
• Publication Number:
  US 20090180928A1
• Time in Patent Office: 3,423 Days
• Field of Search: 4352877, 435970, 436514, 436546, 422420
• CPC Class Codes: G01N 2021/7786 Fluorescence
• CPC Class Codes: G01N 2035/00108 Test strips, e.g. paper
• 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
• CPC Class Codes: G01N 33/582 with fluorescent label

Abstract

In one aspect, an assay test strip includes a test label that specifically binds a target analyte and a control label that is free of any specific binding affinity for the target analyte and has a different optical characteristic than the test label. In another aspect, an assay test strip includes a test label that specifically binds a target analyte and at least one non-specific-binding label that is free of any specific binding affinity for the target analyte. Systems and methods of reading assay test strips also are described.

Claims

1. A diagnostic test system, comprising:

an assay test strip comprising;

a flow path for a fluid sample;

a sample receiving zone coupled to the flow path;

a test label that specifically binds a target analyte;

a control label that is free of any specific binding affinity for the target analyte and has a different optical characteristic than the test label;

a non-specific binding compensation label comprising a labeling substance that has a different optical characteristic than the test label and the control label; and

a detection zone coupled to the flow path downstream of the sample receiving zone and comprising a plurality of regions including at least one capture region having an immobilized test reagent that specifically binds the target analyte and at least one capture region having an immobilized control reagent that specifically binds the control label, wherein the non-specific binding compensation label is free of any specific binding affinity for the immobilized test reagent and the immobilized control reagent, and wherein the non-specific binding compensation label non-specifically binds to the detection zone and is distributed uniformly across the detection zone due to the non-specific binding characteristics of the non-specific binding compensation label,

a reader that obtains light intensity measurements from exposed regions of the detection zone;

a light source that illuminates the detection zone with a light; and

a data analyzer programmed to perform operations comprising determining a test measurement value from light intensity measurements obtained from a test label bound to the immobilized test reagent, determining a compensation measurement value from light intensity measurements obtained from the labeling substance of the non-specific binding compensation label, and determining a parameter value from the test measurement value and the compensation measurement value.

2. The system of claim 1, wherein the data analyzer determines the parameter value based on a ratio of the test measurement value and the compensation measurement value.

3. The system of claim 1, wherein the data analyzer determines the parameter value based on a difference between the test measurement value and the compensation measurement value.

4. The system of claim 1, wherein the data analyzer determines the parameter value based on a comparison of the test measurement value and the compensation measurement value relative to a threshold.

5. The system of claim 1, wherein the test label fluoresces at a first characteristic wavelength and the labeling substance of the compensation label fluoresces at a second characteristic wavelength different from the first characteristic wavelength.

6. The system of claim 5, wherein the test label comprises quantum dots of a first type and the labeling substance of the compensation label comprises quantum dots of a second type.

7. The system of claim 1, wherein the immobilized test reagent and the immobilized control reagent that specifically binds the control label are intermixed in the same at least one capture region of the plurality of regions.

8. The system of claim 1, wherein the test label exhibits non-specific binding in regions of the detection zone outside the at least one capture region, and wherein the data analyzer is programmed to perform operations comprising compensating for the effects of non-specific binding on the light intensity measurements of the test label based on light intensity measurements obtained from the labeling substance of the non-specific binding compensation label.

9. The system of claim 1, wherein the at least one capture region having an immobilized test reagent is a test region, and wherein the at least one capture region having an immobilized control reagent is a control region.

10. The system of claim 9, wherein the test label is accumulated predominantly in the test region and the control label is accumulated predominantly in the control region.

11. The system of claim 9, wherein the detection zone comprises non-capture regions outside of the test region and the control region, and wherein the test label and the control label exhibit non-specific binding in the non-capture regions of the detection zone.

12. The system of claim 11, wherein the data analyzer is programmed to perform operations comprising compensating for the effects of non-specific binding on the light intensity measurements of the test label based on light intensity measurements obtained from the labeling substance of the non-specific binding compensation label.

13. The system of claim 1, wherein determining the compensation measurement value is based on light intensity measurements obtained from the labeling substance of the non-specific binding compensation label non-specifically bound in at least one of the at least one capture regions.