Assay test strips with multiple labels and reading same

• US 9,891,217 B2
• Filed: 03/24/2009
• Issued: 02/13/2018
• 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 M
• Assistant Examiner(s): KILPATRICK, BRYAN T
• Application Number:
  US12/410,167
• Publication Number:
  US 20090214383A1
• Time in Patent Office: 3,248 Days
• Field of Search: 436514, 436546, 4352877, 435970, 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; and

a detection zone coupled to the flow path downstream of the sample receiving zone, the detection zone comprising

a capture region;

an immobilized test reagent that specifically binds the target analyte in the capture region; and

an immobilized control reagent that specifically binds the control label in the capture region, wherein the immobilized test reagent and the immobilized control reagent are intermixed in the capture region; and

a reader comprising an illumination system that focuses a beam of light onto an area of the detection zone, the cross-section of the focused beam of light on the surface of the detection zone having a size and shape substantially corresponding to the size and shape of the capture region.

2. The system of claim 1, wherein the capture region has a plano-elliptical shape, and the illumination system is operable to focus a beam of light onto the plano-elliptical area of the capture region.

3. The system of claim 1, wherein the test label fluoresces at a first characteristic wavelength and the control label fluoresces at a second characteristic wavelength different from the first characteristic wavelength.

4. The system of claim 1, wherein the test label comprises quantum dots of a first type and the control label comprises quantum dots of a second type.

5. The system of claim 1, wherein the assay test strip comprises a set of regularly spaced position markers along an edge of the assay test strip, and wherein the position markers have a different optical characteristic than a surface of the detection zone that is exposed for optical inspection.

6. The system of claim 5, wherein the position markers are configured to encode positions along the assay test strip in a direction parallel to the flow path for the fluid sample.

13. The system of claim 5, further comprising a data analyzer programmed to use the regularly spaced position markers to determine when an illuminated area of the detection zone coincides with the capture region.

14. The system of claim 1, wherein the illumination system focuses the beam of light in a shape and size configured to separate the optical characteristic of the capture region from the rest of the detection zone.

15. The system of claim 1, wherein the illumination system scans the beam of light along a predetermined path across the detection zone, wherein the path includes a direction transverse to the flow path for the fluid sample or a direction parallel to the flow path of the fluid sample.

16. The system of claim 5, wherein the regularly spaced position markers are configured to produce a light intensity contrast pattern comprising a plurality of light intensity measurements, each light intensity measurement corresponding to the position along the edge of the assay test strip associated with each regularly spaced position marker and useable to identify a position of the capture region.

19. The system of claim 1, wherein the test reagent and the control reagent are immobilized in a combined test-and-control region of the detection zone.

20. The system of claim 1, wherein the test reagent and the control reagent are intermixed and immobilized in the capture region before the fluid sample is added to the flow path.

7. 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 detection zone coupled to the flow path downstream of the sample receiving zone, the detection zone comprising

a capture region;

an immobilized test reagent that specifically binds the target analyte in the capture region; and

an immobilized control reagent that specifically binds the control label in the capture region, wherein the immobilized test reagent and the immobilized control reagent are intermixed in the capture region; and

a set of regularly spaced position markers along an edge of the assay test strip distinct from the capture region, the position markers having a different optical characteristic than the surface of the detection zone;

a reader comprising an illumination system that focuses a beam of light onto an area of the detection zone, the cross-section of the focused beam of light on the surface of the detection zone having at least one dimension at most equal to the smallest of a first and a second dimension of the capture region; and

a data analyzer programmed to store light intensity measurements obtained from the position markers and to identify a position of the capture region on the assay test strip using the stored light intensity measurements and predetermined information correlating locations of regions of interest with a light intensity contrast pattern produced by the position markers.

8. The system of claim 7, wherein the position markers have a different reflectivity or fluorescence than the surface of the detection zone.

9. The system of claim 7, wherein the data analyzer is programmed to identify ones of the light intensity measurements obtained from the capture region based on light intensity measurements obtained from at least one position marker on the test strip.

10. The system of claim 7, wherein the capture region has a plano-elliptical shape, and the illumination system is operable to focus a beam of light onto the plano-elliptical area of the capture region.

11. The system of claim 7, wherein the test label fluoresces at a first characteristic wavelength and the control label fluoresces at a second characteristic wavelength different from the first characteristic wavelength.

12. The system of claim 7, wherein the test label comprises quantum dots of a first type and the control label comprises quantum dots of a second type.

17. The system of claim 7, wherein the data analyzer is programmed to use the regularly spaced position markers to determine when an illuminated area of the detection zone coincides with the capture region.

18. The system of claim 7, wherein the position markers are configured to encode positions along the assay test strip in a direction parallel to the flow path for the fluid sample.

21. The system of claim 7, wherein the test reagent and the control reagent are intermixed and immobilized in the capture region before the fluid sample is added to the flow path.