Assay test strips with multiple labels and reading same

• US 7,521,259 B2
• Filed: 09/26/2005
• Issued: 04/21/2009
• Est. Priority Date: 04/01/2004
• Status: Active Grant

• Current Assignee: Alverix, Inc. (Becton, Dickinson & Co)
• Original Assignee: Alverix, Inc. (Becton, Dickinson & Co)
• Inventors: Zhou, Rong, Brosnan, Michael J., Roitman, Daniel B., Petruno, Patrick T., Petrilla, John F.
• Primary Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US11/236,152
• Publication Number:
  US 20070231922A1
• Time in Patent Office: 1,303 Days
• Field of Search: 436/514, 436/518, 436/169, 436/172, 436/175, 436/530, 436/533, 436/807, 436/170, 436/823, 435/823, 435/287.7, 435/287.9, 435/805, 422/56, 422/57, 422/58, 422/59, 422/60
• US Class Current: 436/514
• CPC Class Codes: G01N 2021/6441 with two or more labels
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• 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: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/823 Acetobacter
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/823 Immunogenic carrier or carrier per se
• CPC Class Codes: Y10T 436/25125 Digestion or removing interfering materials

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. 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 and comprising an immobilized test reagent that specifically binds the target analyte and an immobilized control reagent that specifically binds the control label, wherein the test reagent and the control reagent are intermixed in the test and control region.

2. The assay test strip 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.

3. The assay test strip of claim 1, further comprising a test region containing the test reagent and a control region containing the control reagent.

4. The assay test strip of claim 3, wherein the control region is located downstream of the test region.

5. The assay test strip of claim 3, wherein the control region and the test region are equidistant from the sample receiving zone.

6. The assay test strip 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.

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

8. The assay test strip of claim 7, wherein the test reagent and the control reagent are located in separate contiguous sub-regions of the test-and-control region.

9. The assay test strip of claim 7, wherein the test-and-control region has a plano-elliptical shape.

10. The assay test strip of claim 1, wherein the test-and-control region has a plano-circular shape.