ASSAY TEST STRIPS WITH MULTIPLE LABELS AND READING SAME

• US 20090214383A1
• Filed: 03/24/2009
• Published: 08/27/2009
• Est. Priority Date: 04/22/2005
• 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.
• Granted Patent: US 9,891,217 B2
• Time in Patent Office: Days
• US Class Current: 422/56
• 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

1-16. -16. (canceled)

17. A diagnostic test system, comprising:

an assay test strip comprising a detection zone and a flow path for a fluid sample along a lateral flow direction across the detection zone, wherein the detection zone comprises a capture region characterized by a first dimension transverse to the lateral flow direction and a second dimension parallel to the lateral flow direction; and

a reader comprising an illumination system operable to focus a beam of light onto an area of the detection zone having at least one surface dimension at most equal to smallest of the first and second dimensions of the capture region.

18. The system of claim 17, wherein the capture region has a plano-elliptical shape, and the illumination system is operable to focus a beam of light onto a plano-elliptical area of the detection zone substantially corresponding to the capture region in size and shape.

19. The system of claim 17, wherein the capture region has a plano-circular shape, and the illumination system is operable to focus a beam of light onto a plano-circular area of the detection zone substantially corresponding to the capture region in size and shape.

20. The system of claim 17, wherein the test strip comprises a first label that specifically binds a target analyte and fluoresces at a first characteristic wavelength and a second label that fluoresces at a second characteristic wavelength different from the first characteristic wavelength, and the detection zone comprises a first immobilized reagent that specifically binds the target analyte and a second immobilized reagent that specifically binds at least one of the second label and a second target analyte bound to the second label.

21. The system of claim 20, wherein the reader comprises a detection system operable to obtain light intensity measurements within a first wavelength range from an area of the detection zone corresponding to the first immobilized reagent and to obtain light intensity measurements within a second wavelength s range from an area of the detection zone corresponding to the second immobilized reagent, the first wavelength range encompassing the first characteristic wavelength and excluding the second characteristic wavelength, and the second wavelength range encompassing the second characteristic wavelength and excluding the first characteristic wavelength.

22. The system of claim 17, wherein the first and second reagents are immobilized in the same capture region.

23. The system of claim 22, wherein the first and second reagents are intermixed in the same capture region.

24. The system of claim 22, wherein the first and second reagents are located in separate contiguous sub-regions of the same capture region.

25. The system of claim 22, wherein the detection system comprises an imaging sub-system operable to generate light intensity measurements from light and an optical sub-system operable to divide light from the detection zone into different spectral components and to direct the different spectral components to different areas of the imaging sub-system.

26. The system of claim 17, wherein the capture region contains the first immobilized reagent, and the detection zone comprises one or more additional capture regions containing the respective immobilized reagents.

27. The system of claim 26, further comprising a housing comprising a port constructed and arranged to receive the test strip, and wherein the detection system comprises at least two imaging devices that are disposed directly over respective ones of the capture regions when the test strip is loaded within the port.

28-33. -33. (canceled)