Optical assay device and method

• US 6,770,447 B2
• Filed: 07/12/2001
• Issued: 08/03/2004
• Est. Priority Date: 03/18/1999
• Status: Expired due to Fees

• Current Assignee: Inverness Medical-Biostar, Inc. (Abbott Laboratories)
• Original Assignee: Thermo BioStar, Inc. (Abbott Laboratories)
• Inventors: Fujii, Alan J., Crosby, Mark A., Maynard, James E.
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US09/905,146
• Publication Number:
  US 20020064888A1
• Time in Patent Office: 1,118 Days
• Field of Search: 422/55-58, 422/61, 422/82.05, 422/82.08, 435/287.1, 435/287.2, 435/287.7, 435/287.8, 435/287.9, 435/810, 435/808, 435/7.1, 436/164, 436/165, 436/169, 436/172, 436/170, 436/805, 436/518, 436/530, 436/531
• US Class Current: 435/7.1
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/046 Function or devices integrated in the closure
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0832 cylindrical, tube shaped
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: Y10S 435/808 Optical sensing apparatus
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 436/805 Optical property

Abstract

The present invention involves an optical assay device and method of use for the detection of an analyte of interest in a sample that conveniently allows control of the flow characteristics of the sample through the device without significant user intervention. The optical assay device includes a base having an absorbent material, and a member having an optically active test stack that is rotatably coupled to the base for rotation between a lowered position and a raised position. In the lowered position, the optically active test stack contacts the absorbent material for drawing the sample through the surface. In the raised position, the optically active test stack does not contact the absorbent material.

Claims

1. A method for detecting the presence or amount of an analyte of interest in a test sample, comprising:

providing an optical assay device, said optical assay device comprising a base comprising absorbent material, and a member comprising an optically active test stack, said member rotatably coupled to said base for rotation between a lowered position where said optically active test stack contacts said absorbent material and a raised position where said optically active test stack does not contact said absorbent material;

applying said test sample to said optically active test stack, wherein said member is in said lowered position;

applying a conjugate that binds to the analyte on to said optically active test stack;

applying a wash to said optically active test stack;

rotating said member to said raised position;

applying an amplifying reagent solution that amplifies a visual indication of the presence or amount of said analyte on said optically active test stack;

rotating said member to said lowered position; and

observing said optically active test stack for the visual indication of the presence or amount of the analyte of interest.

3. The method of claim 1 or 2 further including incubating said optically active test stack after applying said test sample and after applying said amplifying reagent solution.

2. A method for detecting the presence or amount of an analyte of interest in a test sample, comprising:

providing an optical assay device, said optical assay device comprising a base comprising absorbent material, and a member comprising an optically active test stack, said member rotatably coupled to said base for rotation between a lowered position where said optically active test stack contacts said absorbent material and a raised position where said optically active test stack does not contact said absorbent material;

applying said test sample to said optically active test stack, wherein said member is In said raised position;

rotating said member to said lowered position;

applying a wash to said optically active test stack;

rotating said member to said raised position;

applying an amplifying reagent solution that amplifies a visual indication of the presence or amount of said analyte to said optically active test stack;

rotating said member to said lowered position;

applying a wash to said optically active test stack; and

observing said optically active test stack for the visual indication of the presence or amount of the analyte of interest.