Test device for detecting an analyte in a liquid sample

• US 5,275,785 A
• Filed: 06/25/1992
• Issued: 01/04/1994
• Est. Priority Date: 10/30/1987
• Status: Expired due to Term

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Unilever Patent Holdings BV (Unilever PLC)
• Inventors: May, Keith, Prior, Michael E.
• Primary Examiner(s): Saunders, David
• Assistant Examiner(s): Chin, Christopher L.
• Application Number:
  US07/904,888
• Time in Patent Office: 558 Days
• Field of Search: 422/55-58, 436/518, 436/530, 436/164, 436/169, 436/805, 436/810, 436/807, 436/824, 436/514, 435/7.9, 435/810, 435/970
• US Class Current: 422/408
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/54389 with bidirectional or multidirectional lateral flow, e.g. wherein the sample flows from a single, common sample application point into multiple strips, lanes or zones
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

A chromatographic test device for detecting the presence of an analyte in a liquid sample and incorporating at least two liquid-conductive zones (3, 4) which form separate liquid flow paths which deliver separate liquid streams to a region (8) in the test device during the test procedure, wherein control of the relative liquid flows in the separate flow paths is achieved, at least in part, by ensuring that at least one of the liquid flow paths is enhanced or made and/or broken or restricted during the course of the test procedure. Preferably such control is achieved by incorporating a liquid-swellable material (11) which is arranged to swell by contact with liquid sample and/or reagent and thereby to make or break contact between two liquid-conductive zones.

Claims

1. A test device for performing an assay to detect the presence of an analyte in a liquid sample comprising:

a housing;

means within said housing defining first and second separate flow paths for conveying separate liquid streams from a first end of said housing to a reaction zone within said housing, said reaction zone being in fluid contact with said first flow path and carrying in immobilized form, a reagent that specifically binds to said analyte;

liquid absorbent means downstream from and in fluid contact with said reaction zone;

means defining a passage interconnecting said liquid flow paths;

a liquid swellable material disposed within said passage and in fluid contact with said second flow path, said liquid swellable material being adapted to swell on contact with liquid sample thereby to make contact between said liquid flow paths, whereby liquid in said second flow path reaches said reaction zone after liquid in said first flow path reaches said reaction zone; and

reagents for detection of bound analyte in the reaction zone incorporated in distinct zones in said first and/or second flow paths or said first and second flow paths are capable of directing said detection reagents to said reaction zone when applied separately to said flow paths.

2. A test device as in claim 1, wherein contact between said first and second liquid flow paths initiates transfer of liquid between said two flow paths, said transferred liquid being selected from the group consisting of a washing liquid and a reagent liquid.

3. A test device as in claim 1, wherein said housing includes a transparent portion through which bound analyte can be visualized in said reaction zone.

4. A test device as in claim 1, wherein said liquid swellable material delivers to said reaction zone an auxiliary reagent which is necessary for visual detection of bound analyte in the reaction zone.

5. A test device as in claim 1, wherein said second flow path delivers to said reaction zone an enzyme substrate for visualization of bound analyte in the reaction zone when an enzyme-linked immunoassay is performed in said test device.