Immunochromatographic assay

• US 6,180,417 B1
• Filed: 04/22/1999
• Issued: 01/30/2001
• Est. Priority Date: 04/22/1999
• Status: Active Grant

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Bayer Corporation (Bayer AG)
• Inventors: Hajizadeh, Kiamars, Wijesuriya, Dayaweera
• Primary Examiner(s): Le, Long V.
• Assistant Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US09/295,575
• Time in Patent Office: 649 Days
• Field of Search: 422/56, 422/57, 422/58, 422/60, 422/61, 435/7.1, 435/7.92, 435/7.93, 435/7.94, 435/287.7, 435/287.8, 435/287.9, 435/288.3, 435/288.4, 435/288.5, 435/970, 436/518, 436/541, 436/161, 436/810
• US Class Current: 436/518
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

Disclosed is a device and method for carrying out an assay for an analyte in a fluid test sample by immunochromatography. The device involves a strip having a non-porous receiving member of a hydrophobic material in direct fluid communication with a reagent region of an absorbent material through which the fluid test sample can flow by capillarity. By applying the fluid test sample to the non-porous hydrophobic receiving member rather than directly to the absorbent material the reliability of the assay is enhanced.

Claims

1. An assay for determining the presence or concentration of an analyte in a fluid test sample which comprises:

a) providing an immunochromatographic test strip having a non-porous receiving member of a hydrophobic material in direct fluid communication with a reagent region of an absorbant material through which the fluid test sample and reagents carried therein can flow by capillarity and which reagent region contains a detection site for detecting the presence or concentration of the analyte,

b) applying the fluid test sample to the receiving member, so that a portion of the fluid test sample is in direct contact with the absorbant material of the reagent region of the immunochromatographic test strip, and

determining the presence or concentration of the analyte in the fluid test sample by correlating a detectable response in the reagent region with such presence or concentration.

2. The assay of claim 1 wherein the reagent region contains labeled specific binding partner for the analyte which are free to flow through the reagent region with the fluid test sample and the reagent region also contains an immobilized binder capable of binding the specific binding partner.

3. The assay of claim 2 wherein the labeled specific binding partner is an antibody which is specific for one epitope of the analyte and the immobilized binder is an antibody which is specific for a different epitope of the analyte.

4. The assay of claim 1 wherein the fluid test sample comprises blood.

5. The assay of claim 1 wherein the non-porous receiving member comprises polyethylene, polypropylene, polytetrafluoro-ethylene, or a material whose surface has been treated with a hydrophobic material.

6. The assay of claim 5 wherein the hydrophobic material is perfluoro ethylene or a silanizing agent.

7. The assay of claim 1 wherein the immunochromatographic test strip has a conjugate pad between the receiving member and the reagent region which conjugate pad contains one or more labeled specific binding partners at least one of which is specific for at least one epitope of the analyte.

8. The assay of claim 1 wherein there is a bridging pad which provides a zone for mixing the fluid test sample and labeled specific binding partner before they reach the reagent region of the immunochromatograpic test strip.

9. The assay of claim 8 wherein the bridging pad is comprised of polyester or glass fiber.

10. The assay of claim 1 wherein the immunochromatographic test strip has a separate read region downstream from the bridging pad which region has at least one zone in which there are immobilized immunoreactants for at least one epitope of the analyte or a binding analog thereof.

11. The assay of claim 10 wherein the read region has a separate zone in which there is immobilized an immunoreactant for the labeled specific binding partner in the reagent region.

12. The assay of claim 11 wherein the immunochromatographic test strip has an absorbent pad downstream from and in contact with the read region which serves to draw the fluid test sample through the strip by capillarity.

13. The assay of claim 10 wherein the read region is comprised of cellulose or polyethylenesulfonate.

14. A test strip for the determination of an analyte in a fluid test sample which comprises a base member of a non-porous, hydrophobic material which base member has on its surface a pad of absorbent material through which the fluid test sample and reagents carried therein can flow wherein the base member has sufficient surface area which is not covered by the pad of absorbent material for application of the fluid test sample directly to the base member.