Dry reagent particle assay and device having multiple test zones and method therefor

• US 7,635,597 B2
• Filed: 04/19/2004
• Issued: 12/22/2009
• Est. Priority Date: 08/09/1995
• Status: Expired due to Term

• Current Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Blatt, Joel M., Allen, Michael P.
• Primary Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US10/826,880
• Publication Number:
  US 20050196875A1
• Time in Patent Office: 2,073 Days
• Field of Search: 422 56- 60, 435/287.7, 436/514, 436/518
• 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 436/808 Automated or kit
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

The present invention relates to a dry reagent assay device having at least one test zone and at least one reference zone, which provides an internal mechanism for assuring correct and reliable assay procedures and reagent qualities. In one embodiment, the present invention relates to an assay device having at least one test zone for detecting at least one analyte in a sample by reacting the sample with a labeled indicator reagent, and a reference zone for receiving unreacted labeled indicator reagent.

Claims

1. A dry reagent lateral flow strip assay device for detecting at least one analyte in a test sample within a pre-determined range of analyte concentration using a porous member capable of being traversed by the sample comprising:

a) a sample application zone on the porous member having diffusively immobilized therewith a labeled indicator reagent, which does not bind to the analyte;

b) at least one test zone having non-diffusively bound thereto a pre-determined amount of a first reagent, based on the pre-determined range of analyte concentration, that that binds to both the labeled indicator reagent and to the analyte to produce a corresponding detectable response in the test zone, the pre-determined amount of the first reagent such that the detectable response is inversely proportional to the analyte concentration;

c) at least one reference zone having non-diffusively bound thereto a pre-determined amount of a second reagent, based on the pre-determined range of analyte concentration, that binds to the labeled indicator reagent to produce corresponding detectable response in the reference zone, the pre-determined amount of the second reagent such that the detectable response is directly proportional to the analyte concentration;

wherein the sample application zone, the test zone and the reference zone are in fluid communication with one another through the porous member; and

wherein the detectable response in the test zone plus the detectable response in the reference zone equal a total detectable response that is substantially constant for the pre-determined range of analyte concentration.

2. The assay device of claim 1, wherein the porous member further comprises a bibulous solid phase material.

3. The assay device of claim 2, wherein the porous member further comprises fiberglass, cellulose or nylon.

4. The assay device of claim 1 for detecting multiple analytes in a test sample, further comprising more than one test zone, each corresponding to an analyte.

5. The assay device of claim 1, wherein the porous member further comprises more than one bibulous material, wherein the sample application zone, the test zone and the reference zone are in fluid communication therethrough.

6. The assay device of claim 1, further comprising one or more reagents bound to the porous member, the reagents being selected from the group consisting of:

antibodies, antigens, enzymes, substrates, small molecules, proteins, viral lysate, bacterial lysate, receptors, sugars, carbohydrates, polymers and detergents.

7. The assay device of claim 1, further comprising a sample filtration member in contact with the porous member.

8. The assay device of claim 1, wherein the labeled indicator reagent is a particle-linked antigen or a particle linked antibody.

9. The assay device of claim 1, wherein the first reagent is an antibody or an antigen.

10. The assay device of claim 1, wherein the second reagent is an antibody that binds to the labeled indicator reagent to form the second reaction product.