Diagnostic assay device

• US 7,465,587 B2
• Filed: 12/03/2004
• Issued: 12/16/2008
• Est. Priority Date: 12/03/2004
• Status: Active Grant

• Current Assignee: Sekisui Diagnostics, LLC (Sanofi )
• Original Assignee: Genzyme Corporation (Sanofi )
• Inventors: Imrich, Michael Reece
• Primary Examiner(s): Nguyen; Bao-Thuy L
• Application Number:
  US11/004,370
• Publication Number:
  US 20060121626A1
• Time in Patent Office: 1,474 Days
• Field of Search: 436/518, 436/528, 436/810, 436/825, 436/514, 436/824, 436/529, 435/287.7, 435/97, 435/287.8, 435/287.9, 435/961
• US Class Current: 436/514
• 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: Y10S 435/961 including a step of forming, releasing, or exposing the antigen or forming the hapten-immunogenic carrier complex or the antigen per se
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/824 Immunological separation techniques
• CPC Class Codes: Y10S 436/825 Pretreatment for removal of interfering factors from sample

Abstract

This invention relates to assays for an analyte in a liquid sample such as a body fluid. More particularly, the invention relates to a method and apparatus for the detection of a ligand in a body fluid such as urine or blood, which includes an immobilization zone for interfering agents in a sample.

Claims

1. An assay device for detection of the presence or absence of an analyte in a sample comprising:

(a) a sample receiving membrane which conducts flow of a sample, and in flow contact with,

(b) an analyte detection membrane which conducts flow of the sample comprising an interfering agent immobilization zone at a first situs, a conjugate forming membrane comprising a mobile labeling reagent at a labeling situs located upstream of the interfering agent immobilization zone, and an immobile capture reagent at a capture situs, wherein the labeling reagent is capable of forming a complex with an analyte and an interfering agent, the capture reagent is capable of binding an analyte-labeling reagent complex, and the interfering agent immobilization zone includes a reagent associated therewith that is capable of binding an interfering agent in the sample.

2. The assay device of claim 1, wherein the flow contact between the sample receiving membrane and analyte detection membrane is lateral flow contact.

3. The assay device of claim 1, wherein the reagent of the interfering agent immobilization zone is adapted to immobilize the interfering agent thereon and the interfering agent is labeled at the labeling situs.

4. The assay device of claim 1, wherein the first situs is located between the sample receiving membrane and the capture situs.

5. The assay device of claim 1, wherein the reagent of the interfering agent immobilization zone adapted to include the interfering agent immobilized thereon.

6. The assay device of claim 1, wherein the assay device is capable of detecting an analyte in a sample selected from the group comprising,blood, serum, nasal fluid, urine, sweat, plasma, semen, cerebrospinal fluid, tears, pus, amniotic fluid, saliva, lung aspirate, gastrointestinal contents, vaginal discharge, urethral discharge, chorionic villi specimens, skin epithelials, genitalia epithelials, gum epithelials, throat epithelials, hair, or sputum.

7. The assay device of claim 1, wherein the sample receiving membrane and theanalyte detection membrane are enclosed in a housing.

8. The assay device of claim 1 wherein, the assay device includes a housing that comprises a sample application aperture and an observation window positioned to display the capture situs.

9. The assay device of claim 1, further comprising an absorbent sink in lateral flow contact with the analyte detection membrane.

10. The assay device of claim 1, wherein the assay device further includes a control reagent immobilized at a control situs on the assay device.

11. The assay device of claim 10, wherein the control reagent comprises an antimouse lgG, an anti-goat rgG, an anti-cow lgG, anti-rabbit lgG, or an anti-rat lgG.

12. The assay device of claim 10, wherein the, control reagent is immobilized between the immobile capture reagent and, an end of the analyte detection membrane.

13. The assay device of claim 1, wherein the assay device is configured such that an accumulation of the interfering agent at the interfering agent immobilization zone does not produce a signal indicative of the presence of interfering agent in the sample.

14. The assay device of claim 1, wherein the assay device is capable of detecing an analyte selected from the group comprising a protein, peptide;

small molecule;

antibody, nucleic acid, viruse, virus particle, human chorionic gonadotrophin, luteinizing hormone, estrone-3glucoronide, pregnanediol-3-glucoronide, insulin, glucagon, relaxin, thyrotropin, somatotropin, gonadotropin, follicle-stimulating hormone, gastrin, bradykinin, vasopressin, polysaccharides, estrone, estradiol, cortisol, testosterone, progesterone, chenodeoxycholic acid, digoxin,. cholic acid, digitoxin, deoxycholic acid, lithocholic acids;

vitamins, thyroxine, triiodothyronine, histamine, serotorin, prostaglandin, drug, drug metabolite, ferritin, or CEA.

15. The assay device of claim 1, wherein the interfering agent is an antibody or an analyte mimic.

16. The assay device of claim 1, wherein an accumulation of the interfering agent and reagent at the interfering agent immobilization zone produces a signal indicative of the presence of interfering agent in the sample.

17. An assay device for detection of the presence or absence of an analyte in a sample comprising:

(a) a sample receiving membrane which conducts flow of a liquid sample, in flow contact with;

(b) an analyte detection membrane which conducts flow of the sample comprising an interfering agent immobilization zone at a first situs, a conjugate forming membrane comprising a mobile labeling reagent at a labeling situs, and an immobile capture reagent at a capture situs, wherein the labeling reagent is movable along the membrane and the labeling reagent is capable of forming a complex with an analyte and the interfering agent, the capture reagent is capable of binding an analyte-labeling reagent complex, and the interfering agent immobilization zone includes a reagent associated therewith that is capable of binding an interfering agent-labeling reagent complex thereto; and

(c) an absorbent sink in flow contact with the analyte detection membrane.

18. An assay device for detection of the presence or absence of an analyte in a sample comprising:

(a) an elongate membrane having, a sample receiving area, a conjugate forming area and an analyte detection area which conductthe flow of a sample therealong, and

(b) an analyte detection area which conducts flow of the sample comprising an interfering agent immobilization zone at a first situs, a conjugate forming area comprising a mobile labeling reagent at a labeling situs located upstream of the interfering agent immobilization zone, and an immobile capture reagent at a capture situs, wherein the labeling reagent is capable of forming.a complex with an analyte and an interfering agent, the capture reagent is capable of binding an analyte-labeling reagent complex, and the interfering agent immobilization zone includes a reagent associated therewith that is capable of binding an interfering agent in the sample.