Identification of human urine for drug testing

• US 6,368,873 B1
• Filed: 04/09/1998
• Issued: 04/09/2002
• Est. Priority Date: 04/09/1998
• Status: Expired due to Term

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Applied Biotech Inc. (Johnson & Johnson)
• Inventors: Nguyen, Trang, Tung, Ker-Kong, Guo, Huiyan, Wei, Yun-Fei, Chang, Shong-Ho
• Primary Examiner(s): Le, Long V.
• Assistant Examiner(s): BASKAR, PADMAVATHI
• Application Number:
  US09/057,736
• Time in Patent Office: 1,461 Days
• Field of Search: 436/513, 436/514, 436/2, 436/111, 435/5, 435/6, 435/7.1, 435/7.92, 435/7.93, 435/7.94
• US Class Current: 436/514
• CPC Class Codes: G01N 30/90 Plate chromatography, e.g. thin layer or paper chromatography
• CPC Class Codes: G01N 33/493 urine
• 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: G01N 33/6854 Immunoglobulins
• CPC Class Codes: Y10T 436/173845 Amine and quaternary ammonium

Abstract

This invention features methods and kits for identifying human urine samples for forensic purposes.

Claims

1. A method of screening to identify a sample submitted for drug testing as a human sample and thereafter testing said sample, comprising providing a urine sample for identification and performing an immunoassay on a chromatographic medium for detecting the presence of a single protein antigen present in human urine, said antigen selected from the group consisting of IgG, IgA, albumin, and combinations thereof using an antihuman IgG, IgA, or albumin antibody to identify said sample as a human sample, and thereafter performing drug testing.

2. The method of claim 1 wherein said immunoassay is an enzyme linked immunosorbent assay.

3. The method of claim 1 wherein said assay comprises

(a) providing a chromatographic surface containing

(i) a mobile signal-generating particle to which at least one antibody to said IgG, IgA or albumin protein is attached in a reaction section and

(ii) at least one immobile antibody to said IgG, IgA or albumin is attached in a test section contacted by said sample after contact with said reaction section,

(b) contacting said sample with said surface to react at said reaction section, and

(c) thereafter determining if a signal is present in said test section.

4. The method of claim 3 wherein said reaction section further comprises a second mobile signal-generating particle to which at least one non-human protein as a control for defective chromatographic medium, improper test procedures, or the deterioration of reagents is attached and said test section further comprises at least a second immobile antibody to said non-human protein, and said detecting comprises comparing the presence of said signals generated from said human and said non-human proteins in said test section.