Device for the testing of body fluid samples

• US 6,406,922 B2
• Filed: 01/29/2001
• Issued: 06/18/2002
• Est. Priority Date: 03/11/1996
• Status: Expired due to Term

• Current Assignee: Healgen Scientific, LLC (Zhejiang Orient Gene Biotech Co., Ltd.)
• Original Assignee: American Bio Medica Corporation
• Inventors: Casterlin, Douglas, Cipkowski, Stan, Wells, Henry J.
• Primary Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US09/770,312
• Publication Number:
  US 20010012637A1
• Time in Patent Office: 505 Days
• Field of Search: 436/518, 436/525, 436/164, 436/169, 436/816, 436/901, 436/514, 435/7.1, 435/7.93, 435/7.94, 435/970, 435/287.2, 435/973, 435/288.4, 435/288.7, 435/975, 128/771, 600/574, 600/584, 422/55, 422/56, 422/57, 422/58, 422/68.1, 422/102
• US Class Current: 436/518
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 2010/0003 including means for analysis by an unskilled person
• CPC Class Codes: A61B 2010/0009 Testing for drug or alcohol abuse
• CPC Class Codes: B01L 3/508 rigid containers not provided for above
• CPC Class Codes: G01N 2001/005 Packages for mailing or similar transport of samples
• CPC Class Codes: G01N 2001/007 Devices specially adapted for forensic samples, e.g. tamper-proofing, sample tracking
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• 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 33/94 involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 435/973 Simultaneous determination of more than one analyte
• CPC Class Codes: Y10S 435/975 Kit
• CPC Class Codes: Y10S 436/816 Alkaloids, amphetamines, and barbiturates
• CPC Class Codes: Y10S 436/901 Drugs of abuse, e.g. narcotics, amphetamine

Abstract

A drug of abuse test kit for testing low volumes of a fluid sample having a transparent flat bag container for retaining a fluid sample to be tested and the open end of the container has a recloseable closure. The container is maintained in a substantially vertical position and has an open end which receives a multiple drug test card having a plurality of immunoassay test strips thereon with visual endpoints to indicate presence or absence of a particular drug. A process and a modification thereof for testing of low volumes of a fluid sample and a process for quality control of a test card are also disclosed.

Claims

1. A test kit for testing of fluid samples for drugs of abuse comprising a flat flexible container disposed in substantially a vertical position for retaining a fluid sample to be tested and having a top portion with an opening therein, and a drug test card comprising a thin, flat member having a rectangular outline and having front and rear surfaces and top and bottom ends shaped to be inserted bottom end first in said top portion opening to the bottom of the container to contact the fluid sample, said container having a shape conforming to the configuration of the test card so as to provide a minimum of space to receive a sample when the container is occupied by a test card, said test card having one or more immunoassay test strips with visual end points to indicate presence or absence of a drug disposed side-by-side in parallel between said front and rear surfaces of said flat member, each test strip having a bottom end and a sample receiving portion disposed thereon contacting the fluid sample and further having a test portion spaced longitudinally therefrom to indicate the presence or absence of a particular drug of abuse, at least the sample and test portions of each of said test strips being exposed on a surface of the test card.

2. A test kit for testing of fluid sample as claimed in claim 1 wherein said front surface of said thin flat member has a plurality of pairs of openings therein corresponding to one or more of the test strips and the openings of each pair spaced longitudinally to register with and expose the sample and test portions of each of said test strips.

3. A test kit as claimed in claim 1 wherein said container is one of opaque, translucent or transparent.

4. A test kit as claimed in claim 1 wherein said container comprises a flat envelope.

5. A test kit as claimed in claim 4 wherein one end of said envelope has an opening therein.

6. A test kit as claimed in claim 4 wherein said envelope is made of a flexible transparent material.

7. A test kit as claimed in claim 4 wherein said envelope has a rectangular shape to accommodate a test card therein.

8. A test kit as claimed in claim 5 and further comprising means on the open end of said envelope for closing and opening.

9. A test kit as claimed in claim 8 wherein said closing means is recloseable.

10. A test kit as claimed in claim 4 wherein said envelope has a bottom end opposed from said open end and shaped to accommodate a test card when the bottom end of the test card is positioned at the bottom end of said envelope such that said open end may be closed.