Test kit for determining the presence of organic materials and method of utilizing same

• US 4,900,663 A
• Filed: 09/13/1985
• Issued: 02/13/1990
• Est. Priority Date: 09/13/1985
• Status: Expired due to Term

• Current Assignee: Medtox Scientific, Inc. (Laboratory Corporation Of America Holdings)
• Original Assignee: Environmental Diagnostics Incorporated
• Inventors: Kelton, Arden A., Wie, Siong I., Chung, Roy A.
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): Saunders, David A.
• Application Number:
  US06/775,991
• Time in Patent Office: 1,614 Days
• Field of Search: 422/56, 422/58, 422/102, 436/169, 436/501, 436/518, 436/527, 436/530, 436/807, 436/809, 436/828, 436/514, 436/519, 436/531, 435/7, 435/805, 435/810
• US Class Current: 435/7.32
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/809 Multifield plates or multicontainer arrays

Abstract

A test card incorporates a colorimetric indicator test to determine the presence of a minute amount of a specific substance in a liquid medium. The test card includes top and bottom sheets adhesively secured to an intermediate frame member which, together with the top and bottom sheets, defines a filter chamber having a flat filter therein which incorporates a test portion. The test portion of the filter has a binding substrate to which antibodies of the specific substance have been bound. This binding substrate is in communication with a test port. In the method of the invention a substance to be tested is administered through the test port and contains an unknown amount of antigen. After the sample is administered an aqueous solution of enzyme labelled antigen is administered and, subsequently, a liquid substrate is added to cause a color change in the filter below the test portion inversely proportional to the amount of antigen contained in the sample administered at the test port.

Claims

1. In a colorimetric indicator testing device for determining the presence of at least one specific substance in a liquid medium, the combination of:

a housing, said housing including a top wall, a bottom wall and side edges, said top wall having at least one control port and at least one test port therein and said housing incorporating a filter chamber;

a flat, planar, elongated unitary filter located in said chamber, said filter having at least one control portion, at least one test portion, and a body portion for common wicking of liquid from said control and test portions;

said control and test portions juxtaposed, respectively, to said control and test ports and liquid impervious means located in the plane of the filter between said filter control and test portions.

2. The device of claim 1 in which each of said test and control portions of said filter has a binding substrate located therein in juxtaposition to the respective control and test ports and said binding substrate has bound thereto antibodies for said specific substance.

3. The testing device of claim 1 in which said control and test portions of said filter are constituted by elongated fingers protruding from the body of filter and said liquid impervious means are interspersed between said fingers to prevent communication therebetween.

4. The testing device claim 1 in which said edges are constituted by an intermediate frame member, said intermediate frame member defining said filter chamber and said top and bottom walls retaining said filter in said filter chamber.

5. The testing device claim 4 in which said intermediate frame member incorporates said liquid impervious means located between the test and control portions of said filter.

6. The testing device of claim 5 in which said top and bottom walls are adhesively secured to said frame member to prevent liquid leakage from said filter chamber.

7. The testing device of claim 1 in which atmospheric vent means are provided communicating with said filter chamber.

8. The testing device of claim 1 including binding substrates in said control and test portions of said filter, said binding substrate being a binding bacteria or microspheroids.

9. In a colorimetric indicator testing device to determine the presence of at least one specific substance in a liquid medium, the combination of:

a housing in the form of a card having at least one control port and at least one test port therein and incorporating a filter chamber in communication with said ports;

a flat unitary filter located in said filter chamber and having at least one control portion, at least one test portion, and a body portion for common wicking of liquids from said control and test portions;

said control and test portions underlying, respectively, said control and test ports and liquid impervious means located in the plane of the filter between said filter control and test portions; and

identical binding substrates in said control and test portions of said filter for each specific substance to be tested having antibody for said substance bound thereto.

10. A test device of claim 9 which includes top and bottom retention sheets and an intermediate frame member having said sheets secured thereto.

11. The test device of claim 10 in which said frame member incorporates liquid impervious means between said control and test portions of said filter to prevent fluid communication therebetween.

12. The test device of claim 11 in which said control and test portions of said filter are constituted by elongated fingers underlying, respectively, said control and test ports.

13. The test device of claim 9 in which atmospheric vent means are provided communicating with said filter chamber.

14. The test device of claim 9 where said binding substrate is a binding bacteria or a microspheroids.