Test composition, device, and method

• US 4,038,485 A
• Filed: 09/17/1976
• Issued: 07/26/1977
• Est. Priority Date: 03/18/1976
• Status: Expired due to Term

• Current Assignee: Miles Laboratories, Inc. (Bayer AG)
• Original Assignee: Miles Laboratories, Inc. (Bayer AG)
• Inventors: Greyson, Jerome, Johnston, Katharine Gentry
• Primary Examiner(s): Reese, Robert M.
• Application Number:
  US05/724,365
• Time in Patent Office: 312 Days
• Field of Search: 23/230 B, 23/253 TP, 252/408
• US Class Current: 435/4
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

A test device, test composition, and method are disclosed for determining the presence of a component in a sample. The device comprises a carrier matrix incorporated with a reactant system which produces a detectable response upon contact with the sample component. After a predetermined time interval elapses, the production of the detectable response is terminated by an inhibitor system also incorporated with the matrix. The test composition comprises the reactant and inhibitor systems. The method of use comprises contacting the test device with a test sample suspected of containing the component, permitting a predetermined time to elapse after contacting, and observing any detectable response produced.

Claims

1. A test composition for detecting the presence of a component in a sample comprising

a. a reactant system which, upon contact with said sample, interacts with said component to produce a detectable response, and

b. an inhibitor system which, upon contact with said sample, prevents said reactant system from interacting with said component after elapse of a predetermined time.

2. The test composition of claim 1 in which said detectable response is a color change.

3. The test composition of claim 1 in which said inhibitor system comprises an ester of 2-cyanoacrylic acid.

4. The test composition of claim 1 in which said inhibitor system comprises polyvinyl alcohol.

5. The test composition of claim 1 in which said component is glucose, ketone, occult blood, bilirubin, urobilinogen, cholesterol, hydrogen ion, protein or nitrite.

6. The test composition of claim 1 in which the rate of production of said detectable response is dependent upon the amount of said component in said sample.

7. The test composition of claim 1 in which said inhibitor system terminates the production of the detectable response by undergoing a hardening or gelling reaction in competition with production of said response.

8. The test composition of claim 1 in which said inhibitor system contains a substance capable of producing heat upon contact with said sample, thereby elevating the temperature after a predetermined time, such that said reactant system is prevented from interacting with said component.

9. The test composition of claim 1 in which said inhibitor system is a poison for said reactant system after a predetermined time, thereby preventing said reactant system from interacting with said component.

10. The test composition of claim 1 in which said inhibitor system comprises a water-reactive polyisocyanate.

11. The test composition of claim 1 in which said inhibitor system comprises a material which gels or hardens on contact with said sample.

12. The test composition of claim 11 in which said material hardens or gels at a rate sufficient to inhibit further interaction between said reactant system and said component.

13. The test composition of claim 11 in which the gelling or hardening is initiated upon contact with water.

14. A test device for detecting the presence of a component in a sample comprising a carrier matrix incorporated with

a. a reactant system which, upon contact with said sample, interacts with said component to produce a detectable response, and

b. an inhibitor system which, upon contact with the sample, prevents the reactant system from interacting with the component after elapse of a predetermined time.

15. The test device of claim 14 in which said inhibitor system is capable of producing heat upon contact with said sample, thereby elevating the temperature of said device, after a predetermined time, such that said reactant system is prevented from interacting with said component.

16. The test device of claim 14 in which said inhibitor system is capable of poisoning said reactant system after a predetermined time, thereby preventing said reactant system from interacting with said component.

17. The test device of claim 14 in which the component is glucose, ketone, occult blood, bilirubin, urobilinogen, cholesterol, hydrogenion, protein, or nitrite.

18. The test device of claim 14 in which said detectable response is a color change.

19. The test device of claim 14 in which the rate of production of said detectable response is dependent on the amount of said component in said sample.

20. The test device of claim 14 in which said inhibitor system comprises a material which hardens or gels on contact with said sample.

21. The test device of claim 20 in which said material gels or hardens at a rate sufficient to inhibit production of said detectable response after a predetermined time.

22. The test device of claim 20 in which said material is 2-cyanoacrylic acid or an ester thereof.

23. The test device of claim 20 in which said material comprises polyvinyl alcohol.

24. The test device of claim 20 in which the gelling or hardening of said material is initiated upon contact with water.

25. The test device of claim 20 in which said material is a water-reactive polyisocyanate.

26. A method for detecting the presence of a component in a sample, the method comprising;

a. contacting said sample with a carrier matrix incorporated with (i) a reactant system which, upon contact with said sample, interacts with said component to produce a detectable response, and (ii) an inhibitor system which, upon contact with said sample, prevents the reactant system from interacting with the component after a predetermined time,

b. incubating the matrix, after contact with the said sample, for said predetermined time, and

c. observing said detectable response.

27. The method of claim 26 in which said inhibitor system produces heat upon contact with said sample, thereby elevating the temperature of said matrix, after a predetermined time, such that the reactant system is prevented from interacting with said component.

28. The method of claim 26 in which said inhibitor system is capable of poisoning said reactant system after a predetermined time.

29. The method of claim 26 in which said component is glucose, ketone, occult blood, bilirubin, urobilinogen, cholesterol, hydrogen ion, protein, or nitrite.

30. The method of claim 26 in which said inhibitor system is a material which hardens or gels upon contact with said sample.

31. The method of claim 30 in which said material is 2-cyanoacrylic acid or an ester thereof.

32. The method of claim 30 in which said material is polyvinyl alcohol.

33. A method for producing a test device for detecting the presence of a component in a sample which comprises incorporating a carrier matrix with

a. a reactant system which, when contacted with said sample containing said component, interacts therewith to produce a detectable response, and

b. an inhibitor system which, on contact with said sample, prevents said reactant system from interacting with said component after a predetermined time.

34. The method of claim 33 wherein the rate of production of said detectable response is dependent upon the amount of said component in said sample.

35. The method of claim 33 in which said inhibitor system comprises a material which gels or hardens on contact with said sample.

36. The method of claim 33 in which said reactant and inhibitor systems are incorporated with said carrier sequentially.

37. A method for producing a test device comprising incorporating with a carrier matrix having incorporated therewith a reactant system which, upon contacted with a sample containing a component whose presence is to be detected, interacts therewith to produce a color-change;

an inhibitor system which, on contact with said sample, prevents said color-change production after a predetermined time.

38. The method of claim 37 in which the rate of said color-change production is dependent upon the amount of said component in said sample.