Test strips for detecting the presence of a reduced cofactor in a sample and method for using the same

• US 6,420,128 B1
• Filed: 09/12/2000
• Issued: 07/16/2002
• Est. Priority Date: 09/12/2000
• Status: Expired due to Term

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Ouyang, Tianmei, Yu, Yeung Siu
• Primary Examiner(s): Leary, Louise N.
• Application Number:
  US09/659,938
• Time in Patent Office: 672 Days
• Field of Search: 435/14, 435/25, 435/4, 435/283.1, 435/975, 435/26
• US Class Current: 435/14
• CPC Class Codes: G01N 33/523 the element being adapted for a specific analyte
• CPC Class Codes: Y10S 435/975 Kit

Abstract

Test strips and methods for their use in the detection of an analyte in a sample are provided. The subject test strips are characterized by at least including a water soluble tetrazolium salt on a surface of a positively charged substrate. In many embodiments, the water soluble tetrazolium salt is present as part of an analyte oxidizing signal producing system, which system includes one or more of the following additional components: an analyte oxidizing enzyme, e.g., an analyte dehydrogenase or an analyte oxidase; an electron transfer agent; and an enzyme cofactor. Also provided are systems and kits incorporating the subject test strips. The subject test strips, systems and kits find use in the measurement of a wide variety of analytes in a sample, such as a physiological sample, e.g., blood or a fraction thereof.

Claims

1. A composition of matter comprising:

a non-bibulous positively charged substrate; and

at least one water soluble tetrazolium salt on at least one surface of said positively charged substrate.

2. The composition according to claim 1, wherein said water soluble tetrazolium salt is part of an analyte oxidizing signal producing system.

3. The composition according to claim 2, wherein said analyte oxidizing signal producing system comprises an analyte oxidase.

4. The composition according to claim 2, wherein said analyte oxidizing signal producing system comprises an analyte dehydrogenase.

5. The composition according to claim 2, wherein said analyte oxidizing signal producing system further comprises an electron transfer agent.

6. The composition according to claim 2, wherein said analyte oxidizing signal producing system further comprises an enzyme cofactor.

7. The composition according to claim 2, wherein said analyte oxidizing signal producing system is present as a reagent composition.

8. A reagent test strip comprising:

a positively charged substrate; and

an analyte oxidizing signal producing system present on said positively charged substrate, wherein said analyte oxidizing signal producing system includes a water soluble tetrazolium salt.

9. The test strip according to claim 8, wherein said positively charged substrate is bibulous.

10. The test strip according to claim 8, wherein said positively charged substrate is non-bibulous.

11. The test strip according to claim 8, wherein said water soluble tetrazolium salt accepts a hydride to produce a water soluble formazan product.

12. The test strip according to claim 8, wherein said analyte oxidizing signal producing system comprises an analyte oxidase.

13. The test strip according to claim 12, wherein said analyte oxidizing signal producing system further comprises an electron transfer agent.

14. The test strip according to claim 12, wherein said analyte oxidizing signal producing system further comprises an enzyme cofactor.

15. The test strip according to claim 8, wherein said analyte oxidizing signal producing system is a glucose oxidizing signal producing system.

16. An analyte detection or measurement system comprising:

(a) a reagent test strip comprising;

(i) a positively charged substrate; and

(ii) an analyte oxidizing signal producing system present on said substrate, wherein said signal producing system includes a water soluble tetrazolium salt capable of accepting a hydride to produce a water soluble formazan; and

(b) an automated instrument.

17. A method for detecting the presence or determining the concentration of an analyte in a sample, said method comprising:

(a) applying said physiological sample to a reagent test strip comprising;

(i) a positively charged substrate; and

(ii) an analyte oxidizing signal producing system present on said substrate, wherein said signal producing system includes a water soluble tetrazolium salt capable of producing a water soluble formazan product, whereby a non-washable spot comprising said formazan product is produced on said substrate;

(b) detecting said non-washable spot; and

(c) relating said detected non-washable spot to the presence or concentration of said analyte in said physiological sample.

18. The method according to claim 17, wherein said signal producing system further comprises an analyte oxidase.

19. The method according to claim 18, wherein said signal producing system further comprises at least one of an electron transfer agent.

20. The method according to claim 17, wherein said sample is whole blood or a derivative thereof.

21. The method according to claim 17, wherein said detecting and relating steps are carried out by an automated instrument.

22. A kit for use in determining the concentration of an analyte in a physiological sample, said kit comprising:

(a) a reagent test strip comprising;

(i) a positively charged substrate; and

(ii) an analyte oxidizing signal producing system present on said substrate, wherein said signal producing system includes a water soluble tetrazolium salt capable of producing a water soluble formazan product; and

(b) at least one of;

(i) a means for obtaining said physiological sample and

(ii) an analyte standard.

23. The kit according to claim 22, wherein said means for obtaining said physiological sample is a lance.

24. The kit according to claim 22, wherein said analyte standard comprises a standardized concentration of a known reagent.

25. The kit according to claim 22, wherein said kit comprises a means for obtaining said physiological sample and an analyte standard.