Reagent test strip for analyte determination having a hemolyzing agent

• US 20020192733A1
• Filed: 05/24/2002
• Published: 12/19/2002
• Est. Priority Date: 02/02/2000
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Yani, Adva, Huang, Paing C.
• Granted Patent: US 6,989,243 B2
• Time in Patent Office: Days
• US Class Current: 435/14
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: Y10S 435/975 Kit

Abstract

Reagent test strips and methods for their use in the determination of the concentration of an analyte, e.g. glucose, in a physiological sample, are provided. The subject reagent test strips include one or more members of an analyte oxidation signal producing system and at least one hemolyzing agent. The subject reagent test strips and methods are particularly suited for use in the detection of blood glucose concentrations. Also provided are kits that include the subject test strips for use in practicing the subject methods.

Claims

1. A reagent test strip for use in determining the concentration of an analyte in a physiological sample, said strip comprising:

a porous matrix;

at least one member of an analyte oxidation based signal producing system; and

at least one hemolyzing agent.

2. The test strip according to claim 1, wherein said signal producing system comprises an enzyme that oxidizes an analyte to produce hydrogen peroxide.

3. The test strip according to claim 2, wherein said signal producing system further comprises an enzyme that converts at least one substrate into a chromogenic product in the presence of hydrogen peroxide.

4. The test strip according to claim 1, wherein said analyte is glucose.

5. The test strip according to claim 1, wherein said hemolyzing agent is present in an amount sufficient to produce hemolysis which is equivalent to hemolysate concentration in a physiological sample applied to said porous matrix in an amount ranging from about 5 to 20% by volume

6. A reagent test strip for use in determining blood glucose concentration, said test strip comprising:

a glucose oxidation based signal producing system; and

at least one hemolyzing agent.

7. The test strip according to claim 6, wherein said glucose oxidation based signal producing system comprises:

a glucose oxidizing enzyme;

a peroxidase; and

an indicator that is converted to a chromogenic product in the presence of hydrogen peroxide and said peroxidase.

8. The test strip according to claim 7, wherein said indicator comprises a dye couple.

9. The test strip according to claim 6, wherein said test strip comprises an amount of hemolyzing agent sufficient to produce hemolysis which is equivalent to hemolysate concentration in a physiological sample applied to said porous matrix in an amount ranging from about 5 to 20% by volume

10. The test strip according to claim 6, wherein said glucose oxidizing enzyme is glucose oxidase.

11. A reagent test strip for use in determining blood glucose concentration, said test strip comprising:

(a) a porous matrix;

(b) a glucose oxidation based signal producing system comprising;

(i) a glucose oxidase;

(ii) a peroxidase; and

(iii) an indicator that is converted to a chromogenic product in the presence of hydrogen peroxide and said peroxidase; and

(c) at least one hemolyzing agent in an amount sufficient to produce hemolysis which is equivalent to hemolysate concentration in a physiological sample applied to said porous matrix in an amount ranging from about 5 to 20% by volume.

12. The test strip according to claim 11, wherein said indicator comprises a dye couple.

13. The test strip according to claim 11, wherein said at least one hemolyzing agent is selected from the group consisting of:

N-hexadecyltrimethylammonium chloride, Triton X-100, Brij 58 and Lubrol PX.

14. The test strip according to claim 13, wherein said hemolyzing agent is N-hexadecyltrimethylammonium chloride.

16. The method according to claim 15, wherein said analyte is glucose.

17. The method according to claim 15, wherein said physiological sample is whole blood.

18. The method according to claim 15, wherein said hemolyzing agent is present in an amount sufficient to produce hemolysis which is equivalent to hemolysate concentration in a physiological sample applied to said porous matrix in an amount ranging from about 5 to 20% by volume

19. The method according to claim 15, wherein said detecting and relating steps are carried out by an automated instrument.

15. A method of determining the concentration of an analyte in a physiological sample, said method comprising:

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

(i) a porous matrix;

(ii) at least one member of an analyte oxidation signal producing system; and

(iii) at least one hemolyzing agent;

(b) detecting a signal produced by said signal producing system; and

(c) relating said detected signal to the concentration of analyte in said physiological sample.

20. 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 porous matrix;

(ii) at least one member of an analyte oxidation signal producing system; and

(iii) at least one hemolyzing agent; and

(b) at least one of;

(i) a means for obtaining said physiological sample; and

(ii) an analyte standard.

21. The kit according to claim 20, wherein said analyte is glucose.

22. The kit according to claim 20, wherein said physiological sample is blood.

23. The kit according to claim 20, wherein said means for obtaining said physiological sample is a lance.

24. The kit according to claim 20, wherein said kit further comprises an automated instrument for detecting a signal produced by said signal producing system and relating said detected signal to the amount of analyte in a sample.