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.
- 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.
- 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.
- 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.
CROSS-REFERENCE
[0001] This application is a divisional application of U.S. patent application Ser. No. 09/497,631, filed Feb. 2, 2000, which is incorporated herein by reference in its entirety and to which application we claim priority under 35 USC §120.
Divisions (1)
|
Number |
Date |
Country |
Parent |
09497631 |
Feb 2000 |
US |
Child |
10155949 |
May 2002 |
US |