Method of producing whole blood detecting electrode strip and reaction film formulation and the related products

• US 20040081752A1
• Filed: 03/28/2003
• Published: 04/29/2004
• Est. Priority Date: 03/29/2002
• Status: Active Grant

• Current Assignee: Apex Biotechnology Corporation
• Original Assignee: Apex Biotechnology Corporation
• Inventors: Lin, Yueh-Hui, Shen, Thomas Y.S.
• Granted Patent: US 7,384,659 B2
• Time in Patent Office: Days
• US Class Current: 427/123
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

Abstract

The present invention relates to a method of producing a non-enzymatic detecting electrode strip for use on whole blood, including:

a. coating a conducting film on one side of an electrically insulating substrate to form an electrode system with an isolated and disconnected anode and cathode;

b. coating an electrically insulating film on a part of the anode and cathode of the electrode system, wherein one end of the anode uncovered with the conducting film forms at least a reference electrode and the other end forms an anode connector, one end of the cathode uncovered with the conducting film forms at least a working electrode and the other end forms a cathode connector, and an exposed part of the electrode system not covered with the insulating film forms an electrochemical reaction zone for forming a reaction layer; and

c. adding dropwise a reaction film formulation onto the electrochemical reaction zone described in step (b), and drying it to form the reaction layer, wherein the formulation comprises an electron mediator, a water-soluble polymer carrier and a water solution to aid even dispersion.

The present invention further relates to a reaction film formulation used in the production of a non-enzymatic whole blood uric acid detecting electrode strip, and a whole blood detecting electrode strip, a whole blood biosensor system using the whole blood detecting electrode strip produced by the aforementioned method.

Claims

1. A method of producing a non-enzymatic whole blood detecting electrode strip comprising the steps of:

(a) coating a conducting film on one side of an electrically insulating substrate to form an electrode system with an isolated and disconnected anode and cathode;

(b) coating an electrically insulating film on a part of the anode and cathode of the electrode system, wherein one end of the anode uncovered with the conducting film forms at least a reference electrode and the other end forms an anode connector, and one end of the cathode uncovered with the conducting film forms at least a working electrode and the other end forms a cathode connector; and

an exposed part of the electrode system not covered with the insulating film forms an electrochemical reaction zone for forming a reaction layer; and

(c) adding dropwise a reaction film formulation onto the electrochemical reaction zone in step (b), and drying it to form the reaction layer;

wherein the formulation comprise an electron mediator, a water-soluble polymer carrier and a water solution used as a dispersing agent.

2. The method according to claim 1, wherein the electron mediator is potassium ferricyanide.

3. The method according to claim 1, wherein the amount of the electron mediator is from 0.05% to 6% of the reaction film formulation (calculated by weight).

4. The method according to claim 3, wherein when the whole blood detecting electrode strip is used for detecting uric acid, the amount of the electron mediator is approximately 0.3% of the reaction film formulation (calculated by weight).

5. The method according to claim 3, wherein when the whole blood detecting electrode strip is used for detecting hemoglobin, the amount of the electron mediator is approximately 3% of the reaction film formulation (calculated by weight).

6. The method according to claim 1, wherein the molecular diameter of the water-soluble polymer carrier is smaller than 100 microns.

7. The method according to claim 1, wherein the water-soluble polymer carrier is selected from the group consisting of polyvinyl acetate, polyvinyl pyrrolidone, polyethylene glycol, gelatin, carboxymethyl cellulose, methyl cellulose and mixtures thereof.

8. The method according to claim 1, wherein the amount of the water-soluble polymer carrier is less than 5% of the reaction film formulation (calculated by weight).

9. The method according to claim 1, wherein when the whole blood detecting electrode strip is used for detecting uric acid, the dispersing agent is a volatile organic solvent.

10. The method according to claim 9, wherein the volatile organic solvent is selected from the group consisting of methyl alcohol, ethyl alcohol, ethyl ether, acetone and mixtures thereof.

11. The method according to claim 9, wherein the amount of the volatile organic solvent is from 10% to 80% of the reaction film formulation (calculated by weight).

12. The method according to claim 11, wherein the amount of the volatile organic solvent is about 60% of the reaction film formulation (calculated by weight).

13. The method according to claim 1, wherein when the whole blood detecting electrode strip is used for detecting hemoglobin, the dispersing agent is a surfactant.

14. The method according to claim 13, wherein the surfactant is Triton X-100.

15. The method according to claim 13, wherein the amount of said surfactant is from 1% to 6% of the reaction film formulation (calculated by weight).

16. The method according to claim 15, wherein the amount of said surfactant is about 4% of the reaction film formulation (calculated by weight).

17. The method according to claim 1 further comprising a step (d) involving covering the region of the reaction layer on the surface of the insulating layer with a protection net.

18. The method according to claim 1, wherein the insulating layer has a thickness of 0.01 to 0.6 mm.

30. A non-enzymatic whole blood detecting electrode strip, which is produced by the method according to any of claims 1 to 18.

31. A whole blood biosensor system, which comprises the non-enzymatic whole blood detecting electrode strip according to claim 30 and a biosensing device.

32. A whole blood biosensor system according to claim 31, which is used for detecting uric acid.

33. A whole blood biosensor system according to claim 31, which is used for detecting hemoglobin.

19. A reaction film formulation used in the preparation of a non-enzymatic whole blood uric acid detecting electrode strip, which comprises an electron mediator, a water-soluble polymer carrier, and a volatile organic solvent.

20. A reaction film formulation according to claim 19, wherein the electron mediator is potassium ferricyanide.

21. A reaction film formulation according to claim 19, wherein the amount of the electron mediator is from 0.05% to 6% of the reaction film formulation (calculated by weight).

22. A reaction film formulation according to claim 21, wherein the amount of the electron mediator is about 3% of the reaction layer (calculated by weight).

23. A reaction film formulation according to claim 19, wherein the molecular diameter of the water-soluble polymer carrier is smaller than 100 microns.

24. A reaction film formulation according to claim 19, wherein the water-soluble polymer carrier is selected from the group consisting of polyvinyl acetate, polyvinyl pyrrolidone, polyethylene glycol, gelatin, carboxymethyl cellulose, methyl cellulose and the mixture thereof.

25. A reaction film formulation according to claim 19, wherein the amount of the water-soluble polymer carrier is below 5% of the reaction film formulation (calculated by weight).

26. A reaction film formulation according to claim 19, wherein the volatile organic solvent is selected from the group consisting of methyl alcohol, ethyl alcohol, ethyl ether, acetone and the mixture thereof.

27. A method according to claim 19, wherein the amount of the volatile organic solvent is from 10% to 80% of the reaction film formulation (calculated by weight).

28. A method according to claim 27, wherein the amount of the volatile organic solvent is about 60% of the reaction film formulation (calculated by weight).

29. The formulation according to claim 19, wherein the size of the carrier is less than 100 microns.