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

• US 8,512,532 B2
• Filed: 02/21/2008
• Issued: 08/20/2013
• 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.
• Primary Examiner(s): Noguerola, Alex
• Application Number:
  US12/035,231
• Publication Number:
  US 20080142362A1
• Time in Patent Office: 2,007 Days
• Field of Search: 204/403.01, 204/403.02, 204/400, 205/792, 205/787
• US Class Current: 204/403.01
• 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 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, and to whole blood biosensor systems.

Claims

1. A non-enzymatic whole blood electrode strip, which is produced by a method 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 volatile organic solvent used as a dispersing agent, and wherein the amount of the electron mediator is from 0.05% to 6% of the reaction film formulation calculated by weight, the amount of the water-soluble polymer carrier is below 5% of the reaction film formulation calculated by weight, and the amount of the volatile organic solvent is from 10% to 80% of the reaction film formulation calculated by weight, wherein the formulation does not contain a surfactant; and

wherein the non-enzymatic whole blood electrode strip is used for detecting uric acid.

2. A whole blood biosensor system, which comprises the non-enzymatic whole blood detecting electrode strip according to claim 1 and a biosensing device.

3. The non-enzymatic whole blood electrode strip according to claim 1, wherein the electron mediator is potassium ferricyanide.

4. The non-enzymatic whole blood electrode strip according to claim 1, wherein the molecular diameter of the water-soluble polymer carrier is less than 100 microns.

5. The non-enzymatic whole blood electrode strip 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 the mixture thereof.

6. The non-enzymatic whole blood electrode strip according to claim 1, wherein the volatile organic solvent is selected from the group consisting of methyl alcohol, ethyl alcohol, ethyl ether, acetone and the mixture thereof.

7. The non-enzymatic whole blood electrode strip according to claim 1, wherein the amount of the volatile organic solvent is about 60% of the reaction film formulation calculated by weight.