Method for determining the electrochemical characteristic of a test strip

• US 9,151,730 B2
• Filed: 11/13/2012
• Issued: 10/06/2015
• Est. Priority Date: 11/14/2011
• Status: Active Grant

• Current Assignee: Joinsoon Medical Technology Co., Ltd.
• Original Assignee: Joinsoon Medical Technology Co., Ltd.
• Inventors: Lee, Jen Fang
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US13/675,932
• Publication Number:
  US 20130118919A1
• Time in Patent Office: 1,057 Days
• US Class Current: 1/1
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 27/4163 checking the operation of, or calibrating, the measuring apparatus G01N27/3274, G01N27/4175 and G01N33/0006 take precedence

Abstract

This invention relates to a non-destructive means to determine electrochemical characteristics in biosensor test strips, including first applying a cyclic oxidative and reductive electric potential onto the inspection pads connecting to the reference electrode and working electrode, on which lies a drop of enzyme reagent solution, to homogenize the electrochemical characteristics of the biosensor test strips, and then applying an inspection electric potential within a short period of time over the inspection pads connecting to the reference electrode and working electrode to measure its electrical resistance to identify any abnormal biosensor test strips if present. Afterwards, embodiments of the present invention applies a reverse electric potential, having the same time interval as the inspection electric potential, onto the inspection pads connecting to the reference electrode and working electrode to prevent degradation on mediators such as potassium ferricyanide.

Claims

1. A method for determining an electrochemical characteristic associated with a test strip, comprising:

applying a cyclic electric potential to the test strip to stabilize the electrochemical characteristic of an enzyme reagent on the test strip;

conducting a quality assurance test with an inspection electric potential on the test strip; and

subjecting the test strip to a reverse electric potential adapted to substantially restore the test strip back to an original condition before the inspection electric potential is applied.

2. The method of claim 1, wherein the test strip comprises a working electrode, a reference electrode and an enzyme reagent placed on the working electrode and the reference electrode.

3. The method of claim 2, wherein the working electrode is electrically connected to a first inspection pad, and the reference electrode is electrically connected to a second inspection pad.

4. The method of claim 3, wherein a distance between the working electrode and the first inspection pad is less than 2 centimeters, and a distance between the reference electrode and the second inspection pad is less than 2 centimeters.

5. The method of claim 3, wherein the enzyme reagent comprises potassium ferricyanide.

6. The method of claim 5, wherein the enzyme reagent further comprises glucose oxidase (GOD), glucose dehydrogenase (GDH), citric acid, phosphoric acid, nonionic surfactant, and deionized water.

7. The method of claim 5, wherein the cyclic electric potential has a cycle which is selected from a group consisting of a positive-zero-negative-zero-positive cycle beginning with a positive voltage, a zero-positive-zero-negative-zero cycle beginning with a zero voltage, a zero-negative-zero-positive-zero cycle beginning with a zero voltage, and a negative-zero-positive-zero-negative cycle beginning with a negative voltage.

8. The method of claim 3, wherein the quality assurance test with an inspection electric potential comprises applying an inspection electric potential between the first inspection pad and the second inspection pad for a first time interval to measure electrical resistance associated with the enzyme reagent on the working electrode and the reference electrode.

9. The method of claim 8, wherein said subjecting the test strip to the reverse electric potential comprises applying the reverse electric potential that is opposite to the inspection electric potential between the first inspection pad and the second inspection pad for a second time interval.

10. The method of claim 9, wherein the first time interval and the second time interval required to apply the inspection electric potential and the reverse electric potential are substantially the same.

11. The method of claim 9, wherein the reverse electric potential and the second time interval are adapted to prevent potassium ferricyanide in the enzyme reagent from degradation.

12. The method of claim 11, wherein the first contact pad, the first inspection pad, the working electrode, the second contact pad, the second inspection pad and the reference electrode comprise copper foil with gold plating, and the inspection electric potential is less than 0.35 volt and the first time interval is less than 5 seconds.

13. The method of claim 11, wherein the first contact pad, the first inspection pad, the working electrode, the second contact pad, the second inspection pad and the reference electrode comprise silver paste, and the inspection electric potential is less than 0.35 volt and the first time interval is less than 5 seconds.

14. The method of claim 11, wherein the first contact pad, the first inspection pad, the working electrode, the second contact pad, the second inspection pad and the reference electrode comprise carbon paste, and the inspection electric potential is less than 0.35 volt and the first time interval is less than 5 seconds.

15. A method for determining an electrochemical characteristic associated with a first test section of a test strip, comprising:

applying a cyclic electric potential to the first test section of the test strip to stabilize the electrochemical characteristic of an enzyme reagent on the test strip;

conducting a quality assurance test with an inspection electric potential on the first test section; and

subjecting the first test section to a reverse electric potential adapted to substantially restore the first test section back to an original condition before the inspection electric potential is applied,

wherein the test strip further comprises a second test section, and the first test section can be separated from the test strip through an associated pre-break line.

16. The method of claim 15, wherein the first test section comprises a first working electrode and a first reference electrode, the second test section comprises a second working electrode and a second reference electrode, and the first working electrode is electrically connected to the second working electrode and the first reference electrode is electrically connected to the second reference electrode.

17. A test strip comprising at least one test section for measuring blood glucose in a blood sample, the test section comprising:

a working electrode;

a reference electrode;

an enzyme reagent placed between the working electrode and the reference electrode;

a first inspection pad electrically connected to the working electrode;

a second inspection pad electrically connected to the reference electrode;

a first contact pad electrically connected to the working electrode; and

a second contact pad electrically connected to the reference electrode,

wherein the first contact pad and the second contact pad are applied with a cyclic electric potential to stabilize an electrochemical characteristic of an enzyme reagent on the test strip, and the first inspection pad and the second inspection pad are applied with an inspection electric potential to measure an electrical resistance of the enzyme reagent, the test strip comprises more than one test sections, the first inspection pads of the different test sections are electrically connected with each other, and the second inspection pads of the different test sections are electrically connected with each other.

18. The test strip of claim 17, wherein the test sections share a same first contact pad and a same second contact pad.