Method of using a biosensor

• US 9,410,917 B2
• Filed: 02/28/2014
• Issued: 08/09/2016
• Est. Priority Date: 02/06/2004
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Beer, Greg P., Wu, Huan-Ping, Yip, Kin-Fai
• Primary Examiner(s): Hendricks, Keith
• Assistant Examiner(s): CARLSON, KOURTNEY SALZMAN
• Application Number:
  US14/193,214
• Publication Number:
  US 20140174951A1
• Time in Patent Office: 893 Days
• Field of Search: 20440301-40315, 205/777.5
• US Class Current: 1/1
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• 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 33/54373 involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings

Abstract

A biosensor (102) for determining the presence or amount of a substance in a sample and methods of use of the biosensor (102) are provided. The biosensor (102) for receiving a user sample to be analyzed includes a mixture for electrochemical reaction with an analyte. The mixture includes an enzyme, a mediator and an oxidizable species as an internal reference.

Claims

1. A method of using a biosensor including a mixture of an only one enzyme, a mediator, and an oxidizable species as an internal reference, said oxidizable species being different than the mediator species and having different redox potentials, wherein said mixture is located directly on a surface of at least a portion of a working electrode, said method comprising the steps of:

applying a first voltage potential in a first voltage period;

providing a set delay period;

applying a second voltage potential in a second voltage period following said delay period; and

wherein said first voltage potential and said second voltage potential are selectively provided for oxidizing only said mediator or both said mediator and said internal reference.

2. The method of claim 1 wherein the step of applying said first voltage potential in said first voltage period includes the step of applying a selected first voltage potential in said first voltage period for oxidizing said mediator and said internal reference.

3. The method of claim 1 wherein the step of applying said first voltage potential in said first voltage period includes the step of applying a selected first voltage potential in said first voltage period for oxidizing only said mediator.

4. The method of claim 1 wherein the step of applying said second voltage potential in said second voltage period following said delay period includes the step of applying a selected second voltage potential for oxidizing said mediator and said internal reference.

5. The method of claim 1 wherein the step of applying said second voltage potential in said second voltage period following said delay period includes the step of applying a selected second voltage potential for oxidizing only said mediator.

6. The method of claim 1 wherein the steps of applying said first voltage potential and applying said second voltage potential includes the steps of applying a selected voltage potential in a range between 100 mV and 400 mV.

7. The method of claim 1 wherein the steps of applying said first voltage potential and applying said second voltage potential includes the steps of applying a selected first voltage potential in said first voltage period for oxidizing both said mediator and said internal reference;

and applying a selected second voltage potential for oxidizing only said mediator.

8. The method of claim 1 wherein the biosensor includes a mediator comprising 3-phenylimino-3H-phenothiazine;

and wherein said internal reference comprises ferrocyanide.

9. The method of claim 1 wherein the steps of applying said first voltage potential and applying said second voltage potential includes the steps of applying a selected first and second voltage potential for oxidizing both said mediator and said internal reference;

wherein said internal reference effectively anchoring a calibration intercept within a narrow range and said internal reference effectively maintaining a calibration slope for the biosensor.

10. The method of claim 1 wherein said mediator comprises ruthenium hexamine, and wherein said internal reference comprises ferrocyanide.

11. The method of claim 1 wherein said internal reference comprises ferrocyanide.

12. The method of claim 1 wherein said mediator comprises 3-phenylimino-3H-phenothiazine.

13. The method of claim 1 wherein said mediator comprises ruthenium hexaamine.

14. The method of claim 1 wherein the steps of applying said first voltage potential and applying said second voltage potential includes the steps of applying a selected voltage potential in a range between 0 mV and 400 mV.

15. A method of using a biosensor to assist in determining glucose concentration, the method comprising:

providing a biosensor including a reagent, located directly on a surface of at least a portion of a working electrode, the reagent including an only one enzyme, mediator and an oxidizable species as an internal reference, said oxidizable species being different than the mediator species and having different redox potentials;

applying a first voltage potential in a first voltage period;

providing a set delay period; and

applying a second voltage potential in a second voltage period following said delay period,

wherein said first voltage potential is selectively provided for oxidizing only said mediator or both said mediator and said internal reference, and wherein said second voltage potential is selectively provided for oxidizing only said mediator or both said mediator and said internal reference.

16. The method of claim 15 wherein the enzyme includes glucose oxidase.

17. The method of claim 15 wherein enzyme includes glucose dehydrogenase.

18. The method of claim 15 wherein said mediator reference comprises 3-phenylimino-3H-phenothiazine.

19. The method of claim 18 wherein said internal reference is ferrocyanide.

20. The method of claim 15 wherein the steps of applying said first voltage potential and applying said second voltage potential includes the steps of applying a selected voltage potential in a range between 0 mV and 400 mV.

21. A method of using a biosensor to assist in determining an analyte concentration, the method comprising:

providing a biosensor including a reagent, the reagent, located directly on a surface of at least a portion of the working electrode, including only one enzyme, mediator and an oxidizable species as an internal reference;

applying a first voltage potential in a first voltage period;

providing a set delay period; and

applying a second voltage potential in a second voltage period following said delay period;

wherein one of said first voltage potential and said second voltage potential oxidizes only said mediator and the other one of said first voltage potential and said second voltage potential oxidizes both said mediator and said internal reference.

22. The method of claim 21 wherein the analyte is glucose.

23. The method of claim 22 wherein the enzyme includes glucose oxidase or glucose dehydrogenase.

24. The method of claim 21 wherein said mediator reference comprises 3-phenylimino-3H-phenothiazine.

25. The method of claim 21 wherein the steps of applying said first voltage potential and applying said second voltage potential includes the steps of applying a selected voltage potential in a range between 100 mV and 400 mV.

26. The method of claim 21 wherein said first voltage potential oxidizes both said mediator and said internal reference and said second voltage potential oxidizes only said internal reference.