Method of making an electrochemical sensor strip

• US 9,157,111 B2
• Filed: 02/21/2014
• Issued: 10/13/2015
• Est. Priority Date: 10/24/2003
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Wu, Huan-Ping, Beer, Greg P., Blaschke, Christina
• Primary Examiner(s): Hendricks, Keith
• Assistant Examiner(s): CARLSON, KOURTNEY SALZMAN
• Application Number:
  US14/186,991
• Publication Number:
  US 20140314950A1
• Time in Patent Office: 599 Days
• Field of Search: 20440301-40315, 204/412, 205/775, 205/777.5, 205/792, 205/789
• US Class Current: 1/1
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

A method of making an electrochemical sensor strip that includes: depositing a first electrode on a base; depositing a second electrode on the base; applying a first layer onto the first electrode; and applying a second layer onto the second electrode. The first layer includes an oxidoreductase and a mediator. The second layer includes a soluble redox species.

Claims

1. A method of making an electrochemical sensor strip, the method comprising:

depositing a first electrode on a base;

depositing a second electrode on the base;

applying a first reagent layer onto the first electrode, the first reagent layer comprising an electroactive organic molecule and an oxidoreductase configured to facilitate a redox reaction of an analyte; and

applying a second reagent layer onto the second electrode, the second reagent layer consisting essentially of a redox pair comprising a first soluble redox species and a second soluble redox species, the redox pair being selected from a group consisting of an organotransition metal complex, a transition metal coordination complex, and mixtures thereof,

wherein the first soluble redox species is configured to undergo a redox reaction opposite that of the analyte, and

wherein the molar ratio of the first soluble redox species to the second soluble redox species is greater than about 1.2;

1 prior to use of the sensor strip in an analysis.

2. The method of claim 1, wherein the oxidoreductase comprises an enzyme selected from a group consisting of an oxidase and a dehydrogenase, and wherein the first soluble redox species is a reducible species.

3. The method of claim 1, wherein the analyte comprises glucose, and wherein the oxidoreductase comprises glucose oxidase or glucose dehydrogenase, or a combination thereof.

4. The method of claim 1, wherein the oxidoreductase comprises a reductase, and wherein the second soluble redox species is an oxidizable species.

5. The method of claim 1, wherein the molar ratio of the first soluble redox species to the second soluble redox species is greater than about 10:

1.

6. The method of claim 1, wherein the second soluble redox species is present in the second reagent layer in an amount less than about 1 part per thousand.

7. The method of claim 1, wherein the first soluble redox species has a standard reduction potential of +0.24 volts or greater.

8. The method of claim 1, wherein the first soluble redox species has a reduction potential of about +0.35 volts or greater.

9. The method of claim 1, wherein the depositing the first electrode comprises screen printing a pattern of conductive carbon.

10. The method of claim 1, wherein the depositing the second electrode comprises screen printing a pattern of conductive carbon.

11. The method of claim 1, wherein the depositing the second electrode comprises depositing a pattern of a non-ionizing conductive material.

12. The method of claim 1, further comprising covering a portion of the base with a dielectric layer such that the first and second reagent layers are exposed.

13. The method of claim 1, further comprising mating a lid to the base such that the lid is over the first and second electrodes and the first and second reagent layers.

14. The method of claim 1, wherein the applying the first reagent layer comprises dispensing a first aqueous composition comprising the oxidoreductase and the electroactive organic molecule.

15. The method of claim 14, wherein the first aqueous composition further comprises a redox cofactor for the oxidoreductase.

16. The method of claim 14, wherein the first aqueous composition further comprises a binder.

17. The method of claim 14, wherein the first aqueous composition further comprises a buffer.

18. The method of claim 1, wherein the applying the second reagent layer comprises dispensing a second aqueous composition comprising the first and second soluble redox species.

19. The method of claim 18, wherein the second aqueous composition further comprises a buffer.

20. The method of claim 1, further comprising:

depositing a third electrode on the base; and

applying a third reagent layer onto the third electrode, the third reagent layer comprising a third soluble redox species.

21. The method of claim 20, wherein the third soluble redox species is substantially identical to the first soluble redox species of the second reagent layer.

22. The method of claim 21, wherein the composition of the third reagent layer is substantially identical to the composition of the second reagent layer.

23. A method of making an electrochemical sensor strip, the method comprising:

depositing a first electrode on a base;

depositing a second electrode on the base;

applying a first reagent layer onto the first electrode, the first reagent layer comprising an electroactive organic molecule and an enzyme selected from a group consisting of glucose oxidase, glucose dehydrogenase, and mixtures thereof; and

applying a second reagent layer onto the second electrode, the second reagent layer consisting essentially of a redox pair comprising a first soluble redox species and a second soluble redox species, the redox pair being selected from a group consisting of an organotransition metal complex, a transition metal coordination complex, and mixtures thereof,

wherein the first soluble redox species is a reducible species and the second soluble redox species is an oxidizable species, and

wherein the molar ratio of the first soluble redox species to the second soluble redox species is greater than about 1.2;

1 prior to use of the sensor strip in an analysis.