IP Library Granted Patent US 9,039,878
Granted Patent B2
US 9,039,878 · App. 13/717,024 · Granted May 26, 2015

Mediator for test sensor

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Quick Facts
Patent No.
US 9,039,878
App. No.
13/717,024
Granted
May 26, 2015
Kind
B2
Abstract

A method of forming a 3-phenylimino-3H-phenothiazine or a 3-phenylimino-3H-phenoxazine mediator includes providing a first reactant including phenothiazine or phenoxazine, providing a first solvent, providing a second reactant and providing a second solvent. The first reactant, first solvent, second reactant and second solvent are combined to form a reactants solution. Sodium persulfate is added to the reactants solution to couple the first and second reactants resulting in a reaction solution including the 3-phenylimino-3H-phenothiazine or the 3-phenylimino-3H-phenoxazine mediator.

Claims (40)

1. A test sensor including a base, the base including an enzyme adapted to react with an analyte, and a mediator, the mediator having a background current being less than 200 nA after being exposed to a temperature of 50° C. for a duration of two weeks and further including a neutralizing agent, the neutralizing agent being present in an amount to obtain a pH in a range below 7 to about 5.5 in a mediator solution.

2. The test sensor of claim 1 wherein the neutralizing agent is sodium hydroxide.

3. The test sensor of claim 1 wherein the neutralizing agent is sodium bicarbonate.

4. The test sensor of claim 1 further including a buffer.

5. The test sensor of claim 4 wherein the buffer is sodium phosphate.

6. The test sensor of claim 1 wherein the test sensor is an electrochemical test sensor.

7. The test sensor of claim 1 wherein the test sensor is an optical test sensor.

8. The test sensor of claim 1 wherein the mediator is a 3-phenylimino-3H-phenothiazine mediator.

9. The test sensor of claim 1 wherein the neutralizing agent is sodium phosphate.

10. The test sensor of claim 1 wherein the neutralizing agent is present in an amount to obtain a pH in a range below 7 to about 6 in the mediator solution.

11. The test sensor of claim 1 wherein the neutralizing agent is present in an amount to obtain a pH of from about 5.5 to about 6 in the mediator solution.

12. A test sensor including a reagent, the reagent including a mediator and a neutralizing agent, the reagent having a % bias being within 2.4% between 0 and 400 mg/dL of glucose after being exposed to a temperature of 50° C. for a duration of two weeks, the neutralizing agent being present in an amount to obtain a pH in a range below 7 to about 5.5 in a mediator solution.

13. The test sensor of claim 12 wherein the reagent includes a 3-phenylimino-3H-phenothiazine mediator.

14. The test sensor of claim 12 wherein the reagent further comprises glucose dehydrogenase (GDH) and a cellulose polymer.

15. The test sensor of claim 12 wherein the test sensor includes electrodes.

16. The test sensor of claim 12 wherein the % bias is within 1.8% between 0 and 100 mg/dL of glucose after being exposed to a temperature of 50° C. for a duration of two weeks.

17. The test sensor of claim 12 wherein the neutralizing agent is present in an amount to obtain a pH in a range below 7 to about 6 in the mediator solution.

18. The test sensor of claim 12 wherein the neutralizing agent is present in an amount to obtain a pH of from about 5.5 to about 6 in the mediator solution.

19. A test sensor including electrodes and a reagent including glucose dehydrogenase (GDH), a mediator and a neutralizing agent, the reagent having a % bias being within 2.4% between 0 and 400 mg/dL of glucose after being exposed to a temperature of 50° C. for a duration of two weeks, the neutralizing agent being present in an amount to obtain a pH in a range below 7 to about 5.5 in a mediator solution.

20. The test sensor of claim 19 wherein the reagent further includes 3-phenylimino-3H-phenothiazine mediator and a cellulose polymer.

21. The test sensor of claim 19 wherein the % bias is within 1.8% between 0 and 100 mg/dL of glucose after being exposed to a temperature of 50° C. for a duration of two weeks.

22. The test sensor of claim 19 wherein the neutralizing agent is present in an amount to obtain a pH of from about 6 to about 7 in the mediator solution.

23. The test sensor of claim 19 wherein the neutralizing agent is present in an amount to obtain a pH of from about 5.5 to about 6 in the mediator solution.

24. A test sensor including a base, the base including an enzyme adapted to react with an analyte, and a 3-phenylimino-3H-phenothiazine mediator, the 3-phenylimino-3H-phenothiazine mediator having a background current being less than 200 nA after being exposed to a temperature of 50° C. for a duration of two weeks and further including a neutralizing agent, the neutralizing agent being present in an amount to obtain a pH in a range below 7 to about 6 in a mediator solution.

25. The test sensor of claim 24 wherein the neutralizing agent is present in an amount to obtain a pH of from about 5.5 to about 6 in the mediator solution.

26. The test sensor of claim 24 wherein the neutralizing agent is sodium hydroxide.

27. The test sensor of claim 24 wherein the neutralizing agent is sodium bicarbonate.

28. The test sensor of claim 24 wherein the neutralizing agent is sodium phosphate.

29. The test sensor of claim 24 further including a buffer.

30. The test sensor of claim 29 wherein the buffer is sodium phosphate.

31. The test sensor of claim 24 wherein the test sensor is an electrochemical test sensor.

32. The test sensor of claim 24 wherein the test sensor is an optical test sensor.

33. A test sensor including a base, the base including an enzyme adapted to react with an analyte, and a 3-phenylimino-3H-phenothiazine mediator, the 3-phenylimino-3H-phenothiazine mediator having a background current being less than 200 nA after being exposed to a temperature of 50° C. for a duration of two weeks and further including a neutralizing agent, the neutralizing agent being present in an amount to obtain a pH of about 6.1 in a mediator solution.

34. The test sensor of claim 33 wherein the neutralizing agent is sodium hydroxide.

35. The test sensor of claim 33 wherein the neutralizing agent is sodium bicarbonate.

36. The test sensor of claim 33 wherein the neutralizing agent is sodium phosphate.

37. The test sensor of claim 33 further including a buffer.

38. The test sensor of claim 37 wherein the buffer is sodium phosphate.

39. The test sensor of claim 33 wherein the test sensor is an electrochemical test sensor.

40. The test sensor of claim 33 wherein the test sensor is an optical test sensor.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 23, 2016
From: BAYER HEALTHCARE LLC
To: ASCENSIA DIABETES CARE HOLDINGS AG
Reel/Frame 037880/0604 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE STATE NAME, PREVIOUSLY RECORDED AT REEL: 029896 FRAME: 0506. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Dec 22, 2015
From: MARFURT, KAREN L; ARNDT, HENRY C.
To: BAYER HEALTHCARE LLC
Reel/Frame 037359/0337 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 28, 2013
From: MARFURT, KAREN L.; ARNDT, HENRY C.
To: BAYER HEALTHCARE LLC
Reel/Frame 029896/0506 →