Biosensor having improved hematocrit and oxygen biases

• US 7,754,093 B2
• Filed: 05/26/2006
• Issued: 07/13/2010
• Est. Priority Date: 10/23/2002
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Karinka, Shridhara Alva, Forrow, Nigel J.
• Primary Examiner(s): Bell; Bruce F
• Application Number:
  US11/420,628
• Publication Number:
  US 20060201805A1
• Time in Patent Office: 1,509 Days
• Field of Search: 204/403.01, 204/403.04, 204/403.09, 204/403.1, 204/403.11, 204/403.14
• US Class Current: 252/62.2
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

The present invention provides reagent compositions, and analyte measuring devices and methods that utilize the reagent compositions.

Claims

1. A reagent composition, comprising:

a mediator, wherein the mediator is 1,10-phenanthroline-5,6-dione;

a metal ion, wherein the metal ion is a transition metal ion or a heavier alkaline earth metal ion; and

a counter anion.

2. The reagent composition of claim 1, wherein the metal ion is nickel, manganese, iron, cobalt, osmium, or ruthenium.

3. The reagent composition of claim 1, wherein the metal ion is calcium, strontium, or barium.

4. The reagent composition of claim 1, wherein the metal ion is in the form of a salt.

5. The reagent composition of claim 1, wherein the metal ion is nickel.

6. The reagent composition of claim 1, wherein the metal ion is in the form of a complex with the mediator.

7. The reagent composition of claim 1, wherein the counter anion is a halide, a nitrate, a nitrite, a sulfate, a carbonate, a phosphate, a thiocyanate, an acetate, a formate, a citrate, a succinate, an oxalate, a tartrate, a benzoate, or an alkyl or aromatic sulfonate.

8. The reagent composition of claim 7, wherein the halide is chloride, bromide, fluoride, or iodide.

9. The reagent composition of claim 1, wherein the counter anion is a tungstate, a molybdate, a ferricyanide, a nitroprusside, a tetraphenylborate, or an anionic surfactant.

10. The reagent composition of claim 1, wherein the reagent composition further comprises an enzyme.

11. The reagent composition of claim 10, wherein the enzyme is glucose oxidase or glucose dehydrogenase.

12. The reagent composition of claim 10, wherein the enzyme is NAD(P)⁺-dependent dehydrogenase.

13. The reagent composition of claim 10, wherein the enzyme is glucose dehydrogenase.

14. A biosensor comprising:

(a) an electrode support;

(b) a first electrode disposed on the electrode support, the first electrode being a working electrode,

(c) a second electrode disposed on the electrode support, the second electrode being a reference electrode; and

(d) a reagent composition deposited over the first electrode and second electrode, wherein the reagent composition comprises an enzyme, a mediator, a metal ion, and a counter anion, wherein the metal ion is a transition metal ion or a heavier alkaline earth metal ion, and wherein the mediator is 1,10-phenanthroline-5,6-dione.

15. The biosensor of claim 14, wherein the metal ion is nickel, manganese, iron, cobalt, osmium, or ruthenium.

16. The biosensor of claim 14, wherein the metal ion is calcium, strontium, or barium.

17. The biosensor of claim 14, wherein the metal ion is nickel.

18. The biosensor of claim 14, wherein the metal ion is in the form of a salt.

19. The biosensor of claim 14, wherein the metal ion is in the form of a complex with the mediator.

20. The biosensor of claim 14, wherein the enzyme is a glucose oxidase or a glucose dehydrogenase.

21. The biosensor of claim 14, wherein the enzyme is NAD(P)⁺-dependent dehydrogenase.

22. The biosensor of claim 14, wherein the enzyme is glucose dehydrogenase.

23. The biosensor of claim 14, wherein the counter anion is a halide, a nitrate, a nitrite, a sulfate, a carbonate, a phosphate, a thiocyanate, an acetate, a formate, a citrate, a succinate, an oxalate, a tartrate, a benzoate, or an alkyl or aromatic sulfonate.

24. The biosensor of claim 23, wherein the halide is chloride, bromide, fluoride, or iodide.

25. The biosensor of claim 14, wherein the counter anion is a tungstate, a molybdate, a ferricyanide, a nitroprusside, a tetraphenylborate, or an anionic surfactant.

26. The biosensor of claim 14, further comprising a covering layer defining an enclosed space over the electrodes, the covering layer having an aperture for receiving a sample into the enclosed space.

27. The biosensor of claim 26, further comprising a least one layer of mesh interposed in the enclosed space between the covering layer and the electrodes.

28. The biosensor of claim 14, wherein the counter electrode is positioned relative to the working electrode and the reference electrode such that a liquid sample will contact the working electrode and the reference electrode prior to contacting the counter electrode.

29. The biosensor of claim 14, wherein at least one electrode comprises carbon, palladium, gold, platinum, or iridium.

30. A biosensor comprising:

an electrode support having at least one gold electrode thereon; and

a reagent composition adjacent the at least one gold electrode, the reagent composition comprising;

an enzyme,

a mediator, wherein the mediator is 1,10-phenanthroline-5,6-dione,

a metal ion, wherein the metal ion is a transition metal ion or a heavier alkaline earth metal ion, and

a counter anion.

31. The biosensor of claim 30, wherein the metal ion is nickel, manganese, iron, cobalt, osmium, or ruthenium.

32. The biosensor of claim 30, wherein the metal ion is calcium, strontium, or barium.

33. The biosensor of claim 30, wherein the metal ion is nickel.

34. The biosensor of claim 30, wherein the metal ion is in the form of a salt.

35. The biosensor of claim 30, wherein the metal ion is in the form of a complex with the mediator.

36. The biosensor of claim 30, wherein the enzyme is a glucose oxidase or a glucose dehydrogenase.

37. The biosensor of claim 30, wherein the enzyme is NAD(P)⁺-dependent dehydrogenase.

38. The biosensor of claim 30, wherein the enzyme is glucose dehydrogenase.

39. The biosensor of claim 30, wherein the counter anion is a halide, a nitrate, a nitrite, a sulfate, a carbonate, a phosphate, a thiocyanate, an acetate, a formate, a citrate, a succinate, an oxalate, a tartrate, a benzoate, or an alkyl or aromatic sulfonate.

40. The biosensor of claim 39, wherein the halide is chloride, bromide, fluoride, or iodide.

41. The biosensor of claim 30, wherein the counter anion is a tungstate, a molybdate, a ferricyanide, a nitroprusside, a tetraphenylborate, or an anionic surfactant.

42. The biosensor of claim 30, further comprising a covering layer defining an enclosed space over the electrodes, the covering layer having an aperture for receiving a sample into the enclosed space.

43. The biosensor of claim 42, further comprising a least one layer of mesh interposed in the enclosed space between the covering layer and the electrodes.

44. The biosensor of claim 30, wherein the counter electrode is positioned relative to the working electrode and the reference electrode such that a liquid sample will contact the working electrode and the reference electrode prior to contacting the counter electrode.

45. The biosensor of claim 30, wherein at least one electrode comprises carbon, palladium, gold, platinum, or iridium.

46. A method for determining the concentration of an analyte in a sample of biological fluid, the method comprising the steps of:

(a) inserting a biosensor into an analyte monitor, the biosensor comprising;

an electrode support having at least one electrode thereon; and

a reagent composition adjacent the at least one gold electrode, the reagent composition comprising;

an enzyme,

a mediator, wherein the mediator is 1,10-phenanthroline-5,6-dione,

a metal ion, wherein the metal ion is a transition metal ion or a heavier alkaline earth metal ion, and

a counter anion;

(b) applying the biological fluid to the biosensor;

(c) applying a voltage at the electrode;

(d) measuring the current at the electrode; and

(e) correlating the current measured to the concentration of the analyte.

47. The biosensor of claim 46, wherein the metal ion is nickel, manganese, iron, cobalt, osmium, or ruthenium.

48. The biosensor of claim 47, wherein the metal ion is calcium, strontium, or barium.

49. The biosensor of claim 47, wherein the metal ion is nickel.

50. The biosensor of claim 47, wherein the metal ion is in the form of a salt.

51. The biosensor of claim 47, wherein the metal ion is in the form of a complex with the mediator.

52. The biosensor of claim 47, wherein the enzyme is a glucose oxidase or a glucose dehydrogenase.

53. The biosensor of claim 47, wherein the enzyme is NAD(P)⁺-dependent dehydrogenase.

54. The biosensor of claim 47, wherein the enzyme is glucose dehydrogenase.

55. The biosensor of claim 47, wherein the counter anion is a halide, a nitrate, a nitrite, a sulfate, a carbonate, a phosphate, a thiocyanate, an acetate, a formate, a citrate, a succinate, an oxalate, a tartrate, a benzoate, or an alkyl or aromatic sulfonate.

56. The biosensor of claim 55, wherein the halide is chloride, bromide, fluoride, or iodide.

57. The biosensor of claim 47, wherein the counter anion is a tungstate, a molybdate, a ferricyanide, a nitroprusside, a tetraphenylborate, or an anionic surfactant.

58. The biosensor of claim 47, further comprising a covering layer defining an enclosed space over the electrodes, the covering layer having an aperture for receiving a sample into the enclosed space.

59. The biosensor of claim 58, further comprising a least one layer of mesh interposed in the enclosed space between the covering layer and the electrodes.

60. The biosensor of claim 47, wherein the counter electrode is positioned relative to the working electrode and the reference electrode such that a liquid sample will contact the working electrode and the reference electrode prior to contacting the counter electrode.

61. The biosensor of claim 47, wherein at least one electrode comprises carbon, palladium, gold, platinum, or iridium.