Biosensor having improved hematocrit and oxygen biases

• US 8,163,160 B2
• Filed: 06/14/2010
• Issued: 04/24/2012
• Est. Priority Date: 10/23/2002
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Forrow, Nigel J., Karinka, Shridhara Alva
• Primary Examiner(s): BELL, BRUCE F
• Application Number:
  US12/815,169
• Publication Number:
  US 20110031133A1
• Time in Patent Office: 680 Days
• Field of Search: 205/792, 205/777.5, 204/403.01, 204/403.02, 204/403.04, 204/403.14, 435/287.1, 435/287.3, 435/287.9, 435/817
• US Class Current: 205/777.5
• 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 method for determining the concentration of an analyte in a sample of biological fluid, the method comprising the steps of:

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

an electrode support having at least one electrode thereon; and

a reagent composition disposed on the at least one electrode, the reagent composition comprising;

an enzyme;

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

a magnesium ion; and

a counter anion;

applying the biological fluid to the biosensor;

applying a voltage at the electrode;

measuring the current at the electrode; and

correlating the current measured to the concentration of the analyte.

2. The method of claim 1, wherein the magnesium ion is complexed with the mediator.

3. The method 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.

4. The method of claim 3, wherein the halide is chloride, bromide, fluoride, or iodide.

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

6. The method of claim 1, wherein the enzyme is selected from the group consisting of glucose oxidase, glucose dehydrogenase and 3-hydroxybutyrate dehydrogenase.

7. The method of claim 1, wherein the enzyme is an NAD(P)⁺-dependent dehydrogenase.

8. The method of claim 1, further comprising a covering layer defining an enclosed space over the at least one electrode, the covering layer having an aperture for receiving a sample into the enclosed space.

9. The method of claim 8, further comprising a least one layer of mesh interposed in the enclosed space between the covering layer and the at least one electrode.

10. The method of claim 1, wherein the biosensor comprises a working electrode, a reference electrode and a counter electrode, 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.

11. The method of claim 1, wherein at least one electrode comprises carbon, palladium, gold, platinum, or iridium.

12. A biosensor comprising:

an electrode support;

a working electrode disposed on the electrode support;

a reference electrode disposed on the electrode support; and

a reagent composition deposited over the working electrode and the reference electrode, wherein the reagent composition comprises an enzyme, a mediator, a magnesium ion, and a counter anion, wherein the mediator is 1,10-phenanthroline-5,6-dione or a derivative thereof.

13. The biosensor of claim 12, wherein the magnesium ion is complexed with the mediator.

14. The biosensor of claim 12, 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.

15. The biosensor of claim 14, wherein the halide is chloride, bromide, fluoride, or iodide.

16. The biosensor of claim 12, wherein the counter anion is a tungstate, a molybdate, a ferricyanide, a nitroprusside, a tetraphenylborate, or an anionic surfactant.

17. The biosensor of claim 12, wherein the enzyme is selected from the group consisting of glucose oxidase, glucose dehydrogenase and 3-hydroxybutyrate dehydrogenase.

18. The biosensor of claim 12, wherein the enzyme is an NAD(P)⁺-dependent dehydrogenase.

19. The biosensor of claim 12, further comprising a covering layer defining an enclosed space over the working electrode and reference electrode, the covering layer having an aperture for receiving a sample into the enclosed space.

20. The biosensor of claim 12, further comprising at least one layer of mesh interposed in the enclosed space between the covering layer and the working electrode and reference electrode.

21. The biosensor of claim 12, further comprising a counter electrode, 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.

22. The biosensor of claim 12, wherein at least one electrode comprises carbon, palladium, gold, platinum, or iridium.

23. A reagent composition, comprising:

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

at least one magnesium ion; and

at least one counter anion.

24. The reagent composition of claim 23, wherein the magnesium ion is complexed with the mediator.

25. The reagent composition of claim 23, 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.

26. The reagent composition of claim 25, wherein the halide is chloride, bromide, fluoride, or iodide.

27. The reagent composition of claim 23, wherein the counter anion is a tungstate, a molybdate, a ferricyanide, a nitroprusside, a tetraphenylborate, or an anionic surfactant.

28. The reagent composition of claim 23, wherein the reagent composition further comprises an enzyme.

29. The reagent composition of claim 28, wherein the enzyme is selected from the group consisting of glucose oxidase, glucose dehydrogenase and 3-hydroxybutyrate dehydrogenase.

30. The reagent composition of claim 28, wherein the enzyme is an NAD(P)⁺-dependent dehydrogenase.