System and methods for determination of analyte concentration using time resolved amperometry

• US 8,101,062 B2
• Filed: 03/24/2009
• Issued: 01/24/2012
• Est. Priority Date: 07/26/2007
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Nipro Diagnostics, Inc.
• Inventors: Deng, David
• Primary Examiner(s): Bell, Bruce
• Application Number:
  US12/410,048
• Publication Number:
  US 20090194432A1
• Time in Patent Office: 1,036 Days
• Field of Search: 204/403.01, 204/403.02, 204/403.03, 204/403.04, 204/403.13, 204/403.14, 204/406, 204/412, 205/777.5, 205/778, 205/778.5, 205/779, 205/792, 205/793.5, 435/7.4, 435/10, 435/11, 435/12, 435/287.1, 435/287.2, 435/287.3, 435/817
• US Class Current: 205/777.5
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• 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: Y10S 435/817 Enzyme or microbe electrode

Abstract

A method for determining a concentration of an analyte is disclosed. The method includes applying a potential excitation to a fluid sample containing an analyte and determining if a current decay curve associated with the fluid sample has entered an analyte depletion stage. The method also includes measuring a plurality of current values associated with the fluid sample during the analyte depletion stage and calculating an analyte concentration based on at least one of the plurality of current values.

Claims

1. A method for determining a concentration of an analyte, the steps comprising:

applying a potential excitation to a fluid sample containing an analyte;

determining if a current decay curve associated with the fluid sample has substantially entered an analyte depletion stage;

measuring a plurality of current values associated with the fluid sample during the analyte depletion stage; and

calculating an analyte concentration based on at least one of the plurality of current values.

2. The method of claim 1, wherein the analyte depletion stage corresponds to a diffusion layer thickness generally exceeding a spacer thickness, wherein the spacer thickness represents a depth of the fluid sample adjacent to an electrode configured to apply the potential excitation to the fluid sample.

3. The method of claim 2, wherein the spacer thickness is less than about 110 μ

m.

4. The method of claim 2, wherein the spacer thickness has a coefficient of variation of less than about 4%.

5. The method of claim 2, wherein the spacer thickness has a standard deviation of less than about 4 μ

m.

6. The method of claim 1, further including selecting a calibration curve from a plurality of calibration curves.

7. The method of claim 6, wherein each calibration curve is associated with a time-segment selected from a plurality of time-segments.

8. The method of claim 7, wherein the plurality of time-segments includes at least one of a first time-segment, a second time-segment, and a third time-segment.

9. The method of claim 8, wherein the first time-segment is about four seconds in duration, the second time-segment is about three seconds in duration, and the third time-segment is about three seconds in duration.

10. The method of claim 6, wherein the plurality of calibration curves is associated with at least one of a plurality of calibration ranges and a plurality of hematocrit values.

11. The method of claim 1, wherein the fluid sample includes an enzyme selected from at least one of glucose oxidase and glucose dehydrogenase, and a mediator selected from at least one of potassium ferricyanide and ruthenium hexamine.

12. The method of claim 1, wherein the analyte depletion stage occurs after a diffusion controlled stage and the current decay curve associated with the analyte depletion stage is generally controlled by depletion of an electroactive species.

13. A system for determining an analyte concentration in a fluid sample, comprising:

a set of electrodes positioned within a sample chamber and configured to apply a potential excitation to a fluid sample containing an analyte;

a sample chamber having a spacer height of less than about 110 μ

m;

a processor configured to;

determine if a current decay curve associated with the fluid sample has substantially entered an analyte depletion stage;

measure a plurality of current values associated with the fluid sample during the analyte depletion stage; and

calculate an analyte concentration based on at least one of the plurality of current values.

14. The system of claim 13, wherein the analyte depletion stage corresponds to a diffusion layer thickness generally exceeding a spacer thickness.

15. The system of claim 13, wherein the spacer height is less than at least one of about 100 μ

m and about 90 μ

m.

16. The system of claim 13, wherein the spacer height has a coefficient of variation of less than about 4%.

17. The system of claim 13, wherein the spacer height has a standard deviation of less than about 4 μ

m.

18. The system of claim 13, wherein the processor is further configured to select a calibration curve from a plurality of calibration curves.

19. The system of claim 18, wherein each calibration curve is associated with a time-segment selected from a plurality of time-segments.

20. The system of claim 18, wherein the plurality of calibration curves is associated with at least one of a plurality of calibration ranges and a plurality of hematocrit values.

21. The system of claim 13, wherein the fluid sample includes an enzyme selected from at least one of glucose oxidase and glucose dehydrogenase, and a mediator selected from at least one of potassium ferricyanide and ruthenium hexamine.

22. The system of claim 13, wherein the set of electrodes are coplanar.

23. The system of claim 13, wherein the set of electrodes are contained within in a test strip.

24. The system of claim 13, wherein the system is further configured to a display a value representative of the analyte concentration.

25. The system of claim 13, wherein the system is further configured to store at least one of the analyte concentration and one of more of the plurality of current values.

26. A biosensor, comprising:

a set of coplanar electrodes configured to apply a potential excitation to a fluid sample containing an analyte; and

a sample chamber configured to receive the fluid sample and house the electrodes, wherein the sample chamber has a height above the electrodes of less than about 110 μ

m and the height has a coefficient of variation of less than about 4%.

27. The biosensor of claim 26, wherein the height has a standard deviation of less than about 4 μ

m.

28. The biosensor of claim 26, further including a reagent layer.

29. The biosensor of claim 28, wherein the reagent layer further includes an enzyme selected from at least one of glucose oxidase and glucose dehydrogenase, and a mediator selected from at least one of potassium ferricyanide and ruthenium hexamine.

30. The biosensor of claim 26, wherein the biosensor further includes at least some calibration data.