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

• US 8,574,424 B2
• Filed: 12/20/2011
• Issued: 11/05/2013
• 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 F
• Application Number:
  US13/331,346
• Publication Number:
  US 20120234700A1
• Time in Patent Office: 686 Days
• Field of Search: 204/403.01, 204/403.02, 204/403.03, 204/403.04, 204/403.13, 204/403.14, 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, 702/25, 702/100, 422/82.01, 422/82.02, 422/82.03, 422/98, 436/150, 436/151
• 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 in a fluid sample, the steps comprising:

applying a potential excitation to the fluid sample;

measuring a plurality of first current values during a first time-segment following application of the potential excitation, wherein a first set of calibration data is derived from the first time-segment and a second set of calibration data is derived from a second time-segment that follows at least part of the first time-segment;

determining when the plurality of first current values are within a first target range associated with the first time-segment, wherein the first target range is associated with a low analyte concentration and a second target range is associated with the second time-segment and an analyte concentration higher than the low analyte concentration of the first time-segment; and

calculating a final concentration of the analyte based on data associated with the plurality of first current values and the first set of calibration data when the plurality of first current values are within the first target range.

2. The method of claim 1, wherein calculating the final concentration of the analyte includes inputting the plurality of first current values into at least one of an iterative algorithm, an interpolative algorithm, a line-plot, and an extrapolative algorithm.

3. The method of claim 1, wherein the first set of calibration data includes at least one of a plurality of calibration curves, a lookup table, a data array, and a mathematical equation.

4. The method of claim 1, wherein the first time-segment is less than about two to about ten seconds and the second time-segment is more than about two to about ten seconds.

5. The method of claim 4, wherein the first time-segment is less than about four seconds and the second time-segment is more than about four seconds.

6. The method of claim 1, wherein at least part of the calibration data is determined using at least one of empirical data and predicted data.

7. The method of claim 1, wherein the first and second sets of calibration data are associated with different levels of hematocrit.

8. The method of claim 7, wherein the different levels of hematocrit include at least one of a high level, an intermediate level, and a low level.

9. The method of claim 1, further comprising:

measuring a plurality of second current values during the second time-segment;

determining when the plurality of second current values are within the second target range; and

calculating a final concentration of the analyte based on data associated with the plurality of second current values and the second set of calibration data when the plurality of second measured current values are within the second target range.

10. The method of claim 9, further comprising:

measuring a plurality of third current values during a third time-segment following at least part of the second time-segment; and

calculating a final concentration of the analyte based on data associated with the plurality of third current values and a third set of calibration data derived from the third time-segment, wherein a third target range is associated with an analyte concentration higher than the analyte concentration associated with the second target range.

11. The method of claim 10, wherein calculating the final concentration of the analyte includes using data associated with a predicted current value at a future time-point greater than the third time-segment.

12. The method of claim 11, wherein the predicted current value is determined using an extrapolated current decay curve based on at least one of the plurality of first current values, the plurality of second current values, and the plurality of third current values.

13. The method of claim 9, wherein calculating the final concentration of the analyte includes using data associated with a predicted current value at a future time-point greater than the second time-segment.

14. The method of claim 13, wherein the predicted current value is determined using an extrapolated current decay curve based on at least one of the plurality of first current values and the plurality of second current values.

15. The method of claim 1, wherein the first and second sets of calibration data are associated with different temperatures.

16. The method of claim 1, wherein the first time-segment is about four seconds in duration and the second time-segment is about three seconds in duration.

17. A non-transitory computer readable media, wherein the media comprises a plurality of instructions configured to direct a processor to:

measure a plurality of first current values during a first time-segment following application of a potential excitation, wherein the potential excitation is applied to a fluid sample containing an analyte, a first set of calibration data is derived from the first time-segment, and a second set of calibration data is derived from a second time-segment that follows at least part of the first time-segment;

determine when the plurality of first current values are within a first target range associated with the first time-segment, wherein the first target range is associated with a low analyte concentration and a second target range is associated with the second time-segment and an analyte concentration higher than the low analyte concentration of the first time-segment; and

calculate a final concentration of the analyte based on data associated with the plurality of first current values and the first set of calibration data when the plurality of first current values are within the first target range.

18. The computer readable media of claim 17, wherein the processor is further configured to:

measure a plurality of second current values during the second time-segment;

determine when the plurality of second current values are within the second target range; and

calculate a final concentration of the analyte based on data associated with the plurality of second current values and the second set of calibration data when the plurality of second measured current values are within the second target range.

19. The computer readable media of claim 18, wherein the processor is further configured to:

measure a plurality of third current values during a third time-segment following at least part of the second time-segment; and

calculate a final concentration of the analyte based on data associated with the plurality of third current values and a third set of calibration data derived from the third time-segment, wherein a third target range is associated with an analyte concentration higher than the analyte concentration associated with the second target range.

20. The computer readable media of claim 19, wherein the first, second, and third sets of calibration data are associated with different temperatures.

21. The computer readable media of claim 19, 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.

22. The computer readable media of claim 19, wherein calculating the final concentration of the analyte includes using data associated with a predicted current value at a future time-point greater than the third time-segment.

23. The computer readable media of claim 22, wherein the predicted current value is determined using an extrapolated current decay curve based on at least one of the plurality of first current values, the plurality of second current values, and the plurality of third current values.