System and Methods for Determination of Analyte Concentration Using Time Resolved Amperometry

• US 20090076738A1
• Filed: 07/25/2008
• Published: 03/19/2009
• Est. Priority Date: 07/26/2007
• Status: Abandoned Application

• Current Assignee: Nipro Diagnostics, Inc.
• Original Assignee: Nipro Diagnostics, Inc.
• Inventors: Kayihan, Ferhan, Deng, David
• Application Number:
  US12/179,870
• Publication Number:
  US 20090076738A1
• Time in Patent Office: Days
• US Class Current: 702/25
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875

Abstract

This invention is a method for determining a concentration of an analyte. The steps include applying a potential excitation to a fluid sample containing an analyte, and measuring one or more currents associated with one or more time-segments. The method can also include calculating a final analyte concentration based on a first and second set of analyte concentrations, wherein each set of analyte concentration values is based on a first and second set of calibration data associated with first and second time-segments.

Claims

1. A method for analyzing an analyte, the steps comprising:

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

measuring a first current during a first time-segment following application of the potential excitation;

measuring a second current during a second time-segment following application of the potential excitation;

calculating a plurality of first analyte concentrations based on the first measured current and a first set of calibration data associated with the first time-segment; and

calculating a plurality of second analyte concentrations based on the second measured current and a second set of calibration data associated with the second time-segment.

2. The method of claim 1, further comprising:

determining a final analyte concentration based on at least one of the first analyte concentrations and at least one of the second analyte concentrations.

3. The method of claim 2, wherein determining the final analyte concentration includes at least one of an iterative algorithm, an interpolative algorithm, a line-plot, and an extrapolative algorithm.

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

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

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

7. 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.

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

9. The method of claim 8, wherein the different levels of hematocrit include at least one of a high level greater than about 42%, a physiological level of about 42%, and a low level less than about 42%.

10. The method of claim 1, further comprising:

measuring a third current during a third time-segment following application of the potential excitation;

calculating a plurality of third analyte concentrations based on the third measured current and a third set of calibration data associated with the third time-segment; and

determining a final analyte concentration based on at least one of the first and second analyte concentrations and at least one of the third analyte concentrations.

11. The method of claim 1, wherein the analyte is glucose and the fluid sample includes blood.

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

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

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

a processor configured to;

measure a first current during a first time-segment following application of the potential excitation;

measure a second current during a second time-segment following application of the potential excitation;

calculate a plurality of first analyte concentrations based on the first measured current and a plurality of first calibration curves associated with the first time-segment; and

calculate a plurality of second analyte concentrations based on the second measured current and a plurality of second calibration curves associated with the second time-segment.

14. The system of claim 13, further comprising a processor configured to:

determine a final analyte concentration based on at least one of the first analyte concentrations and at least one of the second analyte concentrations.

15. The system of claim 14, wherein the final analyte concentration is determined using at least one of an iterative algorithm, an interpolative algorithm, a line-plot, and an extrapolative algorithm.

16. The system of claim 14, wherein the system is further configured to a display a value representative of the final analyte concentration.

17. The system of claim 13, wherein the first time-segment is less than about two to ten seconds, and the second time-segment is more than about two to ten seconds.

18. The system of claim 13, wherein the first time-segment is less than about eight seconds, and the second time-segment is more than about eight seconds.

19. The system of claim 13, wherein at least one of the calibration curves is determined using at least one of empirical data, and predicted data.

20. The system of claim 13, wherein the plurality of first and second calibration curves are associated with different levels of hematocrit.

21. The system of claim 20, wherein the different levels of hematocrit include at least one of a high level greater than about 42%, a physiological level of about 42%, and a low level less than about 42%.

22. The system of claim 13, further comprising a processor configured to:

measure a third current during a third time-segment following application of the potential excitation;

calculate a plurality of third analyte concentrations based on the third measured current and a plurality of third calibration curves associated with the third time-segment; and

determine a final analyte concentration based on at least one of the first and second analyte concentrations and at least one of the third analyte concentrations.

23. The system of claim 13, wherein the analyte is glucose and the fluid sample includes blood.

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

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

26. The system of claim 13, wherein the processor is contained within a meter.

27. A computer readable media, wherein the media comprises a plurality of instructions configured to direct a processor to:

measure a first current during a first time-segment following application of a potential excitation, wherein the potential excitation is applied to a fluid sample containing an analyte;

measure a second current during a second time-segment following application of the potential excitation;

calculate a plurality of first analyte concentrations based on the first measured current and a first set of calibration data associated with the first time-segment; and

calculate a plurality of second analyte concentrations based on the second measured current and a second set of calibration data associated with the second time-segment.

28. The computer readable media of claim 27, wherein the instructions further direct the processor to:

determine a final analyte concentration based on at least one of the first analyte concentrations and at least one of the second analyte concentrations.

29. The computer readable media of claim 28, wherein the final analyte concentration is determined using at least one of an iterative algorithm, an interpolative algorithm, a line-plot, and an extrapolative algorithm.

30. The computer readable media of claim 27, wherein the calibration data includes at least one of a plurality of calibration curves, a lookup table, a data array, and a mathematical equation.

31. The computer readable media of claim 27, wherein the first time-segment is less than about two to ten seconds, and the second time-segment is more than about two to ten seconds.

32. The computer readable media of claim 31, wherein the first time-segment is less than about eight seconds, and the second time-segment is more than about eight seconds.

33. The computer readable media of claim 27, wherein at least part of the calibration data is determined using at least one of empirical data, and predicted data.

34. The computer readable media of claim 27, wherein the first and second sets of calibration data are associated with different levels of hematocrit.

35. The computer readable media of claim 34, wherein the different levels of hematocrit include at least one of a high level greater than about 42%, a physiological level of about 42%, and a low level less than about 42%.

36. The computer readable media of claim 27, wherein the instructions further direct the processor to:

measure a third current during a third time-segment following application of the potential excitation;

calculate a plurality of third analyte concentrations based on the third measured current and a third set of calibration data associated with the third time-segment; and

determine a final analyte concentration based on at least one of the first and second analyte concentrations and at least one of the third analyte concentrations.