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

• US 8,088,272 B2
• Filed: 07/25/2008
• Issued: 01/03/2012
• 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 F
• Application Number:
  US12/179,853
• Publication Number:
  US 20090101523A1
• Time in Patent Office: 1,257 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: 205/792
• 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 a current associated with the potential excitation at a plurality of time-points. The method also includes calculating an analyte concentration based on the measured current and a calibration curve, wherein the calibration curve is selected from a plurality of calibration curves and each calibration curve is associated with a time-segment selected from a plurality of time-segments.

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;

measuring a current associated with the potential excitation at a plurality of time-points; and

calculating an analyte concentration based on the measured current and a calibration curve, wherein the calibration curve is selected from a plurality of calibration curves and each calibration curve is associated with a time-segment selected from a plurality of time-segments associated with at least one analyte concentration having a first target-range, a second target-range, a third target-range, and a fourth target-range.

2. The method of claim 1, wherein the plurality of time-segments includes at least one of a first time-segment, a second time-segment, a third time-segment, and a fourth time-segment.

3. The method of claim 2, wherein the first time-segment is about four seconds, the second time-segment is about six seconds, the third time-segment is about nine seconds, and the fourth time-segment is about fourteen seconds.

4. The method of claim 1, wherein the first target-range is about 10 to about 50 mg/dL, the second target-range is about 50 to about 150 mg/dL, the third target-range is about 150 to about 350 mg/dL, and the fourth target-range is about 350 to about 600 mg/dL.

5. The method of claim 1, wherein calculating the analyte concentration includes determining if the measured current is associated with an analyte concentration within at least one of the first target-range, the second target-range, the third target-range, and the fourth target-range.

6. The method of claim 1, wherein the plurality of time-segments is associated with at least one of a first calibration-range, a second calibration-range, a third calibration-range, and a fourth calibration-range.

7. The method of claim 6, wherein the first calibration-range is about 0 to about 75 mg/dL, the second calibration-range is about 30 to about 240 mg/dL, the third calibration-range is about 75 to about 450 mg/dL, and the fourth calibration-range is about 240 to about 600 mg/dL.

8. The method of claim 6, wherein the plurality of calibration curves is associated with at least one the first calibration-range, the second calibration-range, the third calibration-range, and the fourth calibration-range.

9. The method of claim 1, wherein the analyte concentration is calculated based on a first current value measured at a first time-point and a second current value measured at a second time-point.

10. The method of claim 9, wherein the first time-point and the second time-point are consecutive.

11. The method of claim 9, wherein the analyte concentration is calculated using a current decay, wherein the current decay is based on the difference between the first current value and the second current value, and the difference between the first time-point and the second time-point.

12. The method of claim 1, wherein the analyte is glucose.

13. The method of claim 1, wherein the fluid sample includes blood.

14. The method of claim 1, wherein the fluid sample includes an enzyme and a mediator.

15. The method of claim 14, wherein the enzyme is at least one of glucose oxidase and glucose dehydrogenase, and the mediator is at least one of potassium ferricyanide and ruthenium hexamine.

16. The method of claim 1, wherein the method further includes storing the measured current.

17. The method of claim 1, wherein the plurality of time-points includes a sampling rate of about 10 Hz.

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

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

measuring a first current value associated with the potential excitation at a first time-point;

measuring a second current value associated with the potential excitation at a second time-point; and

determining a predicted current at a future time-point, wherein the predicted current is determined using an extrapolated current decay curve based on the first and second current values;

calculating an analyte concentration based on the predicted current and a calibration curve, wherein the calibration curve is selected from a plurality of calibration curves and each calibration curve is associated with a time-segment selected from a plurality of time-segments associated with at least one analyte concentration having a first target-range, a second target-range, a third target-range, and a fourth target-range.

19. The method of claim 18, wherein the extrapolated current decay curve is selected from a plurality of extrapolated current decay curves.

20. The method of claim 19, wherein the plurality of extrapolated current decay curves are based on empirical data.

21. The method of claim 18, wherein the extrapolated current decay curve is determined using an extrapolation algorithm.

22. The method of claim 18, wherein the plurality of time-segments includes at least one of a first time-segment, a second time-segment, a third time-segment, and a fourth time-segment.

23. The method of claim 22, wherein the first time-segment is about four seconds, the second time-segment is about six seconds, the third time-segment is about nine seconds, and the fourth time-segment is about fourteen seconds.

24. The method of claim 18, wherein the first target-range is about 10 to about 50 mg/dL, the second target-range is about 50 to about 150 mg/dL, the third target-range is about 150 to about 350 mg/dL, and the fourth target-range is about 350 to about 600 mg/dL.

25. The method of claim 18, wherein calculating the analyte concentration includes determining if the predicted current is associated with an analyte concentration within at least one of the first target-range, the second target-range, the third target-range, and the fourth target-range.

26. The method of claim 18, wherein the plurality of time-segments is associated with at least one of a first calibration-range, a second calibration-range, a third calibration-range, and a fourth calibration-range.

27. The method of claim 26, wherein the first calibration-range is about 0 to about 75 mg/dL, the second calibration-range is about 30 to about 240 mg/dL, the third calibration-range is about 75 to about 450 mg/dL, and the fourth calibration-range is about 240 to about 600 mg/dL.

28. The method of claim 26, wherein the plurality of calibration curves is associated with at least one the first calibration-range, the second calibration-range, the third calibration-range, and the fourth calibration-range.

29. The method of claim 18, wherein the first time-point and the second time-point are consecutive.

30. The method of claim 18, wherein the analyte concentration is calculated using a current decay, wherein the current decay is based on the difference between the first current value and the second current value, and the difference between the first time-point and the second time-point.

31. The method of claim 18, wherein the analyte is glucose.

32. The method of claim 18, wherein the fluid sample includes blood.

33. The method of claim 18, wherein the fluid sample includes an enzyme and a mediator.

34. The method of claim 33, wherein the enzyme is at least one of glucose oxidase and glucose dehydrogenase, and the mediator is at least one of potassium ferricyanide and ruthenium hexamine.

35. The method of claim 18, wherein the method further includes storing the predicted current.

36. The method of claim 18, wherein the plurality of time-points includes a sampling rate of about 10 Hz.

37. A system for determining an analyte concentration 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 current associated with the potential excitation at a plurality of time-points;

compare a current measured at a first time-segment to a current associated with a first target-range;

if the first measured current is within the first target-range, then determine an analyte concentration based on the first measured current and a first calibration curve;

if the first measured current is outside the first target-range, then compare a current measured at a second time-segment to a current associated with a second target-range;

if the second measured current is within the second target-range, then determine an analyte concentration based on the second measured current and a second calibration curve;

if the second measured current is outside the second target-range, then compare a current measured at a third time-segment to a current associated with a third target-range;

if the third measured current is within the third target-range, then determine an analyte concentration based on the third measured current and a third calibration curve; and

if the third measured current is outside the third target-range, then compare a current measured at a fourth time-segment to a current associated with a fourth target-range and determine an analyte concentration based on the fourth measured current and a fourth calibration curve,

wherein the first calibration curve includes a first calibration-range, the second calibration curve includes a second calibration-range, the third calibration curve includes a third calibration-range, and the fourth calibration curve includes a fourth calibration-range.

38. The system of claim 37, wherein the first time-segment is about four seconds, the second time-segment is about six seconds, the third time-segment is about nine seconds, and the fourth time-segment is about fourteen seconds.

39. The system of claim 37, wherein the first target-range is about 10 to about 50 mg/dL, the second target-range is about 50 to about 150 mg/dL, the third target-range is about 150 to about 350 mg/dL, and the fourth target-range is about 350 to about 600 mg/dL.

40. The system of claim 37, wherein the first calibration-range is about 0 to about 75 mg/dL, the second calibration-range is about 30 to about 240 mg/dL, the third calibration-range is about 75 to about 450 mg/dL, and the fourth calibration-range is about 240 to about 600 mg/dL.

41. The system of claim 37, wherein the plurality of calibration curves is associated with at least one the first calibration-range, the second calibration-range, the third calibration-range, and the fourth calibration-range.

42. The system of claim 37, wherein the analyte concentration is determined based on a first current measured at a first time-point and a second current measured at a second time-point.

43. The system of claim 42, wherein the first time-point and the second time-point are consecutive.

44. The system of claim 42, wherein the analyte concentration is determined using a current decay, wherein the current decay is based on the difference between the first current value and the second current value, and the difference between the first time-point and the second time-point.

45. The system of claim 37, wherein the set of electrodes are contained within in a test strip.

46. The system of claim 45, wherein the test strip includes calibration data.

47. The system of claim 37, wherein the processor is contained within a meter.

48. The system of claim 37, wherein the system is further configured to a display a value representative of the analyte concentration.

49. The system of claim 37, wherein the analyte is glucose.

50. The system of claim 37, wherein the fluid sample includes blood.

51. The system of claim 37, wherein the fluid sample includes an enzyme and a mediator.

52. The system of claim 51, wherein the enzyme is at least one of glucose oxidase and glucose dehydrogenase, and the mediator is at least one of potassium ferricyanide and ruthenium hexamine.

53. The system of claim 37, wherein the system is further configured to store the measured current.

54. The system of claim 37, wherein the plurality of time-points are sampled at a rate of about 10 Hz.

55. A system for determining an analyte concentration 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 value associated with the potential excitation at a first time-point;

measure a second current value associated with the potential excitation at a second time-point;

determine a predicted current at a future time-point, wherein the predicted current is determined using an extrapolated current decay curve based on the first and second current values; and

calculate an analyte concentration based on the predicted current and a calibration curve, wherein the calibration curve is selected from a plurality of calibration curves and each calibration curve is associated with a time-segment selected from a plurality of time-segments associated with at least one analyte concentration having a first target-range, a second target-range, a third target-range, and a fourth target-range.

56. The system of claim 55, wherein the extrapolated current decay curve is selected from a plurality of extrapolated current decay curves.

57. The system of claim 56, wherein the plurality of extrapolated current decay curves are based on empirical data.

58. The system of claim 55, wherein the extrapolated current decay curve is determined using an extrapolation algorithm.

59. The system of claim 55, wherein the plurality of time-segments includes at least one of a first time-segment, a second time-segment, a third time-segment, and a fourth time-segment.

60. The system of claim 59, wherein the first time-segment is about four seconds, the second time-segment is about six seconds, the third time-segment is about nine seconds, and the fourth time-segment is about fourteen seconds.

61. The system of claim 55, wherein the first target-range is about 10 to about 50 mg/dL, the second target-range is about 50 to about 150 mg/dL, the third target-range is about 150 to about 350 mg/dL, and the fourth target-range is about 350 to about 600 mg/dL.

62. The system of claim 55, wherein calculating the analyte concentration includes determining if the predicted current is associated with an analyte concentration within at least one of the first target-range, the second target-range, the third target-range, and the fourth target-range.

63. The system of claim 55, wherein the plurality of time-segments is associated with at least one of a first calibration-range, a second calibration-range, a third calibration-range, and a fourth calibration-range.

64. The system of claim 63, wherein the first calibration-range is about 0 to about 75 mg/dL, the second calibration-range is about 30 to about 240 mg/dL, the third calibration-range is about 75 to about 450 mg/dL, and the fourth calibration-range is about 240 to about 600 mg/dL.

65. The system of claim 63, wherein the plurality of calibration curves is associated with at least one the first calibration-range, the second calibration-range, the third calibration-range, and the fourth calibration-range.

66. The system of claim 55, wherein the first time-point and the second time-point are consecutive.

67. The system of claim 55, wherein the analyte concentration is calculated using a current decay, wherein the current decay is based on the difference between the first current value and the second current value, and the difference between the first time-point and the second time-point.

68. The system of claim 55, wherein the set of electrodes are contained within in a test strip.

69. The system of claim 68, wherein the test strip includes calibration data.

70. The system of claim 55, wherein the processor is contained within a meter.

71. The system of claim 55, wherein the system is further configured to a display a value representative of the analyte concentration.

72. The system of claim 55, wherein the analyte is glucose.

73. The system of claim 55, wherein the fluid sample includes blood.

74. The system of claim 60, wherein the fluid sample includes an enzyme and a mediator.

75. The system of claim 74, wherein the enzyme is at least one of glucose oxidase and glucose dehydrogenase, and the mediator is at least one of potassium ferricyanide and ruthenium hexamine.

76. The system of claim 55, wherein the system is further configured to store the predicted current.

77. The system of claim 55, wherein the plurality of time-points are sampled at a rate of about 10 Hz.

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

measure a current associated with a potential excitation at a plurality of time-points, wherein the potential excitation is applied to a fluid sample containing an analyte;

compare a current measured at a first time-segment to a current associated with a first target-range;

if the first measured current is within the first target-range, then determine an analyte concentration based on the first measured current and a first calibration curve;

if the first measured current is outside the first target-range, then compare a current measured at a second time-segment to a current associated with a second target-range;

if the second measured current is within the second target-range, then determine an analyte concentration based on the second measured current and a second calibration curve;

if the second measured current is outside the second target-range, then compare a current measured at a third time-segment to a current associated with a third target-range;

if the third measured current is within the third target-range, then determine an analyte concentration based on the third measured current and a third calibration curve; and

if the third measured current is outside the third target-range, then compare a current measured at a fourth time-segment to a current associated with a fourth target-range and determine an analyte concentration based on the fourth measured current and a fourth calibration curve,

wherein the first calibration curve includes a first calibration-range, the second calibration curve includes a second calibration-range, the third calibration curve includes a third calibration-range, and the fourth calibration curve includes a fourth calibration-range.