Systems, Devices, and Methods for Improving Accuracy of Biosensors Using Fill Time

• US 20110155589A1
• Filed: 12/17/2010
• Published: 06/30/2011
• Est. Priority Date: 12/30/2009
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Chatelier, Ronald C., Hodges, Alastair M.
• Granted Patent: US 8,623,198 B2
• Time in Patent Office: Days
• US Class Current: 205/782
• CPC Class Codes: C12Q 1/006 for glucose
• 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: G01N 27/416 Systems G01N27/27 takes precedence

Abstract

Methods for determining a concentration of an analyte in a sample, and the devices and systems used in conjunction with the same, are provided herein. In one exemplary embodiment of a method for determining a concentration of an analyte in a sample, the method includes detecting a presence of a sample in an electrochemical sensor including two electrodes. A fill time of the sample is determined with the two electrodes and a correction factor is calculated in view of at least the fill time. The method also includes reacting an analyte that causes a physical transformation of the analyte between the two electrodes. A concentration of the analyte can then be determined in view of the correction factor with the same two electrodes. Systems and devices that take advantage of the fill time to make analyte concentration determinations are also provided.

Claims

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

detecting a presence of the sample in an electrochemical sensor, the electrochemical sensor comprising two electrodes;

determining a fill time of the sample with the two electrodes;

calculating a correction factor in view of at least the fill time;

reacting an analyte to cause a physical transformation of the analyte between the two electrodes; and

determining the concentration of the analyte in view of the correction factor with the same two electrodes.

2. The method of claim 1, wherein determining the fill time of the sample comprises:

applying an electric potential between the two electrodes while the sample is introduced;

measuring a current as a function of time; and

determining a current drop time based on the current as a function of time, wherein the current drop time corresponds to the fill time of the sample.

3. The method of claim 2, wherein determining the current drop time comprises calculating the maximum negative value of the change in the measured current over time.

4. The method of claim 2, wherein determining the current drop time comprises calculating a difference between at least two current values where the difference is greater than a first predetermined threshold.

5. The method of claim 2, wherein determining the current drop time comprises calculating a difference between at least two current values where the difference is less than a second predetermined threshold.

6. The method of claim 2, wherein determining the current drop time comprises calculating a slope in the measured current as a function of time where the slope is greater than a third predetermined threshold.

7. The method of claim 2, wherein determining the current drop time comprises calculating a slope in the measured current as a function of time where the slope is less than a fourth predetermined threshold.

8. The method of claim 2, wherein determining the current drop time comprises calculating an inflection point in the measured current as a function of time.

9. The method of claim 1, in which the detecting the presence of the sample comprises:

applying an electric potential between the two electrodes, and

measuring a change in current values that is greater than a fifth predetermined threshold.

10. The method of claim 1, in which the detecting the presence of the sample comprises:

applying an electric potential between the two electrodes, and

measuring a change in current values that is less than a sixth predetermined threshold.

11. The method of claim 1, in which the detecting the presence of the sample comprises:

applying a generally constant current between the two electrodes, and measuring a change in an electric potential that is greater than a seventh predetermined threshold.

12. The method of claim 1, in which detecting the presence of the sample comprises:

applying a generally constant current between the two electrodes, and measuring a change in an electric potential that is less than an eighth predetermined threshold.

13. The method of claim 1, in which detecting the presence of the sample is performed by a microprocessor of an analyte measuring machine.

14. The method of claim 1, in which reacting of the analyte generates an electroactive species that is measured as a current by the two electrodes.

15. The method of claim 1, in which the two electrodes comprise an opposing faced orientation.

16. The method of claim 1, in which the two electrodes comprise a facing orientation.

17. The method of claim 1, wherein the electrochemical sensor comprises a glucose sensor

18. The method of claim 1, wherein the electrochemical sensor comprises an immunosensor.

19. The method of claim 1, wherein the sample comprises blood.

20. The method of claim 1, wherein the sample comprises whole blood.

21. A method for measuring a corrected analyte concentration, the method comprising:

detecting a presence of the sample in an electrochemical sensor, the electrochemical sensor comprising two electrodes;

determining a fill time of the sample with the two electrodes;

reacting an analyte to cause a physical transformation of the analyte;

determining a first analyte concentration in the sample with the same two electrodes; and

calculating a corrected analyte concentration based on the first analyte concentration and the fill time.

22. The method of claim 21, wherein the step of calculating the corrected analyte concentration comprises:

calculating a correction factor based on the fill time, wherein the corrected analyte concentration is calculated based on the first analyte concentration and the correction factor.

23. The method of claim 22, wherein the correction factor comprises about zero when the fill time is less than a first fill time threshold.

24. The method of claim 22, wherein the correction factor is calculated in view of the fill time when the fill time is greater than a first fill time threshold and less than a second fill time threshold.

25. The method of claim 22, wherein the correction factor comprises a constant value when the fill time is greater than a second fill time threshold.

26. The method of claim 22, wherein the step of calculating the corrected analyte concentration comprises calculating a sum of the correction factor and the first analyte concentration in the sample when the first analyte concentration in the sample is less than a threshold value.

27. The method of claim 22, wherein the step of calculating the corrected analyte concentration when the first analyte concentration in the sample is greater than a threshold value comprises:

dividing the correction factor by one hundred and adding one to give an intermediate term; and

multiplying the intermediate term by the first analyte concentration to give a fill time corrected analyte concentration.

28. The method of claim 21, wherein determining the fill time of the sample comprises:

applying an electric potential between the two electrodes while the sample is introduced;

measuring a current as a function of time; and

determining a current drop time based on the current as a function of time, wherein the current drop time corresponds to the fill time of the sample.

29. The method of claim 28, wherein determining the current drop time comprises calculating the maximum negative value of the change in the measured current over time.

30. The method of claim 28, wherein determining the current drop time comprises calculating a difference between at least two current values where the difference is greater than a first predetermined threshold.

31. The method of claim 28, wherein determining the current drop time comprises calculating a difference between at least two current values where the difference is less than a second predetermined threshold.

32. The method of claim 28, wherein determining the current drop time comprises calculating a slope in the measured current as a function of time where the slope is greater than a third predetermined threshold.

33. The method of claim 28, wherein determining the current drop time comprises calculating a slope in the measured current as a function of time where the slope is less than a fourth predetermined threshold.

34. The method of claim 28, wherein determining the current drop time comprises calculating an inflection point in the measured current as a function of time.

35. The method of claim 21, in which detecting the presence of the sample comprises:

applying an electric potential between the two electrodes, and

measuring a change in current values that is greater than a fifth predetermined threshold.

36. The method of claim 21, in which detecting the presence of the sample comprises:

applying an electric potential between the two electrodes, and

measuring a change in current values that is less than a sixth predetermined threshold.

37. The method of claim 21, in which detecting the presence of the sample comprises:

applying a generally constant current between the two electrodes, and

measuring a change in an electric potential that is greater than a seventh predetermined threshold.

38. The method of claim 21, in which detecting the presence of the sample comprises:

applying a generally constant current between the two electrodes, and

measuring a change in an electric potential that is less than an eighth predetermined threshold.

39. The method of claim 21, in which detecting the presence of the sample is performed by a microprocessor of an analyte measuring machine.

40. The method of claim 21, in which reacting of the analyte generates an electroactive species that is measured as a current by the two electrodes.

41. The method of claim 21, in which the two electrodes comprise an opposing faced orientation.

42. The method of claim 21, in which the two electrodes comprise a facing orientation.

43. An electrochemical system, comprising:

(a) an electrochemical sensor including electrical contacts configured to mate with a test meter, the electrochemical sensor comprising;

(i) a first electrode and a second electrode in a spaced apart relationship, and

(ii) a reagent; and

(b) the test meter including a processor configured to receive current data from the test strip upon application of voltages to the test strip, and further configured to determine a corrected analyte concentration based on a calculated analyte concentration and a measured fill time with the same two electrodes.

44. The electrochemical system of claim 43, wherein the test meter includes data storage containing an analyte concentration threshold, a first fill time threshold, and a second fill time threshold.

45. The electrochemical system of claim 43, further comprising a heating element configured to heat at least a portion of the electrochemical sensor.

46. The electrochemical system of claim 43, wherein the electrochemical sensor comprises a glucose sensor.

47. The electrochemical system of claim 43, wherein the electrochemical sensor comprises an immunosensor.

48. The electrochemical system of claim 43, wherein at least one of the electrochemical sensor, the test meter, and the processor are configured to measure a temperature of the sample.

49. The electrochemical system of claim 43, wherein the analyte comprises C-reactive protein.

50. The electrochemical system of claim 43, wherein the analyte comprises glucose.

51. The electrochemical system of claim 43, wherein the sample comprises blood.

52. The electrochemical system of claim 43, wherein the sample comprises whole blood.

53. The electrochemical system of claim 43, in which the first and second electrodes comprise an opposing faced orientation.

54. The electrochemical system of claim 43, in which the first and second electrodes comprise a facing orientation.