Determination of sample volume adequacy in biosensor devices

• US 6,872,298 B2
• Filed: 11/20/2001
• Issued: 03/29/2005
• Est. Priority Date: 11/20/2001
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Kermani, Mahyar Z.
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/988,495
• Publication Number:
  US 20030094383A1
• Time in Patent Office: 1,225 Days
• Field of Search: 205/777.5, 205/778, 324/662, 324/663, 324/667, 324/671, 324/677, 324/678, 324/686, 324425-437, 324/658, 324/664, 204400-420
• US Class Current: 205/777.5
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875

Abstract

Systems and methods are provided for determining whether a volume of biological sample is adequate to produce an accurate analyte concentration measurement. Certain such systems and methods provide the additional function of compensating for a sample volume determined to be less than adequate in order to proceed with an accurate analyte concentration measurement. The present invention is employed with a biosensor, such as an electrochemical test strip to which the sample volume of biological solution is deposited, and a meter configured to receive such test strip and to measure the concentration of selected analytes within the biological sample.

Claims

1. An electronic circuit configured to be electrically coupled to an electrochemical cell for receiving a biological sample and having a capacitance created by said biological sample upon application of a voltage to said electrochemical cell, said circuit comprising:

an oscillation circuit configured to receive a voltage input signal resulting from the charging and discharging of the electrochemical cell and comprising a Schmidt trigger circuit for converting said voltage input signal to an oscillating voltage output signal proportional to the capacitance of the cell.

2. The electronic circuit of claim 1 further comprising means for deriving the value of the volume of said sample based on the cell capacitance.

3. The electronic circuit of claim 2 further comprising means for determining the adequacy of said volume for measurement of one or more analytes within the sample based on said oscillating voltage signal.

4. The electronic circuit of claim 3 further comprising means for compensating for said one or more analyte measurements when said volume is determined to be inadequate.

5. The electronic circuit of claim 1 further comprising a resistor electrically coupled to said Schmidt trigger circuit.

6. A kit for determining the volume of a biological sample deposited onto an electrochemical test strip comprising an electrochemical cell, said kit comprising at least one electronic circuit according to claim 1.

7. The kit of claim 6 further comprising an automated device within which said electronic circuit is integrally configured.

8. The kit of claim 7 further comprising instructions for using said electronic circuit and said automated device.

9. The electronic circuit of claim 1 further comprising a current supply electrically coupled to said Schmidt trigger circuit.

10. The electronic circuit of claim 1 wherein said capacitance is the equivalent capacitance of the cell.

11. The electronic circuit of claim 1 wherein the oscillation period of the oscillating voltage signal is directly proportional to the cell capacitance.

12. The electronic circuit of claim 1 wherein the oscillation frequency of the oscillating voltage signal is inversely proportional to the cell capacitance.

13. A system comprising:

a meter for receiving an electrochemical cell configured for receiving a biological sample and having a capacitance created by said biological sample when a voltage is applied to said electrochemical cell;

a DC voltage supply configured to be electrically connectable to said electrochemical cell for charging the electrochemical cell, wherein said cell capacitance is created; and

an electronic circuit integrally configured with said meter and configured to be electronically connectable to said electrochemical cell, said circuit comprising an oscillator circuit configured to receive a voltage input signal resulting from the charging and discharging of said electrochemical cell and configured to convert the voltage input signal to an oscillating voltage output signal, wherein the oscillation period of said oscillating voltage output signal is proportional to said cell capacitance.

14. The system of claim 13 wherein said electronic circuit further comprises a microprocessor electrically connected to said oscillator circuit and configured to determine the volume of the biological sample.

15. A method for determining the volume of a biological sample applied to an electrochemical cell, comprising:

providing the system of claim 13;

applying a DC voltage to said cell thereby charging said cell, wherein a capacitance is created within said cell, and generating a charged voltage as a result the capacitance; and

converting the charged voltage to an oscillating voltage having a frequency proportional to the capacitance.

16. A kit for determining the volume of a biological sample within an electrochemical cell, comprising:

a system according to claim 13; and

instructions for using said system.

17. The kit of claim 16 further including an automated device integral with said system configured to operatively receive and engage said electrochemical cell for determining one or more physical or chemical characteristics of the biological sample.

18. A system for determining the volume of a biological sample within an electrochemical cell having a surface area and a volume, comprising:

a voltage supply configured for applying a first voltage to said electrochemical cell;

means for measuring a second voltage generated by said cell when said first voltage is applied to said cell;

means for converting said second voltage into an oscillating voltage;

means for deriving the capacitance of said cell from said oscillating voltage;

means for deriving the volume of said biological sample from said cell capacitance.

19. The system of claim 18 further comprising means for determining whether said sample volume is adequate for making an accurate measurement of the concentration of one or more selected analytes within said biological sample.

20. The system of claim 19 further comprising:

means for measuring the concentration of one or more selected analytes within said biological sample; and

means for compensating for said one or more selected analyte concentration measurements when said sample volume is determined to be inadequate.

21. The system of claim 20 further comprising means for displaying the measured concentration of one or more selected analytes within said biological sample.

22. The system of claim 18 wherein said means for deriving said volume comprises means for deriving the surface area of said cell covered by said biological sample from said cell capacitance and further comprises means for deriving said volume from said surface area.

23. A method for determining the volume of a biological sample applied to an electrochemical biosensor, comprising:

applying a direct current voltage to the biosensor thereby charging the biosensor, wherein a capacitance is created within the biosensor and a voltage is generated by charging the biosensor;

converting the voltage to an oscillating voltage having a period proportional to the capacitance;

determining the capacitance of the biosensor; and

determining the volume of the sample from said capacitance.

24. The method of claim 23 further comprising determining whether said sample volume is adequate for measuring one or more selected characteristics of said sample.

25. The method of claim 24 further comprising:

determining the necessary compensation factor to compensate for said one or more selected characteristics measurements when said sample volume is inadequate;

measuring at least one characterstic of said sample; and

compensating for the inadequate sample volume.

26. The method of claim 25 wherein the at least one characteristic of said sample is the concentration of one or more analytes present within said sample.

27. The method of claim 25 wherein said determining the necessary compensation factor comprises determining the ratio of the capacitance of the biosensor when completely filled with said sample to the capacitance of the biosensor filled with said inadequate sample volume.

28. The method of claim 24 wherein said volume determination comprises determining from said capacitance the surface area of the portion of said biosensor in contact with said biological sample and further comprising determining said volume from said surface area.

29. The method of claim 23 said determining said volume comprises determining the surface area of the portion of said biosensor in contact with said biological sample based on said determined capacitance.

30. The method of claim 29 wherein said electrochemical biosensor comprises at least two electrodes forming an electrochemical cell having a cell volume and wherein said determined surface area is a surface area of said at least two electrodes covered by said biological sample.

31. The method of claim 23 wherein an average of said direct current voltage is in the range from about 0 to 600 mV.

32. An electronic circuit configured to be electrically coupled to an electrochemical cell configured for receiving a biological sample, said circuit comprising:

means for applying a DC voltage to said electrochemical cell wherein, upon application of said DC voltage, said electrochemical cell generates a capacitance;

means for receiving a signal produced by said electrochemical cell; and

means for converting said signal to an oscillating signal proportional to the capacitance of the cell.

33. The electronic circuit of claim 32 wherein said signal conversion means comprises a Schmidt trigger circuit.

34. The electronic circuit of claim 32 further comprising means for deriving the value of the volume of said sample based on the cell capacitance.

35. The electronic circuit of claim 34 further comprising means for determining the adequacy of said volume for measurement of one or more analytes within the sample based on said oscillating signal.

36. The electronic circuit of claim 35 further comprising means for compensating for said one or more analyte measurements when said volume is determined to be inadequate.

37. The electronic circuit of claim 32 wherein the oscillation period of said oscillating signal is proportional to the cell capacitance.

38. The electronic circuit of claim 32 wherein the oscillation frequency of said oscillating signal is inversely proportional to the cell capacitance.

39. An electronic circuit configured to be electrically coupled to an electrochemical cell for receiving a biological sample and having a capacitance created by said biological sample upon application of a voltage to said electrochemical cell, said circuit comprising:

an oscillation circuit configured to receive a voltage input signal resulting from the charging and discharging of the electrochemical cell and comprising a comparator circuit for converting said voltage input signal to an oscillating voltage output signal proportional to the capacitance of the cell.

40. The electronic circuit of claim 39 further comprising means for deriving the value of the volume of said sample based on the cell capacitance.

41. The electronic circuit of claim 40 further comprising means for determining the adequacy of said volume for measurement of one or more analytes within the sample based on said oscillating voltage signal.

42. The electronic circuit of claim 41 further comprising means for compensating for said one or more analyte measurements when said volume is determined to be inadequate.

43. The electronic circuit of claim 39 further comprising a resistor electrically coupled to said comparator circuit.

44. The electronic circuit of claim 39 further comprising a current supply electrically coupled to said comparator circuit.

45. The electronic circuit of claim 39 wherein said capacitance is the equivalent capacitance of the cell.

46. The electronic circuit of claim 39 wherein the oscillation period of the oscillating voltage signal is directly proportional to the cell capacitance.

47. The electronic circuit of claim 39 wherein the oscillation frequency of the oscillating voltage signal is inversely proportional to the cell capacitance.