Meter and method of using the meter for determining the concentration of a component of a fluid

• US 6,645,368 B1
• Filed: 04/24/2000
• Issued: 11/11/2003
• Est. Priority Date: 12/22/1997
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Corporation (Roche Holding AG)
• Inventors: Beaty, Terry Allen, Kuhn, Lance Scott, Burke, David W., Svetnik, Vladimir
• Primary Examiner(s): Tung, T.
• Assistant Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/530,171
• Time in Patent Office: 1,296 Days
• Field of Search: 204/401, 204/403, 204/403.01, 205/777.5, 205/792, 422/82.01, 422/82.02, 422/82.03
• US Class Current: 205/792
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771

Abstract

An apparatus and method for determining the concentration of a medically significant component of a biological fluid comprise providing a cell supporting a chemistry which reacts with the medically significant component. Placement of first and second terminals of the cell in contact with first and second terminals, respectively, of an instrument permits the instrument to assess the reaction. The instrument determines a first response of the cell to a first signal, and determines based upon the first response whether to proceed with the determination of the concentration of the medically significant component of the biological fluid. If the determination is to proceed, the instrument determines the type of sample that has been applied. If the sample is a sample of a particular type, the instrument determines a first correction value based upon the cell'"'"'s response to the third signal and combines the correction value with the result of the reaction assessment to produce an indication of the concentration of the medically significant component in the sample.

Claims

1. An apparatus for determining the concentration of a medically significant component of a biological fluid, the apparatus comprising a cell for receiving a sample of the fluid, the cell supporting a chemistry which reacts with the medically significant component and first and second terminals across which the reaction of the chemistry with the medically significant component can be assessed, an instrument having first and second terminals complementary to the first and second terminals, respectively, of the cell, placement of the first and second terminals of the cell in contact with the first and second terminals, respectively, of the instrument permitting the instrument to assess the reaction, the instrument including an assessment controller configured to apply across the first and second terminals of the instrument a first signal having an AC component, to determine a first correction value in response of the cell to the first signal, to assess the reaction of the medically significant component with the chemistry and to combine the correction value with the result of the reaction assessment to produce an indication of the concentration of the medically significant component in the sample.

2. The apparatus of claim 1 wherein the assessment controller applies across the first and second terminals an AC signal.

3. The apparatus of claim 1 wherein the instrument further comprises a third terminal, placement of the first and second terminals of the cell in contact with the first and second terminals of the instrument placing one of the first and second terminals of the cell in contact with the third terminal of the instrument.

4. The apparatus of claim 3 wherein the assessment controller for determining a first correction value in response to the first signal comprises an assessment controller for feeding back a portion of the first signal appearing at the third terminal.

5. The apparatus of claim 4 wherein the assessment controller applies across a pair of the first, second and third terminals of the instrument a second signal and assesses the reaction of the medically significant component with the chemistry in response to the second signal.

6. The apparatus of claim 1 wherein the assessment controller applies across the first and second terminals of the instrument a second signal, and determines a second response to the second signal, the second response determining if the assessment controller proceeds with the application of the first signal.

7. The apparatus of claim 6 wherein the assessment controller applies across the first and second terminals an AC signal.

8. The apparatus of claim 1 wherein the instrument further comprises a third terminal, placement of the first and second terminals of the cell in contact with the first and second terminals of the instrument placing one of the first and second terminals of the cell in contact with the third terminal of the instrument.

9. The apparatus of claim 8 wherein the assessment controller feeds back a portion of the first signal appearing at the third terminal.

10. The apparatus of claim 9 wherein the assessment controller applies across a pair of the first, second and third terminals of the instrument a second signal and assesses the reaction of the medically significant component with the chemistry in response to the second signal.

11. An apparatus for determining the concentration of a medically significant component of a biological fluid, the apparatus comprising a cell for receiving a sample of the fluid, the cell supporting a chemistry which reacts with the medically significant component and first and second terminals across which the reaction of the chemistry with the medically significant component can be assessed, an instrument having first and second terminals complementary to the first and second terminals, respectively, of the cell, placement of the first and second terminals of the cell in contact with the first and second terminals, respectively, of the instrument permitting the instrument to assess the reaction, the instrument including an assessment controller configured to apply across the first and second terminals of the instrument a first signal having an AC component, determine a first response of the cell to the first signal, and determine based upon the first response whether to proceed with the determination of the concentration of the medically significant component of the biological fluid.

12. The apparatus of claim 11 wherein the assessment controller applies across the first and second terminals an AC signal.

13. The apparatus of claim 11 wherein the assessment controller applies across the first and second terminals of the instrument a second signal, determines a first correction value in response to the second signal, and combines the correction value with the result of the reaction assessment to produce an indication of the concentration of the medically significant component in the sample.

14. The apparatus of claim 13 wherein the assessment controller applies across the first and second terminals a second signal having an AC component.

15. The apparatus of claim 14 wherein the assessment controller applies across the first and second terminals an AC second signal.

16. The apparatus of claim 15 wherein the instrument further comprises a third terminal, placement of the first and second terminals of the cell in contact with the first and second terminals of the instrument placing one of the first and second terminals of the cell in contact with the third terminal of the instrument.

17. The apparatus of claim 16 wherein the assessment controller feeds back a portion of the second signal appearing at the third terminal.

18. The apparatus of claim 17 wherein the assessment controller applies across a pair of the first, second and third terminals of the instrument a third signal and assesses the reaction of the medically significant component with the chemistry in response to the second signal.

19. The apparatus of claim 13 wherein the instrument further comprises a third terminal, placement of the first and second terminals of the cell in contact with the first and second terminals of the instrument placing one of the first and second terminals of the cell in contact with the third terminal of the instrument.

20. The apparatus of claim 19 wherein the assessment controller feeds back a portion of the second signal appearing at the third terminal.

21. The apparatus of claim 20 wherein the assessment controller applies across a pair of the first, second and third terminals of the instrument a third signal and assesses the reaction of the medically significant component with the chemistry in response to the third signal.

22. A method for determining the concentration of a medically significant component of a biological fluid, the method comprising providing a cell for receiving a sample of the fluid, providing on the cell a chemistry which reacts with the medically significant component and first and second terminals across which the reaction of the chemistry with the medically significant component can be assessed, providing an instrument having first and second terminals complementary to the first and second terminals, respectively, of the cell, placement of the first and second terminals of the cell in contact with the first and second terminals, respectively, of the instrument permitting the instrument to assess the reaction, including in the instrument an assessment controller, causing the assessment controller to apply across the first and second terminals of the instrument a first signal having an AC component, causing the assessment controller to determine a first response of the cell to the first signal, and causing the assessment controller to determine based upon the first response whether to proceed with the determination of the concentration of the medically significant component of the biological fluid.

23. The method of claim 22 wherein the step of applying across the first and second terminals of the instrument a first signal comprises applying across the first and second terminals of the instrument a second signal, determining a first correction value in response to the second signal, and combining the first correction value with the result of the reaction assessment to produce an indication of the concentration of the medically significant component in the sample.

24. The method of claim 23 wherein the step of applying across the first and second terminals a second signal comprises applying across the first and second terminals an AC second signal.

25. The method of claim 24 wherein providing an instrument having first and second terminals complementary to the first and second terminals of the cell comprises providing an instrument having first, second and third terminals, placement of the first and second terminals of the cell in contact with the first, second and third terminals of the instrument permitting the instrument to assess the reaction.

26. The method of claim 25 wherein determining the second response of the cell to the second signal and converting that second response to a first correction value comprises feeding back a portion of the second signal appearing at the third terminal.

27. The method of claim 26 wherein assessing the reaction of the medically significant component with the chemistry comprises applying across a pair of the first, second and third terminals of the instrument a third signal and assessing the reaction of the medically significant component with the chemistry in response to the third signal.

28. The method of claim 22 wherein providing an instrument having first and second terminals complementary to the first and second terminals, respectively, of the cell comprises providing an instrument having first, second and third terminals, placement of the first and second terminals of the cell in contact with the first and second terminal of the instrument placing one of the first and second terminals of the cell in contact with the third terminal of the instrument.

29. The method of claim 28 wherein determining the correction value in response to the second signal comprises feeding back a portion of the second signal appearing at the third terminal.

30. The method of claim 29 wherein assessing the reaction of the medically significant component with the chemistry comprises applying across a pair of the first, second and third terminals of the instrument a third signal and assessing the reaction of the medically significant component with the chemistry in response to the third signal.

31. A method for determining the concentration of a medically significant component of a biological fluid, the method comprising providing a cell for receiving a sample of the fluid, providing the cell with a chemistry which reacts with the medically significant component and first and second terminals across which the reaction of the chemistry with the medically significant component can be assessed, providing an instrument having first and second terminals complementary to the first and second terminals, respectively, of the cell, placement of the first and second terminals of the cell in contact with the first and second terminals, respectively, of the instrument permitting the instrument to assess the reaction, providing in the instrument an assessment controller, causing the assessment controller to apply across the first and second terminals of the instrument a first signal having an AC component, determining a first correction value in response to the first signal, assessing the reaction of the medically significant component with the chemistry, and combining the correction value with the result of the reaction assessment to produce an indication of the concentration of the medically significant component in the sample.

32. The method of claim 31 wherein providing an instrument having first and second complementary terminals comprises providing an instrument having first, second and third terminals, placement of the first and second terminals of the cell in contact with the first and second terminals, respectively, of the instrument placing one of the first and second terminals of the cell in contact with the third terminal of the instrument.

33. The method of claim 32 wherein determining a first response of the cell to the first signal and converting that first response to a first correction value comprises feeding back a portion of the first signal appearing at the third terminal.

34. The method of claim 33 wherein assessing the reaction of the medically significant component with the chemistry comprises applying across a pair of the first, second and third terminals of the instrument a second signal and assessing the reaction of the medically significant component with the chemistry in response to the second signal.

35. The method of claim 34 wherein applying a second signal comprises applying a second signal having an AC component.

36. The method of claim 35 wherein applying a second signal comprises applying an AC second signal.

37. The method of claim 31 wherein applying across the first and second terminals of the instrument a first signal comprises applying across the first and second terminals of the instrument a second signal, determining a second response to the second signal, and determining if the assessment controller proceeds with the application of the first signal.

38. The method of claim 31, 32, 33, 34 or 37 wherein applying the first signal comprises applying a first AC signal.

39. An apparatus for determining the concentration of a medically significant component of a biological fluid comprising a cell for receiving a sample of the fluid, the cell supporting a chemistry which reacts with the medically significant component and first and second terminals across which the reaction of the chemistry with the medically significant component can be assessed, an instrument having first and second terminals complementary to the first and second terminals, respectively, of the cell, placement of the first and second terminals of the cell in contact with the first and second terminals, respectively, of the instrument permitting the instrument to assess the reaction, the instrument including an assessment controller configured to apply across the first and second terminals of the instrument a first signal having an AC component, determine the identity of the sample in response of the cell to the first signal, and produce an indication of the identity of the sample.

40. The apparatus of claim 39 wherein the assessment controller applies across the first and second terminals an AC signal.

41. The apparatus of claim 39 wherein the instrument further comprises a third terminal, placement of the first and second terminals of the cell in contact with the first and second terminals of the instrument placing one of the first and second terminals of the cell in contact with the third terminal of the instrument, the assessment controller applying across a pair of the first, second and third terminals of the instrument a second signal, determining a first correction value in response of the cell to the second signal, assessing the reaction of the medically significant component with the chemistry, and combining the correction value with the result of the reaction assessment to produce an indication of the concentration of the medically significant component in the sample.

42. The apparatus of claim 41 wherein the assessment controller applies across a pair of the first, second and third terminals of the instrument a third signal, and determines a third response to the third signal, the third response determining if the assessment controller proceeds with the application of at least one of the first and second signals.

43. The apparatus of claim 39 wherein the assessment controller further comprises a third terminal, placement of the first and second terminals of the cell in contact with the first and second terminals of the instrument placing one of the first and second terminals of the cell in contact with the third terminal of the instrument, the assessment controller applying across a pair of the first, second and third terminals of the instrument a second signal, determining a second response to the second signal, the second response determining if the assessment controller proceeds with the application of the first signal.

44. A method for determining the concentration of a medically significant component of a biological fluid comprising providing a cell for receiving a sample of the fluid, providing on the cell a chemistry which reacts with the medically significant component and first and second terminals across which the reaction of the chemistry with the medically significant component can be assessed, providing an instrument having first, second and third terminals, placement of the first and second terminals of the cell in contact with the first and second terminals of the instrument, providing in the instrument an assessment controller configured to apply across the first and second terminals of the instrument a first signal, determine the identity of the sample in response of the cell to the first signal, the assessment controller applying across a pair of the first, second and third terminals of the instrument a second signal, determining a first correction value in response of the cell to the second signal, assessing the reaction of the medically significant component with the chemistry, and combining the correction value with the result of the reaction assessment to produce an indication of the concentration of the medically significant component in the sample.

45. The method of claim 44 wherein the assessment controller applies across a pair of the first, second and third terminals of the instrument a third signal and determines a third response to the third signal, the third response determining if the assessment controller proceeds with the application of at least one of the first and second signals.

46. A method for determining the concentration of a medically significant component of a biological fluid comprising providing a cell for receiving a sample of the fluid, providing on the cell a chemistry which reacts with the medically significant component and first and second terminals across which the reaction of the chemistry with the medically significant component can be assessed, providing an instrument having first, second and third terminals, placement of the first and second terminals of the cell in contact with the first and second terminals of the instrument placing one of the first and second terminals of the cell in contact with the third terminal of the instrument, providing in the instrument an assessment controller configured to apply across the first and second terminals of the instrument a first signal, determine the identity of the sample in response of the cell to the first signal, and produce an indication of the identity of the sample, the assessment controller applying across a pair of the first, second and third terminals of the instrument a second signal and determining a second response to the second signal, the second response determining if the assessment controller proceeds with the application of the first signal.