CONTROL AND CALIBRATION SOLUTIONS AND METHODS FOR THEIR USE

• US 20090157344A1
• Filed: 10/07/2008
• Published: 06/18/2009
• Est. Priority Date: 12/22/1997
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Beaty, Terry A., Burke, David W., Svetnik, Vladimir, Kuhn, Lance S.
• Granted Patent: US 8,071,384 B2
• Time in Patent Office: Days
• US Class Current: 702/104
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/101666 Particle count or volume standard or control [e.g., platelet count standards, etc.]
• CPC Class Codes: Y10T 436/102499 Blood gas standard or control
• CPC Class Codes: Y10T 436/103332 Bilirubin or uric acid standard or control
• CPC Class Codes: Y10T 436/104165 Lipid, cholesterol, or triglyceride standard or control
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/105831 Protein or peptide standard or control [e.g., hemoglobin, etc.]
• CPC Class Codes: Y10T 436/106664 Blood serum or blood plasma standard or control
• CPC Class Codes: Y10T 436/112499 with sample on test slide
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

Control and calibration solutions are described that provide control and calibration data that is recognized by a test meter allowing the meter to segregate the control and calibration data from regular test data. Recognition and segregation of the control and calibration data can occur automatically with no additional input from the meter'"'"'s user. Methods for use of the solutions are also provided.

Claims

1. A method for identifying control/calibration data generated by a medical device, the method comprising the steps of:

(a) providing a control/calibration solution containing a sufficient amount of a modulator to cause the solution to provide two responses to an applied signal, wherein one response is characteristic of a biological fluid and one response is uncharacteristic of a biological fluid,

(b) applying a signal to the control/calibration solution;

(c) measuring the two responses;

(d) using the characteristic response to provide control/calibration data; and

(e) using the uncharacteristic response to identify control/calibration data.

2. The method of claim 1, wherein providing a control/calibration solution involves providing a solution containing a modulator selected from the group consisting of an ionic modulator, an organic modulator, and a combination thereof.

3. The method of claim 2, wherein using the characteristic response involves providing control data.

4. The method of claim 2, wherein using the characteristic response involves providing calibration data.

5. The method of claim 2, wherein applying a signal involves applying a signal containing AC and DC components.

6. The method of claim 5, wherein applying a signal involves applying a signal containing an AC component having a frequency of between about 1 Hz and about 20 kHz.

7. The method of claim 5, wherein providing a control/calibration solution involves providing a solution containing an ionic modulator and the uncharacteristic response is admittance.

8. The method of claim 7, wherein measuring the responses involves measuring an uncharacteristic response comprising magnitude information.

9. The method of claim 7, wherein measuring the responses involves measuring an uncharacteristic response comprising phase information.

10. The method of claim 7, wherein step (e) comprises determining a Matrix ID using the equation:

MXID=tan<sup>−

1</sup>[m₀+m₁dT+m₂(Y₂−

Y₁)]

where;

MXID is the matrix ID,

m₀, m₁, and m₂ are constants,

dT is the temperature value, and

Y is the admittance determined at frequencies 1 and 2.

11. The method of claim 10, wherein applying a signal involves applying a signal having a frequency of between about 1 Hz and about 20 kHz.

12. The method of claim 7, wherein step (e) comprises determining a Matrix ID using the equation:

MXID=mx₀+mx₁P₁+mx₂P₂+mx₃P₃+mx₄P₄+mx₅P₅+mx₆P₆+mx₇Y₁+mx₈Y₂+mx₉Y₃+mx₁₀Y₄+mx₁₁Y₅+mx₁₂Y₆

where;

MXID is the matrix ID,

mx_1-12 are constants,

P_1-6 are the phases of the admittances for selected frequencies

Y_1-6 are the magnitude of the admittances for the same frequencies.

13. The method of claim 12, wherein applying a signal involves applying a signal having a frequency of between about 1 Hz and about 20 kHz.

wherein providing a control/calibration solution involves providing a solution containing an organic modulator

14. The method of claim 5, wherein providing a control/calibration solution involves providing a solution containing an organic modulator, applying a signal involves applying a signal including a DC component, measuring an uncharacteristic response involves measuring a current, and step (e) comprises determining a Matrix ID using the equation:

$\begin{array}{cc}\mathrm{MXID}={\tan }^{-1}\left[m_0+m_1<br><br>\mathrm{dT}+m_2<br><br>\underset{k=1}{\overset{m}{\sum <br><br>}}<br><br>I_k/\mathrm{Im}\right]& \end{array}$

where;

MXID is the matrix ID,

m₀, m₁, and m₂ are constants,

dT is the temperature value,

I_k is the Cottrell current at time k, and

I_m is the Cottrell current at a subsequent time m.

15. A method for identifying control/calibration data generated by a device having a test chamber and designed to analyze a biological fluid, the method comprising:

(a) selecting a control/calibration solution containing a modulator selected from the group consisting of an ionic modulator, an organic modulator, and a combination thereof, wherein the selecting includes selecting an amount of said modulator sufficient to cause the solution to provide two responses, wherein one response is characteristic of a biological fluid and one response is uncharacteristic of a biological fluid;

(b) introducing the solution into the test chamber;

(c) applying a signal to the solution;

(d) generating and measuring an uncharacteristic response; and

(e) using the uncharacteristic response to identify control/calibration data.

16. The method of claim 15, additionally generating and measuring a characteristic response and using the characteristic response to provide control data.

17. The method of claim 15, additionally generating and measuring a characteristic response and using the characteristic response to provide calibration data.

18. The method of claim 15, wherein the signal includes an AC component and the uncharacteristic response is admittance.

19. The method of claim 18, wherein step (e) comprises determining the Matrix ID using the equation:

MXID=tan<sup>−

1</sup>[m₀+m₁dT+m₂(Y₂−

Y₁)]

where;

MXID is the matrix ID,

m₀, m₁, and m₂ are constants,

dT is the temperature value, and

Y is the admittance determined at frequencies 1 and 2.

20. The method of claim 18, wherein step (d) comprises determining a Matrix ID using the equation:

MXID=mx₀+mx₁P₁+mx₂P₂+mx₃P₃+mx₄P₄+mx₅P₅+mx₆P₆+mx₇Y₁+mx₈Y₂+mx₉Y₃+mx₁₀Y₄+mx₁₁Y₅+mx₁₂Y₆

where;

MXID is the matrix ID,

mx_1-12 are constants,

P_1-6 are the phases of the admittances for selected frequencies

Y_1-6 are the magnitude of the admittances for the same frequencies.

21. The method of claim 17, wherein using the characteristic response to provide calibration data involves providing data relating to the concentration of an analyte.

22. The method of claim 21, wherein the device is a glucose test meter and using the characteristic response to provide the concentration of an analyte involves providing the concentration of glucose.

23. The method of claim 22, wherein applying the signal involves applying a signal having a frequency of between about 1 Hz and about 20 kHz.

24. The method of claim 15, wherein applying the signal involves applying a signal including a DC component.

25. The method of claim 24, wherein step (e) comprises determining a Matrix ID using the equation:

$\mathrm{MXID}={\tan }^{-1}\left[m_0+m_1<br><br>\mathrm{dT}+m_2<br><br>\underset{k=1}{\overset{m}{\sum <br><br>}}<br><br>I_k/\mathrm{Im}\right]$

where;

MXID is the matrix ID,

m₀, m₁, and m₂ are constants,

dT is the temperature value,

I_k is the Cottrell current at time k, and

I_m is the Cottrell current at a subsequent time m.

26. A method for generating and identifying control/calibration data generated by a device designed to analyze a biological fluid, the method comprising:

(a) providing a biological fluid test strip;

(b) providing a control/calibration solution containing a known concentration of analyte and a modulator selected from the group consisting of an ionic modulator, an organic modulator, and a combination thereof, wherein the providing includes providing an amount of the moderator sufficient to cause the solution to provide two responses, wherein one response is characteristic of a biological fluid and one response is uncharacteristic of a biological fluid;

(c) applying the solution to the test strip;

(d) applying test and control/calibration signals to the solution;

(e) measuring the characteristic response to the test signal;

(f) using the characteristic response to determine the analyte concentration;

(g) measuring the uncharacteristic response to the control/calibration signal; and

(h) using the uncharacteristic response to identify the analyte concentration as control/calibration data.

27. The method of claim 26, wherein applying the control/calibration signal involves applying a signal having an AC component and measuring the uncharacteristic response involves measuring admittance.

28. The method of claim 27, wherein applying the control/calibration signal involves applying a signal having an AC component having a frequency of from about 1 Hz to about 20 kHz.

29. The method of claim 28, wherein step (h) comprises determining the Matrix ID using the equation:

MXID=tan⁻

[m₀+m₁dT+m₂(Y₂−

Y₁)]

where;

MXID is the matrix ID,

m₀, m₁, and m₂ are constants,

dT is the temperature value, and

Y is the admittance determined at frequencies 1 and 2.

30. The method of claim 28, wherein step (h) comprises determining a Matrix ID using the equation:

MXID=mx₀+mx₁P₁+mx₂P₂+mx₃P₃+mx₄P₄+mx₅P₅+mx₆P₆+mx₇Y₁+mx₈Y₂+mx₉Y₃+mx₁₀Y₄+mx₁₁Y₅+mx₁₂Y₆

where;

mx_1-12 are constants,

P_1-6 are the phases of the admittances for selected frequencies

Y_1-6 are the magnitude of the admittances for the same frequencies.

31. The method of claim 26, wherein applying a control/calibration signal involves applying a signal having a DC component.

32. The method of claim 31, wherein step (h) comprises determining a Matrix ID using the equation:

$\mathrm{MXID}={\tan }^{-1}\left[m_0+m_1<br><br>\mathrm{dT}+m_2<br><br>\underset{k=1}{\overset{m}{\sum <br><br>}}<br><br>I_k/\mathrm{Im}\right]$

where;

MXID is the matrix ID,

m₀, m₁, and m₂ are constants,

dT is the temperature value,

I_k is the Cottrell current at time k, and

I_m is the Cottrell current at a subsequent time m.

33. A control/calibration solution for a device designed to analyze a biological fluid, the solution comprising water and sufficient amount of a modulator to cause the solution to provide at least one response characteristic of the biological fluid and at least one response uncharacteristic of the biological fluid, wherein the modulator is selected from the group consisting of an ionic modulator, an organic modulator and a combination thereof.

34. The solution of claim 33, wherein a combination thereof is selected.

35. The solution of claim 34, wherein the solution is a control solution suitable for testing the performance of the device.

37. The control solution of claim 34, wherein the water soluble salt is an inorganic salt.

42. The control solution of claim 37, wherein the ionic modulator is sodium chloride.

43. The control solution of claim 42, wherein the organic modulator is selected from the group consisting of ethylene glycol, propylene glycol, dipropylene glycol, sorbitol, and glycerin.

44. The control solution of claim 43, wherein the organic modulator is propylene glycol.

45. The control solution of claim 44, further comprising a preservative.

46. The control solution of claim 45, wherein the preservative is Germall®

II preservative.

47. The control solution of claim 42, wherein the water is dionized water.

48. The solution of claim 34, wherein the composition is a calibration solution and additionally comprises a known concentration of a medically significant component.

49. The calibration solution of claim 48, wherein the ionic modulator is an inorganic salt.

50. The calibration solution of claim 49, wherein the organic modulator is a water soluble, non-polymeric organic material.

51. The calibration solution of claim 50, wherein the composition additionally comprises a buffer.

52. The calibration solution of claim 51, wherein the buffer comprises HEPES and sodium HEPES.

53. The calibration solution of claim 52, wherein the ionic modulator is selected from the group consisting of sodium chloride, potassium chloride, and calcium chloride.

54. The calibration solution of claim 53, wherein the ionic modulator is sodium chloride.

55. The calibration solution of claim 53, wherein the organic modulator is selected from the group consisting of ethylene glycol, propylene glycol, dipropylene glycol, sorbitol, and glycerin.

56. The calibration solution of claim 54, wherein the organic modulator is propylene glycol.

57. The calibration solution of claim 55, further comprising a preservative.

58. The calibration solution of claim 57, wherein the preservative is Germall®

II preservative.

59. The calibration solution of claim 58, wherein the medically significant component is glucose.

60. The calibration solution of claim 59, wherein the known concentration of glucose is from about 0 to 1000 mg/100 g of solution.

61. The calibration solution of claim 60, wherein the water is deionized water.

36. The control solution of claim 36, wherein the ionic modulator is a water soluble salt.

38. The control solution of claim 36, wherein the organic modulator is a water soluble, non-polymeric organic material.

39. The control solution of claim 38, wherein the composition additionally comprises a buffer.

40. The control solution of claim 39, wherein the buffer comprises HEPES and sodium HEPES.

41. The control solution of claim 40, wherein the ionic modulator is selected from the group consisting of sodium chloride, potassium chloride, and calcium chloride.