System and method for determining a temperature during analyte measurement

• US 7,494,816 B2
• Filed: 10/17/2003
• Issued: 02/24/2009
• Est. Priority Date: 12/22/1997
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG), Roche Operations Limited (Roche Holding AG)
• Inventors: Beaty, Terry A., Burke, David W., Svetnik, Vladimir, Kuhn, Lance S.
• Primary Examiner(s): Soderquist; Arlen
• Application Number:
  US10/687,668
• Publication Number:
  US 20040157338A1
• Time in Patent Office: 1,957 Days
• Field of Search: 422 55- 58, 422 8201- 8204, 436/43, 436/46, 436/68, 436 93- 95, 436/131, 436149-151, 436/183
• US Class Current: 436/94
• 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 436/11 Automated chemical analysis
• CPC Class Codes: Y10T 436/112499 with sample on test slide
• CPC Class Codes: Y10T 436/115831 Condition or time responsive
• CPC Class Codes: Y10T 436/12 Condition responsive control
• CPC Class Codes: Y10T 436/142222 Hetero-O [e.g., ascorbic acid, etc.]
• CPC Class Codes: Y10T 436/143333 Saccharide [e.g., DNA, etc.]
• CPC Class Codes: Y10T 436/144444 Glucose
• CPC Class Codes: Y10T 436/203332 Hydroxyl containing

Abstract

A method of measuring an analyte in a biological fluid comprises applying an excitation signal having a DC component and an AC component. The AC and DC responses are measured; a corrected DC response is determined using the AC response; and a concentration of the analyte is determined based upon the corrected DC response. Other methods and devices are disclosed.

Claims

1. A method for measuring a temperature during a test for determining a concentration of medically significant component of a biological fluid, comprising the steps of:

a) providing a sensor having at least one measurement electrode adapted to measure the biological fluid;

b) applying a first signal to the measurement electrode;

c) measuring a first response to the first signal;

d) using the first response to produce an indication of a temperature of the biological fluid;

e) applying a second signal to the measurement electrode;

f) measuring a second response to the second signal to produce an indication of the concentration of the medically significant component; and

g) determining a temperature-corrected concentration of the medically significant component based upon the first responses.

2. The method of claim 1 wherein the sensor comprises a disposable test strip.

3. The method of claim 1, wherein

the first signal comprises a signal having an AC component and the first response comprises and AC response to the first signal.

4. The method of claim 3, wherein the first AC response comprises an admittance.

5. The method of claim 3, further comprising the steps of:

(c) applying a second signal having an AC component to the biological fluid, wherein said first and second signals may be applied sequentially or simultaneously;

(d) measuring a second AC response to the second signal; and

(e) further using the second AC response to produce the indication of a temperature of the biological fluid.

6. A method for measuring a temperature during a test for determining a concentration of a medically significant component of a biological fluid, comprising the steps of:

a) providing a sensor having at least one measurement electrode adapted to measure the biological fluid;

b) applying a first temperature measurement signal having an AC component to the measurement electrode;

c) measuring a first AC temperature measurement response to the first temperature measurement signal;

d) using the first AC temperature measurement response to produce an indication of a temperature of the biological fluid;

e) applying a first concentration measurement signal to the measurement electrode;

f) measuring a first concentration measurement response to the first concentration measurement signal to produce an indication of the concentration of the medically significant component; and

g) determining a temperature-corrected concentration of the medically significant component based upon the first AC temperature measurement response and the first concentration measurement response.

7. The method of claim 6, wherein the first AC response comprises an admittance.

8. The method of claim 6, further comprising the steps of:

(c) applying a second temperature measurement signal having an AC component to the biological fluid, wherein said first and second temperature measurement signals may be applied sequentially or simultaneously;

(d) measuring a second AC temperature measurement response to the second temperature measurement signal; and

(e) further determining the temperature-corrected concentration of the medically significant component based upon the first AC temperature measurement response, the second AC temperature measurement response and the first concentration measurement response.

9. The method of claim 8, wherein the second temperature measurement signal is an AC signal.

10. The method of claim 8, wherein the second AC temperature measurement response comprises an admittance measurement.

11. The method of claim 8, wherein the second AC temperature measurement response comprises magnitude information.

12. The method of claim 6, wherein the first temperature measurement signal is an AC signal.

13. The method of claim 6, wherein the first AC temperature measurement response comprises magnitude information.

14. The method of claim 6, wherein the first temperature measurement signal comprises a number of frequencies applied sequentially or simultaneously, wherein the number is greater than one.

15. The method of claim 14, wherein the number is not less than two and not grater than four.

16. The method of claim 14, wherein the number is greater than four.

17. The method of claim 6, wherein the AC component of the first temperature measurement signal has a frequency not less than 1 Hz and not greater than 20 kHz.

18. The method of claim 6, wherein the biological fluid is blood.

19. The method of claim 6, wherein said first temperature measurement signal comprises four first temperature measurement signals applied sequentially or simultaneously, and wherein step (d) comprises producing an indication of the temperature using

T_est=b₀+b₁(Y₁−

Y₂)+b₂(Y₃−

Y₄)+b₃H_est

Where;

T_est is the temperature,

b₀, b₁, b₂ and b₃ are constants

Y₁, Y₂, Y₃ and Y₄ are respective AC responses of the four first temperature measurement signals (expressed as admittance), and

H_est is an estimated hematocrit value.

20. A method of accounting for the effect of a temperature variation on a test for a glucose concentration of a biological fluid comprising:

a) providing a sensor having at least one measurement electrode adapted to measure the biological fluid;

b) applying a first temperature measurement test signal having an AC component to the measurement electrode, the first temperature measurement test signal having a first frequency;

c) measuring at least a first AC temperature measurement response to the first temperature measurement test signal;

d) determining a temperature value of the biological fluid using the first AC temperature measurement response;

e) applying a first concentration measurement signal to the measurement electrode;

f) measuring at least a first concentration measurement response to the first concentration measurement signal to produce an indication of the glucose concentration of the biological fluid; and

g) determining a temperature-corrected glucose concentration of the biological fluid base at least in part upon the temperature value and the first concentration measurement response.

21. The method of claim 20, wherein the determining a temperature value comprises determining a hematocrit value of the biological fluid and using the hematocrit value in combination with the first AC temperature measurement response to determine the temperature value.

22. The method of claim 20, wherein the first AC temperature measurement response includes an admittance.

23. The method of claim 20, further comprising the steps of:

e) applying a second temperature measurement test signal having an AC component to the biological fluid, the second temperature measurement test signal having a second frequency, wherein said first and second temperature measurement test signals may be applied sequentially or simultaneously; and

f) measuring at least a second AC temperature measurement response to the second temperature measurement test signal; and

g) using the second AC temperature measurement response in the determining a temperature value of the biological fluid.

24. The method of claim 23, further comprising the steps of:

h) applying a third temperature measurement test signal having an AC component to the biological fluid, the third temperature measurement test signal having a third frequency, wherein said first, second and third temperature measurement test signals may be applied sequentially or simultaneously;

i) measuring at least a third AC temperature measurement response to the third temperature measurement test signal;

j) applying a fourth temperature measurement test signal having an AC component to the biological fluid, the fourth temperature measurement test signal having a fourth frequency;

k) measuring at least a fourth AC temperature measurement response to the fourth test signal; and

l) using the third AC temperature measurement response and the fourth AC temperature measurement response in the determining a temperature value of the biological fluid.