IP Library Granted Patent US 8,841,133
Granted Patent B2
US 8,841,133 · App. 13/875,886 · Granted Sep 23, 2014

Temperature-adjusted analyte determination for biosensor systems

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Quick Facts
Patent No.
US 8,841,133
App. No.
13/875,886
Granted
Sep 23, 2014
Kind
B2
Abstract

A biosensor system determines analyte concentration from an output signal generated by an oxidation/reduction reaction of the analyte. The biosensor system adjusts a correlation for determining analyte concentrations from output signals at one temperature to determining analyte concentrations from output signals at other temperatures. The temperature-adjusted correlation between analyte concentrations and output signals at a reference temperature may be used to determine analyte concentrations from output signals at a sample temperature.

Claims (75)

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

determining a sample temperature;

generating an output signal in response to a redox reaction of an analyte in the sample at a sample temperature;

selecting a previously determined correlation between output signals and analyte concentrations for a reference temperature;

selecting a previously developed normalized temperature function, the development of the normalized temperature function comprising:

determining a correlation between output signals and analyte concentrations for at least one other temperature; and

normalizing the correlation at the at least one other temperature to the correlation of the reference temperature;

adjusting the previously determined correlation with the previously developed normalized temperature function, to obtain a temperature-adjusted correlation; and

calculating an analyte concentration from the output signal and the temperature-adjusted correlation.

2. The method of claim 1 , where the temperature-adjusted correlation is represented as follows:

A=c 2 *OS 2 +c 1 *OS+c 0

where A is the analyte concentration;

OS is the output signal; and

c 2 , c 1 , and c 0 are coefficients that describe a temperature dependent weighing factor.

3. The method of claim 1 , where the temperature-adjusted correlation is represented as follows:

OS T =S T *A R +Int t

where OS T is the output signal at the sample temperature, A R is the analyte concentration at the reference temperature, S T is a product of a slope at the reference temperature and a normalized temperature function of the slope, and Int t is a product of an intercept at the reference temperature and a normalized temperature function of the intercept.

4. The method of claim 3 , where S T is represented as follows:

S T =S R *f ( T )

where T is the sample temperature, S R is the slope of the correlation for the reference temperature, and f(T) is a temperature function that adjusts the slope for the sample temperature.

5. The method of claim 4 , where f(T) is represented as follows:

f ( T ) =a 2 T 2 +a 1 T +a 0

where T is the sample temperature, and a 2 , a l , and a 0 are coefficients of a regression analysis representing normalized slopes.

6. The method of claim 3 , where Int T is represented as follows:

Int T =Int R *g ( T )

where T is the sample temperature, Int R is the intercept of the correlation for the reference temperature, and g(T) is a temperature function that adjusts the intercept for the sample temperature.

7. The method of claim 6 , where g(T) is represented as follows:

g( T ) =b 2 T 2 +b 1 T+b 0,

where T is the sample temperature, and b 2 , b 1 , and b 0 are coefficients of a regression analysis representing normalized intercepts.

8. The method of claim 1 , further comprising generating the output signal in response to an electrochemical process.

9. The method of claim 1 , where the output signal comprises light.

10. The method of claim 1 , where the output signal comprises an electric signal.

11. The method of claim 1 , further comprising generating the output signal in response to pulsed input signals.

12. A biosensor for determining an analyte concentration in a biological fluid, comprising:

a measuring device having a processor connected to a sensor interface and a temperature sensor;

a sensor strip having a sample interface on a base, where the sample interface is adjacent to a reservoir formed by the base;

where the processor:

selects a previously determined correlation between output signals and analyte concentrations for a reference temperature;

selects a previously developed normalized temperature function, the development of the normalized temperature function comprising:

determining a correlation between output signals and analyte

concentrations for at least one other temperature; and

normalizing the correlation at the at least one other temperature to the

correlation of the reference temperature;

adjusts the previously determined correlation with the previously developed normalized temperature function, to obtain a temperature-adjusted correlation adjusted to a sample temperature from the temperature sensor; and

determines an analyte concentration from the temperature-adjusted correlation in response to an output signal from the sample interface.

13. The biosensor of claim 12 , where the temperature-adjusted correlation is represented as follows:

A=c 2 *OS 2 +c 1 *OS+c 0

where A is the analyte concentration;

OS is the output signal; and

c 2 , c 1 , and c 0 are coefficients that describe a temperature dependent weighing factor.

14. The biosensor of claim 12 , where the temperature-adjusted correlation is represented as follows:

OS T =S T *A R +Int T

where OS T is the output signal at the sample temperature, A R is the analyte concentration at the reference temperature, S T is a product of a slope at the reference temperature and a normalized temperature function of the slope, and Int T is a product of an intercept at the reference temperature and a normalized temperature function of the intercept.

15. The biosensor of claim 14 , where S T is represented as follows:

S T =S R *f ( T )

where T is the sample temperature, S R is the slope of the correlation for the reference temperature, and f( T ) is a temperature function that adjusts the slope for the sample temperature.

16. The biosensor of claim 15 , where f(T) is represented as follows:

f ( T ) =a 2 T 2 +a 1 T+a 0

where T is the sample temperature, and a 2 , a 1 , and a 0 are coefficients of a regression analysis representing normalized slopes.

17. The biosensor of claim 14 , where Int T is represented as follows:

Int T =Int R *g ( T )

where T is the sample temperature, Int R is the intercept of the correlation for the reference temperature, and g(T) is a temperature function that adjusts the intercept for the sample temperature.

18. The biosensor of claim 17 , where g(T) is represented as follows:

g ( T ) =b 2 T 2 +b 1 T+b 0 ,

where T is the sample temperature, and b 2 , b 1 , and b 0 are coefficients of a regression analysis representing normalized intercepts.

19. A method for determining an analyte concentration in a sample of a biological fluid, comprising:

applying the sample to the sensor strip of the biosensor of claim 12 ;

determining a sample temperature;

generating an output signal in response to a redox reaction of an analyte in the sample at the sample temperature;

adjusting a correlation between analyte concentrations and output signals at a reference temperature in response to normalized functions of slope and intercept; and

determining the analyte concentration from the temperature-adjusted correlation and the output signal at the sample temperature.

20. The method of claim 19 , where the output signal comprises light.

21. The method of claim 19 , where the output signal comprises an electrical signal.

22. The method of claim 19 , where the output signal is responsive to pulsed input signals.

23. The method of claim 19 , where the analyte comprises glucose and the biological fluid comprises whole blood.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 23, 2016
From: BAYER HEALTHCARE LLC
To: ASCENSIA DIABETES CARE HOLDINGS AG
Reel/Frame 037880/0604 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 29, 2014
From: WU, HUAN-PING; NELSON, CHRISTINE
To: BAYER HEALTHCARE LLC
Reel/Frame 032076/0193 →