METHODS AND SYSTEMS TO CORRECT FOR HEMATOCRIT EFFECTS

• US 20110190607A1
• Filed: 02/04/2010
• Published: 08/04/2011
• Est. Priority Date: 02/04/2010
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: McGarraugh, Geoffrey, Matzinger, David P., Pugh, Jerry T.
• Granted Patent: US 8,391,940 B2
• Time in Patent Office: Days
• US Class Current: 600/316
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04

Abstract

Described and illustrated herein are exemplary methods of operating an analyte measurement system having a meter and a test strip. Such methods may be exemplarily achieved by determining a first glucose concentration by measuring a first reflectance at about a first wavelength at a testing surface of the pad; measuring a second reflectance at about a second wavelength; formulating at least one equation to correct the first glucose concentration for temperature or hematocrit effects using the second reflectance at about the second wavelength; determining a second glucose concentration using the first glucose concentration, the second reflectance at about a second wavelength; and displaying the second glucose concentration that is corrected for temperature and hematocrit effects.

Claims

1. A method of correcting a glucose concentration in a glucose measurement system having a test strip and an optical reading device, the method comprising:

determining a first glucose concentration by measuring a first reflectance at about a first wavelength proximate a surface of the test strip having a membrane impregnated with a color-producing reagent;

measuring a temperature and a second reflectance at about a second wavelength;

determining a second glucose concentration with at least one equation to correct the first glucose concentration with the temperature and the second reflectance at about the second wavelength; and

displaying the second glucose concentration.

7. The method of claim 1, wherein the second glucose concentration comprises a value obtained with an equation of the form:

G2=a0+a1*G1+a2*T+a3*K/S<sub>λ

2</sub>+a4*G1*T+a5*G1*K/S<sub>λ

2</sub>+a6*T*K/S<sub>λ

2</sub>+a7*(G1)²+a8*(T)²+a9*(K/S<sub>λ

2</sub>)²+a10*(G1)³+a11*(T)³+a12*(K/S<sub>λ

2</sub>)³+a13*G1*T*K/S<sub>λ

2</sub>+a14*(G1)²*T+a15*(G1)²*(K/S<sub>λ

2</sub>)+a16*G1*T²+a17*G1*(K/S<sub>λ

2</sub>)²+a18*T*(K/S<sub>λ

2</sub>)²+a19*T²*(K/S<sub>λ

2</sub>)

where;

G2 is the second glucose concentration;

G1 is the first glucose concentration;

T is temperature; and

K/S<sub>λ

2</sub> comprises a value obtained with an equation of the form;

K/S<sub>λ

2</sub>=(1−

R₂)²/(2*R₂)

where;

R₂ is the second reflectance at about the second wavelength, λ

2, taken at an endpoint time; and

Coefficients a0 through a9 are constants.

8. The method of claim 1, wherein the at least one equation comprises an equation of the form:

G2=a0+a1*G1+a2*T+a3*K/S<sub>λ

2</sub>+a4*(G1)²+a5*(T)²+a6*(K/S<sub>λ

2</sub>)²

where;

G2 is the second glucose concentration corrected for temperature and hematocrit effects;

G1 is the first glucose concentration and is determined from the first reflectance measured at about a first wavelength, λ

1;

T is temperature;

K/S<sub>λ

2</sub> comprises a value obtained with an equation of the form;

K/S<sub>λ

2</sub>=(1−

R₂)²/(2*R₂)

where;

R₂ is the second reflectance at about the second wavelength, λ

2, taken at an endpoint time; and

Coefficients a0 through a6 depend on the endpoint time at which the first reflectance at about the first wavelength, λ

1, is measured.

9. The method of claim 1, wherein the at least one equation comprises an equation of the form:

G2=a0+a1*G1+a2*K/S<sub>λ

2</sub>+a3*T+a4*G1*K/S<sub>λ

2</sub>+a5*G1*T

where;

G2 is the second glucose concentration and corrected for temperature and hematocrit effects;

G1 is the first glucose concentration and is determined from the first reflectance measured at about a first wavelength, λ

1;

T is temperature;

K/S<sub>λ

2</sub> comprises a value obtained with an equation of the form;

K/S<sub>λ

2</sub>=(1−

R₂)²/(2*R₂)

where;

R₂ is the second reflectance at about the second wavelength, λ

2, taken at an endpoint time; and

Coefficients a0 through a5 depend on the endpoint time at which the first reflectance at about the first wavelength, λ

1, is measured.

13. The method of any one of claims 1-12, wherein the first wavelength ranges from about 600 nm to about 700 nm and the second wavelength ranges from about 800 nm to about 1100 nm.

14. The method of any one of claims 1-12, wherein the first wavelength is about 660 nm and the second wavelength is about 940 nm.

15. The method of any one of claims 1-7, in which the determining of one of the first and second glucose concentration comprises calculating with a microprocessor.

2. A method of correcting a glucose concentration in a glucose measurement system having a test strip and an optical reading device, the method comprising:

determining a first glucose concentration by measuring a first reflectance at about a first wavelength proximate a surface of the test strip having a membrane impregnated with a color-producing reagent;

measuring a second reflectance at about a second wavelength;

determining a second glucose concentration with at least one equation based on the second reflectance at about the second wavelength; and

displaying the second glucose concentration.

10. The method of claim 2, wherein the at least one equation comprises an equation of the form:

G2=a0+a1*G1+a2*K/S<sub>λ

2</sub>+a3*G1*K/S<sub>λ

2</sub>+a4*(G1)²+a5*(K/S<sub>λ

2</sub>)²+a6*(G1)³+a7*(K/S<sub>λ

2</sub>)³+a8*(G1)²*(K/S<sub>λ

2</sub>)+a9*G1*(K/S<sub>λ

2</sub>)²

where;

G2 is the second glucose concentration corrected for and hematocrit effects;

G1 is the first glucose concentration and is determined from the first reflectance measured at about a first wavelength, λ

1;

K/S<sub>λ

2</sub> comprises a value obtained with an equation of the form;

K/S<sub>λ

2</sub>=(1−

R₂)²/(2*R₂)

where;

R₂ is the second reflectance at about the second wavelength, λ

2, taken at an endpoint time, t; and

Coefficients a₁₀ through a9 depend on the endpoint time at which the first reflectance at about the first wavelength, λ

1, is measured.

11. The method of claim 2, wherein the second glucose concentration comprises a value obtained with an equation of the form:

G2=a1*G1+a2*K/S<sub>λ

2</sub>+a3*(G1)²+a4*(K/S<sub>λ

2</sub>)²

where;

G2 is the second glucose concentration and corrected for temperature and hematocrit effects;

G1 is the first glucose concentration and is determined from the first reflectance measured at about a first wavelength, λ

1;

K/S<sub>λ

2</sub> comprises a value obtained with an equation of the form;

K/S<sub>λ

2</sub>=(1−

R₂)²/(2*R₂)

where;

R₂ is the second reflectance at about the second wavelength, λ

2, taken at an endpoint time; and

Coefficients a1 through a4 depend on the endpoint time at which the first reflectance at about the first wavelength, λ

1, is measured.

12. The method of claim 2, wherein the at least one equation comprises an equation of the form:

G2=a0+a1*G1+a2*K/S<sub>λ

2</sub>+a3*G1*K/S<sub>λ

2</sub>

where;

G2 is the second glucose concentration corrected for temperature and hematocrit effects;

G1 is the first glucose concentration and is determined from the first reflectance measured at about a first wavelength, λ

1;

K/S<sub>λ

2</sub> comprises a value obtained with an equation of the form;

K/S<sub>λ

2</sub>=(1−

R₂)²/(2*R₂)

where;

R₂ is the second reflectance at about the second wavelength, λ

2,

taken at an endpoint time; and

Coefficients a0 through a3 depend on the endpoint time at which the first reflectance at about the first wavelength, λ

1, is measured.

3. A method of correcting a glucose concentration in a glucose measurement system having a test strip and an optical reading device, the method comprising:

determining a first glucose concentration by measuring a first reflectance at about a first wavelength proximate a surface of the test strip having a membrane impregnated with a color-producing reagent;

measuring a second reflectance at about a second wavelength;

determining a second glucose concentration based on the second reflectance at about the second wavelength with an equation of the form;

G2=a0+a1*G1+a2*K/S<sub>λ

2</sub>+a3*G1*K/S<sub>λ

2</sub>+a4*(G1)²+a5*(K/S<sub>λ

2</sub>)²+a6*(G1)³+a7*(K/S<sub>λ

2</sub>)³a8*(G1)²*(K/S<sub>λ

2</sub>)+a9*G1*(K/S<sub>λ

2</sub>)²

where;

G2 is the second glucose concentration corrected for temperature and hematocrit effects;

G1 is the first glucose concentration and is determined from the first reflectance measured at about a first wavelength, λ

1;

K/S<sub>λ

2</sub> comprises a value obtained with an equation of the form;

K/S<sub>λ

2</sub>=(1−

R₂)²/(2*R₂)

where;

R₂ is the second reflectance at about the second wavelength, λ

2, taken at an endpoint time; and

Coefficients a0 through a9 depend on the endpoint time at which

the reflectance at about the first wavelength, λ

1, is measured; and

displaying the second glucose concentration.

4. A method of correcting a glucose concentration in a glucose measurement system having a test strip and an optical reading device, the method comprising:

determining a first glucose concentration by measuring a first reflectance at about a first wavelength proximate a surface of the test strip having a membrane impregnated with a color-producing reagent;

measuring a temperature and a second reflectance at about a second wavelength;

determining a second glucose concentration based on the temperature and the second reflectance at about the second wavelength with an equation of the form;

G2=a0+a1*G1+a2*T+a3*K/S₂₂+a4*G1*T+a5*G1*K/S₂₂+a6*T*K/S₂₂+a7*(G1)²+a8*(T)²+a9*(K/S<sub>λ

2</sub>)²+a10*(G1)³+a11*(T)³+a12*(K/S<sub>λ

2</sub>)³+a13*G1*T*K/S<sub>λ

2</sub>+a14*(G1)²*T+a15*(G1)²*(K/S<sub>λ

2</sub>)+a16*G1*T²+a17*G1*(K/S<sub>λ

2</sub>)²+a18*T*(K/S<sub>λ

2</sub>)²+a19*T²*(K/S<sub>λ

2</sub>)

where;

G2 is the second glucose concentration corrected for temperature and hematocrit effects;

G1 is the first glucose concentration and is determined from the reflectance measured at about a first wavelength, λ

1;

T is temperature;

K/S<sub>λ

2</sub> comprises a value obtained with an equation of the form;

K/S<sub>λ

2</sub>=(1−

R₂)²/(2*R₂)

where;

R₂ is the second reflectance at about the second wavelength, λ

2, taken at an endpoint time; and

Coefficients a0 through a19 depend on the endpoint time at which the first reflectance at about the first wavelength, λ

1, is measured; and

displaying the second glucose concentration.

5. A method of correcting a glucose concentration in a glucose measurement system having a test strip and an optical reading device, the method comprising:

determining a first glucose concentration by measuring a first reflectance at about a first wavelength proximate a surface of the test strip having a membrane impregnated with a color-producing reagent;

measuring a temperature and a second reflectance at about a second wavelength;

determining a second glucose concentration based on the temperature measurement and the second reflectance made at about the second wavelength with an equation of the form;

G2=a1*G1+a2*T+a3*K/S₂₂+a4*G1*T+a5*G1*K/S<sub>λ

2</sub>+a6*T*K/S<sub>λ

2</sub>+a7*(G1)²+a8*(T)²+a9*(K/S<sub>λ

2</sub>)²

where;

G2 is the second glucose concentration corrected for temperature and hematocrit effects;

G1 is the first glucose concentration and is determined from the first reflectance measured at about a first wavelength, λ

1;

T is temperature;

K/S<sub>λ

2</sub> is determined with an equation of the form;

K/S<sub>λ

2</sub>=(1−

R₂)²/(2*R₂)

where;

R₂ is the second reflectance at about the second wavelength, λ

2, taken at an endpoint time; and

Coefficients a1 through a6 depend on the endpoint time at which the first reflectance at first wavelength, λ

1, is measured; and

displaying the second glucose concentration.

6. A method of correcting a glucose concentration in a glucose measurement system having a test strip and an optical reading device, the method comprising:

determining a first glucose concentration by measuring a first reflectance at about a first wavelength at a surface of the test strip having a membrane impregnated with a color-producing reagent;

measuring a temperature and a second reflectance at about a second wavelength;

determining a second glucose concentration based on the second reflectance at about the second wavelength and the measured temperature with the equation of the form;

G2=a0+a1*G1+a2*T+a3*K/S<sub>λ

2</sub>+a4*G1*K/S<sub>λ

2</sub>+a5*G1*T

where;

G2 is the second glucose concentration corrected for temperature and hematocrit effects;

G1 is the first glucose concentration and is determined from the reflectance measured at about a first wavelength, λ

1;

T is temperature;

K/S<sub>λ

2</sub> comprises a value obtained with an equation of the form;

K/S<sub>λ

2</sub>=(1−

R₂)²/(2*R₂)

where;

R₂ is the second reflectance at about the second wavelength, λ

2, taken at an endpoint time; and

Coefficients a0 through a5 depend on the endpoint time at which the first reflectance at first wavelength, λ

1, is measured; and

displaying the second glucose concentration.