Analyte determination method and analyte meter

• US 8,361,307 B2
• Filed: 07/27/2011
• Issued: 01/29/2013
• Est. Priority Date: 04/15/2005
• Status: Active Grant

• Current Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Original Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Inventors: Harding, Ian, Williams, Richard, Iyengar, Sridhar
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US13/191,831
• Publication Number:
  US 20110278180A1
• Time in Patent Office: 552 Days
• Field of Search: 205/775, 205/777.5, 205782-786, 205/792, 436/149, 436/150, 436/68, 435/14, 435 25- 28, 600345-347, 600/364, 600/365, 204/403.01
• US Class Current: 205/792
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/307 Disposable laminated or multilayered electrodes G01N27/3272 takes precedence
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• 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

The presence of oxygen or red blood cells in a sample applied to an electrochemical test strip that makes use of a reduced mediator is corrected for by an additive correction factor that is determined as a function of the temperature of the sample and a measurement that reflects the oxygen carrying capacity of the sample. The measured oxygen carrying capacity can also be used to determine hematocrit and to distinguish between blood samples and control solutions applied to a test strip.

Claims

1. A method for determining an analyte in a sample comprising the steps of:

(a) placing the sample in an electrochemical test cell comprising a working electrode and a counter electrode and a mediator that serves in reduced form as a charge carrier in the electrochemical determination of the analyte, wherein the sample is subject to oxygen attrition in the electrochemical test cell,

(b) applying a DC signal between the working and counter electrodes to produce a DC output signal,

(c) evaluating the DC output signal to determine an uncorrected result for the determination of analyte in the sample;

(d) determining an additive correction term for the amount of oxygen in the sample, said additive correction term being independent of pO₂ and glucose concentration in the sample, and

(e) adding the correction term of step (d) to the uncorrected result of step (c) to provide a corrected determination of analyte in the sample,

wherein the additive correction term for the amount of oxygen in the sample is determined as a function of the temperature of the sample and a measurement that reflects the oxygen carrying capacity of the sample.

2. The method of claim 1, wherein the working and counter electrodes are in a facing arrangement.

3. The method of claim 2, wherein the sample is a blood sample.

4. The method of claim 3, wherein the analyte is glucose.

5. The method of claim 2, wherein the measurement that reflects the oxygen carrying capacity is hematocrit (hct).

6. The method of claim 5, wherein additive correction term is given by the equation

additive correction term=constant×

[(S×

T)+I]×

hct

wherein T is the temperature,

S and I are the slope and intercept, respectively, of a plot of the slope of a line plotting uncorrected analyte measurement as a function of hematocrit of the y axis and temperature on the X axis, and

constant is an empirically determined constant for the particular apparatus and method of determining hematocrit.

7. The method of claim 2, wherein additive correction term is given by the equation

additive correction term=constant×

[(S×

T)+I]×

OCC

wherein T is the temperature,

OCC is the measure of oxygen carrying capacity,

S and I are the slope and intercept, respectively, of a plot of the slope of a line plotting uncorrected analyte measurement as a function of OCC of the y axis and temperature on the X axis, and

constant is an empirically determined constant for the particular apparatus and method of determining OCC.

8. The method of claim 1, wherein the sample is a blood sample.

9. The method of claim 8, wherein the analyte is glucose.

10. The method of claim 9, wherein the measurement that reflects the oxygen carrying capacity is hematocrit (hct).

11. The method of claim 10, wherein additive correction term is given by the equation

additive correction term=constant×

[(S×

T)+I]×

hct

wherein T is the temperature,

S and I are the slope and intercept, respectively, of a plot of the slope of a line plotting uncorrected analyte measurement as a function of hematocrit of the y axis and temperature on the X axis, and

constant is an empirically determined constant for the particular apparatus and method of determining hematocrit.

12. The method of claim 1, wherein additive correction term is given by the equation

additive correction term=constant×

[(S×

T)+I]×

OCC

wherein T is the temperature,

OCC is the measure of oxygen carrying capacity,

S and I are the slope and intercept, respectively, of a plot of the slope of a line plotting uncorrected analyte measurement as a function of OCC of the y axis and temperature on the X axis, and

constant is an empirically determined constant for the particular apparatus and method of determining OCC.

13. The method of claim 1, wherein the DC signal applied is a DC potential, and the measurement that reflects the oxygen carrying capacity is a measurement of potential between the electrodes performed at a time after step (c), wherein the method further comprises the step of ending the application of DC potential prior to measuring the potential between the electrodes.

14. The method of claim 7, wherein the slope S is determined at the measurement temperature, and the intercept I is a constant established from data available for measurements made at multiple temperatures using a single strip and meter combination.