Analyte determination method and analyte meter

• US 8,758,594 B2
• Filed: 12/21/2012
• Issued: 06/24/2014
• 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:
  US13/723,713
• Publication Number:
  US 20130118921A1
• Time in Patent Office: 550 Days
• Field of Search: None
• 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 in which the sample is applied to an electrochemical test strip and evaluated using an analyte detection apparatus, wherein the applied sample may be a sample for evaluation or a control solution, wherein the analyte detection apparatus performs the steps of discriminating between a sample for evaluation and a control solution by the steps of:

(a) applying a potential difference between first and second electrodes in the test strip for a period of time sufficient to establish a chemical potential gradient between the electrodes;

(b) thereafter switching off the applied potential whereby the chemical potential gradient begins to decay;

(c) determining the rate of decay of the chemical potential gradient in the absence of applied potential,

(d) comparing the determined rate of decay of the chemical potential gradient to pre-determined reference value, and

(e) determining from the comparison of (d) whether the applied sample is a sample for evaluation or a control solution.

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

3. The method of claim 2, wherein the decay of the chemical potential gradient is determined by monitoring the potential difference between the electrodes after the applied potential has been switched off.

4. The method of claim 3, wherein the rate of decay of the chemical potential gradient is determined by measuring the time required for the potential between the electrodes to decay to a pre-defined level.

5. The method of claim 4, wherein the applied potential difference is 250 to 300 mV, and the predefined level is 25 to 100 mV.

6. The method of claim 3, wherein the rate of decay of the chemical potential gradient is determined by measuring the square root of the time required for the potential between the electrodes to decay to a pre-defined level.

7. The method of claim 4, wherein the applied potential difference is 250 to 300 mV, and the predefined level is 25 to 100 mV.

8. An analyte-detection apparatus for determination of analyte in a sample in which the sample is applied to an electrochemical test strip disposed in operative connection with the analyte-detection apparatus, wherein the applied sample may be a sample for evaluation or a control solution, wherein the analyte-detection apparatus comprises a data processor programmed to discriminate between a sample for evaluation and a control solution, wherein the apparatus performs the steps of:

(a) applying a potential difference between first and second electrodes in the test strip when disposed in the apparatus for a period of time sufficient to establish a chemical potential gradient between the electrodes;

(b) thereafter switching off the applied potential whereby the chemical potential gradient begins to decay;

(c) determining the rate of decay of the chemical potential gradient in the absence of applied potential,

(d) comparing the determined rate of decay of the chemical potential gradient to pre-determined reference value, and

(e) determining from the comparison of (d) whether the applied sample is a sample for evaluation or a control solution.

9. The analyte-detection apparatus of claim 8, wherein the decay of the chemical potential gradient is determined by the apparatus by monitoring the potential difference between the electrodes after the applied potential has been switched off.

10. The analyte-detection apparatus of claim 9, wherein the rate of decay of the chemical potential gradient is determined by the apparatus by measuring the time required for the potential between the electrodes to decay to a pre-defined level.

11. The analyte-detection apparatus of claim 10, wherein the applied potential difference is 250 to 300 mV, and the predefined value is 25 to 100 mV.

12. The analyte-detection apparatus of claim 9, wherein the rate of decay of the chemical potential gradient is determined by the apparatus by measuring the square root of the time required for the potential between the electrodes to decay to a pre-defined level.

13. The analyte-detection apparatus of claim 12, wherein the applied potential difference is 250 to 300 mV, and the predefined value is 25 to 100 mV.