Method and apparatus for assay of electrochemical properties

• US 8,877,033 B2
• Filed: 08/19/2013
• Issued: 11/04/2014
• Est. Priority Date: 08/21/2003
• 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: Iyengar, Sridhar G., Harding, Ian
• Primary Examiner(s): Noguerola, Alex
• Application Number:
  US13/970,117
• Publication Number:
  US 20140048425A1
• Time in Patent Office: 442 Days
• Field of Search: 205/775, 205/777.5, 205/792, 204/400, 204/406, 20440301-40315
• US Class Current: 205/775
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/26 by investigating electrochemical variables; by using electrolysis or electrophoresis
• 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: G01N 27/4168 Oxidation-reduction potential, e.g. for chlorination of water water analysis G01N33/18

Abstract

The presence of a select analyte in the sample is evaluated in an electrochemical system using a conduction cell-type apparatus. A potential or current is generated between the two electrodes of the cell sufficient to bring about oxidation or reduction of the analyte or of a mediator in an analyte-detection redox system, thereby forming a chemical potential gradient of the analyte or mediator between the two electrodes After the gradient is established, the applied potential or current is discontinued and an analyte-independent signal is obtained from the relaxation of the chemical potential gradient. The analyte-independent signal is used to correct the analyte-dependent signal obtained during application of the potential or current. This correction allows an improved measurement of analyte concentration because it corrects for device-specific and test specific factors such as transport (mobility) of analyte and/or mediator, effective electrode area, and electrode spacing (and as a result, sample volume), without need for separate calibration values. The analysis can be performed using disposable test strips in a hand held meter, for example for glucose testing.

Claims

1. A method for increasing accuracy of a determination of an analyte in a sample, comprising the steps of:

(a) applying the sample to an electrochemical test strip;

(b) applying a potential signal to the sample in the electrochemical test strip to result in a current signal that is indicative of the amount of analyte in the sample;

(c) ceasing application of the potential signal and determining a transient potential;

(d) determining from the transient potential a correction factor for the effective transport parameter (P_T) or the electrode area (A) or both the effective transport parameter (P_T) or the electrode area (A), and

(e) applying the correction factor(s) determined in (d) to arrive at a final determination of the analyte in the sample, said final determination of the analyte in the sample being more accurate than an estimated analyte value derivable from the current signal without application of correction factor(s).

2. The method of claim 1, wherein a measure of P_T is determined and compared to a calibration value of P_T, and wherein an estimated analyte value is determined from the current signal, and then is adjusted to account for differences between the measured P_T and the calibration value of P_T to arrive at the final determination of analyte.

3. The method of claim 1, wherein a measure of P_T is determined and compared to a calibration value of P_T, and the current signal is adjusted to account for differences between the measured P_T and the calibration value of P_T, and the final determination of analyte is calculated from the adjusted current signal.

4. The method of claim 1, wherein a measure of P_T is determined and compared to a calibration value of P_T, and Faradaic calibration data is adjusted to the account for differences between the measured P_T and the calibration value of P_T, the adjusted Faradaic calibration data is applied to the current signal to produce a calibrated current signal, and a final determination of analyte is calculated from the calibrated current signal.

5. The method of claim 1, wherein the electrochemical test strip comprises reagents for determination of glucose in a sample.

6. The method of claim 5, wherein a measure of P_T is determined and compared to a calibration value of P_T, and wherein an estimated analyte value is determined from the current signal, and then is adjusted to account for differences between the measured P_T and the calibration value of P_T to arrive at the final determination of analyte.

7. The method of claim 5, wherein a measure of P_T is determined and compared to a calibration value of P_T, and the current signal is adjusted to account for differences between the measured P_T and the calibration value of P_T, and the final determination of analyte is calculated from the adjusted current signal.

8. The method of claim 5, wherein a measure of P_T is determined and compared to a calibration value of P_T, and Faradaic calibration data is adjusted to the account for differences between the measured P_T and the calibration value of P_T, the adjusted Faradaic calibration data is applied to the current signal to produce a calibrated current signal, and a final determination of analyte is calculated from the calibrated current signal.

9. The method of claim 1, wherein the electrochemical test strip comprises facing working and counter electrodes.

10. The method of claim 9, wherein a measure of P_T is determined and compared to a calibration value of P_T, and wherein an estimated analyte value is determined from the current signal, and then is adjusted to account for differences between the measured P_T and the calibration value of P_T to arrive at the final determination of analyte.

11. The method of claim 10, wherein a measure of P_T is determined and compared to a calibration value of P_T, and Faradaic calibration data is adjusted to the account for differences between the measured P_T and the calibration value of P_T, the adjusted Faradaic calibration data is applied to the current signal to produce a calibrated current signal, and a final determination of analyte is calculated from the calibrated current signal.

12. The method of claim 9, wherein a measure of P_T is determined and compared to a calibration value of P_T, and the current signal is adjusted to account for differences between the measured P_T and the calibration value of P_T, and the final determination of analyte is calculated from the adjusted current signal.

13. The method of claim 1, wherein the electrochemical test strip comprises side-by-side electrodes.

14. The method of claim 13, wherein a measure of P_T is determined and compared to a calibration value of P_T, and wherein an estimated analyte value is determined from the current signal, and then is adjusted to account for differences between the measured P_T and the calibration value of P_T to arrive at the final determination of analyte.

15. The method of claim 13, wherein a measure of P_T is determined and compared to a calibration value of P_T, and the current signal is adjusted to account for differences between the measured P_T and the calibration value of P_T, and the final determination of analyte is calculated from the adjusted current signal.

16. The method of claim 13, wherein a measure of P_T is determined and compared to a calibration value of P_T, and Faradaic calibration data is adjusted to the account for differences between the measured P_T and the calibration value of P_T, the adjusted Faradaic calibration data is applied to the current signal to produce a calibrated current signal, and a final determination of analyte is calculated from the calibrated current signal.

17. The apparatus of claim 13, wherein the circuitry of (c) determines a measure of P_T and compares it to a calibration value of P_T,

the apparatus further comprises data storage for storing Faradaic calibration data;

the circuitry of (d) adjusts the stored Faradaic calibration to the account for differences between the measured P_T and the calibration value of P_T, and

the apparatus further comprises circuitry for applying the adjusted Faradaic calibration data to the current signal to produce a calibrated current signal, and for making a final determination of analyte from the calibrated current signal.

18. An apparatus for determining an analyte in a sample with increased accuracy when the apparatus is operatively connected to an electrochemical test strip specific for the analyte, said apparatus comprising:

(a) circuitry for applying a potential signal to the sample in the electrochemical test strip to result in a current signal that is indicative of the amount of analyte in the sample;

(b) circuitry for ceasing application of the potential signal and determining a transient potential;

(c) circuitry for determining from the transient potential a correction factor for the effective transport parameter (P_T) or the electrode area (A) or both the effective transport parameter (P_T) or the electrode area (A), and

(d) circuitry for applying the correction factor(s) determined in (c) to arrive at a final determination of the analyte in the sample, said final determination of the analyte in the sample being more accurate than an estimated analyte value derivable from the current signal without application of correction factor(s).

19. The apparatus of claim 18, wherein the circuitry of (c) determines a measure of P_T and compares this measure to a calibration value of P_T,

wherein the apparatus further comprises circuitry for determining an estimated analyte value from the current signal, and

wherein the circuitry of (d) adjusts the estimated analyte value to account for differences between the measured P_T and the calibration value of P_T to arrive at the final determination of analyte.

20. The apparatus of claim 18, wherein a measure of P_T is determined and compares this value to a calibration value of P_T, and circuitry of step (d) adjusts the current signal to account for differences between the measured P_T and the calibration value of P_T, and

wherein the apparatus further comprises circuitry for making the final determination of analyte from the adjusted current signal.