Error detection in analyte measurements based on measurement of system resistance

• US 20110073496A1
• Filed: 12/07/2010
• Published: 03/31/2011
• Est. Priority Date: 10/18/2006
• 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: Diamond, Steven, Harding, Ian, Williams, Richard
• Granted Patent: US 8,192,610 B2
• Time in Patent Office: Days
• US Class Current: 205/782
• 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

Measurement of the series track resistance of a working and counter electrode pair in an electrochemical test strip provide error detection for multiple variations in the quality of the test strip, as well as the operation of strip in the test meter. In particular, a single measurement of series resistance can be used to detect and generate an error message when an incorrect reading is likely to result due to (1) damaged electrode tracks, (2) fouled electrode surfaces, (3) dirty strip contacts, or (4) short circuit between the electrodes.

Claims

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

(a) introducing the sample to an electrochemical test strip having working and counter electrodes;

(b) applying a potential difference, V_app, between the electrodes of the test strip and observing a current signal sufficient to provide an initial determination of analyte in the sample and for a period of time sufficient to determine a plateau current, I_plateau;

(c) switching off the applied potential at time t_switch and determining the magnitude, V_drop), of a voltage drop arising from series electrode resistance, if present;

(d) calculating a track resistance R_track, and comparing the determined magnitude of R_track against a predetermined range, and rejecting the test if the magnitude of R_track falls outside of the range wherein the value of R_track=V_drop/I_plateau, and

(e) if the magnitude is within the predetermined range, correcting the initial determination of analyte to compensate for track resistance and proceeding to display or communicate the result from the corrected determination of analyte.

2. The method of claim 1, wherein V_drop is defined as the difference in potential between V_app and the potential measured at a predetermined time after the potential is switched off.

3. The method of claim 1, wherein V_drop is defined as the difference in potential between V_app and the electrochemical potential, V_elect.

4. The method of claim 3, wherein V_elect is determined by extrapolating voltage decay observed in a time interval after the potential is switched off when decrease in potential associated with series electrode resistance has occurred and determining the extrapolated value of potential at the time the potential was switched off.

5. The method of claim 4, wherein the time interval is from 0.5 to 2 milliseconds.

6. The method of claim 5, wherein the time interval is 1 millisecond.

11. The method of claim 1, wherein the analyte is glucose and the sample is a blood sample.

7-10. -10. (canceled)