Rapid analyte measurement assay

• US 7,699,973 B2
• Filed: 06/30/2006
• Issued: 04/20/2010
• Est. Priority Date: 06/30/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Tonks, Simon
• Primary Examiner(s): Olsen; Kaj K
• Application Number:
  US11/479,544
• Publication Number:
  US 20080000780A1
• Time in Patent Office: 1,390 Days
• Field of Search: 204/403.01, 204/403.02, 204/403.04, 204/403.14, 204/406, 205/777.5, 205/792
• US Class Current: 205/777.5
• 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 present the invention provides methods, devices and systems for rapidly measuring analytes within a biological sample.

Claims

1. A method of measuring the concentration of a target analyte within a biological sample, the method comprising:

applying the biological sample to an electrochemical cell having a redox reagent system comprising a first redox couple and at least one secondary redox couple, wherein the first redox couple is selected to mediate the target analyte;

applying a square wave excitation voltage across the electrochemical cell;

measuring a response current of the electrochemical cell, wherein the response current has a primary peak associated with mediation of the target analyte and one or more secondary peaks associated with the mediation of at least one secondary redox couple; and

determining the concentration of the target analyte within the biological sample based on the primary and secondary current peaks.

2. The method of claim 1, wherein determining the concentration of the target analyte comprises applying a correction factor to the value of the measurement from the primary peak based on the value of the measurement from the secondary peak.

3. The method of claim 2, wherein determining the concentration of the target analyte comprises compensating for the effect that hematocrit in a blood sample has on the value of the primary peak measurement.

4. The method of claim 2, wherein determining the concentration of the target analyte comprises compensating for the effect that the temperature of the biological sample has on the value of the primary peak measurement.

5. The method of claim 1, wherein the first redox couple comprises a mediator for the glucose reaction with a glucose specific enzyme, and at least one secondary redox couple comprises a redox couple that does not interfere with the primary glucose reaction or it'"'"'s mediation.

6. The method of claim 1, wherein the square wave is superimposed over a potential step function to provide a potential waveform.

7. The method of claim 1, wherein the measuring a response current is performed within less than about 1 second.

8. The method of claim 1, wherein the square wave excitation voltage is applied at a frequency not less than about 100 Hz and scanned across range of about 1 volt.

9. The method of claim 1, wherein the target analyte is glucose and the biological sample is blood.

10. A system comprising:

a test strip comprising an electrochemical cell having a redox reagent system comprising a first redox couple and at least one secondary redox couple, wherein the first redox couple is selected and configured to mediate the target analyte and provide a primary peak and the at least one secondary redox couple selected and configured so as to provide a secondary peak; and

a meter configured for applying a square wave excitation voltage across the electrochemical cell and providing the primary peak and secondary peak, wherein the test strip is configured for electrical engagement with the meter.

11. The system of claim 10, wherein the target analyte is glucose.

12. The system of claim 10, wherein the target analyte is glucose and the secondary redox couple signal is used to compensate for hematocrit.

13. The system of claim 10, wherein the first redox couple comprises a glucose mediator and at least one secondary redox couple comprises a redox couple that does not interfere with the primary glucose reaction or it'"'"'s mediation.

14. A device comprising:

an electrochemical cell having a redox reagent system comprising a first redox couple and at least one secondary redox couple, wherein the first redox couple is selected and configured to mediate the target analyte and provide a primary peak and the at least one secondary redox couple selected and configured to provide a secondary peak; and

a meter configured for applying a square wave excitation voltage across the electrochemical cell and providing the primary peak and the secondary peak, wherein the meter is in electrical communication with the electrochemical cell.

15. The device of claim 14, wherein the target analyte is glucose.

16. The device of claim 14, wherein the target analyte is glucose and the secondary redox couple signal is used to compensate for sample temperature.

17. The device of claim 14, wherein the first redox couple comprises a glucose mediator and at least one secondary redox couple comprises a redox couple that does not interfere with the primary glucose reaction or it'"'"'s mediation.