Rapid analyte measurement assay

• US 8,617,369 B2
• Filed: 03/04/2010
• Issued: 12/31/2013
• Est. Priority Date: 06/30/2006
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Tonks, Simon
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): ROSENWALD, STEVEN ERIC
• Application Number:
  US12/717,686
• Publication Number:
  US 20100206750A1
• Time in Patent Office: 1,398 Days
• Field of Search: 204/403.01, 204/403.04, 205/777.5, 205/792
• US Class Current: 204/403.01
• 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 concentration of a target analyte in a sample, the method comprising:

contacting a sample of no more than 1 μ

L comprising the target analyte with a test strip comprising a working electrode;

a counter electrode; and

a redox reagent system, the redox reagent system comprising a first redox couple and a secondary redox couple, wherein the first redox couple is selected and configured to mediate the target analyte in the sample;

applying a square wave excitation voltage to the test strip;

measuring a response current from the test strip, wherein the response current comprises a primary peak associated with mediation of the target analyte by the first redox couple and a secondary peak from the secondary redox couple; and

determining the concentration of the target analyte from the no more than 1 μ

L of sample based on the primary and secondary peaks.

2. The method of claim 1, wherein the secondary peak comprises a response current in response to a hematocrit level of the sample.

3. The method of claim 1, wherein the secondary peak comprises a response current in response to the temperature of the sample.

4. The method of claim 1, wherein measuring the response current further comprises:

decoupling the first peak from the secondary peak; and

correcting the first peak using the secondary peak.

5. The method of claim 1, wherein the target analyte is glucose.

6. The method of claim 1, wherein determining the concentration of the target analyte is performed within less than 1 second.

8. The method of claim 1, wherein measuring the response current comprises measuring a value of the primary peak and a value of the secondary peak and correcting the value of the primary peak based on the value of the secondary peak.

9. The method of claim 2, wherein the primary and secondary peaks are similarly affected by the hematocrit level of the sample.

10. The method of claim 3, wherein the primary and secondary peaks are similarly affected by the temperature of the sample.

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

12. 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.

13. The method of claim 1, wherein the redox reagent system comprises another secondary redox couple.

7. A method of measuring the concentration of glucose in a sample, the method comprising:

contacting a sample of no more than 1 μ

L comprising glucose with a test strip comprising a working electrode;

a counter electrode; and

a redox reagent system, the redox reagent system comprising a first redox couple and a secondary redox couple, wherein the first redox couple is selected and configured to mediate glucose in the sample;

applying a square wave excitation voltage to the test strip;

measuring a response current, wherein the response current comprises a primary peak from mediation of glucose by the first redox couple and a secondary peak from the secondary redox couple; and

determining the concentration of glucose from the no more than 1 μ

L of sample within less than 1 second based on the first and second peaks.

14. The method of claim 7, wherein measuring the response current comprises measuring a value of the primary peak and a value of the secondary peak and correcting the value of the primary peak based on the value of the secondary peak.

15. The method of claim 7, wherein the secondary peak comprise a response current in response to a hematocrit level of the sample and the primary and secondary peaks are similarly affected by the hematocrit level of the sample.

16. The method of claim 7, wherein the secondary peak comprise a response current in response to the temperature of the sample and the primary and secondary peaks are similarly affected by the temperature of the sample.

17. The method of claim 7, wherein the square wave is superimposed over a potential step function to provide a potential waveform.

18. The method of claim 7, 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.

19. The method of claim 7, wherein the redox reagent system comprises another secondary redox couple.