Method for measuring analyte concentration in a liquid sample

• US 8,691,075 B2
• Filed: 12/30/2009
• Issued: 04/08/2014
• Est. Priority Date: 12/30/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Lica, Georgeta
• Primary Examiner(s): DINH, BACH T
• Application Number:
  US12/649,929
• Publication Number:
  US 20110155588A1
• Time in Patent Office: 1,560 Days
• Field of Search: 20440301-40315, 205/777.5, 205/778, 205/792
• US Class Current: 205/792
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875

Abstract

The blood glucose analysis technique and system described herein address the issue of hematocrit interference when rapidly detecting glucose concentrations. It addresses this issue by using a differential pulse voltammetry technique in which short high, frequency voltage pulses are applied to keep the diffusion layer within the reagent of the working electrode, and the pulses are applied in a limited voltage window (or range) that is below the peak, diffusion-limited current. The readings below the peak are then used to determine glucose concentrations. With this technique, glucose concentrations can be determined relatively fast (e.g., within 5 seconds) and independently of the hematocrit levels of the fluid being analyzed.

Claims

1. A method, comprising:

analyzing glucose concentration in a body fluid received in a biosensor through differential pulse voltammetry, wherein the biosensor at least includes a reagent covering a working electrode, said analyzing including

applying short, high frequency voltage pulses to the body fluid in the biosensor to keep a diffusion layer within the reagent of the working electrode, wherein the voltage of the pulses are incrementally increased,

determining the glucose concentration of the body fluid based only on a response to the pulses within a voltage window that is less than a voltage where a peak, diffusion-limited current occurs, and

outputting glucose concentration results from said determining.

2. The method of claim 1, wherein the voltage window is from −

0.05 V to 0 V.

3. The method of claim 1, wherein the voltage window is no more than 300 mV.

4. The method of claim 1, wherein said determining includes performing a single measurement.

5. The method of claim 1, wherein the voltage window is 0.05 V to 0.25 V.

6. The method of claim 1, wherein during said applying the pulses have a pulse length of 25 msec, a pulse interval 25 msec, a pulse voltage 50 mV, and a voltage step 4 mV.

7. The method of claim 1, wherein during said applying the pulses have a pulse interval of 50 msec.

8. The method of claim 7, wherein during said applying the pulses have a pulse length of 50 msec.

9. The method of claim 1, further comprising:

wherein a meter performs said outputting the glucose concentration results;

detecting dosing of the body fluid into the biosensor with the meter before said applying; and

where no more than 5 seconds elapse between said detecting dosing of the body fluid and said outputting the glucose concentration results.

10. The method of claim 1, further comprising:

detecting dosing of the body fluid into the biosensor before said applying; and

allowing the body fluid to incubate for 2 seconds before said applying.

11. The method of claim 1, wherein no incubation period occurs.

12. The method of claim 1, wherein said determining includes measuring difference between current at the end of each pulse and current just before each pulse.

13. The method of claim 1, wherein said determining includes adjusting the response based on or more calibration parameters.

14. The method of claim 1, wherein the biosensor has a two-electrode configuration.

15. The method of claim 1, wherein the biosensor has a three-electrode configuration.

25. The method of claim 1, wherein said determining includes adjusting the response based on or more calibration parameters.

16. A method, comprising:

analyzing glucose concentration in a body fluid with differential pulse voltammetry, wherein said analyzing includes

applying one or more pulses to the body fluid in a voltage window that is less than a voltage where a peak, diffusion-limited current occurs, and

determining the glucose concentration based only on a response to the pulses in the voltage window.

17. The method of claim 16, wherein the voltage window is from −

0.05 V to 0 V.

18. The method of claim 16, wherein the voltage window is no more than 300 mV.

19. The method of claim 16, wherein said determining includes performing a single measurement.

20. The method of claim 16, wherein the voltage window is 0.05 V to 0.25 V.

21. The method of claim 16, wherein during said applying the pulses have a pulse length of 25 msec, a pulse interval 25 msec, a pulse voltage 50 mV, and a voltage step 4 mV.

22. The method of claim 16, wherein during said applying the pulses have a pulse interval of 50 msec.

23. The method of claim 22, wherein during said applying the pulses have a pulse length of 50 msec.

24. The method of claim 16, further comprising:

detecting dosing of the body fluid into a biosensor before said applying;

outputting with a meter glucose concentration results from said determining; and

where no more than 5 seconds elapse between said detecting dosing of the body fluid and said outputting the glucose concentration results.