Methods of electrochemically measuring an analyte with a test sequence having a pulsed DC block as well as devices, apparatuses and systems incorporating the same

• US 10,119,931 B2
• Filed: 09/11/2015
• Issued: 11/06/2018
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Beaty, Jr., Terry A., Carpenter, Scott E., Pan, Zheng Zheng, Surridge, Nigel A.
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US14/851,621
• Publication Number:
  US 20160003764A1
• Time in Patent Office: 1,152 Days
• 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

Methods are disclosed for measuring an analyte concentration in a fluidic sample. Such methods further allow one to correct and/or compensate for confounding variables such as hematocrit (Hct), temperature or both before providing an analyte concentration. The measurement methods utilize information obtained from test sequences having at least one AC block and at least one pulsed DC block, where pulsed DC block includes at least one recovery potential, and where a closed circuit condition of the electrode system is maintained during the DC block. Also disclosed are devices, apparatuses and systems incorporating the various measurement methods.

Claims

1. A method of electrochemically measuring an analyte in a fluid sample, the method comprising the steps of:

applying an electrical test sequence to an electrochemical biosensor, the biosensor comprising;

an electrode system,

a reagent in electrical communication with the electrode system, and

a receptacle configured to contact the fluid sample provided to the biosensor,

with the fluid sample in fluidic contact with the reagent, wherein the test sequence comprises at least two blocks, each block configured to produce response information to the test sequence, wherein one block is an alternating current (AC) block and another block is a direct current (DC) block, wherein the DC block includes at least one recovery potential, and wherein a closed circuit condition of the electrode system is maintained during the DC block;

measuring the information from the response to the test sequence, including information from the at least one recovery potential; and

determining an analyte concentration of the fluid sample using the information, the determining based at least in part upon the information from the at least one recovery potential.

2. The method of claim 1, wherein the AC block is applied before the DC block, after the DC block or interspersed within the DC block.

3. The method of claim 1, wherein the AC block is applied before the DC block.

4. The method of claim 1, wherein the AC block comprises a multi-frequency excitation waveform of at least two different frequencies.

5. The method of claim 4, wherein the frequencies of the AC block are about 10 kHz, about 20 kHz, about 10 kHz, about 2 kHz and about 1 kHz, and wherein each frequency is applied for about 0.5 seconds to about 1.5 seconds.

6. The method of claim 1, wherein the DC block comprises a pulsed sequence alternating between an excitation potential and the at least one recovery potential, and wherein the determining comprises determining an effective current based upon the information of the excitation current response and the recovery current response and determining the analyte concentration based upon the effective current.

7. The method of claim 6, wherein the pulsed sequence includes at least one pulse to about ten pulses, wherein the excitation pulse is at about +450 mV and the recovery pulse is at about 0 mV, and wherein each pulse is applied for about 50 msec to about 500 msec.

8. The method of claim 7, wherein each excitation pulse at about +450 mV is applied for about 250 msec and each recovery pulse at about 0 mV is applied for about 500 msec.

9. The method of claim 6, wherein a ramp rate between the excitation pulse and recovery pulse is controlled to be within a predetermined range, and wherein the ramp rate is from about 10 mV/msec to about 50 mV/msec.

10. The method of claim 1, wherein the information of the response to the test sequence is selected from the group consisting of current response, duration, shape and magnitude.

11. The method of claim 1, further comprising the step of correcting an effect on the analyte concentration by at least one confounding variable from the information obtained from the recovery potential.

12. The method of claim 11, wherein the at least one confounding variable is selected from the group consisting of hematocrit, temperature and variation in thickness of the reagent.

13. The method of claim 1, wherein the test sequence further comprises a preconditioning potential applied prior to the DC block.

14. The method of claim 13, wherein the preconditioning potential comprises a positive DC pulse.

15. The method of claim 13, wherein the preconditioning potential comprises a triangular waveform.

16. The method of claim 1, wherein the analyte concentration is a glucose concentration.

17. The method of claim 1, wherein the test sequence further comprises a second DC block, the second DC block having a waveform distinct from a waveform of the first DC block.

18. The method of claim 17, wherein the second DC waveform has a shape selected from the group consisting of a triangular excitation, sinusoidal excitation and trapezoidal excitation.

19. A method of electrochemically measuring an analyte in a fluid sample, the method comprising the steps of:

applying an electrical test sequence to an electrochemical biosensor, the biosensor comprising;

an electrode system,

a reagent in electrical communication with the electrode system, and

a receptacle configured to contact the fluid sample provided to the biosensor,

with the fluid sample in fluidic contact with the reagent, wherein the test sequence comprises at least one direct current (DC) block configured to produce response information to the test sequence, wherein the DC block includes at least one recovery potential, and wherein a closed circuit condition of the electrode system is maintained during the DC block;

measuring information from the response to the test sequence, including information from the at least one recovery potential; and

determining an analyte concentration of the fluid sample using the information, the determining based at least in part upon the information from the at least one recovery potential.

20. The method of claim 19, wherein the DC block comprises a pulsed sequence of about one pulse to about ten pulses, wherein an excitation pulse is at about +450 mV and the at least one recovery pulse is at about 0 mV, and wherein each pulse is applied for about 50 msec to about 500 msec.

21. The method of claim 20, wherein each excitation pulse at about +450 mV is applied for about 250 msec and each recovery pulse at about 0 mV is applied for about 500 msec, and wherein a ramp rate between the excitation pulse and recovery pulse is controlled to be within a predetermined range, and wherein the ramp rate is from about 10 mV/msec to about 50 mV/msec.