Rapid-read gated amperometry devices

• US 10,345,255 B2
• Filed: 04/16/2015
• Issued: 07/09/2019
• Est. Priority Date: 12/10/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Wu, Huan-Ping
• Primary Examiner(s): Kessel, Maris R
• Application Number:
  US14/688,055
• Publication Number:
  US 20150219586A1
• Time in Patent Office: 1,545 Days
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875

Abstract

A sensor system, device, and methods for determining the concentration of an analyte in a sample is described. Input signals including multiple duty cycles of sequential excitation pulses and relaxations are input to the sample. One or more signals output from the sample within 300 ms of the input of an excitation pulse may be correlated with the analyte concentration of the sample to improve the accuracy and/or precision of the analysis. Determining the analyte concentration of the sample from these rapidly measured output values may reduce analysis errors arising from the hematocrit effect, mediator background, and other error sources.

Claims

1. A method for determining a concentration of an analyte in a sample, comprising:

receiving the sample at a sample reservoir of a test sensor, the sample including a biological fluid;

applying, by a signal generator of a measurement device, an electrical input signal to the sample via a sensor interface including at least two electrodes extending or projecting into the sample reservoir, the sample being in electrical communication with the signal generator of the measurement device, wherein the electrical input signal has at least 3 duty cycles within 30 seconds, and wherein each of the at least 3 duty cycles includes an excitation pulse and a relaxation;

measuring, by a processor of the measurement device via the sensor interface, an electrical output signal responsive to a measurable species within 300 milliseconds from a start of an excitation pulse of at least one of the at least 3 duty cycles, the measurement of the electrical output signal terminating prior to an end of the excitation pulse of the at least one of the at least 3 duty cycles, wherein a pulse width of the excitation pulse of the at least one of the at least 3 duty cycles is from 0.1 to 2 seconds;

determining, by the processor of the measurement device, the concentration of the analyte in the sample based on the measured electrical output signal; and

causing to be displayed on a display device an indication of the concentration of the analyte.

2. The method of claim 1, wherein the electrical input signal comprises at least 4 duty cycles within 7 seconds.

3. The method of claim 1, wherein the electrical input signal comprises at least 3 duty cycles within 10 seconds.

4. The method of claim 1, wherein the pulse width of the excitation pulse of the at least one of the at least 3 duty cycles is from 0.3 to 0.8 seconds.

5. The method of claim 1, wherein a pulse interval of the least one of the at least 3 duty cycles is less than 3 seconds.

6. The method of claim 1, wherein the pulse width of the excitation pulse of the at least one of the at least 3 duty cycles is from 0.3 to 0.5 seconds, and wherein a pulse interval of the least one of the at least 3 duty cycles is from 0.7 to 2 seconds.

7. The method of claim 1, wherein the measuring the electrical output signal occurs within less than 175 milliseconds of the excitation pulse of the at least one of the at least 3 duty cycles.

8. The method of claim 1, wherein the measuring the electrical output signal occurs within 60 to 150 milliseconds from the start of the excitation pulse of the at least one of the at least 3 duty cycles.

9. The method of claim 1, further comprising:

transferring at least one electron from the analyte in the sample to a mediator in a sensor strip; and

electrochemically exciting the measurable species in response to the electrical input signal, wherein the measurable species is from at least one of the analyte and the mediator.

10. The method of claim 1, wherein the excitation pulse has a substantially constant voltage.

11. The method of claim 1, wherein the electrical input signal includes square-wave excitations.

12. The method of claim 1, wherein the determining the concentration of the analyte in the sample is carried out with less bias than a concentration of the analyte determined in response to an electrical output signal measured at more than 300 milliseconds from the start of the excitation pulse of one of the duty cycles.

13. The method of claim 12, wherein the determining the concentration of the analyte in the sample is carried out with less bias than a concentration of the analyte determined in response to an electrical input signal having less than 3 duty cycles within 10 seconds.

14. The method of claim 1, further comprising recording at least one current as a function of time during the application of the electrical input signal.

15. The method of claim 1, further comprising applying at least one data treatment to at least one current of the electrical output signal, wherein the at least one data treatment determines at least one of a decay rate, a K constant, and a ratio value.

16. The method of claim 1, further comprising:

exciting the measurable species internal to a diffusion barrier layer; and

substantially excluding from excitation the measurable species external to the diffusion barrier layer.

17. The method of claim 1, wherein the relaxation includes a current reduction to at least one-half of a current flow at an excitation maxima of the excitation pulse.

18. The method of claim 1, wherein the relaxation includes a current flow reduction to at least an order of magnitude less than the current flow at an excitation maxima of the excitation pulse.

19. The method of claim 1, wherein the relaxation includes a substantially zero current flow or an open circuit.

20. The method of claim 19, wherein the relaxation is at least 0.5 seconds.

21. The method of claim 1, wherein the determining the analyte concentration includes determining the analyte concentration from a transient decay, wherein the electrical output signal includes the transient decay.

22. The method of claim 1, wherein the sample is at least one of a biological fluid and a derivative of a biological fluid.

23. The method of claim 1, wherein the electrical input signal comprises a terminal read pulse not followed by a relaxation.

24. The method of claim 1, wherein the measuring the electrical output signal occurs within less than 175 milliseconds from the start of the excitation pulse, wherein the excitation pulse has the pulse width from 0.3 to 0.8 second.

25. The method of claim 1, wherein the measuring the electrical output signal occurs within 60 to 150 milliseconds from the start of the excitation pulse, wherein the excitation pulse has the pulse width from 0.3 to 0.8 second.

26. The method of claim 1, wherein the measuring the electrical output signal occurs within 175 milliseconds from the start of the excitation pulse, and wherein the excitation pulse has a pulse width from 0.2 to 1 second.

27. The method of claim 1, wherein the pulse width of the excitation pulse is greater than 3 seconds and less than or equal to 2 seconds.

28. The method of claim 1, wherein the electrical output signal responsive to the measurable species is measured prior to a termination of the excitation of the at least one of the at least 3 duty cycles.

29. The method of claim 1, wherein the electrical output signal responsive to the measurable species is measured prior to a beginning of the relaxation of the at least one of the at least 3 duty cycles.

30. The method of claim 1, wherein the electrical input signal includes a current or a potential, and wherein the electrical output signal includes a current or a potential.

31. A method for determining a concentration of an analyte in a sample, comprising:

receiving the sample at a sample reservoir of a test sensor, the sample including a biological fluid;

applying, by a signal generator of a measurement device, an electrical input signal to the sample via a sensor interface including at least two electrodes extending or projecting into the sample reservoir, the sample being in electrical communication with the signal generator of the measurement device, wherein the electrical input signal has at least 3 duty cycles within 30 seconds, and wherein each of the at least 3 duty cycles includes an excitation pulse and a relaxation;

measuring, by a processor of the measurement device via the sensor interface, an electrical output signal responsive to a measurable species within 300 milliseconds from the start of an excitation pulse of at least one of the at least 3 duty cycles, the measurement of the electrical output signal terminating while the excitation pulse of the at least one of the at least 3 duty cycles is still being applied to the sample, wherein a pulse width of the excitation pulse of the at least one of the at least 3 duty cycles is from 0.1 to 2 seconds;

determining, by the processor of the measurement device, the concentration of the analyte in the sample based on the measured electrical output signal; and

causing to be displayed on a display device an indication of the concentration of the analyte.

32. The method of claim 31, wherein the electrical input signal includes a current or a potential, and wherein the electrical output signal includes a current or a potential.

33. A handheld measuring device adapted to receive a sensor strip for determining the concentration of an analyte in a sample, the handheld measuring device comprising:

at least two electrodes configured to contact the sample; and

electrical circuitry in electrical communication with the at least two electrodes, the electrical circuitry including a processor in electrical communication with a signal generator and a computer readable storage medium,

wherein the processor is programmed to;

cause the signal generator to apply an electrical input signal to the sample, the electrical input signal having at least 3 duty cycles within 30 seconds, each of the at least 3 duty cycles including an excitation pulse and a relaxation;

measure an electrical output signal responsive to a measurable species within 300 milliseconds from a start of an excitation pulse of at least one of the at least 3 duty cycles, the measurement of the electrical output signal terminating prior to an end of the excitation pulse of the at least one of the at least 3 duty cycles, a pulse width of the excitation pulse of the at least one of the at least 3 duty cycles being from 0.1 to 2 seconds; and

determine the concentration of the analyte in the sample based on the measured electrical output signal.

34. The handheld measuring device of claim 33, wherein the electrical input signal includes a current or a potential, and wherein the electrical output signal includes a current or a potential.

35. A handheld measuring device adapted to receive a sensor strip for determining the concentration of an analyte in a sample, the handheld measuring device comprising:

at least two electrodes configured to contact the sample; and

electrical circuitry in electrical communication with the at least two electrodes, the electrical circuitry including a processor in electrical communication with a signal generator and a computer readable storage medium,

wherein the processor is programmed to;

cause the signal generator to apply an electrical input signal to the sample, the electrical input signal having at least 3 duty cycles within 30 seconds, each of the at least 3 duty cycles including an excitation pulse and a relaxation;

measure an electrical output signal responsive to a measurable species within 300 milliseconds from a start of an excitation pulse of at least one of the at least 3 duty cycles, the measurement of the electrical output signal terminating while the excitation pulse of the at least one of the at least 3 duty cycles is still being applied to the sample, a pulse width of the excitation pulse of the at least one of the at least 3 duty cycles being from 0.1 to 2 seconds; and

determine the concentration of the analyte in the sample based on the measured electrical output signal.

36. The handheld measuring device of claim 35, wherein the electrical input signal includes a current or a potential, and wherein the electrical output signal includes a current or a potential.