Transient decay amperometry biosensors

• US 9,005,527 B2
• Filed: 05/29/2013
• Issued: 04/14/2015
• Est. Priority Date: 10/24/2006
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Wu, Huan-Ping, Charlton, Steven C., Chu, Amy H., Edelbrock, Andrew J., Jung, Sung-Kwon, Huang, Dijia
• Primary Examiner(s): Fritchman, Rebecca M
• Application Number:
  US13/904,208
• Publication Number:
  US 20130334066A1
• Time in Patent Office: 685 Days
• Field of Search: 422/518, 422/82.01, 436/149, 205/775, 205/777.5, 205/778
• US Class Current: 422/82.01
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

A biosensor system determines an analyte concentration of a biological sample using an electrochemical process without Cottrell decay. The biosensor system generates an output signal having a transient decay, where the output signal is not inversely proportional to the square root of the time. The transient decay is greater or less than the −0.5 decay constant of a Cottrell decay. The transient decay may result from a relatively short incubation period, relatively small sample reservoir volumes, relatively small distances between electrode surfaces and the lid of the sensor strip, and/or relatively short excitations in relation to the average initial thickness of the reagent layer. The biosensor system determines the analyte concentration from the output signal having a transient decay.

Claims

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

a measurement device having a processor in electrical communication with a sensor interface; and

a sensor strip having a sample interface on a base, the sensor interface in electrical communication with the sample interface, the sample interface in electrical communication with a reservoir formed by the base;

where the processor is configured to instruct a charger to apply an input signal including excitations and relaxations to the reservoir after an incubation period of at most 8 seconds, and

where the processor is configured for determining the analyte concentration in the sample from an output signal of at least one excitation, the output signal having a transient decay in response to a redox reaction of a measurable species, the measurable species formed by way of a redox reaction of a portion of the analyte in the sample, and

where the transient decay is not inversely related to the square root of time and has a decay constant greater or less than −

0.5.

2. The biosensor of claim 1, where the at least one excitation has a duration from 0.1 to 5 seconds.

3. The biosensor of claim 2, where the relaxation preceding the at least one excitation has a duration from 0.1 to 3 seconds.

4. The biosensor of claim 2, where the processor is capable of determining the analyte concentration in the sample from the output signal of the at least one excitation having the duration from 0.1 to 5 seconds.

5. The biosensor of claim 1, where the at least one excitation has a duration from 0.1 to 1 second.

6. The biosensor of claim 1, where the processor is capable of instructing the charger to apply the input signal including excitations and relaxations to the reservoir after an incubation period from 0.1 to 8 seconds.

7. The biosensor of claim 1, where the processor is capable of instructing the charger to apply the input signal including excitations and relaxations to the reservoir after an incubation period of at most 4.75 seconds.

8. The biosensor of claim 1, where the processor is capable of measuring the transient decay within 0.5 to 5 seconds of the charger applying the signal to the sample.

9. The biosensor of claim 1, where the processor is capable of determining the analyte concentration of the sample from decreasing currents of the transient decay.

10. The biosensor of claim 9, where the processor is capable of measuring the decreasing currents of the transient decay within 0.5 to 3 seconds of the charger applying the signal to the sample.

11. The biosensor of claim 1, where the processor is capable of determining the analyte concentration of the sample from a variant concentration distribution of the measurable species in the reservoir.

12. The biosensor of claim 1, where the processor is capable of determining the analyte concentration from the transient decay within 3 seconds of the charger applying the input signal to the sample.

13. The biosensor of claim 1, where the processor is capable of instructing the charger to turn off in at most 4 seconds of instructing the charger to apply the input signal to the sample interface of the sensor strip.

14. The biosensor of claim 1, where the processor is in electrical communication with a storage medium and the processor is capable of determining the analyte concentration in the sample from the output signal with a correlation equation stored in the storage medium.

15. The biosensor of claim 1, where the processor is capable of determining the analyte concentration of the sample from a variant concentration distribution of a measurable species in the sample, where the measurable species is formed from a chemical redox reaction of the analyte.

16. The biosensor of claim 1, where the charger is capable of applying at least 3 excitations to the sample interface of the sensor strip.

17. The biosensor of claim 1, where the charger is capable of applying at least 2 duty cycles within 5 seconds to the sample interface of the sensor strip.

18. The biosensor of claim 1, where the reservoir is defined by the sensor strip base and the bottom surface of a lid, where the base is 50 to 150 micrometers from the bottom surface of the lid, and where the volume of the sample within the reservoir is at most 3.5 microliters.

19. The biosensor of claim 18, where the reservoir height from the sensor strip base to the bottom of the lid is at most 100 micrometers, the volume of the sample within the reservoir is at most 3 microliters, and the reservoir includes at least one reagent layer having an average initial thickness of at most 2 micrometers.

20. The biosensor of claim 1, where a working electrode and a counter electrode in the reservoir are capable of providing electrical communication between the sample interface and the sample.

21. The biosensor of claim 20, where the working electrode and the counter electrode are separated by greater than 200 micrometers.

22. The biosensor of claim 20, where the working electrode includes a reagent layer including a binder, an enzyme system, and at least one mediator.

23. The biosensor of claim 22, where the reservoir comprises at least one working electrode in electrical communication with the charger, and where the reagent layer on the working electrode includes a combination diffusion barrier layer/reagent layer having an average initial thickness from 1 micrometer to 20 micrometers.

24. The biosensor of claim 22, where the reservoir comprises at least one working electrode in electrical communication with the charger, and where the reagent layer on the working electrode includes a combination diffusion barrier layer/reagent layer having an average initial thickness of at most 1 micrometer.

25. The biosensor of claim 1, where the measurable species comprises at least one mediator.

26. The biosensor of claim 1, where the transient decay has a decay constant from 0.52 to 1.

27. The biosensor of claim 1, where the transient decay has a decay constant of at most −

0.35.

28. The biosensor of claim 1, where the processor is capable of instructing the charger to apply the input signal including excitations and relaxations to the reservoir after an incubation period of at most 6 seconds.

29. The biosensor of claim 1, where the processor is capable of instructing the charger to apply the input signal including excitations and relaxations to the reservoir after an incubation period from 0.5 to 4 seconds.