Transient decay amperometry

• US 8,026,104 B2
• Filed: 10/21/2007
• Issued: 09/27/2011
• 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: Jung, Sung-Kwon, Chu, Amy H., Wu, Huan-Ping, Huang, Dijia, Edelbrock, Andrew J., Charlton, Steven C.
• Primary Examiner(s): Menon; Krishnan S
• Assistant Examiner(s): FRITCHMAN, REBECCA M
• Application Number:
  US11/875,942
• Publication Number:
  US 20090068754A1
• Time in Patent Office: 1,437 Days
• Field of Search: 436/149, 436/150, 422/82.01, 422/518, 205/775, 205/777.5, 205/778
• US Class Current: 436/150
• 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 method for determining an analyte concentration in a sample after forming a measurable species from a reaction between the analyte and an ionizing agent during an incubation period, comprising:

applying a signal to a sample after an incubation period from 0.4 to 1 second, the signal including excitations, each excitation having a duration from 0.1 to 5 seconds;

generating a signal having a transient decay in response to a redox reaction of a measurable species, where

the generated signal results from at least one of the excitations having the duration from 0.1 to 5 seconds, and where

the measurable species concentration in the sample is responsive to the analyte concentration in the sample; and

determining the analyte concentration from the transient decay of the generated signal.

2. The method of claim 1, where the measurable species comprises at least one mediator.

3. The method of claim 1, where the transient decay is obtained within 0.5 to 5 seconds of applying the signal to the sample.

4. The method of claim 1, where the transient decay is decreasing.

5. The method of claim 1, where the transient decay is obtained within about 0.5 to about 3 seconds of applying the signal to the sample.

6. The method of claim 4, where the analyte concentration is determined from a current measurement, the current measurement determined from the transient decreasing current decay.

7. The method of claim 1, further comprising generating a variant concentration distribution of the measurable species in a sample reservoir.

8. The method of claim 1, where the incubation period and the application of the signal are complete in at most 6 seconds.

9. The method of claim 1, where the incubation period and the application of the signal are complete in at most 4 seconds.

10. The method of claim 1, where the transient decay has a decay constant from −

0.52 to −

1.

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

0.35.

12. The method of claim 1, where the generated signal from which the analyte concentration is determined comprises a current value generated within 2 seconds of applying the signal to the sample.

13. The method of claim 1, where determining the analyte concentration from the generated signal is complete within 3 seconds of applying the signal to the sample.

14. The method of claim 1, where the sample resides in a reservoir defined by a 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

the volume of the sample within the reservoir is at most 3.5 microliters.

15. The method of claim 14, 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.

16. The method of claim 1, where the excitations are separated by at least two relaxations, each relaxation having a duration from 0.1 to 3 seconds.

17. The method of claim 1, where the applied signal includes at least 2 duty cycles applied within a 1 to 3 second time period.

18. The method of claim 1, where the generated signal results from at least one of the excitations having a duration from 0.1 to 1 second.

19. The method of claim 1, where the signal application is complete in at most 4 seconds.

20. The method of claim 1, the applied signal including at least 4 excitations.

22. The method of claim 4, where the transient decreasing current decay from which the analyte concentration is determined is obtained within about 2 seconds, within about 1 second, or less of applying the signal to the sample.

23. The method of claim 6, where the current measurement determined from the transient decreasing current decay from which the analyte concentration is determined is a current measurement generated within 2 seconds of applying the signal to the sample.

24. The method of claim 1, where the measurable species is formed by way of a redox reaction of a portion of the analyte in the sample.

25. The method of claim 14, where the signal applied to the sample is applied across two electrodes residing on the sensor strip base.

21. A method for determining an analyte concentration in a sample after forming a measurable species from a reaction between the analyte and an ionizing agent during an incubation period, comprising:

applying a signal to a sample after an incubation period of at most 8 seconds, the signal including excitations and relaxations;

generating a signal having a transient decay in response to a redox reaction of a measurable species, where the transient decay has a decay constant from −

0.001 to −

0.48 or from −

0.52 to −

1; and

determining the analyte concentration from the transient decay of the generated signal.

26. The method of claim 21, where the transient decay has a decay constant from −

0.001 to −

0.48.

27. The method of claim 21, where the transient decay has a decay constant from −

0.52 to −

1.

28. The method of claim 21, where the transient decay has a decay constant of at most −

0.45.

29. The method of claim 21, where the transient decay has a decay constant of at most −

0.35.