Analytical test strip with an electrode having electrochemically active and inert areas of a predetermined size and distribution

• US 8,940,141 B2
• Filed: 05/19/2010
• Issued: 01/27/2015
• Est. Priority Date: 05/19/2010
• Status: Expired due to Fees

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: Macfie, Gavin, Redpath, Craig, Rodgers, James Iain, Whitehead, Neil
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): Kessel, Maris R
• Application Number:
  US12/783,437
• Publication Number:
  US 20110284393A1
• Time in Patent Office: 1,714 Days
• Field of Search: 204/400, 20440301-40315, 205/775, 205/777.5, 205/792
• US Class Current: 204/403.01
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

An electrochemical-based analytical test strip for the determination of an analyte (e.g., glucose) in a bodily fluid sample (such as a whole blood sample) includes an electrically insulating base layer and a patterned conductor layer (for example, a gold patterned conductor layer) disposed over the electrically-insulating layer. The patterned conductor layer includes at least one electrode with the electrode having electrochemically inert areas and an electrochemically active area(s). Moreover, the electrochemically inert areas and electrochemically active area(s) are of a predetermined size and a predetermined distribution such that electrochemical response of the electrode during use of the electrochemical-based analytical test strip is essentially equivalent to a predetermined electrochemical response.

Claims

1. An electrochemical-based analytical test strip for the determination of an analyte in a bodily fluid sample, the electrochemical-based analytical test strip comprising:

an electrically insulating base layer; and

a patterned conductor layer disposed over the electrically-insulating layer, the patterned conductor layer including at least one electrode,

wherein the at least one electrode has electrochemically inert areas, an electrically continuous electrochemically active area lattice, and non-conductive border regions separating the electrochemically inert areas and the electrically continuous electrochemically active area lattice, the electrochemically inert areas and the at least one electrochemically active area being of a predetermined size and a predetermined distribution such that electrochemical response of the electrode during use of the electrochemical-based analytical test strip is essentially equivalent to a predetermined electrochemical response of a different electrode.

2. The electrochemical-based analytical test strip of claim 1 wherein the patterned conductor layer is a gold patterned conductor layer and the at least one electrode is a working electrode.

3. The electrochemical-based analytical test strip of claim 1 wherein the electrochemically inert areas are rendered electrochemically inert via physical electrical isolation from the electrically continuous electrochemically active area lattice.

4. The electrochemical-based analytical test strip of claim 3 wherein the physical electrical isolation is achieved using laser ablation.

5. The electrochemical-based analytical test strip of claim 1 wherein the electrochemically inert areas and electrically continuous electrochemically active area lattice of a predetermined size and a predetermined distribution are configured in a regular array.

6. The electrochemical-based analytical test strip of claim 5 wherein the regular array is a regular square lattice array.

7. The electrochemical-based analytical test strip of claim 6 wherein a width of the electrically continuous electrochemically active area lattice is in the range of 3 μ

m to 50 μ

m.

8. The electrochemical-based analytical test strip of claim 6 wherein the width of the electrochemically inert areas is in the range of 20 μ

m to 200 μ

m.

9. The electrochemical-based analytical test strip of claim 1 wherein the analytical test strip is configured for the determination of glucose in a whole blood sample.

10. The electrochemical-based analytical test strip of claim 1 wherein the patterned conductor layer has a first working electrode, a second working electrode and a counter/reference electrode and wherein each of the first working electrode and the second working electrode have electrochemically inert areas and an electrically continuous electrochemically active area lattice, the electrochemically inert areas and electrically continuous electrochemically active area lattice being of a predetermined size and a predetermined distribution such that an electrochemical response of the electrode during use of the electrochemical-based analytical test strip is essentially equivalent to a predetermined electrochemical response of a screen-printed carbon electode.

11. The electrochemical-based analytical test strip of claim 1 wherein the predetermined electrical response is a peak current response.

12. The electrochemical-based analytical test strip of claim 1 wherein the predetermined electrical response is a peak separation response.

13. The electrochemical-based analytical test strip of claim 1 wherein the predetermined electrical response is an early transient response occurring within approximately 500 milliseconds of a potential application to the electrochemical-based analytical test strip.

14. The electrochemical-based analytical test strip of claim 1 wherein the predetermined electrical response is an interferent sensitivity response.

15. The electrochemical-based analytical test strip of claim 1 further including:

an enzymatic reagent layer disposed at least over at least a portion of the patterned conductor layer;

a top layer disposed over the enzymatic reagent layer; and

a sample receiving chamber defined within the electrochemical-based analytical test strip.

16. The electrochemical-based analytical test strip of claim 1 wherein the patterned conductor layer includes a plurality of electrodes, each of the plurality of electrodes having a different predetermined size and predetermined distribution of electrochemically inert areas and electrically continuous electrochemically active area lattice.

17. An electrochemical-based analytical test strip and associated meter for the determination of an analyte in a bodily fluid sample, the electrochemical-based analytical test strip and associated meter comprising:

an electrochemical-based analytical test strip having;

an electrically insulating base layer; and

a patterned conductor layer disposed over the electrically-insulating layer, the patterned conductor layer including at least one electrode;

wherein the at least one electrode has electrochemically inert areas, an electrically continuous electrochemically active area lattice, and non-conductive border regions separating the electrochemically inert areas and the electrically continuous electrochemically active area lattice, the electrochemically inert areas and electrically continuous electrochemically active area lattice being of a predetermined size and a predetermined distribution such that electrochemical response of the electrode during use of the electrochemical-based analytical test strip is essentially equivalent to a predetermined electrochemical response of a screen-printed carbon electrode; and

a meter that includes an algorithm, the meter and algorithm configured to determine an analyte in a bodily fluid sample applied to the electrochemical-based analytical test strip based on the electrochemical response of the electrode.

18. The electrochemical-based analytical test strip and associated meter of claim 17 wherein the electrode is a gold electrode.

19. The electrochemical-based analytical test strip and meter of claim 17 wherein the electrochemically inert areas are rendered electrochemically inert via physical electrical isolation from the electrically continuous electrochemically active area lattice.

20. The electrochemical-based analytical test strip and meter of claim 19 wherein the physical electrical isolation is achieved using laser ablation.

21. The electrochemical-based analytical test strip and meter of claim 17 wherein the electrochemically inert areas and electrically continuous electrochemically active area lattice of a predetermined size and a predetermined distribution are configured in a regular array.

22. The electrochemical-based analytical test strip and meter of claim 20 wherein the regular array is a regular square lattice array.

23. The electrochemical-based analytical test strip and meter of claim 21 wherein a width of the electrically continuous electrochemically active area lattice is in the range of 3 μ

m to 50 μ

m.

24. The electrochemical-based analytical test strip and meter of claim 21 wherein the width of the electrochemically inert areas is in the range of 20 μ

m to 200 μ

m.

25. The electrochemical-based analytical test strip and meter of claim 17 wherein the analytical test strip is configured for the determination of glucose in a whole blood sample.

26. The electrochemical-based analytical test strip and meter of claim 17 wherein the predetermined electrical response is a peak current response.

27. The electrochemical-based analytical test strip and meter of claim 17 wherein the predetermined electrical response is a peak separation response.

28. The electrochemical-based analytical test strip and meter of claim 17 wherein the predetermined electrical response is an early transient response.

29. The electrochemical-based analytical test strip and meter of claim 17 wherein the predetermined electrical response is an interferent sensitivity response.

30. The electrochemical-based analytical test strip and meter of claim 17 wherein the patterned conductor layer includes a plurality of electrodes, each of the plurality of electrodes having a different predetermined size and predetermined distribution of electrochemically inert areas and an electrochemically active area lattice.