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

• US 8,932,449 B2
• Filed: 07/20/2012
• Issued: 01/13/2015
• 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: Redpath, Craig, Rodgers, James Iain, Whitehead, Neil, Macfie, Gavin
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): Kessel, Maris R
• Application Number:
  US13/554,378
• Publication Number:
  US 20120285837A1
• Time in Patent Office: 907 Days
• Field of Search: 20440301-40315, 205/775, 205/777.5, 205/792
• US Class Current: 205/792
• 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. A method for determining an analyte in a bodily fluid sample, the method comprising:

applying a bodily fluid sample to 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 configured 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 electrode;

measuring an electrochemical response of the electrochemical-based analytical test strip; and

determining the analyte based on the measured electrochemical response.

2. The method of claim 1 wherein the measuring step employs a meter to measure the electrochemical response of the electrode of the electrochemical-based analytical test strip.

3. The method of claim 1 wherein the patterned conductor layer is a gold patterned conductor layer and the at least one electrode is a working electrode.

4. The method of claim 1 wherein the electrochemically inert areas have rendered electrochemically inert via physical electrical isolation from the electrochemically active areas.

5. The method of claim 1 wherein the electrochemically inert areas and electrochemically active areas of a predetermined size and a predetermined distribution are configured in a regular array.

6. The method of claim 5 wherein the regular array is a regular square lattice array.

7. The method of claim 6 wherein the width of the electrically continuous electrochemically active area lattice is in the range of 3 μ

m to 50 μ

m.

8. The method 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 method of claim 1 wherein the analyte is glucose and the bodily fluid sample is whole blood.

10. The method 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 electrochemical response of the first working electrode and second working electrode during use of the electrochemical-based analytical test strip are essentially equivalent to predetermined electrochemical responses of a screen-printed carbon electrode.

11. The method of claim 1 wherein the predetermined electrical response is a peak current response.

12. The method of claim 1 wherein the predetermined electrical response is a peak separation response.

13. The method of claim 1 wherein the predetermined electrical response is an early transient response.

14. The method of claim 1 wherein the predetermined electrical response is an interferent sensitivity response.

15. The method of claim 1 wherein the electrochemical-based analytical test strip further includes:

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 method of claim 1 wherein the electrochemically inert areas and electrically continuous electrochemically active area lattice of predetermined size and predetermined distribution are configured in a regular array and such that the measured electrochemical response of the electrochemical-based analytical test strip is dominated by overlapping and non-linear diffusion.

17. The method 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, and

wherein the determining step employs an algorithm to deconvolute analyte measurement signals from at least one of noise and interferent signals in the electrochemical response.