Electrochemical test device and related methods

• US 7,018,848 B2
• Filed: 08/21/2002
• Issued: 03/28/2006
• Est. Priority Date: 06/17/1996
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Jeffrey N., Douglas, Joel S., Priest, John H.
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US10/224,875
• Publication Number:
  US 20030106810A1
• Time in Patent Office: 1,315 Days
• Field of Search: 422/82.05, 422/100, 204/400, 204/403, 435/287.1, 435/287.2, 435/289, 435/291, 435/817, 436/169, 436/170, 436/518, 436/524, 436/525, 436/805
• US Class Current: 436/524
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: Y10S 435/817 Enzyme or microbe electrode
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/806 Electrical property or magnetic property

Abstract

An electrochemical test device is provided for determining the presence or concentration of an analyte in an aqueous fluid sample. The electrochemical test device includes a working electrode and a counter electrode made of an amorphous semiconductor material. The working electrode is overlaid with a reagent capable of reacting with an analyte to produce a measurable change in potential which can be correlated to the concentration of the analyte in the fluid sample. The test device optionally contains a reference electrode made of an amorphous semiconductor material having a reference material on the reference electrode. The test device electrodes can be constructed on a flexible film substrate, such as a polymeric film or a metal foil coated with a non-conductive coating.

Claims

1. A method for determining the presence or concentration of an analyte in an aqueous fluid sample, said method comprising:

(a) providing an electrochemical test device comprising;

(i) a single substrate, the single substrate comprising a non-conductive coating affixed to one side of a flexible material;

(ii) a working electrode comprising an amorphous semiconductor material affixed to the non-conductive coating, said working electrode having an first electrode area, a first lead and a first contact pad;

(iii) a counter electrode comprising an amorphous semiconductor material affixed to the non-conductive coating, said counter electrode having a second electrode area, a second lead, and a second contact pad; and

(iv) a reagent capable of reacting with the analyte to produce a measurable change in potential which can be correlated to the presence or concentration of the analyte in the fluid sample, said reagent overlaying at least of portion of the first electrode area of the working electrode;

(b) inserting the electrochemical test device into a meter device;

(c) applying a sample of art aqueous fluid to the first electrode area of the working electrode; and

(d) reading the meter device to determine the presence or concentration of the analyte in the fluid sample.

2. The method of claim 1, wherein the electrochemical test device further comprises a reference electrode comprising an amorphous semiconductor material affixed to the non-conductive coating, said reference electrode having a third electrode area, a third lead, and a third contact pad, and wherein at least a portion of the third electrode area is overlaid with a reference material.

3. The method of claim 2 wherein the reference material is silver/silver chloride.

4. The method of claim 1 wherein the flexible material is metallic.

5. The method of claim 1 wherein the flexible material is a polymeric sheet material.

6. The method of claim 5 wherein the polymeric sheet material is selected from the group consisting of polyesters, polycarbonates and polyimides.

7. The method of claim 1 wherein the non-conductive coating is an epoxy resin.

8. The method of claim 1 wherein the amorphous semiconductor material is amorphous silicon oxide.

9. The method of claim 8 wherein the amorphous silicon oxide is doped with an ion to increase conductivity.

10. The method of claim 9 wherein the amorphous silicon oxide is doped with lithium.

11. The method of claim 1 where the amorphous semiconductor material is gold.

12. The method of claim 1 where the amorphous semiconductor material is silver.

13. The method of claim 1 wherein the reagent comprises an enzyme and a redox mediator.

14. The method of claim 13 wherein the enzyme is glucose oxidase.

15. The method of claim 13 wherein the redox mediator is potassium ferricyanide.

16. The method of claim 1 wherein the electrochemical test device further comprises a blood separating membrane.