Electrochemical test device and related methods

• US 7,115,362 B2
• Filed: 11/23/2005
• Issued: 10/03/2006
• 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:
  US11/287,522
• Publication Number:
  US 20060088945A1
• Time in Patent Office: 314 Days
• Field of Search: None
• US Class Current: 435/4
• 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 process for preparing an electrochemical test device suitable for determining the presence or concentration of an analyte in an aqueous fluid sample, said process comprising the steps of:

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

(b) depositing an amorphous semiconductor material on said non-conductive coating to form a conductive layer;

(c) chemically machining the conductive layer to form a working electrode comprising a first electrode having a first electrode area, a first lead and a first contact pad, and to form a counter electrode comprising a second electrode having a second electrode area, a second lead and a second contact pad; and

(d) applying a reagent to at least a portion of the first electrode area of the working electrode, said reagent being capable of reacting with an analyte in an aqueous fluid sample to produce a measurable change in potential which can be correlated to the concentration of the analyte in the fluid sample.

2. The process of claim 1 wherein step (c) further comprises forming a reference electrode comprising a third electrode having a third electrode area, a third lead and a third contact pad.

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

4. The process of claim 1 wherein step (c) further comprises the steps of:

(e) applying a photoresist to the conductive layer to form a first photoresist layer;

(f) positioning a first developer mask on the first photoresist layer;

(g) exposing the unmasked first photoresist layer to ultraviolet light to form a first patterned photoresist area;

(h) removing the first developer mask;

(i) removing the first photoresist layer not exposed to ultraviolet light with a developer to form a first exposed conductive layer;

(j) contacting the first exposed layer with a chemical etchant to remove the first exposed conductive layer;

(k) removing the first patterned photoresist area with a solvent to form a second exposed conductive layer, said second exposed conductive area comprising (i) a working electrode comprising a first electrode having a first electrode area, a first lead and a first contact pad, (ii) a counter electrode comprising a second electrode having a second electrode area, a second lead and a second contact pad, and optionally (iii) a reference electrode comprising a third electrode having a third electrode area, a third lead and a third contact pad.

5. The process of claim 4 wherein step (c) above further comprises the steps of:

(l) applying a photoresist to the second exposed conductive layer to form a second photoresist layer;

(m) positioning a second developer mask on the second photoresist so that the second photoresist layer covering the third electrode area is masked;

(n) exposing the unmasked second photoresist layer to ultraviolet light to form a second patterned photoresist layer;

(o) removing the second developer mask;

(p) removing the second photoresist layer not exposed to ultraviolet light with a developer to expose the third electrode area;

(q) applying a reference material to the third electrode area;

(r) removing the second patterned photoresist layer with a solvent.

6. A process of claim 1 wherein said process is continuous.

7. The process of claim 1 wherein the flexible material is metallic.

8. The process of claim 1 wherein the flexible material is a polymeric sheet material.

9. The process of claim 8 wherein the polymeric sheet material is selected from the group consisting of polyesters, polycarbonates and polyimides.

10. The process of claim 1 wherein the non-conductive coating is an epoxy resin.

11. The process of claim 1 wherein the amorphous semiconductor material is amorphous silicon oxide.

12. The process of claim 11 wherein the amorphous silicon oxide is doped with an ion to increase conductivity.

13. The process of claim 12 wherein the amorphous silicon oxide is doped with lithium.

14. The process of claim 1 where the amorphous semiconductor material is gold.

15. The process of claim 1 where the amorphous semiconductor material is silver.

16. The process of claim 1 wherein the reagent comprises an enzyme and a redox mediator.

17. The process of claim 16 wherein the enzyme is glucose oxidase.

18. The process of claim 17 wherein the redox mediator is potassium ferricyanide.

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