Membrane based electrochemical test device and related methods

• US 6,245,215 B1
• Filed: 09/22/1999
• Issued: 06/12/2001
• Est. Priority Date: 09/30/1998
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Amira Medical (Roche Holding AG)
• Inventors: Roe, Jeffrey N., Douglas, Joel S., Priest, John H., Hasker, David A.
• Primary Examiner(s): Tung, T.
• Assistant Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/401,062
• Time in Patent Office: 629 Days
• Field of Search: 204/403, 204/400, 204/415, 204/416, 204/433, 204/431, 205/775, 205/777.5, 205/789, 205/792, 205/793, 427/2.1, 427/2.11, 427/2.13
• US Class Current: 205/775
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 33/54386 Analytical elements

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.

Claims

1. An electrochemical test device for determining the presence or concentration of an analyte in an aqueous fluid sample, said electrochemical test device comprising:

a working electrode comprising an amorphous semiconductor material;

an opposing electrode comprising an amorphous semiconductor material; and

a reagent capable of reacting with the analyte to produce a measurable change in potential which can be correlated to the concentration of the analyte in the fluid sample, said reagent located between the working electrode and the opposing electrode.

2. The electrochemical test device of claim 1, wherein said device further comprises:

a non-conductive membrane located between the working electrode and the opposing electrode.

3. The electrochemical test device of claim 2, wherein the non-conductive membrane is selected from polysulphone, polyethersulphone, or nylon.

4. The electrochemical test device of claim 2, wherein the non-conductive membrane is cased with a tight porous skin on each side and a relatively isotropic matrix is located between the skin surfaces.

5. The electrochemical test device of claim 1, wherein the amorphous semiconductor material is amorphous silicon oxide.

6. The electrochemical test device of claim 1, wherein the reagent comprises a glucose oxidase and a redox mediator.

7. An electrochemical test device for determining the presence or concentration of an analyte in an aqueous fluid sample, said electrochemical test comprising:

a non-conductive membrane having a first skin and a second skin and a matrix therebetween;

a working electrode being affixed to the non-conductive membrane first skin;

an opposing electrode affixed to the non-conductive membrane second skin; and

a reagent capable of reacting with the analyte to produce a measurable change in potential which can be correlated to the concentration of the analyte in the fluid sample, said reagent located between the working electrode and the opposing electrode;

wherein at least one of said electrodes comprises an amorphous semiconductor material.

8. The electrochemical test device of claim 7 wherein the reagent is imbibed in the membrane matrix.

9. The electrochemical test device of claim 7, wherein the opposing electrode is

a reference electrode comprising an amorphous semiconductor material affixed to the non-conductive membrane second skin.

10. The electrochemical test device of claim 9, wherein at least a portion of the reference electrode is overlaid with a reference material.

11. The electrochemical test device of claim 10, wherein said reference material is silver/silver chloride.

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

(a) providing an electrochemical device comprising;

a working electrode comprising an amorphous semiconductor material;

an opposing electrode comprising an amorphous semiconductor material; and

a reagent capable of reacting with the analyte to produce a measurable change in potential which can be correlated to the concentration of the analyte in the fluid sample, said reagent located between the working electrode and the opposing electrode;

(b) applying a sample of an aqueous fluid to the first electrode area of the working electrodes;

(c) inserting the electrochemical test device into a meter device; and

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

13. 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:

providing a non-conductive membrane having a first skin and a second skin and a matrix therebetween;

depositing an amorphous semiconductor material on the first skin surface to form a conductive layer which forms a working electrode;

depositing an amorphous semiconductor material on the second skin surface to form a conductive layer which forms an opposing electrode; and

applying a reagent to imbibe the membrane.

14. The process for preparing an electrochemical test device of claim 13, wherein the reagent is applied through the electrode area of the working electrode.

15. The process for preparing an electrochemical test device of claim 13, further comprising:

forming a reference electrode on the second skin surface.

16. The process for preparing an electrochemical test device of claim 13, wherein the non-conductive membrane is selected from polysulphone, polyethersulphone, or nylon.

17. The process for preparing an electrochemical test device of claim 13, wherein the reagent comprises a glucose oxidase and redox mediator.

18. The process for preparing an electrochemical test device of claim 13, wherein the non-conductive membrane is cased with a tight porous skin on each side and a relatively isotropic matrix is located between each skin surface.