Membrane based electrochemical test device

• US 6,582,573 B2
• Filed: 06/08/2001
• Issued: 06/24/2003
• Est. Priority Date: 09/30/1997
• 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): Nguyen, Nam
• Assistant Examiner(s): Noguerola, Alex
• Application Number:
  US09/878,774
• Publication Number:
  US 20020020632A1
• Time in Patent Office: 746 Days
• Field of Search: 204/403.14, 204/403.1, 204/403.11, 204/403.09
• US Class Current: 204/403.1
• 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 electromechanical test device for determining the presence or concentration of an analyte in an aqueous fluid sample, said electromechanical test device comprising:

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

b. a working electrode comprising an amorphous semiconductor material affixed to the non-conductive membrane first skin, said working electrode having a first electrode area, a first lead and a first contact pad;

c. an opposing electrode comprising an amorphous semiconductor material affixed to the non-conductive membrane second skin, said opposing electrode having a second electrode area, a second lead, and a second contact pad; and

d. 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 imbibed in the membrane matrix between the working electrode and opposing electrode;

wherein said reagent comprises an enzyme and a redox mediator, wherein said enzyme is a member selected from the group consisting of glucose dehydrogenase, glucose oxidase, cholesterol esterase, and alcohol oxidase, and wherein said redox mediator is a member selected from the group consisting of ferricyanide, tetracyanoquinodimethane, and phenylenediamine.

2. The electrochemical test device of claim 1 wherein said ferricyanide is potassium ferricyanide.

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

a. a working electrode comprising an amorphous semiconductor material;

b. an opposing electrode comprising an amorphous semiconductor material; and

c. 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 opposing electrode;

wherein said reagent comprises an enzyme and a redox mediator;

wherein said enzyme is a member selected from the group consisting of glucose dehydrogenase, glucose oxidase, cholesterol esterase, and alcohol oxidase; and

wherein said redox mediator is a member selected from the group consisting of ferricyanide, tetracyanoquinodimethane, and phenylenediamine.

4. The electrochemical test device of claim 3 wherein said ferricyanide is potassium ferricyanide.