Electrochemical test strip

• US 8,758,582 B2
• Filed: 07/21/2008
• Issued: 06/24/2014
• Est. Priority Date: 07/23/2007
• Status: Active Grant

• Current Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Original Assignee: Agamatrix Incorporated (AgaMatrix Holdings LLC d/b/a WaveForm Diabetes)
• Inventors: Harding, Ian, Iyengar, Sridhar
• Primary Examiner(s): DINH, BACH T
• Application Number:
  US12/176,648
• Publication Number:
  US 20090026091A1
• Time in Patent Office: 2,164 Days
• Field of Search: 20440301-40315, 2057775-781
• US Class Current: 204/403.01
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• 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 test strip is formed from a first insulating substrate layer, a second substrate layer, and an intervening insulating spacer layer. An opening in the insulating spacer layer defines a test cell which is in contact with the inner surface of the first substrate on one side and the inner surface of the second substrate on the other side. The size of the test cell is determined by the area of substrate exposed and the thickness of the spacer layer. Working and counter electrodes appropriate for the analyte to be detected are disposed on the first insulating substrate in a location within the test cell. The working and counter electrodes are associated with conductive leads that allow The second substrate is conductive at least in a region facing the working and counter electrodes. No functional connection of this conductive surface of the second substrate to the meter is required. When a potential difference is applied between the working and counter electrodes, because of the presence of the conductive surface on the second substrate, the relevant diffusion length is not dependent on the distance between working and counter electrodes, but is instead dependent on the distance between the first and second substrates (i.e., on the thickness of the spacer layer). This means that shorter measurement times can be achieved without having to reduce the spacing of the working and counter electrodes.

Claims

1. A method for detecting an analyte in a sample comprising the steps of:

introducing the sample into a test cell of an electrochemical test strip for detection of the analyte comprising;

a first insulating substrate layer,

a second substrate layer, and

an intervening insulating spacer layer, wherein

(a) an opening in the insulating spacer layer defines the test cell which is in contact with the inner surface of the first substrate on one side and the inner surface of the second substrate on the other side; and

(b) the size of the test cell is determined by the area of the first and second substrates exposed and the thickness of the spacer layer;

working and counter electrodes appropriate for the analyte to be detected disposed on the first insulating substrate in a location within the test cell, said working and counter electrodes being associated with conductive leads that allow connection of the electrodes to a meter for determination of analyte;

wherein a region of the second substrate facing the working and counter electrodes is conductive and has no connector for connection with a meter for determination of analyte;

wherein a redox mediator is disposed in the test cell;

applying a potential between the working and counter electrodes, but not to the conductive region of the second substrate, thereby reducing an oxidized form of the redox mediator at the counter electrode and oxidizing a reduced form of the redox mediator at the working electrode, thereby generating a current indicative of analyte in the sample;

wherein the overall transfer of electrons from the counter electrode to the working electrode is accomplished by diffusion of reduced mediator from the counter electrode to the conductive region of the second substrate and then diffusion of reduced mediator from the conductive region of the second substrate to the working electrode, and

measuring the current to obtain a determination of analyte in the sample.

2. The method of claim 1, wherein the working electrode comprises an enzyme and the redox mediator.

3. The method of claim 2, wherein the analyte is glucose and the enzyme is glucose oxidase or glucose reductase.

4. The method of claim 3, wherein the entirety of the second substrate layer is conductive.

5. The method of claim 4, wherein the working electrode comprises an enzyme and the redox mediator.

6. The method of claim 5, wherein the analyte is glucose and the enzyme is glucose oxidase or glucose reductase.

7. The method of claim 4, further comprising the step of monitoring the resistance between the conductive second substrate layer and the working and/or counter electrodes as a measure of filling of the test cell with sample.

8. The method of claim 7, wherein the working electrode comprises an enzyme and the redox mediator.

9. The method of claim 8, wherein the analyte is glucose and the enzyme is glucose oxidase or glucose reductase.

10. The method of claim 1, wherein the second substrate layer comprises a second insulating substrate and a conductive coating.

11. The method of claim 10, wherein the working electrode comprises an enzyme and the redox mediator.

12. The method of claim 11, wherein the enzyme is glucose oxidase or glucose reductase.

13. The method of claim 1, wherein the working electrode is a single strip of conductive material and the counter electrode is a single strip of conductive material, wherein the working and counter electrodes are in side-by-side parallel arrangement in the test cell.