Electrochemical test sensor

• US 7,122,110 B2
• Filed: 11/18/2004
• Issued: 10/17/2006
• Est. Priority Date: 05/21/2001
• Status: Expired due to Fees

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Edelbrock, Andrew J., Deng, Yingping, Jamison, Sherry J.
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US10/992,593
• Publication Number:
  US 20060037870A1
• Time in Patent Office: 698 Days
• Field of Search: 204/403.04, 204/403.09, 204/403.1, 204/403.11, 204/403.14, 204416-418, 204/403.01, 427/2.13, 427/2.12, 205/777.5, 205/778, 205/789, 205/789.5, 205/787
• US Class Current: 205/777.5
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/54 involving glucose or galactose

Abstract

Disclosed is an improved electrochemical sensor for the detection of an analyte in a fluid test sample. The electrochemical sensor is of the type in which the fluid test sample is drawn into a capillary space and the improvement to the sensor involves an arrangement where a portion of the sensor'"'"'s counter electrode is placed on the edge of the capillary space in a relationship to the sensor'"'"'s working electrode such that if the capillary space is not completely filled there will be generated only a very weak current. When the sensor is connected to a properly programmed current detector, the weak current caused by the underfilling of the capillary space will be detected as an error and will notify the user of the sensor that the test should not be continued.

Claims

1. An electrochemical test sensor for detecting the concentration of an analyte in a fluid test sample, the test sensor comprising:

(1) a non-conductive base which provides a flow path for the fluid test sample, the base having a front edge, and a counter electrode and a working electrode on an upper surface thereof, the counter and working electrodes being adapted to be in electrical communication with a detector of electrical current;

(2) a reaction layer on at least the surface of the working electrode the reaction layer comprising an enzyme which reacts with the analyte to produce electrons which are transferred to the working electrode; and

(3) a cover coupled with the base and forming a capillary space with an opening for the introduction of fluid test sample thereto, the space containing a flow path for the fluid test sample, a major portion of the counter electrode being located downstream relative to the opening and at least a portion of the working electrode, and wherein a sub-element of the counter electrode is located upstream from the working electrode such that when electrochemical communication occurs between only the sub-element of the counter electrode and the working electrode there is insufficient flow of electrical current through the detector to constitute a valid test for determining the concentration of the analyte in the fluid test sample, the sub-element of the counter electrode being located on the upper surface of the base and being flush with the front edge of the base.

2. The electrochemical sensor of claim 1 further including a dielectric layer being located over the working electrode and counter electrode, the reaction layer being located over the dielectric layer, the dielectric layer forming at least one opening to expose the working and counter electrodes to the reaction layer, the area of the sub-element of the counter electrode that is exposed being 2% to 7% of the area of the working electrode that is exposed.

3. The electrochemical sensor of claim 2 wherein the sub-element of the counter electrode is not in contact with the reaction layer.

4. The electrochemical sensor of claim 1 wherein the sub-element is physically disconnected from the rest of the counter electrode, the sub-element being provided with its own connector that is adapted to contact with the detector.

5. The electrochemical sensor of claim 1 wherein the cover has a concave portion, the concave portion forming the capillary space when the cover is coupled with the base.

6. The electrochemical sensor of claim 1 further including a spacer element with a U shaped indentation, the U shaped indentation being located between the cover and the base and forming the capillary space.

7. A method for the production of a base member for an electrochemical test sensor for detecting the concentration of an analyte in a fluid test sample, the method comprising the acts of:

a) providing an insulating base material in the form of a sheet, the sheet being adapted to form a plurality of bases, each of the plurality of bases having a front edge;

b) screen printing an electrically conductive pattern onto the insulating base material;

c) screen printing a plurality of working electrodes and a plurality of counter electrodes onto the conductive pattern so that a respective main portion of the plurality counter electrodes lies further from the front edge of a respective base than the working electrode and a respective sub-element of the plurality of counter electrodes overlaps the front edge of the respective base; and

d) forming the plurality of bases from the sheet of insulating base material in a pattern such that the respective sub-elements of the plurality of counter electrodes are flush with the respective front edges of the plurality of bases.

8. An electrochemical test sensor adapted to assist in determining the concentration of an analyte in a fluid test sample, the test sensor comprising:

a base that assists in forming an opening for introducing the fluid test sample, the base having a front edge;

a working electrode being coupled to the base;

a counter electrode being coupled to the base, the counter electrode and the working electrode being adapted to be in electrical communication with a detector of electrical current, a portion of the counter electrode being located downstream relative to the opening and at least a portion of the working electrode; and

a sub-element being coupled to the base, the sub-element being located on the upper surface of the base and being flush with the front edge of the base, the sub-element being located upstream relative to the working electrode such that when electrical communication occurs between only the sub-element and the working electrode there is insufficient flow of electrical current through the detector to determine the concentration of the analyte in the fluid test sample.

9. The sensor of claim 8 further comprising a cover adapted to be coupled to the base to form a capillary space, the capillary space having an opening for introducing the fluid test sample therein, the capillary space forming a flow path for the fluid test sample, the working electrode and the counter electrode being situated in the flow path.

10. The sensor of claim 9 wherein the cover has a concave portion, the concave portion forming the capillary space when the cover is coupled with the base.

11. The sensor of claim 9 further including a spacer element with a U shaped indentation, the U shaped indentation being located between the cover and the base and forming the capillary space.

12. The sensor of claim 8 further comprising a reaction layer located on the surface of at least the working electrode, the reaction layer comprising an enzyme adapted to react with the analyte to produce electrons, the electrons being adapted to be transferred to the working electrode.

13. The sensor of claim 8, wherein the sub-element is physically disconnected from the counter electrode.

14. The sensor of claim 8 further including an enzyme that is adapted to react with the analyte, the enzyme being located on a surface of the working electrode.

15. A method of determining whether a sufficient quantity of a fluid test sample has been introduced to an electrochemical test sensor, the method comprising the acts of:

providing the electrochemical test sensor adapted to assist in determining the concentration of an analyte in a fluid test sample, the sensor comprising a base, a working electrode, a counter electrode and a sub-element, the base assisting in forming an opening for introducing the fluid test sample, the base having a front edge, the working electrode being coupled to the base, the counter electrode being coupled to the base, a portion of the counter electrode being located downstream relative to the opening and at least a portion of the working electrode, the sub-element being coupled to the base, the sub-element being located on the upper surface of the base and being flush with the front edge of the base, the sub-element being located upstream relative to the working electrode such that when electrical communication occurs between only the sub-element and the working electrode there is insufficient flow of electrical current through the detector to determine the concentration of the analyte in the fluid test sample;

introducing the fluid test sample to the test sensor; and

determining whether a sufficient quantity of the fluid test sample has been introduced and, if not, notifying a user that an insufficient quantity of the fluid test sample has been introduced.

16. The method of claim 15 wherein the test sensor further comprises a cover adapted to be coupled to the base to form a capillary space, the capillary space having an opening for introducing the fluid test sample therein, the capillary space forming a flow path for the fluid test sample, the working electrode and the counter electrode being situated in the flow path.

17. The method of claim 16 wherein the cover has a concave portion, the concave portion forming the capillary space when the cover is coupled with the base.

18. The method of claim 16 further including a spacer element with a U shaped indentation, the U shaped indentation located between the cover and the base and forming the capillary space.

19. The method of claim 15, wherein the test sensor further comprises a reaction layer located on the surface of at least the working electrode, the reaction layer comprising an enzyme adapted to react with the analyte to produce electrons, the electrons being adapted to be transferred to the working electrode.

20. The method of claim 15, wherein the sub-element is physically disconnected from the counter electrode.

21. The method of claim 15 further including an enzyme that is adapted to react with the analyte, the enzyme being located on a surface of the working electrode.