Electrochemical test sensor

• US 7,993,512 B2
• Filed: 07/05/2007
• Issued: 08/09/2011
• Est. Priority Date: 07/11/2006
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Brown, Daniel V.
• Primary Examiner(s): Ruddock; Ula C
• Assistant Examiner(s): Ball; J. Christopher
• Application Number:
  US11/825,231
• Publication Number:
  US 20080011616A1
• Time in Patent Office: 1,496 Days
• Field of Search: 205/777.5, 205/792, 204/403.01, 204/403.02, 204/403.14
• US Class Current: 205/777.5
• CPC Class Codes: C12Q 1/001 Enzyme electrodes

Abstract

An electrochemical test sensor for detecting the concentration of an analyte in a sample. The electrochemical test sensor comprises a base that provides a flow path for the fluid test sample having a counter electrode and a working electrode on its surface in electrical communication with a detector of electrical current. The electrochemical test sensor further includes a reagent layer directly located on the surface of the working electrode. The reagent layer includes an enzyme that is adapted to react with the analyte. The electrochemical test sensor further comprises a lid adapted to mate with the base and to assist in forming a capillary space with an opening for the introduction of the sample thereto. The capillary space is formed with a three-dimensional portion of the lid.

Claims

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

a base that provides a flow path for the fluid test sample having on its surface a counter electrode and a working electrode in electrical communication with a detector of electrical current, the working electrode including a main portion and at least one secondary portion extending therefrom;

a reagent layer directly located on the surface of at least a part of the main portion of the working electrode and at least a part of the at least one secondary portion of the working electrode, the reagent layer including an enzyme that reacts with the analyte; and

a lid that mates with the base to form a capillary space with an opening for the introduction of fluid test sample thereto, the capillary space being defined only by the base and a three-dimensional portion of the lid such that the fluid test sample contacts the main portion after being introduced to the capillary space.

2. The test sensor of claim 1, wherein the reagent layer is further located on the surface of the counter electrode.

3. The test sensor of claim 1, wherein the main portion of the working electrode has a first width in a first direction and the at least one secondary portion has a second width in the first direction, the first width being at least 2 times greater than the second width.

4. The test sensor of claim 3, wherein the main portion of the working electrode has a first height in a second direction and the at least one secondary portion has a second height in the second direction, the second direction being generally perpendicular to the first direction, the first height being from about 5 to about 15 times greater than the second height.

5. The test sensor of claim 1, wherein the at least one secondary portion of the working electrode is generally polygonal.

6. The test sensor of claim 5, wherein the main portion of the working electrode is generally polygonal.

7. The test sensor of claim 5, wherein the main portion of the working electrode is generally non-polygonal.

8. The test sensor of claim 1, wherein the capillary space is less than about 0.75 μ

L.

9. The test sensor of claim 1, wherein the capillary space is less than about 0.6 μ

L.

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

a base that provides a flow path for the fluid test sample having on its surface a counter electrode and a working electrode in electrical communication with a detector of electrical current, the working electrode includes a main portion and at least two secondary portions extending therefrom;

a reagent layer directly located on the surface of at least a part of the main portion of the working electrode and at least a part of the at least two secondary portions of the working electrode, the reagent layer including an enzyme that reacts with the analyte; and

a lid that mates with the base and form a capillary space with an opening for the introduction of fluid test sample thereto, the capillary space being defined only by the base and a three-dimensional portion of the lid such that the fluid test sample contacts the main portion after being introduced to the capillary space.

11. The test sensor of claim 10, wherein one of the secondary portions of the working electrode is in electrical communication with the detector.

12. The test sensor of claim 10, wherein the main portion of the working electrode is disposed between the at least two secondary portions of the working electrode, the at least two secondary portions of the working electrode being generally opposite from each other.

13. The test sensor of claim 11, wherein the area of the main portion of the working electrode is substantially larger than the area of the secondary portions of the working electrode.

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

a base that provides a flow path for the fluid test sample having on its surface a counter electrode and a working electrode in electrical communication with a detector of electrical current, the working electrode including a main portion having a first width in a first direction and further including at least one secondary portion extending from the main portion having a second width in the first direction, the first width being at least about 2 times greater than the second width;

a reagent layer directly located on the surface of at least a part of the main portion of the working electrode and at least a part of the at least one secondary portion of the working electrode, the reagent layer including an enzyme that reacts with the analyte; and

a lid that mates with the base to form a capillary space with an opening for the introduction of fluid test sample thereto, the capillary space being defined only by the base and a three-dimensional portion of the lid such that the fluid test sample contacts the main portion after being introduced to the capillary space.

15. The test sensor of claim 14, wherein the main portion of the working electrode has a first height in a second direction and the at least one secondary portion has a second height in the second direction, the second direction being generally perpendicular to the first direction, the first height being from about 5 to about 15 times greater than the second height.

16. The test sensor of claim 14, wherein the at least one secondary portion of the working electrode is generally polygonal.

17. The test sensor of claim 16, wherein the main portion of the working electrode is generally polygonal.

18. The test sensor of claim 16, wherein the main portion of the working electrode is generally non-polygonal.

19. The test sensor of claim 17, wherein the capillary space is less than about 0.75 μ

L.

20. The test sensor of claim 17, wherein the capillary space is less than about 0.6 μ

L.

21. A method for determining the concentration of an analyte in a fluid test sample with a test sensor, the method comprising the acts of:

providing a base that provides a flow path for the fluid test sample having on its surface a counter electrode and a working electrode in electrical communication with a detector of electrical current, the working electrode includes a main portion and at least two secondary portions extending therefrom, a reagent layer being directly located on the surface of at least a part of the main portion of the working electrode and at least a part of the at least two secondary portions of the working electrode, the reagent layer including an enzyme that reacts with the analyte, a lid being that mates with the base and form a capillary space with an opening for the introduction of fluid test sample thereto, the capillary space being defined by the base and a three-dimensional portion of the lid such that the fluid test sample contacts the main portion;

contacting the reagent layer with the fluid sample via the capillary space;

generating an electrical signal in the test sensor in response to the presence of the analyte; and

determining the concentration of the analyte from the electrical signal.

22. A method for determining the concentration of an analyte in a fluid sample with a test sensor, the method comprising the acts of:

providing an electrochemical test sensor comprising a base that provides a flow path for the fluid test sample having on its surface a counter electrode and a working electrode in electrical communication with a detector of electrical current, the working electrode including a main portion and at least one secondary portion extending therefrom, a reagent layer being directly located on the surface of at least a part of the main portion of the working electrode and at least a part of the at least one secondary portion of the working electrode, the reagent layer including an enzyme that reacts with the analyte, and a lid being that mates with the base to form a capillary space with an opening for the introduction of fluid test sample thereto, the capillary space being defined only by the base and a three-dimensional portion of the lid such that the fluid test sample contacts the main portion after being introduced to the capillary space;

contacting the reagent layer with the fluid sample via the capillary space;

generating an electrical signal in the test sensor in response to the presence of the analyte; and

determining the concentration of the analyte from the electrical signal.

23. The method of claim 22, wherein the area of the main portion of the working electrode is at least 10 times the area of the at least two secondary portions of the working electrode adapted to interact with the fluid sample.

24. The method of claim 22, wherein the analyte is glucose.

25. The method of claim 22, wherein the capillary space is less than about 0.75 μ

L.