Electrochemical test device

• US 6,638,772 B1
• Filed: 06/17/1997
• Issued: 10/28/2003
• Est. Priority Date: 06/17/1996
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Amire Medical
• Inventors: Roe, Jeffrey N., Douglas, Joel S., Priest, John H.
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US08/876,812
• Time in Patent Office: 2,324 Days
• Field of Search: 422/82.05, 422/100, 204/400, 204/403, 435/287.1, 435/289, 435/291, 435/817, 435/153.12, 436/169, 436/170, 436/518, 436/805
• US Class Current: 436/518
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: Y10S 435/817 Enzyme or microbe electrode
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/806 Electrical property or magnetic property

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. The test device electrodes can be constructed on a flexible film substrate, such as a polymeric film or a metal foil coated with a non-conductive coating.

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) a single substrate, the single substrate comprising a non-conductive coating affixed to one side of a flexible material;

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

(c) a counter electrode comprising an amorphous semiconductor material affixed to the non-conductive-coating, said counter electrode having a second electrode are, 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 presence or concentration of the analyte in the fluid sample, said reagent overlaying at least a portion of the first electrode area of the working electrode.

2. The electrochemical test device of claim 1 wherein said device further comprises a reference electrode comprising an amorphous semiconductor material affixed to the non-conductive surface, said reference electrode having a third electrode area, a third lead, and a third contact pad, and wherein at least a portion of the third electrode area is overlaid with a reference material.

3. The electrochemical test device of claim 2 wherein said reference material is silver/silver chloride.

4. The electrochemical test device of claim 1 wherein the flexible material is a metallic material.

5. The electrochemical test device of claim 4 wherein the non-conductive coating is an epoxy resin.

6. The electrochemical test device of claim 1 wherein the flexible material comprises a polymeric sheet material.

7. The electrochemical test device of claim 5 wherein the polymeric sheet material is selected from the group consisting of polyesters, polycarbonates and polyimides.

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

9. The electrochemical test device of claim 8 wherein the amorphous silicon oxide is doped with an ion to increase conductivity.

10. The electrochemical test device of claim 9 wherein the amorphous silicon oxide is doped with lithium.

11. The electrochemical test device of claim 1 where the amorphous semiconductor material is gold.

12. The electrochemical test device of claim 1 where the amorphous semiconductor material is silver.

13. The electrochemical test device of claim 1 wherein the reagent comprises an enzyme and a redox mediator.

14. The electrochemical test device of claim 13 wherein the enzyme is glucose oxidase.

15. The electrochemical test device of claim 14 wherein the redox mediator is potassium ferricyanide.

16. The electrochemical test device of claim 1 wherein the electrochemical test device further comprises a blood separating membrane.

17. A device comprising:

a single substrate, the single substrate being of sufficient flexibility to undergo roll-type processing, the single substrate comprising a flexible metallic material;

a non-conductive, surface morphology-improving coating affixed to a surface of the single substrate, said coating comprising an epoxy coating; and

an amorphous semiconductor material layer affixed to the non-conductive coating.

18. The device of claim 17, wherein the substrate has a thickness of 0.0005-0.005 inches.

19. The device of claim 18, wherein the metallic material comprises aluminum.

20. The device of claim 17, wherein the coating has a thickness less than about 0.005 inches.

21. The device of claim 17, wherein the semiconductor material comprises amorphous silicon oxide.

22. The device of claim 21, wherein the amorphous silicon oxide is doped with an ion to increase conductivity.

23. The device of claim 17, wherein the semiconductor material layer has a thickness of 1-5 microns.

24. The device of claim 17, wherein the device comprises an electrochemical testing device, the device further comprising a reagent capable of reacting with an analyte to produce a measurable change in potential, and at least one electrode formed on the surface coating.

25. A device comprising:

a single substrate, the single substrate being of sufficient flexibility to undergo roll-type processing, the single substrate comprising an annealed, preshrunk polymeric material;

a surface morphology-improving coating affixed to a surface of the single substrate, wherein the coating is a non-conductive coating, and

an amorphous semiconductor material affixed to the coating.

26. The device of claim 25, wherein the polymeric material comprises one of a polyester, polycarbonate, and polyimide material.

27. The device of claim 25, wherein the coating has a thickness less than about 0.005 inches.

28. The device of claim 25, wherein the semiconductor material comprises amorphous silicon oxide.

29. The device of claim 28, wherein the amorphous silicon oxide is doped with an ion to increase conductivity.

30. The device of claim 25, wherein the semiconductor material layer has a thickness of 1-5 microns.

31. The device of claim 25, wherein the device comprises an electrochemical testing device, the device further comprising a reagent capable of reacting with an analyte to produce a measurable change in potential, and at least one electrode formed on the surface coating.

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

a substrate, the substrate consisting of a single layer of flexible material, the flexible material having sufficient flexibility to undergo roll-type processing;

a non-conductive coating affixed to one side of the substrate;

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

a counter electrode comprising an amorphous semiconductor material affixed to the non-conductive coating, said counter electrode having a second electrode area, a second lead and a second contact pad; and

a reagent capable of reacting with the analytic to produce a measurable change in potential which can be correlated to the presence or concentration of the analyte in the fluid sample, said reagent overlaying at least a portion of the first electrode area of the working electrode.

33. The device of claim 32, wherein the non-conductive coating has a thickness sufficient to fill surface valleys on the substrate.

34. The device of claim 33, wherein the thickness is less than about 0.005 inches.

35. The device of claim 32, wherein the non-conductive coating comprises an epoxy coating.

36. The device of claim 32, wherein the semiconductor material comprises amorphous silicon oxide.

37. The device of claim 36, wherein the amorphous silicon oxide is doped with an ion.

38. The device of claim 32, wherein the flexible material comprises a metallic foil having a thickness of 0.0005-0.005 inches.

39. The device of claim 32, wherein the amorphous semiconductor material has a surface texture less than 0.33 microns.

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

a single substrate, the single substrate comprising a layer of flexible material, the flexible material having sufficient flexibility to undergo roll-type processing;

a non-conductive coating affixed to a side of the single substrate, the non-conductive coating having sufficient thickness to fill surface valleys of the single substrate thereby providing improved surface flatness relative to the substrate;

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

a counter electrode comprising an amorphous semiconductor material affixed to the non-conductive coating, said counter electrode having a second electrode area, a second lead and a second contact pad; and

a reagent capable of reacting with the analyte to produce a measurable change in potential which can be correlated to the presence or concentration of the analyte in the fluid sample, said reagent overlaying at least a portion of the first electrode area of the working electrode.

41. The device of claim 40, wherein the thickness of the non-conductive coating is less than about 0.005 inches.

42. The device of claim 40, wherein the non-conductive coating comprises an epoxy coating.

43. The device of claim 40, wherein the semiconductor material comprises amorphous silicon oxide.

44. The device of claim 43, wherein the amorphous silicon oxide is doped within an ion.

45. The device of claim 40, wherein the flexible material comprises a metallic foil having a thickness of 0.0005-0.005 inches.

46. The device of claim 40, wherein the amorphous semiconductor material has a surface texture less than 0.33 microns.