Disposable sub-microliter volume biosensor with enhanced sample inlet

• US 6,942,770 B2
• Filed: 04/19/2002
• Issued: 09/13/2005
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Nova Biomedical Corporation (Nova Chemicals)
• Original Assignee: Nova Biomedical Corporation (Nova Chemicals)
• Inventors: Young, Chung Chang, Cai, Xiaohua, Vo, Andy, Winarta, Handani
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US10/126,818
• Publication Number:
  US 20030196894A1
• Time in Patent Office: 1,243 Days
• Field of Search: 20440301-40315
• US Class Current: 204/403.04
• 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

A disposable electrode strip for testing a fluid sample including a laminated strip with a first and second end, a vent, an open path for receiving a fluid sample of less than one microliter beginning from the first end and connecting to the vent, a working electrode, a reference electrode and a pseudo-working electrode embedded in the laminated strip within the open path and proximate to the first end, a reagent matrix coextensive within the open path and covering the three electrodes, and conductive contacts located at the second end of the laminated strip.

Claims

1. A disposable electrode strip for testing a fluid sample comprising:

a laminated strip having a first strip end, a second strip end and a vent opening spaced from said first strip end, said laminated strip comprising a base layer having a conductive layer disposed thereon, said conductive layer having scribe lines delineated thereon and forming three electrode paths, a channel forming layer carried on said base layer, and a cover having an inlet notch at said first strip end;

an enclosed channel between said first strip end and said vent opening, said enclosed channel sized to hold a volume of said fluid sample less than one microliter;

a reagent matrix containing at least an enzyme, a stabilizer, wherein said stabilizer is a dissolvable polyalkylene glycol, and a redox mediator disposed on said base layer in said enclosed channel;

conductive contacts at said second strip end and insulated from said enclosed channel.

2. The electrode strip of claim 1 wherein said enzyme is selected from the group consisting of glucose oxidase, lactate oxidase, cholesterol oxidase, and creatinine amidohydrolase.

3. The electrode strip of claim 1 wherein said redox mediator is at least one metal complex.

4. The electrode strip of claim 3 wherein said redox mediator is potassium ferricyanide or other inorganic or organic redox mediators.

5. The electrode strip of claim 1 wherein said conductive coating is gold.

6. The electrode strip of claim 1 wherein said conductive coating comprising gold and tin oxide.

7. The electrode strip of claim 1 wherein said base layer, said channel forming layer and said cover are made of a plastic dielectric material.

8. The electrode strip of claim 7 wherein said plastic material is selected from the group consisting of polyvinyl chloride, polycarbonate, polysulfone, nylon, polyurethane, cellulose nitrate, cellulose propionate, cellulose acetate, cellulose acetate butyrate, polyester, acrylic, and polystyrene.

9. The electrode strip of claim 1 wherein said enclosed channel is hydrophilic.

10. The electrode strip of claim 1 wherein said enclosed channel has a volume of about 0.2 microliters.

11. The electrode strip of claim 1 wherein said cover has a hydrophilic coating on at least one side.

12. The electrode strip of claim 1 wherein said reagent matrix further contains at least one of a binder, a surfactant, and a buffer.

13. The electrode strip of claim 12 wherein said binder is a cellulose material, and said surfactant is a polyoxyethylene ether.

14. The electrode strip of claim 13 wherein said binder is methyl cellulose, said surfactant is t-octylphenoxypolyethoxyethanol, and said buffer is a citrate buffer.

15. The electrode strip of claim 14 wherein said reagent matrix is made from a mixture having starting components comprising about 1 wt % to about 6.5 wt % of said redox mediator, about 2.5 wt % of said stabilizer, about 1 wt % of said binder, about 0.03 wt % of said surfactant, and about 1 wt % of said enzyme in said citrate buffer.

16. The electrode strip of claim 15 wherein said citrate buffer is about 0.05M.

17. The electrode strip of claim 15 wherein said potassium ferricyanide is 6.5 wt %.

18. The electrode strip of claim 15 wherein said enzyme is glucose oxidase.

19. The electrode strip of claim 1 wherein said channel forming layer has a thickness sufficient to optimize the flow of said fluid sample along said open path.

20. The electrode strip of claim 19 wherein said thickness is about 0.0035 inches (0.089 mm).

21. The electrode strip of claim 1 wherein said enclosed channel contains a working electrode, a pseudo-working electrode and a reference electrode.

22. The electrode strip of claim 21 wherein said pseudo-working electrode is a counter electrode.

23. The electrode strip of claim 21 wherein said pseudo-working electrode is a triggering electrode.

24. The electrode strip of claim 21 wherein said pseudo-working electrode and said reference electrode pair are a resistance-measuring electrode pair.

25. A disposable electrode strip for detecting or measuring the concentration of an analyte in a fluid sample, said electrode strip comprising:

an insulating base strip having a first base end and a second base end;

a conductive layer disposed on one side of said base strip, said conductive layer having a pattern scribed into said conductive layer, said pattern delineating three electrically-distinct conductive paths insulated from each other;

a middle insulator sized smaller thin said insulating base strip and overlaying a substantial portion of said conductive layer, said middle insulator having a cutout portion spaced from said first base end, said cutout portion exposing a limited area of said three conductive paths;

an electrode material comprising an enzyme, a redox mediator, a stabilizer wherein said stabilizer is a dissolvable polyalkylene glycol, a binder, a surfactant, and a buffer, said electrode material being disposed in said cutout portion; and

a covering insulator sized to fit over and be coextensive with said middle insulator creating a sample fluid channel, said covering insulator having an inlet notch at a first covering insulator end, said first covering insulator end being coextensive with said first base end, and a covering insulator aperture spaced from said first base end and configured to expose at least a small portion of said cutout portion of said middle insulator.

26. The strip of claim 25 wherein said sample fluid channel has a volume of about 0.22 microliters.

27. The strip of claim 25 wherein said sample fluid channel is hydrophilic.

28. The strip of claim 25 wherein said redox mediator is at least one metal complex selected from the group consisting of ferrocene, ferrocene derivatives and potassium ferricyanide, said binder is a cellulose material, said surfactant is a polyoxyethylene ether, and said buffer has a pH of about 5 to about 6.

29. The strip of claim 28 wherein said mediator is potassium ferricyanide, said binder is methyl cellulose, said surfactant is t-octylphenoxypolyethoxyethanol, and said buffer is a citrate buffer.

30. The strip of claim 29 wherein said electrode material is made of a mixture having starting components comprising about 6.5 wt % of said potassium ferricyanide, about 2.5 wt % of said polyethylene glycol, about 1 wt % of said methyl cellulose, and about 0.03 wt % of said t-octylphenoxypolyethoxyethanol, and about 1 wt % of said enzyme in said citrate buffer.

31. The strip of claim 30 wherein said enzyme is glucose oxidase.

32. The strip of claim 25 wherein said insulating base strip, said middle insulator, and said covering insulator are made from a plastic material selected from the group consisting of polyvinyl chloride, polycarbonate, polysulfone, nylon, polyurethane, cellulose nitrate, cellulose propionate, cellulose acetate, cellulose acetate butyrate, polyester, acrylic, and polystyrene.

33. The electrode strip of claim 25 wherein said sample fluid channel contains a working electrode, a pseudo-working electrode and a reference electrode.

34. The electrode strip of claim 33 wherein said pseudo-working electrode is a counter electrode.

35. The electrode strip of claim 33 wherein said pseudo-working electrode is a triggering electrode.

36. The electrode strip of claim 33 wherein said pseudo-working electrode and said reference electrode pair are a resistance-measuring electrode pair.

37. A laminated biosensor strip comprising:

a base layer with an electrode end and an electrical contact end, said base layer having an electrically conductive coating on one side wherein said conductive coating has a plurality of scribed lines delineating a first conductive path having an L-shape, a second conductive path having a mirror-image L-shape wherein the L-shape ends of said first and second conductive paths are adjacent to each other, and a third conductive path which is shorter than either of said first and second conductive paths, has a linear, elongated shape wherein said L-shaped ends of said first and second conductive paths and the end of said third conductive path are aligned with each other along the central axis of said base layer;

a channel forming layer disposed over said base layer, said channel forming layer having a U-shaped end portion defining a central elongated channel sized to expose a portion of each of said L-shaped ends of said first and second conductive paths and a portion of said third conductive path, said channel forming layer being shorter in length than said base layer wherein a portion of each of said three conductive paths is exposed at said electrical contact end;

a reagent material having at least a redox mediator, a stabilizer, wherein said stabilizer is a dissolvable polyalkylene glycol, and an enzyme disposed within said U-shaped end portion and covering the exposed portions of said first, second and third conductive paths; and

a cover with a vent, said cover disposed on and coextensive with said channel forming layer, said cover, said channel forming layer and said base layer forming a capillary channel with an inlet at one end and communicating with said vent at the other end.

38. The biosensor strip of claim 37 further comprising an inlet notch in said cover.

39. A disposable electrode strip for testing a fluid sample comprising:

a laminated strip having a first strip end, a second strip end and a vent opening spaced from said first strip end, said laminated strip comprising a base layer having a conductive layer disposed thereon, said conductive layer having scribe lines delineated thereon and forming at least two electrode paths, a channel forming layer carried on said base layer, and a cover having an inlet notch at said first strip end;

an enclosed channel between said first strip end and said vent opening, said enclosed channel sized to hold a volume of said fluid sample less than one microliter;

a reagent matrix containing at least an enzyme, a stabilizer, wherein said stabilizer is a dissolvable polyalkylene glycol, and a redox mediator disposed on said base layer in said enclosed channel;

conductive contacts at said second strip end and insulated from said enclosed channel.

40. The biosensor of claim 39 wherein said enzyme is selected from the group consisting of glucose oxidase, lactate oxidase, cholesterol oxidase, and creatinine amidohydrolase.

41. The biosensor of claim 39 wherein said reagent further contains at least one of a binder, a surfactant, and a buffer.

42. The biosensor of claim 41 wherein said binder is a cellulose material and said surfactant is a polyoxyethylene ether.

43. The biosensor of claim 42 wherein said binder is methyl cellulose, said surfactant is t-octylphenoxypolyethoxyethanol, and said buffer is a citrate buffer.

44. The biosensor of claim 41 wherein said reagent is made from a mixture having starting components comprising about 1 wt % to about 6.5 wt % of said redox mediator, about 2.5 wt % of said stabilizer, about 1 wt % of said binder, about 0.03 wt % of said surfactant, and about 1 wt % of said enzyme in said buffer.

45. The biosensor of claim 41 wherein said reagent is made from a mixture having starting components comprising about 6.5 wt % of said redox mediator, about 2.5 wt % of said stabilizer, about 1 wt % of said binder, about 0.03 wt % of said surfactant, about 1 wt % of said enzyme dissolved in a buffered solvent.

46. The biosensor of claim 41 wherein said enzyme is glucose oxidase.

47. The biosensor of claim 41 wherein said reagent is made of a mixture having starting components comprising about 6.5 wt % of potassium ferricyanide, about 2.5 wt % of polyethylene glycol, about 1 wt % of methyl cellulose, about 0.03 wt % t-octylphenoxypolyethoxyethanol, about 1 wt % of said enzyme dissolved in said buffer wherein said buffer is about a 0.05M citrate buffer.