Method and reagent for producing narrow, homogenous reagent stripes

• US 7,749,437 B2
• Filed: 06/18/2004
• Issued: 07/06/2010
• Est. Priority Date: 06/20/2003
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG), Roche Operations Limited (Roche Holding AG)
• Inventors: Mosoiu, Dan, Wilsey, Christopher D.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US10/871,966
• Publication Number:
  US 20050008537A1
• Time in Patent Office: 2,209 Days
• Field of Search: 422/57, 422/61, 436/166, 436/169
• US Class Current: 422/504
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10T 156/1059 Splitting sheet lamina in plane intermediate of faces
• CPC Class Codes: Y10T 156/1084 of continuous or running length bonded web

Abstract

The present invention concerns a reagent coating mass which can be used in slot-die-coating of flat support materials in the manufacturing processes of test strips. Advantageously, the reagent mass of the invention exhibits certain superior rheological properties such as viscosity, surface tension and thixotropy. The reagent mass is preferably used to coat thin, narrow and homogeneous stripes of reagent material onto flat web material.

Claims

1. An analytic test element comprising:

a polymer web as a first solid support material; and

a reagent stripe coated onto said first solid support material wherein said reagent stripe is coated on said support material as a shear thinning, at least slightly thixotropic composition having a viscosity between about 70 and 130 mPa−

s and a surface tension of between about 33 and 42 mN/m.

2. The analytic test element according to claim 1, said reagent including at least one of buffers, enzymes, mediators, stabilizers, thickeners, proteins, indicators, dyes, film formers, surfactants and co-factors.

3. The analytic test element according to claim 2, said reagent further including at least one of silica, xanthan gum and CMC.

4. The analytic test element according to claim 2, said reagent further including silica and at least one of xanthan gum and CMC.

5. The analytic test element according to claim 2, said reagent further including silica, xanthan gum and CMC.

6. The analytic test element according to claim 1, further including two electrodes, at least one of said electrodes in contact with said reagent stripe.

7. The analytic test element according to claim 6, said reagent including at least one of buffers, enzymes, mediators, stabilizers, thickeners, proteins, indicators, dyes, film formers, surfactants and co-factors.

8. The analytic test element according to claim 7, said reagent further including at least one of silica, xanthan gum and CMC.

9. The analytic test element according to claim 7, said reagent further including silica and at least one of xanthan gum and CMC.

10. The analytic test element according to claim 7, said reagent further including silica, xanthan gum and CMC.

11. The analytic test element according to claim 1, further including:

a second solid support material; and

a portion of double-sided adhesive tape, wherein said adhesive tape covers a portion of said reagent stripe and serves as a spacer, said spacer being positioned between said first support material and said second support material such that they define a capillary space and an area of said reagent stripe that is not covered by said tape and is located between said first support material and said second support material.

12. The analytic test element according to claim 11, said reagent including at least one of buffers, enzymes, mediators, stabilizers, thickeners, proteins, indicators, dyes, film formers, surfactants and co-factors.

13. The analytic test element according to claim 12, said reagent further including at least one of silica, xanthan gum and CMC.

14. The analytic test element according to claim 12, said reagent further including silica and at least one of xanthan gum and CMC.

15. The analytic test element according to claim 12, said reagent further including silica, xanthan gum and CMC.

16. The analytic test element according to claim 11, further including at least a pair of electrodes, wherein a portion of at least one of said electrodes is in contact with said reagent stripe.

17. The analytic test element according to claim 16, said reagent including at least one of buffers, enzymes, mediators, stabilizers, thickeners, proteins, indicators, dyes, film formers, surfactants and co-factors.

18. The analytic test element according to claim 17, said reagent further including at least one of silica, xanthan gum and CMC.

19. The analytic test element according to claim 17, said reagent further including silica and at least one of xanthan gum and CMC.

20. The analytic test element according to claim 17, said reagent further including silica, xanthan gum and CMC.

21. An analytic test element comprising:

a polymer web as a first solid support material; and

a reagent stripe deposited onto said first support material by a slot-die-coating process including the steps of;

moving said solid support relative to a slot-die-coating head;

maintaining a defined distance between said solid support material and said slot-die-coating head; and

depositing said reagent stripe as a shear thinning at least slightly thixotropic reagent composition having a viscosity between about 70 and 130 mPa−

s and a surface tension of between 33 and 42 mN/m, on said solid support material.

22. The analytic test element according to claim 21, said reagent including at least one of buffers, enzymes, mediators, stabilizers, thickeners, proteins, indicators, dyes, film formers, surfactants and co-factors.

23. The analytic test element according to claim 22, said reagent further including at least one of silica, xanthan gum and CMC.

24. The analytic test element according to claim 22, said reagent further including silica and at least one of xanthan gum and CMC.

25. The analytic test element according to claim 22, said reagent further including silica, xanthan gum and CMC.

26. The analytic test element according to claim 21, further including two electrodes, at least one of said electrodes in contact with said reagent stripe.

27. The analytic test element according to claim 26, said reagent including at least one of buffers, enzymes, mediators, stabilizers, thickeners, proteins, indicators, dyes, film formers, surfactants and co-factors.

28. The analytic test element according to claim 27, said reagent further including at least one of silica, xanthan gum and CMC.

29. The analytic test element according to claim 27, said reagent further including silica and at least one of xanthan gum and CMC.

30. The analytic test element according to claim 27, said reagent further including silica, xanthan gum and CMC.

31. The analytic test element according to claim 21, further including:

a second solid support material; and

a portion of double-sided adhesive tape, wherein said adhesive tape covers a portion of said reagent stripe and serves as a spacer, said spacer being positioned between said first support material and said second support material such that they define a capillary space and an area of said reagent stripe that is not covered by said tape and is located between said first support material and said second support material.

32. The analytic test element according to claim 31, said reagent including at least one of buffers, enzymes, mediators, stabilizers, thickeners, proteins, indicators, dyes, film formers, surfactants and co-factors.

33. The analytic test element according to claim 32, said reagent further including at least one of silica, xanthan gum and CMC.

34. The analytic test element according to claim 32, said reagent further comprising silica and at least one of xanthan gum and CMC.

35. The analytic test element according to claim 32, said reagent further comprising silica, xanthan gum and CMC.

36. The analytic test element according to claim 31, further including two electrodes, at least one of said electrodes in contact with said reagent stripe.

37. The analytic test element according to claim 36, said reagent including at least one of buffers, enzymes, mediators, stabilizers, thickeners, proteins, indicators, dyes, film formers, surfactants and co-factors.

38. The analytic test element according to claim 37, said reagent further including at least one of silica, xanthan gum and CMC.

39. The analytic test element according to claim 37, said reagent further including silica and at least one of xanthan gum and CMC.

40. The analytic test element according to claim 37, said reagent further including silica, xanthan gum and CMC.