Method for the manufacture of a self-supporting test field material

• US 5,290,515 A
• Filed: 10/20/1992
• Issued: 03/01/1994
• Est. Priority Date: 02/28/1991
• Status: Expired due to Fees

• Current Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Plesch, Winfried, Gotschel, Hans, Mosoiu, Dan
• Primary Examiner(s): WARDEN, JILL ALICE
• Application Number:
  US07/937,877
• Time in Patent Office: 497 Days
• Field of Search: 422/56-58, 427/2, 427/358, 427/389.9, 427/420, 427/434.2
• US Class Current: 422/401
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements

Abstract

Method for the manufacture of a self-supporting test field material of very small layer thickness. In a strip of test material (1) comprising an open-pored fibre structure a reagent film mass (6) is embedded from an application side (1a) in such a way that it extensively penetrates into the pores of the carrier material. The reagent film mass (6) is smoothed on the opposite side (1b) by the relative motion of the ribbon and a smoothing tool (4) in such a way that the pores of the composite fibre structure are spanned by the reagent film mass (6). Finally, the carrier material ribbon (10) thus produced is dried essentially free of contact.

Claims

1. A method for manufacturing a self-supporting test field material, said method comprising the steps of:

providing a reagent film mass, said reagent film mass including at least one reagent for performing an analysis of a liquid sample;

providing a carrier material comprising an open-pored fibre structure, and having a thickness of less than 0.1 mm;

pressing said reagent film mass into a first side of said carrier material wherein said reagent film mass substantially penetrates into pores of the open-pored fibre structure of the carrier material and wherein a portion of said reagent film mass penetrates through from the first side of the carrier material to a second side of the carrier material;

smoothing the reagent film mass on the second side of the carrier material by a relative motion of the carrier material and a smoothing tool wherein said pores are substantially filled by the reagent film mass wherein a resulting thickness of the test field material is less than 0.1 mm, and wherein the reagent film mass is distributed essentially symmetrically through the test field material; and

drying the carrier material in a non-contact manner.

2. Method according to claim 1, wherein the carrier material is a single-layer woven fabric which preferably consists of monofilamentous threads.

3. Method according to claim 1, wherein a viscosity of the reagent film mass during pressing into the carrier material is between 10 mPasec and 300 mPasec.

4. Method according to claim 1, wherein the reagent film mass contains a colour-forming reagent and a pigment.

5. Method according to claim 1, wherein the reagent film mass includes a dispersion film former.

6. Method according to claim 1, wherein the smoothing tool has an edge at its end rearward in a transport direction.

7. A method for manufacturing a self-supporting test field material as recited in claim 1, further comprising the step of metering said reagent film mass applied to said carrier material such that no excess reagent film mass is removed from the carrier material during said smoothing step.

8. A method as recited in claim 1, wherein said first side upon which said reagent film mass is applied is an upper side of the carrier material, said reagent film mass being applied from a doctor box which includes a doctor at a rear portion thereof with respect to a transport direction of the carrier material, said doctor contacting the carrying material thereby performing a smoothing of said upper side, and wherein a smoothing tool contacts said carrier material from a bottom surface, thereby smoothing said first side and said second side.

9. Method according to claim 8, wherein the smoothing tool includes a sharp edge which in a transport direction follows a course flush with a sharp edge of the doctor of the doctor box.

10. A method of manufacturing according to claim 1, further comprising the steps of guiding said carrier material over a slit orifice, wherein said reagent film mass is applied through said slit orifice to said first side of said carrier material, said first side being a bottom surface thereof, said carrier material then being subjected to said smoothing step.

11. A method according to claim 1, wherein the carrier material is a single layer knitted fabric which consists of monofilamentous threads.

12. A method according to claim 1, wherein a viscosity of the reagent film mass during pressing into the carrier material is between 20 mPasec and 200 mPasec.

14. Test field material according to claim 11, wherein an average pore size of the fibre structure is between 0.02 mm and 0.08 mm.

13. A self-supporting test field material for a test carrier for the determination of an analyte in a body fluid, said test field material comprising:

a reagent film mass embedded in an open-pored fibre structure (19) wherein said reagent film mass spans and thus closes pores of said open-pored fibre structure, the reagent film mass including at least one reagent of an analysis reagent system and a polymer film former, said reagent film mass being pressed into the composite fibre structure and smoothed on first and second sides thereof, such that said test field material has substantially smooth first and second sides, and wherein a mean thickness of said test field material is less than 0.1 mm.

15. Test field material according to claim 13, wherein a mean thickness of said test field material is less than 0.07 mm.

16. Test field material according to claim 13, wherein an average pore size of the fibre structure is between 0.03 and 0.05 mm.

17. A self-supporting test field material for a test carrier for the determination of an analyte in a body fluid, said test field material comprising:

an open-pored fibre structure of a single layer fabric having pores with an average pore size between 0.02 and 0.08 mm;

a reagent film mass disposed upon and pressed through said fibre structure, wherein said reagent film mass spans and closes the pores of said fibre structure, said reagent film mass containing at least one reagent of an analysis reagent system and a polymer film former,

wherein said reagent film mass is pressed into the fibre structure and smoothed on first and second sides thereof, such that the single layer fabric is covered by a thin layer of said reagent film mass wherein said test field material has a thickness of less than 0.1 mm and wherein the test field material has substantially smooth first and second sides which correspond to the first and second sides of the fibre structure.

18. A test field material as recited in claim 17, wherein said single layer fabric is a woven single layer fabric.

19. A test field material as recited in claim 17, wherein single layer fabric is a knitted fabric.