Functional layers of high precision, process for their production and test strips containing these functional layers

• US 6,455,001 B1
• Filed: 10/22/1999
• Issued: 09/24/2002
• Est. Priority Date: 10/23/1998
• Status: Expired due to Term

• Current Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Original Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Inventors: Mosoiu, Dan, Knappe, Wolfgang-Reinhold
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): Siefke, Samuel P
• Application Number:
  US09/426,939
• Time in Patent Office: 1,068 Days
• Field of Search: 430/518, 430/539, 430/635, 106/154, 436/170, 422/56, 422/58
• US Class Current: 422/429
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/545 Synthetic resin

Abstract

A skeleton-free functional layer of high precision which contains a wetting agent of formula I, II and/or III

R¹—CO—N(R²)—CH₂—COOMe  (I)

R¹—CO—N(R²)—CH₂—CH₂—SO₃Me  (II)

HO₂C—CH₂—CH₂—CH(NH—COR¹)—CO₂Me  (III)

in which R¹ is a long-chained aliphatic residue, R² is an alkyl residue with 1 to 8 C atoms and Me represents hydrogen or a metal atom, a diagnostic test strip having this functional layer as well as processes for the production of these objects are described.

Claims

1. A high precision, skeleton-free functional layer comprising a film, the film comprising a film-forming polymer and reagents for the qualitative detection or quantitative determination of analytes, wherein the layer comprises a wetting agent compound of Formulas I, II and/or III:

2. The skeleton-free functional layer of claim 1, wherein R¹ comprises an aliphatic chain of lauric acid, myristic acid, palmitic acid, stearic acid, palmitoleic acid, oleic acid, linoleic acid, linolenic acid or isomers thereof and R² is a methyl or ethyl group.

3. The skeleton-free functional layer of claim 1 wherein R¹ represents a quantity of alkyl residues in which the structure and proportion in the mixture of the individual alkyl residues corresponds to their structure and abundance in natural fats.

4. The skeleton-free functional layer of claim 1 wherein R¹ —

CO in Formulas I and II and COR¹ in Formula III is an oleoyl, cocoyl or tallow fatty acid residue and R² is methyl.

5. The skeleton-free functional layer of claim 1 wherein the compounds of Formulas I, II and III are water-soluble.

6. The skeleton-free functional layer of claim 1 wherein Me denotes an alkali metal.

7. The skeleton-free functional layer of claim 1 wherein the wetting agent compound comprises a mixture of compounds of Formulas I, II and/or III.

8. The skeleton-free functional layer of claim 1 wherein the layer comprises a total of 0.0075 to 2.5% by weight of the wetting agent compound.

9. The skeleton-free functional layer of claim 1 wherein the layer additionally comprises auxiliary substances and/or additives for the qualitative detection or quantitative determination of analytes.

10. A test strip comprising a flexible flat-shaped carrier on which at least one test field is arranged in a test region wherein each test field comprises at least one functional layer wherein at least one of the functional layers of the test strip comprises a high precision, skeleton-free functional layer comprising a film, the film comprising a film-forming polymer and reagents for the qualitative detection or quantitative determination of analytes, wherein the layer comprises a wetting agent compound of Formulas I, II and/or III:

11. The test strip of claim 10 wherein each test field comprises a transparent foil and mounted thereon a first and a second functional layer lying on top of each other, wherein the first layer located on the transparent foil scatters light considerably less in a wet state than the overlying second layer and wherein the side of the foil which is opposite to that side of the foil on which the first layer is applied is the detection side and the side of the second layer which is opposite to the side of the second layer which rests on the first layer is the sample application side.

12. The test strip of claim 11 wherein the combined thickness of the first and second functional layers in the dry state is no greater than 0.20 mm.

13. The test strip of claim 10 wherein the carrier comprises a hole over which a detection layer comprising a plurality of adjacent reaction zones is located.