Membranes and methods for coating membranes

• US 8,202,490 B2
• Filed: 04/19/2011
• Issued: 06/19/2012
• Est. Priority Date: 12/07/2004
• Status: Active Grant

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Klepp, Juergen, Fischer, Thomas, Lerch, Rolf, Mangold, Dieter, Schaeffler, Juergen
• Primary Examiner(s): Nagpaul, Jyoti
• Application Number:
  US13/089,721
• Publication Number:
  US 20110194980A1
• Time in Patent Office: 427 Days
• Field of Search: 422500-502, 436/180, 156/77, 156/230
• US Class Current: 422/501
• CPC Class Codes: B01D 67/0088 Physical treatment with compounds, e.g. swelling, coating or impregnation
• CPC Class Codes: B01D 69/106 Membranes in the pores of a support, e.g. polymerized in the pores or voids
• CPC Class Codes: B01D 69/12 Composite membranes; Ultra-thin membranes
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A method for applying reactive films containing solids to microporous membranes is provided wherein the membrane is firstly moistened and the reactive film containing solids is applied to the membrane while it is still moist. Membranes produced in this manner can contain reactive films having a high proportion of film openers and can be used advantageously in diagnostic elements for detecting constituents and, in particular, large hydrophobic analytes in body fluids.

Claims

1. A microporous, absorbent, blood-separating membrane having opposed surfaces, a reactive film coated on one of said membrane surfaces, wherein the reactive film is a water-resistant, water-insoluble film which contains

(a) all or at least portions of a detection reagent for an analyte to be detected in a hydrophobic matrix of one or more film formers and

(b) film openers comprising inorganic or organic particulate, water insoluble, non-swelling wettable fillers which do not substantially scatter light and which enable large molecules and cells to penetrate into said reactive film wherein the mass ratio of film opener to film former is about 10:

1 to about 1;

1,

wherein said microporous, absorbent, blood-separating membrane is substantially free of detection reagents for an analyte.

2. The membrane according to claim 1, wherein the mass ratio of film opener to film former in said reactive film coated on one surface thereof is about 5:

1 to about 2;

1.

3. The membrane according to claim 1, wherein the microporous, absorbent, blood-separating membrane is operable to separate plasma or serum from whole blood.

4. The membrane according to claim 1, wherein the reactive film coated on one surface thereof further contains one or more optically blocking pigments, wetting agents, swelling agents, and combinations thereof.

5. A diagnostic element for detecting constituents of body fluids comprising a microporous, absorbent, blood-separating membrane coated with a reactive film according to claim 1.

6. The membrane of claim 1 wherein at least some of said fillers in said reactive film coated on one surface thereof are selected from one or more of chalk, cellulose, diatomaceous earth, and silicic acid.

7. The membrane of claim 1 wherein said one or more film formers in said reactive film coated on one surface thereof is selected from one or more of vinyl propionate, acrylic, and polyvinyl alcohol.

8. A composite structure for determining the presence of an analyte in a sample of blood, said composite structure comprising

(a) a microporous absorbent, blood-separating membrane having opposed first and second surfaces, said membrane being operable to separate plasma or serum from whole blood, and

(b) a water-resistant, water-insoluble reactive film coated on one of said opposed surfaces of said membrane, said reactive film comprising

(i) a hydrophobic film matrix of one or more film formers, said matrix containing a detection reagent for an analyte to be determined in said blood sample, and

(ii) film openers comprising inorganic or organic particulate, water insoluble, non-swelling wettable fillers which do not substantially scatter light and which enable large molecules and cells to penetrate into said reactive film wherein the mass ratio of film opener to film former is about 10:

1 to about 1;

1.

9. The structure according to claim 8, wherein the mass ratio of film opener to film former is about 5:

1 to about 2;

1.

10. The structure according to claim 8, wherein the reactive film further contains one or more optically blocking pigments, wetting agents, swelling agents, and combinations thereof.

11. A diagnostic element for detecting constituents of body fluids comprising a structure according to claim 8.

12. The structure of claim 8 wherein at least some of said fillers are selected from one or more of chalk, cellulose, diatomaceous earth, and silicic acid.

13. The structure of claim 8 wherein said film former is selected from one or more of vinyl propionate, acrylic, and polyvinyl alcohol.