Test device resistant to cross contamination between reactant areas and process for making it

• US 4,301,115 A
• Filed: 06/22/1979
• Issued: 11/17/1981
• Est. Priority Date: 06/22/1979
• Status: Expired due to Term

• Current Assignee: Miles Laboratories, Inc. (Bayer AG)
• Original Assignee: Miles Laboratories, Inc. (Bayer AG)
• Inventors: Rapkin, Myron C., Tabb, David L.
• Primary Examiner(s): Turk, Arnold
• Application Number:
  US06/051,224
• Time in Patent Office: 879 Days
• Field of Search: 422/55, 422/56, 422/57, 435/805, 427/2, 428/206
• US Class Current: 422/424
• CPC Class Codes: G01N 31/22 using chemical indicators G01N31/02 takes precedence
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: Y10S 435/805 Test papers

Abstract

A test device for detecting the presence of constituents in a liquid test sample, and method for preparing it are disclosed. The device comprises a base support member coated with a hydrophobic barrier layer onto which is affixed a plurality of spaced apart reagents respectively responsive to different constituents of the test sample. The barrier layer comprises finely divided silica particles, to the surface of which are randomly covalently bound groups having the structure

--O--SiR.sub.3

wherein the R substituents, same or different, are hydrogen, lower alkyl or aryl.

Claims

1. In a test device for analyzing a test sample for the presence of one or more constituents, the device comprising a base support member, a hydrophobic layer affixed to the support member, and two or more reagent compositions affixed to the hydrophobic layer, each respectively responsive to a particular sample constituent or concentration thereof, the improvement wherein said hydrophobic layer comprises finely divided silica particles having covalently affixed to the surfaces thereof groups having the structure

View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)

2. The improvement of claim 1 wherin the R substituents are all lower alkyl.

3. The improvement of claim 1 wherein the R substituents are all methyl.

4. The improvement of any of claims 1-3 wherein each reagent is incorporated, respectively, with a hydrophilic carrier matrix, each matrix being affixed to the hydrophobic layer.

5. The improvement of any of claims 1-3 wherein each reagent, respectively, is incorporated with a paper carrier matrix, each matrix being affixed to the hydrophobic layer.

6. The improvement of any of claims 1-3 wherein the binder is an acrylic polymer.

7. The improvement of claim 1 wherein the base support member is a polystyrene film, the R substituents in the hydrophobic layer are lower alkyl, the binder is an acrylic polymer, and the reagent compositions are incorporated, respectively, with hydrophilic carrier matrices.

8. The improvement of claim 7 wherein the reagent compositions are responsive, respectively, to albumin, bilirubin, glucose, hydrogen ion, ketone, nitrite, occult blood, urobilinogen or combinations thereof.

9. The improvement of claim 8 wherein reagent compositions are additionally provided which ae responsive to ascorbic acid, specific gravity or both.

10. A method for preparing a test device capable of determining the presence of a constituent in a test sample wherein the device has the property of eliminating the occurrence of runover, the method comprising the steps of

preparing a hydrophobic coating material comprising (a) finely divided silica particles having covalently affixed thereto groups having the structure -O-SiR₃, wherein the R substituents, same or different, are hydrogen, lower alkyl or aryl, and (b) a suitable binder,

affixing the hydrophobic coating material to a base support member to form a hydrophobic layer on the support member, and

affixing to the hydrophobic layer a reagent capable of producing a detectable response in the presence of the test sample constituent.

11. The method of claim 10 wherein said reagent is incorporated with a hydrophilic carrier matrix which is affixed to said hydrophobic layer.

12. The method of claim 10 wherein said reagent is incorporated with a paper carrier matrix which is affixed to said hydrophobic layer.

13. The method of claim 10 which includes the additional steps of affixing to the hydrophobic layer additional reagents respectively responsive to other constituents of a test sample, said reagents being affixed to the hydrophobic layer in spaced relation to each other.