Method of preparing immunological analytical element

• US 5,266,460 A
• Filed: 05/20/1992
• Issued: 11/30/1993
• Est. Priority Date: 03/17/1987
• Status: Expired due to Fees

• Current Assignee: Fuji Photo Film Co Limited (Fujifilm Holdings Corporation)
• Original Assignee: Fuji Photo Film Co Limited (Fujifilm Holdings Corporation)
• Inventors: Sudo, Yukio, Masuda, Nobuhito
• Primary Examiner(s): WARDEN, JILL ALICE
• Application Number:
  US07/887,425
• Time in Patent Office: 559 Days
• Field of Search: 422/56-58, 435/7.2, 435/7.72, 435/970, 435/7.9, 435/7.92, 435/969
• US Class Current: 435/7.9
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: Y10S 435/969 Multiple layering of reactants
• CPC Class Codes: Y10S 435/97 Test strip or test slide

Abstract

A method of preparing a dry-type analytical element for immunoassay having at least one water-permeable porous layer and containing a labeled antigen and an antibody to said labeled antigen and to an unlabeled antigen as the components participating in antigen-antibody reaction in said porous layer, which comprises applying or impregnating a first composition containing one of said labeled antigen and said antibody and thereafter applying or impregnating a second composition containing the other of said labeled antigen and said antibody dissolved or suspended in a solvent not dissolving substantially said labeled antigen or said antibody in the first composition onto said porous layer.

Claims

1. A method for preparing a dry-type analytical element for immunoassay using an antibody-antigen reaction, said element having at least two water-permeable layers, one of said layers being a porous spreading layer having a sample receiving side, and the other of said layers being located on a side of said spreading layer opposite to the sample-receiving side and being a hydrophilic polymer, and containing a labeled antigen and an antibody to said labeled antigen and to an unlabeled antigen as the components participating in the antigen-antibody reaction which occurs in said spreading layer, which comprises the steps of applying or impregnating on or into the spreading layer, a first composition of an enzyme labeled antigen in water and thereafter, applying or impregnating a second composition in an organic solvent selected from the group consisting of alcohols, ketones, and ethers, on or into the spreading layer, said second composition containing the other of said labeled antigen and said antibody dissolved or suspended in the organic solvent, which solvent does not substantially dissolve said enzyme labeled antigen in the first composition wherein at least either of the first composition or the second composition contains polyvinylpyrrolidone.

2. A method for preparing a dry-type analytical element having at least two water-permeable porous layers, one of said layers a being spreading layer having a sample receiving side, the other of said layers being a hydrophilic polymer reagent layer located on a side of said spreading layer opposite to the sample-receiving side, and containing a labeled antigen and an antibody to said labeled antigen and to an unlabeled antigen as components which participate in an antigen-antibody reaction in said reagent layer, which comprises the steps of applying or impregnating a first composition of an enzyme labeled antigen in water on or into the porous layer and thereafter applying or impregnating a second composition containing the other of said labeled antigen and said antibody dissolved or suspended in an organic solvent selected from the group consisting of alcohols, ketones and ethers, which solvent does not substantially dissolve said enzyme labeled antigen in the first composition wherein at least either of the first composition or the second composition contains polyvinylpyrrolidone.

3. A method for preparing a dry-type analytical element for immunoassay using an antibody-antigen reaction, said element having at least two water-permeable layers, one of said layers being a porous spreading layer having sample receiving side, and the other of said layers being located on a side of said spreading layer opposite to the sample-receiving side and being a hydrophilic polymer, and containing a labeled antigen and an antibody to said labeled antigen and to an unlabeled antigen as the components participating in the antigen-antibody reaction which occurs in said spreading layer, which comprises the steps of applying or impregnating on or into the spreading layer, a first composition of an enzyme labeled antigen in water and thereafter, applying or impregnating a second composition in an organic solvent selected from the group consisting of methanol, ethanol, acetone and 2-ethoxyethanol, on or into the spreading layer, said second composition containing the other of said labeled antigen and said antibody dissolved or suspended in the organic solvent, which solvent does not substantially dissolve said enzyme labeled antigen in the first composition wherein at least either of the first composition or the second composition contains a hydrophilic polymer.

4. The method of claim 3 wherein the solvent is an alcohol and said alcohol is ethanol.

5. A method for preparing a dry-type analytical element having at least two water-permeable porous layers, one of said layers being a spreading layer having a sample receiving side, the other of said layers being a hydrophilic polymer reagent layer located on a side of said spreading layer opposite to the sample-receiving side, and containing a labeled antigen and an antibody to said labeled antigen and to an unlabeled antigen as components which participate in an antigen-antibody reaction in said reagent layer, which comprises the steps of applying or impregnating a first composition of an enzyme labeled antigen in water on or into the porous layer and thereafter applying or impregnating a second composition containing the other of said labeled antigen and said antibody dissolved or suspended in an organic solvent selected from the group consisting of methanol, ethanol, acetone and 2-ethoxyethanol, which solvent does not substantially dissolve said enzyme labeled antigen in the first composition wherein at least either of the first composition or the second composition contains a hydrophilic polymer.

6. The method of claim 5 wherein the solvent is an alcohol and said alcohol is ethanol.