EP0503459A2
Expired / Lapsed
EP
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Immunoassay element and process for immunoassay
Assignee: Fujifilm Holdings Corp
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Filing: 1992-03-04
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Granted: —
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Expires: 2012-03-04
Abstract
Abstract An immunoassay element for quantitatively analyzing a ligand by determining the change in enzymatic activity. When the ligand is a low molecular weight antigen, competitive reactions between the ligand, enzyme-labelled antibody and conjugate of the antigen and high molecular weight compound are utilized. When the ligand is a macromolecular antigen, a reaction between the ligand and an enzyme-labelled antibody is utilized directly. The immunoassay element comprises a substrate layer containing a non-diffusible substrate which forms a diffusible material in the presence of the enzyme, and a reagent layer for detecting the thus formed diffusible material. The non-diffusible substrate is composed of a pulverized insoluble polysaccharide. The reagent layer may further contain a fragmenting enzyme for further fragmenting the non-diffusible material. Also provided are processes for quantitatively analyzing both of low molecular weight and macromolecular antigens contained in any samples by the use of the immunoassay elements of the invention.
Inventors
- 👤 Hiroshi c/o Fuji Photo Film Co. Ltd. Shinoki
- 👤 Toshikage c/o Fuji Photo Film Co. Ltd. Hiraoka
- 👤 Masashi c/o Fuji Photo Film Co. Ltd. Ogawa
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-05 06:43
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/558
Claims Analysis
Total Claims: 24
Claim 1
Independent Claim
92 words
In an immunoassay element for quantitatively analyzing a low molecular weight antigen by determining the change in enzymatic activity caused by competitive reactions between an enzyme-labelled antibody and said low molecular weight antigen and a conjugate of said low molecular weight antigen with a high molecular weight compound, wherein said element comprises a substrate layer containing a non-diffusible substrate which forms a diffusible material in the presence of said enzyme and a reagent layer for detecting said diffusible material; an improvement characterized in that said non-diffusible substrate is a pulverized water-insoluble polysaccharide.
Claim 2
Dependent Claim
24 words
The immunoassay element of claim 1, wherein said pulverized insoluble polysaccharide is classified after pulverization to have a particle diameter within a predetermined range.
Claim 3
Dependent Claim
22 words
The immunoassay element of claim 1, wherein said pulverized insoluble polysaccharide has an average particle diameter of from 2 to 32 µm.
Claim 4
Dependent Claim
14 words
The immunoassay element of claim 1, wherein said pulverized insoluble polysaccharide is carboxymethlated starch.
Claim 5
Dependent Claim
19 words
The immunoassay element of claim 1, wherein said pulverized insoluble polysaccharide is denaturated by an alkali or thermal treatment.
Claim 6
Dependent Claim
18 words
The immunoassay element of claim 4, wherein said carboxymethylated starch is denaturated by an alkali or thermal treatment.
Claim 7
Dependent Claim
16 words
The immunoassay element of claim 1, wherein said enzyme labelling to said antigen is a glucosidase.
Claim 8
Dependent Claim
11 words
The immunoassay element of claim 7, wherein said glucosidase is α-amylase.
Claim 9
Dependent Claim
36 words
The immunoassay element of claim 1, further comprising a fragmenting enzyme for fragmenting said diffusible material into a lower molecular weight product and contained in said reagent layer or another layer laminated under said reagent layer.
Claim 10
Dependent Claim
42 words
The immunoassay element of claim 9, further comprising a reagent composition for reacting with said lower molecular weight product to form a dye having an absorption peak in the visible wavelength range and contained in said reagent layer or another water-permeable layer.
Claim 11
Dependent Claim
28 words
The immunoassay element of any of claims 1 to 10, wherein said enzyme-lablelled antibody is contained in said substrate layer or another layer laminated on said substrate layer.
Claim 12
Dependent Claim
73 words
In an immunoassay element for quantitatively analyzing a macromolecular antigen by determining the change in enzymatic activity caused by a reaction between an enzyme-labelled antibody and said macromolecular antigen, wherein said element comprises a substrate layer containing a non-diffusible substrate which forms a diffusible material in the presence of said enzyme and a reagent layer for detecting said diffusible material; an improvement characterized in that said non-diffusible substrate is a pulverized insoluble polysaccharide.
Claim 13
Dependent Claim
24 words
The immunoassay element of claim 12, wherein said pulverized insoluble polysaccharide is classified after pulverization to have a particle diameter within a predetermined range.
Claim 14
Dependent Claim
22 words
The immunoassay element of claim 12, wherein said pulverized insoluble polysaccharide has an average particle diameter of from 2 to 32 µm.
Claim 15
Dependent Claim
14 words
The immunoassay element of claim 12, wherein said pulverized insoluble polysaccharide is carboxymethlated starch.
Claim 16
Dependent Claim
19 words
The immunoassay element of claim 12, wherein said pulverized insoluble polysaccharide is denaturated by an alkali or thermal treatment.
Claim 17
Dependent Claim
18 words
The immunoassay element of claim 15, wherein said carboxymethylated starch is denaturated by an alkali or thermal treatment.
Claim 18
Dependent Claim
16 words
The immunoassay element of claim 12, wherein said enzyme labelling to said antigen is a glucosidase.
Claim 19
Dependent Claim
11 words
The immunoassay element of claim 18, wherein said glucosidase is α-amylase.
Claim 20
Dependent Claim
36 words
The immunoassay element of claim 12, further comprising a fragmenting enzyme for fragmenting said diffusible material into a lower molecular weight product and contained in said reagent layer or another layer laminated under said reagent layer.
Claim 21
Dependent Claim
42 words
The immunoassay element of claim 20, further comprising a reagent composition for reacting with said lower molecular weight product to form a dye having an absorption peak in the visible wavelength range and contained in said reagent layer or another water-permeable layer.
Claim 22
Dependent Claim
26 words
The immunoassay element of claims 12 to 21, wherein said enzyme-lablelled antibody is contained in said substrate layer or another layer laminated on said substrate layer.
Claim 23
Dependent Claim
123 words
An immunoassaying process for quantitatively analyzing an amount of a low molecular weight antigen in a sample by determining the change in eyzymatic activity caused by competitive reactions between an enzyme-labelled antibody and said low molecular weight antigen and a conjugate of said low molecular weight antigen with a high molecular weight compound, comprising a step of: (a) applying said sample on a substrate layer containing a non-diffusible substrate for forming a diffusible material in the presence of said enzyme, said non-diffusible substrate being a pulverized insoluble polysaccharide; (b) allowing to migrate said diffusible material formed in said substrate layer into a reagent layer for detecting said diffusible material; and (c) measuring the amount of said diffusible material migrating into said reagent layer.
Claim 24
Dependent Claim
104 words
An immunoassaying process for quantitatively analyzing an amount of a macromolecular antigen in a sample by determining the change in eyzymatic activity caused by a reaction between an enzyme-labelled antibody and said macromolecular antigen, comprising a step of: (a) applying said sample on a substrate layer containing a non-diffusible substrate for forming a diffusible material in the presence of said enzyme, said non-diffusible substrate being a pulverized insoluble polysaccharide; (b) allowing to migrate said diffusible material formed in said substrate layer into a reagent layer for detecting said diffusible material; and (c) measuring the amount of said diffusible material migrating into said reagent layer.
References Cited (Backward Citations)
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