Multi-layered element for quantitative analysis of immuno-reactant.

摘要

A multi-layered element for the quantitative analysis of an immuno-reactant is provided. The element comprises: a water-impermeable and light-transmissible support layer; a coloring reagent layer carried by said support layer and containing a hydrophilic polymer as a binder; and a reaction layer covering said reagent layer and made of a porous matrix. The analyte immuno-reactant is analysed as it is mixed with an enzyme-labelled complex thereof. The analyte immuno-reactant may be mixed with the enzyme-labelled complex thereof before it is applied on the multi-layered element. The reaction layer further contains an enzyme substrate immobilized by a second water-insoluble carrier which is different from said first water-insoluble carrier for immobilizing said antibody or antigen. The coloring reagent layer contains a detection reagent composition for coupling with an enzymatic reaction product which is produced by the reaction between the <!-- EPO <DP n="57"> --> enzyme-labelled complex of the immuno-reactant and the enzyme substrate contained in the reaction layer while being immobilized by the second water-insoluble carrier. Upon coupling of the detection reagent composition with the enzymatic reaction product, a color is developed and the optical density of the thus developed color is measured to determine the quantity of the analyte immuno-reactant contained in a liquid sample.