PARTICLE-STABILIZED EPITOPES FOR STANDARDIZATION AND CONTROL OF IMMUNOASSAYS

摘要

The invention relates to a process for preparing standards and controls for immunoassays employing monoclonal antibodies. Monoclonal antibodies are used to isolate a restricted portion of an antigen containing an epitope that determines the specifity of the monoclonal antibody-antigen reaction so as to distinguish it fr om the antigen as a whole following fragmentation of the complex antigen by procedures including proteolysis. Isolated epitopes are attached covalently or by physical adsorption to particles to immobilize and stabilize the epitope. The particles c an be composed of iodipamide ethyl ester, polyvinyl chloride polystyrene and other ine rt substances and can be chemically activated to improve epitope binding and stabil ity. Experimental details demonstrate the binding of lipoprotein epitopes to IDE, pol yvinyl chloride and polystyrene and the subsequent reaction of monoclonal antibodies to these particle-stabilized epitopes.