Standardized allergen extracts: past, present and future

Abstract

Consistent high-quality allergen extracts are essential for accurate diagnosis and effective treatment of allergic disease. Allergens represent complex heterogenous mixtures of allergenic and nonallergenic proteins, glycoproteins and polysaccharides. They are derived from natural sources (i.e., collected pollen) or cultures (dust mites and fungi). The goal of allergen standardization is to produce well-characterized extracts of known biologic potency and composition. This process requires the selection of an appropriate reference extract and methods to compare the test extract with the reference. Two methods are currently used in the standardization of these complex allergen extracts: marking and functional assays. Marking assays, which include allergen-specific, qualitative monoclonal antibody assays, indicate the presence of an individual protein but do not confer information regarding the biologic action of the protein. Functional assays, such as allergen skin tests, will provide information about the biologic function, but not about the specific composition of the extract.