Deleterious effects of electron beam radiation on allergen extracts.

Background: The recent threat to the public posed by the dissemination of Bacillus anthracis through the US postal system has resulted in increased security measures, including electron beam irradiation for the sterilization of some mail. The deleterious effects of electron beam radiation on biological products are not fully understood.

Objective: The purpose of this investigation was to assess the effect of electron beam radiation, as currently used to sterilize packages and mail in the United States, on several standardized or characterized allergen extracts.

Major allergen measurements: sources of variability, validation, quality assurance, and utility for laboratories, manufacturers, and clinics.

The isolation and characterization of prominent allergenic proteins or glycoproteins is an important step in the development of allergenic extracts exhibiting improved definition, consistency, and clinical utility. Quantitative analyses specific for major allergenic components currently are being performed in numerous corporate and academic laboratories but have not been validated within or across laboratories in a systematic manner. In our laboratory, validation of double-bind (sandwich) ELISA assays for a diverse group of major allergens or extract components revealed a number of critical assay variables and reagent incubation conditions that directly influenced the precision, accuracy, specificity, and robustness of these tests.