ALLERGEN SOURCE MATERIALS AND QUALITY-CONTROL OF ALLERGENIC EXTRACTS

Allergen extracts are prepared from a wide variety of source materials including pollens, fungi, arthropods, animal danders, foods, and dust s. The composition of allergen extracts can vary depending on the alle rgen source, manufacturing process, and storage conditions. Allergen-s pecific immunoglobulin E (IgE) assays and skin tests employ a variety of allergen-containing reagents that confer specificity on the test. G iven that the allergen source materials are heterogenous mixtures of p roteins, glycoproteins, carbohydrates, and other substances that are n ot allergenic, it is not unexpected that variability exists between te st results obtained with different allergen-containing reagents. Varia bility within a single manufacturer's allergen product can be controll ed by using reproducible extraction and processing procedures, single large lots of allergen source materials, and solid-phase supports. The se controls do not, however, ensure the consistency of products betwee n manufacturers or laboratories because allergen source materials, man ufacturing procedures, and acceptance criteria for allergen reagents m ay vary. (C) 1997 Academic Press.