title: Allergen source materials and quality control of allergenic extracts.
abstract: Allergen extracts are prepared from a wide variety of source materials including pollens, fungi, arthropods, animal danders, foods, and dusts. The composition of allergen extracts can vary depending on the allergen source, manufacturing process, and storage conditions. Allergen-specific immunoglobulin E (IgE) assays and skin tests employ a variety of allergen-containing reagents that confer specificity on the test. Given that the allergen source materials are heterogenous mixtures of proteins, glycoproteins, carbohydrates, and other substances that are not allergenic, it is not unexpected that variability exists between test results obtained with different allergen-containing reagents. Variability within a single manufacturer's allergen product can be controlled by using reproducible extraction and processing procedures, single large lots of allergen source materials, and solid-phase supports. These controls do not, however, ensure the consistency of products between manufacturers or laboratories because allergen source materials, manufacturing procedures, and acceptance criteria for allergen reagents may vary.
authors.affiliation: Greer Laboratories, Inc., Lenoir, North Carolina 28645, USA.
authors.forename: R E
authors.initials: RE
authors.lastname: Esch
mesh_terms: D000485:Allergens / Q000276:immunology / Q000302:isolation & purification; D000818:Animals; D039741:Antigens, Dermatophagoides; D052179:Antigens, Plant; D002415:Cats; D017277:Drug Approval; D004797:Enzyme-Linked Immunosorbent Assay; D006023:Glycoproteins / Q000276:immunology / Q000592:standards; D006801:Humans; D007106:Immune Sera; D007073:Immunoglobulin E / Q000097:blood; D010936:Plant Extracts / Q000276:immunology / Q000592:standards; D010940:Plant Proteins / Q000276:immunology / Q000592:standards; D011058:Pollen / Q000276:immunology; D011786:Quality Control; D012015:Reference Standards; D012463:Saliva / Q000276:immunology; D012867:Skin / Q000276:immunology; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000485:Allergens; C026967:Amb a I protein, Ambrosia artemisiifolia; D039741:Antigens, Dermatophagoides; D052179:Antigens, Plant; D006023:Glycoproteins; D007106:Immune Sera; D010936:Plant Extracts; D010940:Plant Proteins; D007073:Immunoglobulin E; C059296:Fel d 1 protein, Felis domesticus