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 dusts. The composition of allergen extracts can vary depending on the allergen source, manufacturing process, and storage conditions. Allergen-specific immunoglobul...

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Veröffentlicht in:Methods (San Diego, Calif.) Calif.), 1997-09, Vol.13 (1), p.2-13
1. Verfasser: Esch, Robert E
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description 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.
doi_str_mv 10.1006/meth.1997.0491
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subjects Allergens - immunology
Allergens - isolation & purification
Animals
Antigens, Dermatophagoides
Antigens, Plant
Cats
Drug Approval
Enzyme-Linked Immunosorbent Assay
Glycoproteins - immunology
Glycoproteins - standards
Humans
Immune Sera
Immunoglobulin E - blood
Plant Extracts - immunology
Plant Extracts - standards
Plant Proteins - immunology
Plant Proteins - standards
Pollen - immunology
Quality Control
Reference Standards
Saliva - immunology
Skin - immunology
United States
United States Food and Drug Administration
title Allergen Source Materials and Quality Control of Allergenic Extracts
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