Biomaterial Database

Biological standardization of allergenic extracts. 1989

P C Turkeltaub

Food and Drug Administration, Bethesda, MD 20892.

Accurate and precise methods of skin testing are essential for "in vivo" standardization of extracts from the same and different sources, for diagnostic efficacy as well as an important prognostic factor for evaluating the risk and benefit of immunotherapy. Skin test methods such as parallel line bioassay and ID50EAL which are based on the intradermal erythema response and yield the most sensitive, accurate, and precise bioassays as well as requiring the fewest injections and replicates should be preferentially selected for clinical use. Differentiating characteristics of parallel line bioassay and the ID50EAL method are presented. Proficiency test methods for assessing puncture and intradermal skin test methodologies should be made part of the clinicians' training and be incorporated into clinical practice in conjunction with standardized allergenic extracts. Assignment of Allergy Units to reference extracts based on accurate and precise "in vivo" methods such as the ID50EAL and to test extracts based on "in vitro" assays predictive of their "in vivo" relative potency as determined by parallel-line bioassay should facilitate the safe and effective clinical use of allergenic extracts.

UI	MeSH Term	Description	Entries
D012015	Reference Standards	A basis of value established for the measure of quantity, weight, extent or quality, e.g. weight standards, standard solutions, methods, techniques, and procedures used in diagnosis and therapy.	Standard Preparations,Standards, Reference,Preparations, Standard,Standardization,Standards,Preparation, Standard,Reference Standard,Standard Preparation,Standard, Reference
D005060	Europe	The continent north of AFRICA, west of ASIA and east of the ATLANTIC OCEAN.	Northern Europe,Southern Europe,Western Europe
D006632	Histamine	An amine derived by enzymatic decarboxylation of HISTIDINE. It is a powerful stimulant of gastric secretion, a constrictor of bronchial smooth muscle, a vasodilator, and also a centrally acting neurotransmitter.	Ceplene,Histamine Dihydrochloride,Histamine Hydrochloride,Peremin
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000485	Allergens	Antigen-type substances that produce immediate hypersensitivity (HYPERSENSITIVITY, IMMEDIATE).	Allergen
D001681	Biological Assay	A method of measuring the effects of a biologically active substance using an intermediate in vivo or in vitro tissue or cell model under controlled conditions. It includes virulence studies in animal fetuses in utero, mouse convulsion bioassay of insulin, quantitation of tumor-initiator systems in mouse skin, calculation of potentiating effects of a hormonal factor in an isolated strip of contracting stomach muscle, etc.	Bioassay,Assay, Biological,Assays, Biological,Biologic Assay,Biologic Assays,Assay, Biologic,Assays, Biologic,Bioassays,Biological Assays
D012882	Skin Tests	Epicutaneous or intradermal application of a sensitizer for demonstration of either delayed or immediate hypersensitivity. Used in diagnosis of hypersensitivity or as a test for cellular immunity.	Skin Test,Test, Skin,Tests, Skin
D013810	Therapeutic Equivalency	The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease.	Bioequivalence,Clinical Equivalency,Equivalency, Therapeutic,Generic Equivalency,Clinical Equivalencies,Equivalencies, Clinical,Equivalencies, Therapeutic,Equivalency, Clinical,Therapeutic Equivalencies,Bioequivalences,Equivalencies, Generic,Equivalency, Generic,Generic Equivalencies
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.