NDLI: The 3rd International Standard for serum IgE: international collaborative study to evaluate a candidate preparation.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Thorpe, Susan J. Heath, Alan Fox, Bernard Patel, Dina Egner, William
Abstract	BACKGROUND: The measurement of serum IgE aids in the diagnosis and management of atopic allergic disease and hyper-IgE immunodeficiency syndromes. The 2nd World Health Organization (WHO) International Reference Reagent (IRR) for serum IgE (75/502; 5000 IU/ampoule), is widely used to calibrate assays for serum IgE. Exhaustion of stocks of the 2nd IRR necessitated the production of a replacement preparation and its evaluation in an international collaborative study to determine its suitability to serve as the 3rd International Standard (IS) for serum IgE. METHODS: Sera and defibrinated plasma with elevated IgE levels were pooled and lyophilised in ampoules. This preparation, coded 11/234, was assayed by 18 laboratories in 11 countries using commercial assay methodology for IgE, along with the 2nd IRR, 75/502, and two lyophilised serum samples. RESULTS: Overall, there were no consistent differences in the way that the candidate IS (11/234), the IRR (75/502), and the two serum samples behaved in the assays with respect to linearity and parallelism. The mean IgE value of the candidate IS, 11/234, relative to the IRR, 75/502, was 13,411 IU/mL based on parallel line analysis of raw assay data at NIBSC, and 13,551 IU/mL based on the laboratories' own estimates after correcting for the values obtained for 75/502. CONCLUSIONS: The use of 11/234 will ensure that assays for serum IgE continue to be well standardised. The preparation was established by the WHO Expert Committee on Biological Standardization as the 3rd IS for serum IgE with an assigned value of 13,500 IU/mL, corresponding to 6750 IU/ampoule.
File Format	HTM / HTML
ISSN	14346621
Issue Number	9
Volume Number	52
e-ISSN	14374331
Journal	Clinical Chemistry and Laboratory Medicine
Language	English
Publisher	Walter de Gruyter
Publisher Date	2014-09-01
Publisher Place	Germany
Access Restriction	Subscribed
Subject Keyword	Immunoassay World Health Organization Blood Chemical Analysis Discipline Clinical chemistry Laboratories Humans Freeze Drying Isolation & Purification Immunoglobulin E Indicators And Reagents Standards Blood Journal Article Reference Standards Discipline Clinical Chemistry Proteolysis Analysis Of Variance Statistics & Numerical Data Evaluation Studies
Content Type	Text
Resource Type	Article
Subject	Biochemistry (medical) Clinical Biochemistry

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