Document Detail

Validation procedures for quantitative food allergen ELISA methods: community guidance and best practices.
MedLine Citation:
PMID:  20480889     Owner:  NLM     Status:  MEDLINE    
This document provides supplemental guidance on specifications for the development and implementation of studies to validate the performance characteristics of quantitative ELISA methods for the determination of food allergens. It is intended as a companion document to other existing publications on method validation. The guidance is divided into two sections: information to be provided by the method developer on various characteristics of the method, and implementation of a multilaboratory validation study. Certain criteria included in the guidance are allergen-specific. Two food allergens, egg and milk, are used to demonstrate the criteria guidance. These recommendations will be the basis of the harmonized validation protocol for any food allergen ELISA method, whether proprietary or nonproprietary, that will be submitted to AOAC and/or regulatory authorities or other bodies for status recognition. Regulatory authorities may have their own particular requirements for data packages in addition to the guidance in this document. Future work planned for the implementation and validation of this guidance will include guidance specific to other priority allergens.
Michael Abbott; Stephen Hayward; William Ross; Samuel Benrejeb Godefroy; Franz Ulberth; Arjon J Van Hengel; James Roberts; Hiroshi Akiyama; Bert Popping; Jupiter M Yeung; Paul Wehling; Steve L Taylor; Roland Ernest Poms; Philippe Delahaut
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of AOAC International     Volume:  93     ISSN:  1060-3271     ISO Abbreviation:  J AOAC Int     Publication Date:    2010 Mar-Apr
Date Detail:
Created Date:  2010-05-19     Completed Date:  2010-06-14     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9215446     Medline TA:  J AOAC Int     Country:  United States    
Other Details:
Languages:  eng     Pagination:  442-50     Citation Subset:  IM    
Health Canada, Food Directorate, Health Products and Food Branch, PL 2201C, Ottawa, ON, Canada K1A 0L2.
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MeSH Terms
Chemistry Techniques, Analytical
Enzyme-Linked Immunosorbent Assay / methods*,  standards*
Food Analysis / methods*
Food Contamination
Food Hypersensitivity / immunology*,  prevention & control
Legislation, Food / trends*
Mass Spectrometry / methods
Reference Standards
Reproducibility of Results
Reg. No./Substance:

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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