| Validation procedures for quantitative food allergen ELISA methods: community guidance and best practices. | |
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MedLine Citation:
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PMID: 20480889 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Journal Article |
Journal Detail:
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Title: Journal of AOAC International Volume: 93 ISSN: 1060-3271 ISO Abbreviation: J AOAC Int Publication Date: 2010 Mar-Apr |
Date Detail:
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Created Date: 2010-05-19 Completed Date: 2010-06-14 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9215446 Medline TA: J AOAC Int Country: United States |
Other Details:
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Languages: eng Pagination: 442-50 Citation Subset: IM |
Affiliation:
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Health Canada, Food Directorate, Health Products and Food Branch, PL 2201C, Ottawa, ON, Canada K1A 0L2. Michael.Abbott@hc-sc.gc.ca |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Allergens Animals Calibration Cattle 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 Milk Ovum Reference Standards Reproducibility of Results |
| Chemical | |
Reg. No./Substance:
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0/Allergens |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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