title: Validation procedures for quantitative gluten ELISA methods: AOAC allergen community guidance and best practices.
abstract: The food allergen analytical community is endeavoring to create harmonized guidelines for the validation of food allergen ELISA methodologies to help protect food-sensitive individuals and promote consumer confidence. This document provides additional guidance to existing method validation publications for quantitative food allergen ELISA methods. The gluten-specific criterion provided in this document is divided into sections for information required by the method developer about the assay and information for the implementation of the multilaboratory validation study. Many of these recommendations and guidance are built upon the widely accepted Codex Alimentarius definitions and recommendations for gluten-free foods. The information in this document can be used as the basis of a harmonized validation protocol for any ELISA method for gluten, whether proprietary or nonproprietary, that will be submitted to AOAC andlor regulatory authorities or other bodies for status recognition. Future work is planned for the implementation of this guidance document for the validation of gluten methods and the creation of gluten reference materials.
authors.affiliation: Health Canada, Food Directorate, Health Products and Food Branch, PL 2203C, Ottawa, ON, Canada, K1A 0L2. Terry.Koerner@hc-sc.gc.ca
authors.forename: Terry B
authors.initials: TB
authors.lastname: Koerner
authors.forename: Michael
authors.initials: M
authors.lastname: Abbott
authors.forename: Samuel Benrejeb
authors.initials: SB
authors.lastname: Godefroy
authors.forename: Bert
authors.initials: B
authors.lastname: Popping
authors.forename: Jupiter M
authors.initials: JM
authors.lastname: Yeung
authors.forename: Carmen
authors.initials: C
authors.lastname: Diaz-Amigo
authors.forename: James
authors.initials: J
authors.lastname: Roberts
authors.forename: Steve L
authors.initials: SL
authors.lastname: Taylor
authors.forename: Joseph L
authors.initials: JL
authors.lastname: Baumert
authors.forename: Franz
authors.initials: F
authors.lastname: Ulberth
authors.forename: Paul
authors.initials: P
authors.lastname: Wehling
authors.forename: Peter
authors.initials: P
authors.lastname: Koehler
mesh_terms: D000485:Allergens / Q000032:analysis*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005983:Glutens / Q000032:analysis*
chemical_list: D000485:Allergens; D005983:Glutens