Validation procedures for quantitative food allergen ELISA methods: community guidance and best practices.
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.
Abbott
Michael
M
Health Canada, Food Directorate, Health Products and Food Branch, PL 2201C, Ottawa, ON, Canada K1A 0L2. Michael.Abbott@hc-sc.gc.ca
Hayward
Stephen
S
Ross
William
W
Godefroy
Samuel Benrejeb
SB
Ulberth
Franz
F
Van Hengel
Arjon J
AJ
Roberts
James
J
Akiyama
Hiroshi
H
Popping
Bert
B
Yeung
Jupiter M
JM
Wehling
Paul
P
Taylor
Steve L
SL
Poms
Roland Ernest
RE
Delahaut
Philippe
P
D000485:Allergens; D000818:Animals; D002138:Calibration; D002417:Cattle; D002623:Chemistry Techniques, Analytical; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods* / Q000592:standards*; D005504:Food Analysis / Q000379:methods*; D005506:Food Contamination; D005512:Food Hypersensitivity / Q000276:immunology* / Q000517:prevention & control; D007881:Legislation, Food / Q000639:trends*; D013058:Mass Spectrometry / Q000379:methods; D008892:Milk; D010063:Ovum; D012015:Reference Standards; D015203:Reproducibility of Results
D000485:Allergens