Validation procedures for quantitative food allergen ELISA methods: Community guidance and best practices

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

Research output: Contribution to journalArticle

87 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)442-450
Number of pages9
JournalJournal of AOAC International
Volume93
Issue number2
StatePublished - Mar 1 2010

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allergens
Practice Guidelines
Allergens
Enzyme-Linked Immunosorbent Assay
enzyme-linked immunosorbent assay
Food
food
methodology
Validation Studies
milk
Ovum
Publications
Milk
allergen
method
egg
Specifications
document

ASJC Scopus subject areas

  • Analytical Chemistry
  • Food Science
  • Environmental Chemistry
  • Agronomy and Crop Science
  • Pharmacology

Cite this

Abbott, M., Hayward, S., Ross, W., Godefroy, S. B., Ulberth, F., Van Hengel, A. J., ... Delahaut, P. (2010). Validation procedures for quantitative food allergen ELISA methods: Community guidance and best practices. Journal of AOAC International, 93(2), 442-450.

Validation procedures for quantitative food allergen ELISA methods : Community guidance and best practices. / Abbott, Michael; Hayward, Stephen; Ross, William; Godefroy, Samuel Benrejeb; Ulberth, Franz; Van Hengel, Arjon J.; Roberts, James; Akiyama, Hiroshi; Popping, Bert; Yeung, Jupiter M.; Wehling, Paul; Taylor, Steve L.; Poms, Roland Ernest; Delahaut, Philippe.

In: Journal of AOAC International, Vol. 93, No. 2, 01.03.2010, p. 442-450.

Research output: Contribution to journalArticle

Abbott, M, Hayward, S, Ross, W, Godefroy, SB, Ulberth, F, Van Hengel, AJ, Roberts, J, Akiyama, H, Popping, B, Yeung, JM, Wehling, P, Taylor, SL, Poms, RE & Delahaut, P 2010, 'Validation procedures for quantitative food allergen ELISA methods: Community guidance and best practices', Journal of AOAC International, vol. 93, no. 2, pp. 442-450.
Abbott M, Hayward S, Ross W, Godefroy SB, Ulberth F, Van Hengel AJ et al. Validation procedures for quantitative food allergen ELISA methods: Community guidance and best practices. Journal of AOAC International. 2010 Mar 1;93(2):442-450.
Abbott, Michael ; Hayward, Stephen ; Ross, William ; Godefroy, Samuel Benrejeb ; Ulberth, Franz ; Van Hengel, Arjon J. ; Roberts, James ; Akiyama, Hiroshi ; Popping, Bert ; Yeung, Jupiter M. ; Wehling, Paul ; Taylor, Steve L. ; Poms, Roland Ernest ; Delahaut, Philippe. / Validation procedures for quantitative food allergen ELISA methods : Community guidance and best practices. In: Journal of AOAC International. 2010 ; Vol. 93, No. 2. pp. 442-450.
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