AOAC GFA Stakeholder Program Meeting Book (March 15, 2023)

Allergen analysis at FDA

Analysis is done to detect allergen cross-contact

Manufacturers are required to implement controls to prevent allergen cross-contact. Allergen cross-contact occurs between foods of different allergen profiles. At FDA, we rely on immunochemical methods ( ELISA and xMAP FADA ) for allergen analysis and to support regulatory decisions. Antibody-based methods target allergenic proteins or representative protein from the allergenic food Target protein is usually stable to processing (heat, pH) Antibodies targeting the proteins are produced Monoclonal- produced in vitro, against single epitope Polyclonal- produced by injecting animals, against multiple epitopes

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