AOAC ISPAM Food Allergen WG Meeting Book (12-15-16)

Lisa Monteroso (3M)

DRAFT AOAC Allergen SMPR Version 2; November 30, 2016 1 2 Quantitation of Whole Chicken Egg Allergens by ELISA-based Methods 3 4 Intended Use : Reference mM ethod for cGMP compliance. 5 6 1. Purpose: AOAC SMPRs describe the minimum recommended performance characteristics 7 to be used during the evaluation of a method. The evaluation may be an on-site 8 verification, a single-laboratory validation, or a multi-site collaborative study. SMPRs are 9 written and adopted by AOAC Stakeholder Panels composed of representatives from the 10 industry, regulatory organizations, contract laboratories, test kit manufacturers, and 11 academic institutions. AOAC SMPRs are used by AOAC Expert Review Panels in their 12 evaluation of validation study data for method being considered for Performance Tested 13 Methods or AOAC Official Methods of Analysis , and can be used as acceptance criteria for 14 verification at user laboratories.

Formatted: Numbering: Continuous

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2. Applicability :

Comment [D1]: May want to consider adding environmental samples

Quantitation of whole chicken egg allergens in selected finished food products and ingredients as listed in table 2 (may need to revise table to be consistent with OMA

Appendix M) .

3. Analytical Technique :

Enzyme-linked immunosorbent assay (ELISA) based assays or other binding based

technologies .

4. Definitions :

Enzyme-linked immunosorbent assay (ELISA) based assays .

An assay that uses antibodies and color change to identify a substance. ELISA can perform other forms of ligand binding assays instead of strictly "immuno" assays, though the name carried the original "immuno" because of the common use and history of development of this method. The technique essentially requires any ligating reagent that can be immobilized on the solid phase along with a detection reagent that will bind specifically and use an

enzyme to generate a signal that can be properly quantified.

Binding Based Technology

Allergens

Commodities

Limit of Quantitation (LOQ)

The minimum concentration or mass of analyte in a given matrix that can be reported as a

quantitative result.