APAC SPSFAM Mid Year 2016

Allergen Working Group Topics for Discussion

1. Nature of Analyte

The precise nature of the analyte has not been resolved. Working Group members have discussed peptides, proteins, and commodities. Allergens are regulated by the FDA and EU as the whole allergen (i.e., peanuts) and products thereof. The draft SMPR specifies mass spectrometry as the analytical technique, and presumably methods will detect/measure the peaks associated with certain peptides. However, the exact peptide is left up to the method developer. Methods may differ as to the peptide and fragmentation methods. Therefore the exact ratio of peptide to whole commodity may differ. It should be left up to the method develop to: 1) decide which peptide and fragmentation method; and 2) determine the appropriate conversion factor. The AOAC Expert Review Panel will review the method developer’s proposed conversion factors as part of the method review. 2. Commutability It was suggested that reference materials should be commutable. The term “commutability” was first used to describe the ability of a reference or control material to have interassay properties comparable to the properties demonstrated by authentic clinical samples when measured by more than one analytical method. Commutability is not an AOAC requirement for evaluation of methods. While commutability would seem ideal, it may not be practical. A commutable allergen reference material would require that a reference material provider demonstrate that equivalent results are obtained using a variety of techniques, or example ELISA. Lateral flow, LC-MS, MALDI-TOF-MS, and PCR. It would seem unlikely that many, if any, reference materials would be characterized by multiple techniques, and just as unlikely that equivalent results would be demonstrated. RECOMMENDATION: DO NOT REQUIRE COMMUTABILITY OF REFERENCE MATERIALS. WORKING GROUP DECISION: AGREED. ADDITIONAL: COATES TO REACH OUT TO DAIRY COMMUNITY TO IDENTIFY ADDITIONAL REFERENCE MATERIALS USED BY THE INDUSTRY. RECOMMENDATION: PPM OF ALLERGEN PER COMMODITY. WORKING GROUP DECISION: AGREED.