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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.
RECOMMENDATION: PPM OF ALLERGEN PER COMMODITY.
WORKING GROUP DECISION:
AGREED.
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.