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

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AOAC ISPAM "Food Allergen" Working Group Questions/Comments Form
2016-12-08 06:27:30
Makrus Lacorn
R-Biopharm
12-08-2016
Title: The title mentions ELISA but chapter 3. Analytical Techniques also mention
“other binding based technologies”. Furthermore, we always detect proteins and but
not allergens in all cases; these proteins may be allergens to sensitized customers;
National legislations demand to declare “egg” and not egg allergens.
Change title: Quantitation of whole chicken egg proteins by immunochemical methods
Title: Why “whole” egg proteins? One method provider could also measure ovalbumin
and recalculate this to whole egg
Change: to be discussed by the group
Applicability: If surfaces and cleaning in place solutions should be included this need to
taken into account in the whole document
Change: to be discussed by the group
Definition “allergens”: Do not define allergens because this is quite broad (they may
derive from food but also from dust) but explain for “whole egg” that egg constituents
may be allergenic to consumers for an individual extent
Definitions “commodities”: If surfaces and CIP water are included, commodities would
not be sufficient as a definition; you may call them matrices but at the end we need to
define matrices (food, CIP water ) and surfaces
Definition “ELISA”: Several formats are possible for ELISA:
1. Sandwich: analyte ligating agent is bound on surface and second analyte-ligating
reagent is coupled to an enzyme: sandwich format
2. Analyte from calibrator or sample is coupled to surfaces (by the user) and ligating
agent is coupled to enzyme: calibration curve like sandwich curve
3. Fixed amount of analyte is bound to surface and competes with free analyte in
solution for ligating binding sites; this ligand is labelled to a marker (not only an
enzyme); competitive format
4. Ligating reagent is coupled to surface: free analyte (from calibrator or sample) is
competing with a fixed amount of labelled analyte for binging sites: competitive format
These are only examples for microtiterplate based methods; LFD devices are even
more complex and other systems may also be
Change: Delete ELISA and insert new definition: “Binding-based assays: Antigen or
ligand based methods where one of the components is attached to a surface. The
measurement signal is directly or inversely proportional to the amount of measurand. ”
This will also include quantitative LFDs or dip-sticks.