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

AOAC ISPAM "Food Allergen" Working Group Questions/Comments Form

Submission Date

2016-12-08 06:27:30

First & Last Name

Makrus Lacorn

Organization

R-Biopharm

E-mail Address

m.lacorn@r-biopharm.de

Date Submitted

12-08-2016

Question/Comment-1

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

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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.