Review

Should digestion assays be used to estimate persistence of potential allergens in tests for safety of novel food proteins?

Santiago Schnell¹ and Rod A Herman²

¹  Department of Molecular & Integrative Physiology, and Center for Computational Medicine & Biology, University of Michigan Medical School, 100 Washtenaw Avenue, Palmer Commons 2017, Ann Arbor, MI 48109-2218, USA

²  Dow AgroSciences LLC, 9330 Zionsville Rd., Indianapolis, IN 46268, USA

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Clinical and Molecular Allergy 2009, 7:1doi:10.1186/1476-7961-7-1

Published:	15 January 2009

Abstract

Food allergies affect an estimated 3 to 4% of adults and up to 8% of children in developed western countries. Results from in vitro simulated gastric digestion studies with purified proteins are routinely used to assess the allergenic potential of novel food proteins. The digestion of purified proteins in simulated gastric fluid typically progresses in an exponential fashion allowing persistence to be quantified using pseudo-first-order rate constants or half lives. However, the persistence of purified proteins in simulated gastric fluid is a poor predictor of the allergenic status of food proteins, potentially due to food matrix effects that can be significant in vivo. The evaluation of the persistence of novel proteins in whole, prepared food exposed to simulated gastric fluid may provide a more correlative result, but such assays should be thoroughly validated to demonstrate a predictive capacity before they are accepted to predict the allergenic potential of novel food proteins.