Analytical criteria for performance characteristics of IgE binding methods for evaluating safety of biotech food products

Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association
T HolzhauserGary A Bannon

Abstract

There is detailed guidance on how to perform bioinformatic analyses and enzymatic degradation studies for genetically modified crops under consideration for approval by regulatory agencies; however, there is no consensus in the scientific community on the details of how to perform IgE serum studies. IgE serum studies are an important safety component to acceptance of genetically modified crops when the introduced protein is novel, the introduced protein is similar to known allergens, or the crop is allergenic. In this manuscript, we describe the characteristics of the reagents, validation of assay performance, and data analysis necessary to optimize the information obtained from serum testing of novel proteins and genetically modified (GM) crops and to make results more accurate and comparable between different investigations.

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Citations

Apr 14, 2009·Toxicological Sciences : an Official Journal of the Society of Toxicology·MaryJane K SelgradeSusan A Laessig
May 9, 2009·Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association·Karluss ThomasLaura Privalle
Jul 26, 2011·Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association·Rod A Herman, Gregory S Ladics
Feb 19, 2016·Molecular Nutrition & Food Research·Richard E GoodmanSteve L Taylor
Jul 15, 2020·Journal of the Science of Food and Agriculture·Marana Sandini BorgesDarlene Cavalheiro

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