Analytical criteria for performance characteristics of IgE binding methods for evaluating safety of biotech food products.
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.
Holzhauser
Thomas
T
Division of Allergology, Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51-59, 63225 Langen, Germany. holth@pei.de
Ree
Ronald van
Rv
Poulsen
Lars K
LK
Bannon
Gary A
GA
D000485:Allergens / Q000276:immunology*; D003257:Consumer Product Safety; D004044:Dietary Proteins / Q000276:immunology*; D005512:Food Hypersensitivity / Q000175:diagnosis* / Q000517:prevention & control; D030841:Food, Genetically Modified / Q000009:adverse effects; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood* / Q000276:immunology; D030821:Plants, Genetically Modified / Q000276:immunology*
D000485:Allergens; D004044:Dietary Proteins; D007073:Immunoglobulin E