1. Development, Validation, and Interlaboratory Evaluation of a Quantitative Multiplexing Method To Assess Levels of Ten Endogenous Allergens in Soybean Seed and Its Application to Field Trials Spanning Three Growing Seasons
- Author
-
Ryan Christopher Hill, Rowel Tobias, Austin Xu, Jason Bradshaw, Guomin Shan, Barry W. Schafer, Trent J. Oman, Bhaskar Malayappan, Li Sheng, Rod A. Herman, Xiujuan Wang, and Jeff Shippar
- Subjects
Growing season ,Natural variation ,medicine.disease_cause ,Mass Spectrometry ,0404 agricultural biotechnology ,Allergen ,Lc ms ms ,medicine ,Multiplex ,Chromatography, High Pressure Liquid ,Chemistry ,business.industry ,Genetically engineered ,Soybean allergen ,food and beverages ,04 agricultural and veterinary sciences ,General Chemistry ,Allergens ,Antigens, Plant ,Plants, Genetically Modified ,040401 food science ,Biotechnology ,Seeds ,Soybean Proteins ,Seasons ,Soybeans ,General Agricultural and Biological Sciences ,business - Abstract
As part of the regulatory approval process in Europe, comparison of endogenous soybean allergen levels between genetically engineered (GE) and non-GE plants has been requested. A quantitative multiplex analytical method using tandem mass spectrometry was developed and validated to measure 10 potential soybean allergens from soybean seed. The analytical method was implemented at six laboratories to demonstrate the robustness of the method and further applied to three soybean field studies across multiple growing seasons (including 21 non-GE soybean varieties) to assess the natural variation of allergen levels. The results show environmental factors contribute more than genetic factors to the large variation in allergen abundance (2- to 50-fold between environmental replicates) as well as a large contribution of Gly m 5 and Gly m 6 to the total allergen profile, calling into question the scientific rational for measurement of endogenous allergen levels between GE and non-GE varieties in the safety assessment.
- Published
- 2017
- Full Text
- View/download PDF