Global commercial production of genetically modified (GM) crops has grown to over 67 million hectares annually, primarily of herbicide-tolerant and insect protection crop varieties. GM crops are produced by the insertion of specific genes that either encode a protein, or a regulatory RNA sequence. A comprehensive safety evaluation is conducted for each new commercial GM crop, including an assessment of the potential allergenicity of any newly introduced protein. If the gene was derived from an allergenic organism, or the protein sequence is highly similar to a known allergen, immunoassays, e.g., Western blot assays and enzyme-linked immunosorbent assay tests, are performed to identify protein-specific IgE binding by sera of individuals allergic to the gene source, or the source of the sequence-matched allergen. Although such assays are commonly used to identify previously unknown allergens, criteria have not been established to demonstrate that a protein is unlikely to cause allergic reactions. This review discusses factors that affect the predictive value of these tests, including clinical selection criteria for serum donors, selection of blocking reagents to reduce nonspecific antibody binding, inhibition assays to verify specificity of binding, and scientifically justified limits of detection (sensitivity) in the absence of information regarding biological thresholds.
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