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Commercial ELISA Measurement of Allergens and Gluten: What We Can Learn from Case Studies.

During the last decade, results from ELISA test kits have often been criticized as being flawed. Therefore, it may appear counterintuitive that ELISAs are used for most food allergen and gluten analytical needs. One reason, in addition to the nonavailability of comparable alternative methods, is the fact that the methods used underwent a long validation and learning period in the market. This publication presents several case studies on interference, cross-reactivity issues, calibrators, fragmented allergens and gluten, matrix influences, and misunderstood intended-use statements. Afterward, the relevant validation parameter LOD, LOQ, selectivity, and precision are discussed. Finally, a comprehensive list of practical recommendations for ELISA test kit users is presented.