Validation of the method for determining the egg albumin allergen in food products by enzyme-linked immunosorbent assay

Abstract

An egg is an ecological food product containing protein, balanced vitamins, trace elements, and essential amino acids in the correct ratio. At the same time, egg albumin is an obligate allergen with no species specificity; consuming eggs from other birds does not eliminate the risk of an allergic reaction. The development of an allergy to chicken eggs in children, manifested by exudative diathesis, is especially likely. Allergy to egg protein leads to deterioration of the quality of life and health; therefore, its detection in food products is relevant today. The article contains information on the validation of the method of determining the egg protein content in food products by the enzyme-linked immunosorbent assay method and the main parameters for assessing the suitability of this method. The quantitative determination of processed chicken egg protein in food products was validated using the Ridascreen Egg ELISA test system, R-Biopharm, based on the State Research Institute for Laboratory Diagnostics and Veterinary-Sanitary Examination. The material for the study was negative samples of the matrix and enriched samples of CRM (certified reference material cake mix). Validation of the method for the quantitative determination of processed chicken egg protein in food products was carried out by determining and evaluating the following parameters: the limit of detection, quantification, convergence, reproducibility, accuracy, and uncertainty. The ELISA method for quantitatively determining processed chicken egg protein in food products has been successfully tested and meets the requirements of EU Commission Regulation 2002/657; all validation parameters are within acceptable limits. The method is suitable for food research and recommended for testing laboratories.