Evaluation of the analytical reliability of methods for allergen analysis

The presence of undeclared allergens in food poses a significant health risk to individuals with food allergies. Central public health laboratories carry out fiscal analyses to ensure compliance in products subject to health surveillance. Reliable allergen detection requires robust, validated, and traceable methods capable of producing accurate and reliable results. In this context, proficiency tests (PE) are essential tools for verifying laboratory performance and ensuring the quality of results. This study evaluated the performance of the Product Physical Chemistry Service of the Health Surveillance Division of the Ezequiel Dias Foundation (FUNED) in PEs promoted by the Food Analysis Performance Assessment Scheme (FAPAS), in the year 2025. Three rounds of PE were evaluated, covering five samples and 15 trials. The matrices analyzed included: baked biscuit (gluten, total milk protein – PTL, casein, beta-lactoglobulin and egg), cumin powder (gluten) and infant formula (gluten, PTL, casein and beta-lactoglobulin). The analyses were performed by ELISA and immunochromatography techniques, with previously validated commercial R-Biopharm® kits. The results were compiled from the performance reports, and the evaluation was carried out by the z-score index (satisfactory: ≤|2|; questionable: >|2|; unsatisfactory: ≥|3|) for the quantitative tests and by agreement with the expected result, for the qualitative tests. Of the 15 trials performed, 13 presented satisfactory results, 2 questionable and none unsatisfactory.