Comparative assessment of commercial ELISA kits for the screening of chloramphenicol residues in meat and aquaculture products according to European Regulation (EU) 2021/808 and to the new Reference Point for Action (Commission Regulation (EU) 2019/1871).

Abstract

This study covered the evaluation of performance characteristics and validation of five commercial ELISA kits for the detection of a banned antimicrobial, chloramphenicol (CAP), in muscle and aquaculture products. CAP has been banned in the European Union since 1994, but is still authorised in some countries in the world. In 2019, the European Union set a new Reference Point for Action (RPA), decreasing the acceptable limit of CAP in animal tissues for human consumption from 0.30 µg/kg to 0.15 µg/kg. Validations were performed according to the European Regulation EC/2021/808 and to the European Guideline on Screening Method Validation (2023). The detection capabilities CCβ were all determined under the RPA, but were 3 to 15 times higher than the announced limit of detection (LOD). False negative rates were satisfactory for all the kits (≤ 5%) and false positive rates were acceptable. All of them were found out to be applicable to aquaculture products and meat at a common CCβ.