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AbstractThis 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. [ABSTRACT FROM AUTHOR]

The administration of nitrofurans to livestock to treat or prevent animal diseases has been banned in the EU for the production of food of animal origin. The corresponding marker residues are tissue-related metabolites AMOZ, AHD, SEM, and AOZ. The MRPL (minimum required performance limit)/RPA (Reference point for action) was set at 1 µg kg−1 in the EU. Thus, all the laboratories involved in the control of nitrofuran metabolites must detect at least at this analytical limit of performance. The objectives of the work reported here were to evaluate the performance of ELISA kits from two different manufacturers (R-Biopharm, Germany; Europroxima, the Netherlands) for the individual screening of the four nitrofuran metabolites (AOZ, AMOZ; AHD; and SEM) in aquaculture products (fish, shrimps), and then to validate the kits according to the European Decision EC/2002/657 and to the European guideline for the validation of screening methods. The false positive rates were below 9 % for the kits from both manufacturers. The detection capabilities CCβ determined were all below the current RPA (1 µg/kg). However, regarding the updated RPA at 0.5 µg/kg that shall apply in 2022, the AMOZ and SEM kits from R-Biopharm and the SEM kit from Europroxima will not be able to reach it. [ABSTRACT FROM AUTHOR]