Anses, Laboratory of Fougeres, European Union Reference Laboratory (EU-RL) for Antimicrobial and Dye Residue Control in Food-Producing Animals , Fougères, France.
Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2021 Feb;38(2):237-254. doi: 10.1080/19440049.2020.1849821. Epub 2020 Dec 10.
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 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.
在欧盟，为了生产动物源食品，已经禁止将硝基呋喃类药物用于牲畜治疗或预防动物疾病。相应的标记残留是与组织相关的代谢物 AMOZ、AHD、SEM 和 AOZ。欧盟设定的 MRPL（最低要求性能限制）/RPA（行动参考点）为 1μg/kg。因此，所有参与控制硝基呋喃类代谢物的实验室都必须至少在这个性能分析限上进行检测。本报告工作的目的是评估来自两个不同制造商（德国的 R-Biopharm；荷兰的 Europroxima）的 ELISA 试剂盒在水产养殖产品（鱼类、虾类）中对四种硝基呋喃类代谢物（AOZ、AMOZ；AHD；和 SEM）的单独筛选性能，然后根据欧洲决定 EC/2002/657 和欧洲筛选方法验证指南对试剂盒进行验证。来自两个制造商的试剂盒的假阳性率均低于 9%。确定的检测能力 CCβ均低于现行 RPA（1μg/kg）。然而，关于将于 2022 年适用的更新的 0.5μg/kg 的 RPA，R-Biopharm 的 AMOZ 和 SEM 试剂盒以及 Europroxima 的 SEM 试剂盒将无法达到这一标准。
