Pascale Michelangelo, De Girolamo Annalisa, Lippolis Vincenzo, Stroka Joerg, Mol Hans G J, Lattanzio Veronica M T
National Research Council of Italy, Institute of Sciences of Food Production, Via G. Amendola 122/O, 70126 Bari, Italy.
European Commission, Joint Research Centre-Geel, Retieseweg 111, B-2440 Geel, Belgium.
J AOAC Int. 2019 Nov 1;102(6):1708-1720. doi: 10.5740/jaoacint.19-0068. Epub 2019 May 21.
The co-occurrence of regulated mycotoxins in foods and feeds, together with modified ("masked") and emerging mycotoxins, has been increasingly reported worldwide in recent years. Therefore, sensitive, accurate, and validated methods for the simultaneous determination of these hazardous contaminants in different matrices are highly demanded to fulfil regulatory requirements and to carry out reliable surveillance programs. In these last years, LC-MS methodologies for multimycotoxin screening and/or quantification are being routinely used in control laboratories. However, to date, only one European Standard for multimycotoxin determination is based on LC-MS (EN 16877:2016). The need for standardized LC-MS methods for multimycotoxin determination has been highlighted by regulatory authorities and scientific advisory bodies, including the U.S. Food and Drug Administration and the European Commission. The European Committee for Standardization (CEN) has issued calls for tender for the development of standardized LC-MS methods for mycotoxins in food and animal feeding stuffs. As deliverables, some LC-MS based methods for multimycotoxin determination are currently under approval as European Standards. In addition, the European Commission has recently established specific criteria with which screening methods for mycotoxins, including LC-MS methods, have to comply for use for regulatory purposes. Validation procedures by single-laboratory and collaborative trials have been defined. This paper provides insights and advances on guidelines and tools for performance evaluation of LC-MS methods intended for quantitative determination and for semiquantitative screening of multimycotoxins. In particular, performance criteria set in the European Union and the United States are critically overviewed, and expectations, needs, and future challenges relevant to LC-MS methods for multimycotoxin determination are also discussed.
近年来，世界各地越来越多地报道了食品和饲料中受管制的霉菌毒素与改性（“隐蔽”）霉菌毒素和新出现的霉菌毒素同时存在的情况。因此，迫切需要灵敏、准确且经过验证的方法，以同时测定不同基质中的这些有害污染物，从而满足监管要求并开展可靠的监测计划。在过去几年中，用于多霉菌毒素筛查和/或定量的液相色谱-质谱（LC-MS）方法已在控制实验室中常规使用。然而，迄今为止，只有一项基于LC-MS的多霉菌毒素测定欧洲标准（EN 16877:2016）。监管机构和科学咨询机构，包括美国食品药品监督管理局和欧盟委员会，都强调了制定多霉菌毒素测定标准化LC-MS方法的必要性。欧洲标准化委员会（CEN）已发布招标书，以开发食品和动物饲料中霉菌毒素的标准化LC-MS方法。作为交付成果，一些基于LC-MS的多霉菌毒素测定方法目前正在作为欧洲标准进行审批。此外，欧盟委员会最近制定了具体标准，包括LC-MS方法在内的霉菌毒素筛查方法必须符合这些标准才能用于监管目的。已经定义了单实验室验证程序和协同试验。本文提供了有关用于多霉菌毒素定量测定和半定量筛查的LC-MS方法性能评估的指南和工具的见解与进展。特别是，对欧盟和美国设定的性能标准进行了批判性概述，并讨论了与多霉菌毒素测定LC-MS方法相关的期望、需求和未来挑战。
