Monteiro Bastos da Silva Juliana, Chaker Jade, Martail Audrey, Costa Moreira Josino, David Arthur, Le Bot Barbara
Oswaldo Cruz Foundation (FIOCRUZ), National School of Public Health, Leopoldo Bulhões, 1480, CESTEH, Rio de Janeiro 21041-210, Brazil.
Univ Rennes, Inserm, EHESP, Irset (Institut de Recherche en santé, Environnement et Travail)-UMR_S 1085, F-35000 Rennes, France.
J Xenobiot. 2021 Jan 26;11(1):1-15. doi: 10.3390/jox11010001.
The recent advances of novel methodologies such as non-targeted and suspect screening based on high-resolution mass spectrometry (HRMS) have paved the way to a new paradigm for exposure assessment. These methodologies allow to profile simultaneously thousands of small unknown molecules present in environmental and biological samples, and therefore hold great promises in order to identify more efficiently hazardous contaminants potentially associated with increased risks of developing adverse health outcomes. In order to further explore the potential of these methodologies and push the transition from research applications towards regulatory purposes, robust harmonized quality standards have to be implemented. Here, we discuss the feasibility of using ISO/IEC 17025: 2017 as a guideline to implement non-targeted and suspect screening methodologies in laboratories, whether it is for accreditation purposes or not. More specifically, we identified and then discussed how specificities of non-targeted HRMS methodology can be accounted for in order to comply with the specific items of ISO/IEC 17025: 2017. We also discussed other specificities of HRMS methodologies (e.g., need for digital storage capacity) that are so far not included in the ISO/IEC 17025 requirements but should be considered. This works aims to fuel and expand the discussion in order to subsidize new opportunities of harmonization for non-targeted and suspect screening.
基于高分辨率质谱（HRMS）的非靶向和可疑物筛查等新方法的最新进展，为暴露评估的新范式铺平了道路。这些方法能够同时对环境和生物样品中存在的数千种未知小分子进行分析，因此在更高效地识别可能与不良健康后果风险增加相关的有害污染物方面具有巨大潜力。为了进一步探索这些方法的潜力，并推动从研究应用向监管目的的转变，必须实施稳健统一的质量标准。在此，我们讨论将ISO/IEC 17025: 2017用作实验室实施非靶向和可疑物筛查方法指南的可行性，无论是否用于认可目的。更具体地说，我们确定并讨论了如何考虑非靶向HRMS方法的特殊性，以符合ISO/IEC 17025: 2017的特定条款。我们还讨论了HRMS方法的其他特殊性（例如对数字存储容量的需求），这些特殊性目前未包含在ISO/IEC 17025要求中，但应予以考虑。这项工作旨在推动并扩大讨论，以便为非靶向和可疑物筛查的协调统一提供新机会。
