Abstract
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.
Highlights
Exposure assessment is the process of measuring or estimating the intensity, frequency, and duration of human exposures to an environmental agent [1]
The normative requirements of ISO/IEC 17025 regarding measurement uncertainties are focused on quantitative results, which is coherent in the case of targeted analyses, as these results are usually the main pursued objective
In the context of an accredited laboratory already relying on this framework for targeted analyses, or of a team or a scientist’s individual will, the ISO/IEC 17025 framework can be a useful tool to formalize quality assurance and quality control procedures in non-targeted analyses (NTA)/suspect screening (SS) studies
Summary
Exposure assessment is the process of measuring or estimating the intensity, frequency, and duration of human exposures to an environmental agent [1]. In the last few years, the advances of new technologies based on high-resolution mass spectrometry (HRMS), usually coupled to liquid or gas chromatography, and omics-based methodologies have been implemented to profile thousands of unknown small molecules (mass-to-charge ratio comprised between 50 and 1500) in complex samples [3,4] Some of these small molecules profiled with HRMS include organic contaminants mixtures, and all their transformation products present in the environment and that can accumulate in humans through different routes of exposure. These new approaches based on non-targeted analyses (NTA) and suspect screening (SS) strategies hold great promises to help identifying emerging substances or characterizing mixtures in samples without requiring a predefined list of compounds of interest [2]. It must be noted that it is hardly possible to avoid all initial hypothesis, since choice of sample preparation and analysis method enforce restrictions on the observable chemical space (e.g., eliminating compounds when using selective sample preparation methods or seeing mainly volatile compounds when using gas chromatography); NTA truly aims to limit restrictions as much as possible
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