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Standardisation of targeted and untargeted metabolomic quantitative methods for their future use in routine clinical diagnosis

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About projekt

Metabolomics methods have the potential to provide highly multiplexed biomarker quantification, offering a reduction in cost and extending current capability to meet the emerging needs of personalised medicine. When operated in a targeted manner, the methods provide metabolite specific concentrations, while untargeted methods provide a wealth of complex (semi) quantitative data. However, the reporting of this data in units that can be easily used in clinical laboratory medicine and the metrological infrastructure to support such innovative methods are lacking. This project aims to generate the knowledge, techniques, and infrastructure that will enable the reporting of metabolomics measurement results that will be traceable to the SI.

 

The specific objectives of the project

  • To improve the comparability of metabolomic methods across laboratories/countries by establishing the reference measurement systems that are needed to support the use of targeted metabolomics data. This will include the fully automated preparation of calibration standards. Reference measurement procedures will be developed for the characterisation of specific multiplexed (> 50 measurands) metabolite standard solutions. These will be suitable for use as calibrators and/or RMs within the traceability requirements of relevant ISO standards (ISO17511, ISO15193, ISO15194, ISO17034). (WP1)​

  • To develop approaches for the standardisation of untargeted methods, which are used to generate large-scale quantitative metabolomic measurement results. This will include the development of calibration strategies, including >10 “beacon” molecules and the selection of internal standards for converting instrument signals to SI-traceable units using chemoinformatic, data mining, machine learning (ML), and artificial intelligence (AI)methods. In addition, to prepare internal standards to allow the reporting of traceable untargeted metabolomics measurement results supported by the development of algorithms and processing protocols. (WP2)

  • To prepare three matrix RMs, which will be regularly improved and updated in collaboration with the Metabolomics Quality Assurance and Quality Control Consortium (mQACC), and to ensure a European contribution to the mQACC to establish and promote QA/QC best practice in metabolomics measurements. (WP3)​

  • To improve the acceptance and use of patient metabolomics measurement results foruse in clinical diagnostics and treatment. This will be addressed in collaboration with agroup of EU clinical omics facilities and Biobanks to ensure that the developed calibrationapproaches help clinical labs meet the ISO15189 requirements. Estimates of theuncertainty, repeatability, reproducibility, and accuracy of the measurement results generated will be provided. To assess the suitability of statistical methods and ML protocolsfor use in metabolomics, including the evaluation of measurement uncertainty in clinical cohorts. (WP4)

  • To establish a sustainable European infrastructure for the standardisation of metabolomics measurement results with support from the European Metrology Network fortraceability in laboratory medicine (EMN TLM) and European and International metabolomics societies. To facilitate the uptake of the metabolomics technology and measurement infrastructure developed in the project by the measurement supply chain (accredited laboratories, instrumentation manufacturers, metabolomics standards providers),legislators, and end users (e.g., clinical laboratory medicine: to support personalised and precision medicine) (WP4 & WP5)