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Manufacturing of commutable calibrators and quality control materials for standardisation

Medical decisions often depend on accurate, informative and comparable biomarker measurement results from commercial in vitro diagnostic (IVD) tests. According to the in vitro diagnostic regulation (IVDR) EU/2017/746, the metrological traceability of values assigned to calibrators and/or control materials shall be assured through suitable reference measurement procedures (RMPs) and/or suitable Certified Reference Materials (CRMs) of a higher metrological order. Due to a lack of biological CRMs and RMPs (spanning from small molecules to protein to nucleic acids), IVD manufacturers are often unable to comply with regulation. This project will enable the IVD industry to meet the requirements of the IVDR EU/2017/746 regarding metrological traceability and performance verification of IVD tests. This will be achieved by establishing the necessary metrological infrastructure to provide cost-effective calibration services to IVD manufacturers to properly establish calibrated IVD tests and better monitor their performance. New certified reference materials and quality control materials will be produced for IVD tests which are in need for standardisation and post-market surveillance. By developing more efficient ways to conduct commutability studies, the project will identify common causes of poor commutability and improve the manufacturing process.

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The project (23IND02 COMET) has received funding from the European Partnership on Metrology, co-financed from the European Union’s Horizon Europe Research and Innovation Programme and by the Participating States.

Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or EURAMET. Neither the European Union nor the granting authority can be held responsible for them.

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COMET session at the EQALM Symposium in Vienna

septembre 27, 2024

Kickoff meeting

septembre 27, 2024

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