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M. Milavec

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2025

The COMET Project : Manufacturing commutable calibrators and quality control materials for standardisation and post-market surveillance of 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...

V. Delatour, Amandine Boeuf, Chiara Giangrande et al. · 0 citations
Review 2025

The European Metrology Network TraceLabMed : coordinating activities of European NMIs/DIs and calibration laboratories in the field of laboratory Medicine

A coherent strategy for a joint European response to the need for establishing and verifying results metrological traceability in accordance with the IVD Regulation (EU) 2017/746 is created.

V. Delatour, G. O'Connor, Rainer Stosch et al. · 0 citations
Open access Jul 2026

New candidate reference measurement procedure for NRAS p.Q61R quantification by digital PCR.

Overall, this work establishes a metrologically characterized and transferable dPCR-based RMP for NRAS p.Q61R quantification that can support the harmonization of molecular measurements, the value assignment of RM, and the alignment of routine and secondary methods, thereby strengthening the reliability of quantitative...

Jessica Petiti, Sabrina Caria, L. Revel et al. · 0 citations

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