Author

Sverre Sandberg

3 papers indexed here

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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. · 150th anniversary of the Met... · 0 citations

Sep 2026

Filling the gaps in high-priority reference materials for implementing metrological traceability in laboratory medicine

Abstract The global harmonization of measurements in laboratory medicine is facilitated by the development and implementation of reference measurement systems, including suitable certified reference materials (CRMs). There are, however, a relatively small number of CRM producers worldwide. In the context of limited res...

Mauro Panteghini, C. Cobbaert, V. Delatour et al. · Clinical Chemistry and Labor... · 0 citations

Open access Aug 2026

Model 1b analytical performance specifications – report on the Prague 2025 workshop

Abstract The main purpose of establishing APS is to ensure that test performance aligns with their specific clinical goals. Analytical performance specifications serve multiple functions: as acceptance criteria to verify that in vitro diagnostic medical devices (IVD MD) meet regulatory and quality standards before mark...

A. Horvath, Sverre Sandberg, M. Thelen et al. · Clinical Chemistry and Labor... · 0 citations