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Author

Sverre Sandberg

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Review Oct 2026

A-203 Biological variation reference data; EFLM initiatives and developments to address data quality issues and deliver reliable data.

Biological variation data (BVD), which describes within-subject (CVI) and between-subject (CVG) variability of laboratory measurands, are essential reference data in laboratory medicine. BVD are used to define analytical performance specifications (APS) for imprecision, bias, maximum allowable measurement uncerta...

Kornelia D. Galior, William A. Bartlett, Sverre Sandberg et al. · 0 citations
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
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. · 0 citations
Open access Aug 2026

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

This report presents the expert presentations from the 2025 workshop, which exclusively focused on APS based on Model 1b, which effectively supported the European Federation of Clinical Chemistry and Laboratory Medicine’s database and its interactive tools for calculating APS.

A. Horvath, Sverre Sandberg, M. Thelen et al. · 0 citations

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