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Author

Patricia Kaiser

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. · 0 citations
Review Open access Sep 2026

Strengthening the interpretation of longitudinal EQA data through the sporadic inclusion of native human sera in general clinical chemistry

Comparative external quality assessment (EQA) surveys using native human sera alongside routinely distributed processed EQA materials (EQAMs) provide valuable information on measurement procedure (MP) trueness and the status of standardization. They also allow EQA providers to retrospectively identify critical or l...

L. Vierbaum, Patricia Kaiser, Ingo Schellenberg 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

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