Stimulating dialogue and planning a metrology infrastructure for traceability in laboratory medicine
Insufficient reliability and comparability in clinical testing negatively affects the health outcomes of European citizens. Disease diagnostics and health monitoring test kits would offer better quality results if they were comparable, independent of measurement procedure or laboratory performing the measurement, yet most important tests lack SI traceability to referenced measurement procedures or certified reference materials. With a backdrop of European regulations now requiring metrologically-based quality assessments of in vitro diagnostic device tests, EURAMET is supporting a European Metrology Network on Traceability in Laboratory Medicine to prioritise stakeholder needs, coordinate services, and foster standards development.
This project will accelerate development of the network, by promoting dialogue among measurement institutes and stakeholders, and by supporting a metrology infrastructure for traceability in laboratory medicine. The project will integrate proficiency testing schemes for reference laboratories and develop strategies to prioritise tests for which SI-traceability is required. Successful implementation of the new European regulation offers the prospect of more accurate clinical diagnostics, benefiting patients and lowering costs for healthcare systems.