Accurate, informative, and comparable biomarker measurements from commercial in vitro diagnostic (IVD) tests are essential for sound medical decision-making. In accordance with the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the metrological traceability of values assigned to calibrators and/or control materials must be ensured through appropriate reference measurement procedures (RMPs) and/or certified reference materials (CRMs) of higher metrological order.
Despite this requirement, there remains a significant shortage of biological CRMs and RMPs. While ISO 17511:2020 outlines alternative pathways for establishing traceability, achieving this through the highest metrological standards remains the preferred approach whenever feasible.
Why we need your help
The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the European Metrology Network for Traceability in Laboratory Medicine (EMN-TLM) are conducting this survey to gather crucial input from industry professionals. The goal is to determine which measurands should be prioritised in the development of Reference Measurement Procedures (RMPs), Certified Reference Materials (CRMs), and calibration services. This essential feedback will support Reference Materials producers and developers of Reference Measurement Procedures prioritise their activities.
Moreover, it will enable the metrology community to evaluate the technical feasibility of creating reference standards within a reasonable timeframe, and to establish a coordinated research and development roadmap to address these needs promptly. Your insights are invaluable in enhancing metrological traceability in laboratory medicine. We kindly ask that you take the survey which will take approximately 15 minutes to complete.
The survey can be accessed via the link provided. Complete survey here
The EMN TraceLabMed
The European Association of National Metrology Institutes, EURAMET, has recognised the strategic importance of laboratory diagnostics as a key backbone for safe and reliable patient diagnosis in Europe. To address this challenge, they created the European Metrology Network (EMN) on Traceability in Laboratory Medicine (TLM) to focus on the European and global metrology needs and to support IFCC and industry efforts in this field.
More information about the EMN TLM can be found here.
Thank you for your valuable contribution!
