The European Metrology Network (EMN) “Traceability in Laboratory Medicine” was born in 2019 from the cooperation between metrology institutes and clinical and industrial partners, with the aim of supporting the application of metrology, the science of measurement, to in vitro diagnostic tests, to have accurate and traceable measurements to the International System (SI) of units of measurement, and results comparable from laboratory to laboratory.
In vitro diagnostic (IVD) tests are done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases, infections and health conditions. The results of these tests are not always reliable nor comparable between different laboratories, therefore the network wants to provide support by creating connections at European level, common strategies and synergies that can facilitate the standardization of tests, the creation of guidelines and reference materials where still absent. The metrological traceability and the measurement uncertainty evaluation of IVD tests ensures accurate test results regardless of the laboratory, IVD supplier or instrumentation used for testing. Traceability also reduces the financial burden on healthcare systems by avoiding non-essential testing and enables IVD manufacturers to comply with legal requirements, such as EU Regulation 2017/746 (IVDR), or to gain and maintain market access.
The end users of the work and results of the network, the recipients of the network, are all those who work in the field of IVD, and therefore hospitals, research centers, universities, reference laboratories for IVD tests, manufacturers of reference materials, manufacturers of molecular, biochemical and biological kits in general.
The activities and results of the network are disseminated to a wider audience through workshops, webinars, conference presentations, meetings with experts, stakeholder and other end users and European/World Health and Metrology Days. Furthermore, the network supports several European projects aimed at standardization in medicine and the traceability of measurements in the biomedical field which have highlighted the need for new reference materials and new diagnostic methods in medicine, but also the possibility of improving existing ones, making them standardized and traceable. One example among all is the AntiMicroResist project to improve diagnostic analysis and support the standardization of antimicrobial resistance tests through the development of reference methods and materials. Another example is a survey among European NMIs on the topic of pandemics, with the aim of guaranteeing shared and rapid responses. The contribution of EMN TraceLabMed was to facilitate and expand the dissemination of the survey, also including European calibration laboratories and Joint Research Center of the European Commission
INRiM is an active member of the network and has contributed to the development of the network since its foundation, to the drafting of network documents and guidelines, such as the "Strategic Research Agenda", to the creation of a broader network which also includes companies,clinical laboratories, accreditation bodies, to widely disseminate the network’s results and directly interact with experts. Furthermore, INRiM brings its experience on molecular and cellular biology tests that require standardization, experience also gained in the metrological field, in synergy with other European National Metrology Institutes (NMIs). One of the aims of TraceLabMed is to guide laboratories interested in developing measurement and calibration capabilities, through the organization of interlaboratory measurement comparisons. INRiM has gained this experience and makes it available in the network, helping to increase its potential. Currently, in addition to INRiM, 13 other NMIs and 4 partner bodies are members of the network, including reference centers for the evaluation of the quality of clinical laboratory results (EQAs laboratories), which offer a fundamental contribution to define future steps in the field of metrology for IVD.