Inspired by measurement: impact of the (r)evolution in metrology on laboratory medicine - Christa Cobbaert
Christa Cobbaert, Professor and Chair of the IFCC Scientific Division
Leiden University Medical Centre, Leiden, the Netherlands
Modern metrology is the result of more than 200 years of development that began with the creation of the decimal metric system at the time of the French Revolution and the beginning, at about the same time, of mass production using interchangeable parts. This plenary lecture will trace these developments and will reveal how world metrology is organized today. Main emphasis will be given to applications and challenges of metrology in laboratory medicine.
The sciences of metrology, laboratory medicine and laboratory quality management were brought together by The Joint Committee for Traceability in Laboratory Medicine (JCTLM). The aim of this collaboration is to support worldwide comparability and equivalence of measurement results in clinical laboratories for the purpose of improving healthcare. The JCTLM has its origins in the activities of international metrology treaty organizations, professional societies and federations devoted to improving measurement quality in physical, chemical and medical sciences. The three founding organizations, the International Committee for Weights and Measures (CIPM), the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the International Laboratory Accreditation Cooperation (ILAC) are the leaders of this activity. The main service of the JCTLM is an open access web-based database (https://www.jctlmdb.org/#/app/home) with a list of higher-order reference materials, measurement methods and services to be used in calibration hierarchies for value assigning calibrators and trueness control materials for quantities measured by in vitro diagnostic medical devices.
The listed reference materials, measurement methods and services when applied following the models described in ISO 17511:2020, ‘In vitro diagnostic medical devices —Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples’, can be used to establish metrological traceability. As of mid-2023 the database lists 284 reference materials, 217 reference measurement procedures and 247 reference measurement services. Database entries have undergone independent review and are compliant with the criteria in documentary standards developed by ISO TC 212 WG2 (Reference Measurement Systems), with reference measurements services listed for accredited calibration laboratories, as described in the JCTLM procedures. This database allows IVD-manufacturers to select internationally endorsed references for medical tests traceability and provides support for suppliers of these services. So far, there remains a need for the development and implementation of metrological traceability in many areas of laboratory medicine. Therefore, the JCTLM committee and its founders continuously promote and facilitate these activities.