Filling the gaps in high-priority reference materials for implementing metrological traceability in laboratory medicine

Abstract

Abstract The global harmonization of measurements in laboratory medicine is facilitated by the development and implementation of reference measurement systems, including suitable certified reference materials (CRMs). There are, however, a relatively small number of CRM producers worldwide. In the context of limited resources, strategic prioritization and coordinated action among CRM producers are critical. This position paper summarizes a Joint Committee for Traceability in Laboratory Medicine (JCTLM) workshop held in May 2026 that addressed the prioritization issue and relied on feedback from standardization leaders, experts in the field, and representatives of CRM producers. The workshop goals were to: a) determine whether ongoing activities can meet high-priority CRM development and maintenance needs; b) assess existing prioritization exercises and their level of consistency; and c) make recommendations on how to optimize processes for filling gaps in CRM availability, maintaining CRM supply, and avoiding unnecessary CRM redundancy. The identified stakeholder gaps and needs, the proposed solutions to address these needs, and an outline of a global coordination framework to optimize CRM coverage are discussed.