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

Clinical Chemistry and Laboratory Medicine (CCLM)

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.

Authors 13

1. Mauro Panteghini

   Nicolaus Copernicus University · Collegium Medicum in Bydgoszcz

   Affiliation as printed

   Department of Laboratory Medicine , Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun , Torun , Poland

2. Christa M. Cobbaert Aachen Department of Clinical Chemistry Laboratory Medicine

   Leiden University · Leiden University Medical Center

   Affiliation as printed

   Department of Clinical Chemistry and Laboratory Medicine , Leiden University Medical Centre , Leiden , the Netherlands

3. Vincent Delatour

   Laboratoire National de Métrologie et d'Essais

   Affiliation as printed

   Laboratoire National de Métrologie et d’Essais , Paris , France

4. Liesbet Deprez

   European Commission · Joint Research Center

   Affiliation as printed

   European Commission, Joint Research Centre (JRC) , Geel , Belgium

5. Anja Keßler

   Reference Institute for Bioanalytics · Foundation for Pathobiochemistry and Molecular Diagnostics

   Affiliation as printed

   Reference Institute for Bioanalytics (RfB), Foundation for Pathobiochemistry and Molecular Diagnostics (SPMD) , Bonn , Germany

6. Magdalena Krintus

   Nicolaus Copernicus University · Collegium Medicum in Bydgoszcz

   Affiliation as printed

   Department of Laboratory Medicine , Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun , Torun , Poland

7. Gavin O’Connor

   Physikalisch-Technische Bundesanstalt

   Affiliation as printed

   Physikalisch-Technische Bundesanstalt (PTB) , Braunschweig , Germany

8. Karen Phinney

   National Institute of Standards and Technology · Material Measurement Laboratory

   Affiliation as printed

   Biomolecular Measurement Division, Material Measurement Laboratory, National Institute of Standards and Technology (NIST) , Gaithersburg , MD , USA

9. Sverre Sandberg

   Haukeland University Hospital · University of Bergen

   Affiliation as printed

   Department of Global Public Health and Primary Care , University of Bergen , Bergen , Norway

   Department of Medical Biochemistry and Pharmacology , Norwegian Organization for Quality Improvement of Laboratory Examinations (NOKLUS), Haraldsplass Deaconess Hospital, Bergen, Norway Norwegian Porphyria Centre, Haukeland University Hospital , Bergen , Norway

10. Dewei Song

    National Institute of Metrology

    Affiliation as printed

    Division of Chemical Metrology and Analytical Science, National Institute of Metrology (NIM) , Beijing , China

11. Claudia Swart

    Physikalisch-Technische Bundesanstalt

    Affiliation as printed

    Physikalisch-Technische Bundesanstalt (PTB) , Braunschweig , Germany

12. Christian Vogl
    Affiliation as printed

    Roche Diagnostics GmbH , Penzberg , Germany

13. R. Wielgosz

    Bureau international des poids et mesures

    Affiliation as printed

    Bureau International des Poids et Mesures (BIPM) Sèvres , France