Overcoming challenges regarding reference materials and regulations that influence global standardization of medical laboratory testing results.
Fiche publication
Date publication
octobre 2022
Journal
Clinical chemistry and laboratory medicine
Auteurs
Membres identifiés du Cancéropôle Est :
Pr GILLERY Philippe
Tous les auteurs :
Miller WG, Myers G, Cobbaert CM, Young IS, Theodorsson E, Wielgosz RI, Westwood S, Maniguet S, Gillery P
Lien Pubmed
Résumé
Standardized results for laboratory tests are particularly important when their interpretation depends on fixed medical practice guidelines or common reference intervals. The medical laboratory community has developed a roadmap for an infrastructure to achieve standardized test results described in the International Organization for Standardization standard 17511:2020 . Among the challenges to implementing metrological traceability are the availability of fit-for-purpose matrix-based certified reference materials (CRMs) and requirements for regulatory review that differ among countries. A workshop in December 2021 focused on these two challenges and developed recommendations for improved practices.
Mots clés
certified reference material, harmonization, regulations, standardization
Référence
Clin Chem Lab Med. 2022 10 17;: