Overcoming challenges regarding reference materials and regulations that influence global standardization of medical laboratory testing results
Clinical Chemistry and Laboratory Medicine (CCLM), vol. 61, pp. 48–54
Abstract
Abstract Background 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 In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples. 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. Discussion The participants agreed that prioritization of measurands for standardization should be based on their impact on medical decisions in a clinical pathway. Ensuring that matrix-based CRMs are globally available for more measurands will enable fit-for-purpose calibration hierarchies for more laboratory tests. Regulation of laboratory tests is important to ensure safety and effectiveness for the populations served. Because regulations are country or region specific, manufacturers must submit recalibration changes intended to standardize results for regulatory review to all areas in which a measuring system is marketed. Recommendations A standardization initiative requires collaboration and planning among all interested stakeholders. Global collaboration should be further developed for prioritization of measurands for standardization, and for coordinating the production and supply of CRMs worldwide. More uniform regulatory submission requirements are desirable when recalibration is implemented to achieve internationally standardized results.
Authors 9
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W. Greg Miller corresponding
Virginia Commonwealth University
Affiliation as printed
Department of Pathology , Virginia Commonwealth University , Richmond , VA , USA
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Affiliation as printed
Myers Consulting , Smyrna , GA , USA
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Leiden University · Leiden University Medical Center
Affiliation as printed
Department of Clinical Chemistry and Laboratory Medicine , Leiden University Medical Centre , Leiden , The Netherlands
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Affiliation as printed
Centre for Public Health, Queens University Belfast , Belfast , Northern Ireland
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Affiliation as printed
Department of Biomedical and Clinical Science, Clinical Chemistry , Linköping University , Linköping , Sweden
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Bureau international des poids et mesures
Affiliation as printed
Bureau International des Poids et Mesures (BIPM) , Sèvres Cedex , France
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Bureau international des poids et mesures
Affiliation as printed
Bureau International des Poids et Mesures (BIPM) , Sèvres Cedex , France
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Bureau international des poids et mesures
Affiliation as printed
Bureau International des Poids et Mesures (BIPM) , Sèvres Cedex , France
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Centre Hospitalier Universitaire de Reims
Affiliation as printed
Laboratory of Biochemistry-Pharmacology-Toxicology, University Hospital of Reims , Reims , France
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