Metrological traceability and harmonization of medical tests: a quantum leap forward is needed to keep pace with globalization and stringent IVD-regulations in the 21st century!

Clin Chem Lab Med. 2018 Sep 25;56(10):1598-1602. doi: 10.1515/cclm-2018-0343.

Authors

Christa Cobbaert¹, Nico Smit², Philippe Gillery³

Affiliations

¹ Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, P.O. Box 9600, 2300 RC Leiden, The Netherlands.
² Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, The Netherlands.
³ University of Reims Champagne-Ardenne, Faculty of Medicine, UMR CNRS/URCA n° 7369, and University Hospital of Reims, Department of Biochemistry, Reims, France.

PMID: 29730648
DOI: 10.1515/cclm-2018-0343

No abstract available

Keywords: IVDR 2017/746; globalization; metrological traceability; test harmonization; test standardization.

Publication types

Historical Article

MeSH terms

Calibration
Clinical Laboratory Techniques / standards
Diagnostic Tests, Routine / history
Diagnostic Tests, Routine / standards*
Equipment and Supplies / standards
Guidelines as Topic
History, 21st Century
Laboratories, Hospital / standards*
Laboratory Personnel
Societies, Scientific