Metrological traceability in laboratory medicine |
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Authors: | R Dybkaer |
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Institution: | (1) Department of Standardization in Laboratory Medicine, Frederiksberg Hospital, H:S Copenhagen Hospital Corporation, Copenhagen, Denmark Fax: +45 38 16 38 79, DK |
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Abstract: | The establishment of a reference examination system necessary for metrological traceability of the many types of sophisticated
examination result in laboratory medicine is a daunting task, which has been made mandatory by the EU Directive on in vitro
diagnostic medical devices and the requirements for accreditation. Following a definition of examinand and allowed examination
uncertainty, a dedicated calibration hierarchy is established from stated reference through alternating reference examination
procedures and calibrators providing a traceability chain from examination result to the reference, often a definition of
a measurement unit. The various types of possible calibration hierarchy are outlined in EN ISO Standards. Recent efforts by
national and international stakeholders to establish a global reference examination system have led to the creation of a Joint
Committee on Traceability in Laboratory Medicine with the International Committee for Weights and Measures, International
Bureau of Weights and Measures, International Federation of Clinical Chemistry and Laboratory Medicine, International Laboratory
Accreditation Cooperation, and World Health Organization as the principal promoters. This structure will identify reference
procedures, reference materials, and reference laboratories, and seek support for further prioritised and coordinated development
of the system.
Received: 1 August 2002 Accepted: 22 November 2002
Based on a lecture at an IUPAC Seminar, EC JRC Institute for Reference Materials and Measurements, Geel, BE, 2001–12–18
Correspondence to R. Dybkaer |
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Keywords: | Calibration hierarchy Comparability of results Joint Committee on Traceability in Laboratory Medicine Metrological traceability Reference examination system |
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