Journal article

Defining acceptable limits for the metrological traceability of specific measurands

Renze Bais, Dave Armbruster, Rob TP Jansen, George Klee, Mauro Panteghini, Joseph Passarelli, Ken A Sikaris

CLINICAL CHEMISTRY AND LABORATORY MEDICINE | WALTER DE GRUYTER GMBH | Published : 2013

Abstract

Although manufacturers are compelled by the European IVD Directive, 98/79/EC, to have traceability of the values assigned to their calibrators if suitable higher order reference materials and/or procedures are available, there is still no equivalence of results for many measurands determined in clinical laboratories. The adoption of assays with metrological traceable results will have a significant impact on laboratory medicine in that results will be equivalent across different laboratories and different analytical platforms. The IFCC WG on Allowable Errors for Traceable Results has been formed to define acceptable limits for metrological traceability chains for specific measurands in order..

View full abstract

University of Melbourne Researchers