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Documenting metrological traceability as intended by ISO 15189:2012: A consensus statement about the practice of the implementation and auditing of this norm element by Marc Thelen; Florent Vanstapel; Pika Meško Brguljan; Bernard Gouget; Guilaine Boursier; Edward Barrett; Christos Kroupis; Maria Lohmander; Luděk Šprongl; Tatjana Vodnik; Francisco Bernabeu-Andreu; Ines Vukasović; Çiğdem Sönmez; Solveig Linko; Duilio Brugnoni; Michel Vaubourdolle; Willem Huisman; Mauro Panteghini is a Medicine article available to read on EtoBox.

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## Abstract ISO15189:2012 requires medical laboratories to document metrological traceability of their results. While the ISO17511:2003 standard on metrological traceability in laboratory medicine requires the use of the highest available level in the traceability chain, it recognizes that for many measurands there is no reference above the manufacturer’s selected measurement procedure and the manufacturer’s working calibrator. Some immunoassays, although they intend to measure the same quantity and may even refer to the same reference material, unfortunately produce different results because of differences in analytical selectivity as manufacturers select different epitopes and antibodies for the same analyte. In other cases, the cause is the use of reference materials, which are not commutable. The uncertainty associated with the result is another important aspect in metrological traceability implementation. As the measurement uncertainty on the clinical samples is influenced by the uncertainty of all steps higher in the traceability chain, laboratories should be provided with adequate and appropriate information on the uncertainty of the value assignment to the commercial calibr

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Author

Marc Thelen; Florent Vanstapel; Pika Meško Brguljan; Bernard Gouget; Guilaine Boursier; Edward Barrett; Christos Kroupis; Maria Lohmander; Luděk Šprongl; Tatjana Vodnik; Francisco Bernabeu-Andreu; Ines Vukasović; Çiğdem Sönmez; Solveig Linko; Duilio Brugnoni; Michel Vaubourdolle; Willem Huisman; Mauro Panteghini

Publisher

Walter de Gruyter GmbH

Published

2018

Language

EN

Field

Medicine (Health Sciences)