Trueness verification and traceability assessment of results from commercial systems for measurement of six enzyme activities in serum: an international study in the EC4 framework of the Calibration 2000 project

Clinica Chimica Acta; International Journal of Clinical Chemistry
Rob JansenMauro Panteghini

Abstract

The in vitro diagnostics directive of the European Union requires traceability to higher order reference measurement procedures and materials for analytes in assuring the result trueness and comparability of laboratory measurements. Manufacturers must ensure that the systems they market are calibrated against available reference systems. Validation of metrologically traceable calibrations is, however, required. A commutable serum-based material was analyzed in three reference laboratories and target values for six enzymes (ALT, AST, CK, GGT, LD, amylase) were assigned using IFCC reference measurement procedures. 70 laboratories in Germany, Italy, and The Netherlands measured the same enzymes in the material using procedures from six commercial companies. A system for maximum allowable error was developed from the biological variation model and the results of the various procedures were tested on their compliance to trueness and between-laboratory and within-laboratory variations relative to the maximum allowable. For ALT results were relatively good. >95% of laboratories using systems from Dade, Olympus, Ortho and Roche are expected to comply traceability within the biologically derived limits, and 94% respectively 89% from Abb...Continue Reading

References

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Citations

Feb 2, 2010·Clinical Chemistry and Laboratory Medicine : CCLM·Ilenia InfusinoMauro Panteghini
Nov 3, 2010·Clinical Chemistry and Laboratory Medicine : CCLM·Ferruccio CeriottiUNKNOWN Committee on Reference Systems for Enzymes (C-RSE)
Dec 3, 2013·Clinica Chimica Acta; International Journal of Clinical Chemistry·C PerichR Jansen
Oct 10, 2015·Scandinavian Journal of Clinical and Laboratory Investigation·Fengfeng KangZhiguo Wang
Oct 13, 2006·Liver International : Official Journal of the International Association for the Study of the Liver·Ferruccio CeriottiMauro Panteghini
Mar 17, 2010·Clinica Chimica Acta; International Journal of Clinical Chemistry·Giampaolo CattozzoUNKNOWN Enzyme working group of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC)
Dec 24, 2008·Annals of Clinical Biochemistry·Ferruccio CeriottiMauro Panteghini
Oct 6, 2009·Clinica Chimica Acta; International Journal of Clinical Chemistry·Francesca CanaliasMaribel Sánchez
Feb 6, 2017·Clinics in Laboratory Medicine·David Armbruster
Jun 10, 2008·Clinical Chemistry·Giampaolo CattozzoUNKNOWN Enzyme Working Group of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC)
Jun 16, 2018·Clinical Chemistry·Liesbet DeprezFerruccio Ceriotti
Dec 9, 2016·Clinical Chemistry and Laboratory Medicine : CCLM·Christa Cobbaert
Jan 18, 2018·Clinical Chemistry and Laboratory Medicine : CCLM·Rob T P JansenMarc Thelen
Jul 19, 2016·Clinica Chimica Acta; International Journal of Clinical Chemistry·Yufei WangChuanbao Zhang
Jul 29, 2011·Annals of Clinical Biochemistry·Graham H White

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