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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

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Metrological traceability of values for catalytic concentration of enzymes assigned to a calibration material

Francesca Canalias1 / Sandra Camprubí2 / Maribel Sánchez3 / F.-Javier Gella4





Corresponding author: Dr. Francesca Canalias, Universitat Autònoma de Barcelona, Departament de Bioquímica i Biologia Molecular, Unitat de Bioquímica de Medicina, Campus de Bellaterra, Edifici M, 08193 Bellaterra, Spain Phone: +34-935-811575, Fax: +34-935-811573,

Citation Information: Clinical Chemical Laboratory Medicine. Volume 44, Issue 3, Pages 333–339, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2006.058, March 2006

Publication History

September 29, 2005
December 7, 2005


Background: The metrological traceability of values for the catalytic concentration of several enzymes assigned to a calibration material has been assured by following the recently published International Standard ISO 18153.

Methods: A traceable value with a measurement uncertainty was assigned for the catalytic concentration of alanine aminotransferase, creatine kinase, γ-glutamyltransferase and lactate dehydrogenase in two materials from different sources. These are all measurable quantities, with the primary reference measurement procedure described by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and a primary calibrator giving metrological traceability to the SI unit of measurement. The metrologically traceable calibration was validated by measuring human serum samples using the primary reference measurement procedure and a routine commercial measurement procedure calibrated with the traceable materials.

Results: Results showed that the primary reference procedure, selected manufacturers' procedures and the end-user's routine procedure for each enzyme have the same analytical specificity. Four of eight commercial calibrators tested were commutable, whereas the others had a very small difference in absolute terms, indicating that these materials would be useful for calibration.

Conclusion: The implementation of a reference system for enzyme measurements was demonstrated that assures the traceability of patient results to SI units.

Keywords: commercial calibrator; commutability; enzymes; metrological traceability; primary calibrator

Citing Articles

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Laura Rami, Montserrat Roura, and Francesca Canalias
Clinica Chimica Acta, 2012, Volume 413, Number 15-16, Page 1249
Francesca Canalias, Ester García, and Maribel Sánchez
Clinica Chimica Acta, 2010, Volume 411, Number 1-2, Page 7
Brigitte Toussaint, Hendrik Emons, Heinz G. Schimmel, Steffen Bossert-Reuther, Francesca Canalias, Ferruccio Ceriotti, Georges Férard, Carlo A. Ferrero, Paul F.H. Franck, F. Javier Gella, Joseph Henny, Poul J. Jørgensen, Rainer Klauke, Jean-Marc Lessinger, Daniel Mazziotta, Mauro Panteghini, Shigeru Ueda, and Gerhard Schumann
Clinical Chemistry and Laboratory Medicine, 2010, Volume 48, Number 6

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