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Licensed Unlicensed Requires Authentication Published by De Gruyter September 21, 2011

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

  • Francesca Canalias , Sandra Camprubí , Maribel Sánchez and F.-Javier Gella

Abstract

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.


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,

References

1. Directive 98/79/EC of the European Parliament and the Council of 27 October 1998 on in vitro diagnostic medical devices.Search in Google Scholar

2. International Organization for Standardization. Medical laboratories – particular requirements for quality and competence. ISO 15189. Geneva: ISO, 2003.Search in Google Scholar

3. International Organization for Standardization. In vitro diagnostic medical devices – measurement of quantities in biological samples – metrological traceability of values assigned to calibrators and control materials. ISO 17511. Geneva: ISO, 2003.Search in Google Scholar

4. International Organization for Standardization. In vitro diagnostic medical devices – measurement of quantities in biological samples – metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials. ISO 18153. Geneva: ISO, 2003.Search in Google Scholar

5. Siekmann L, Bonora R, Burtis CA, Ceriotti F, Clerc-Renaud P, Férard G, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C. Part 1. The concept of reference procedures for the measurement of catalytic activity concentrations of enzymes. Clin Chem Lab Med 2002; 40:631–4.10.1515/CCLM.2002.109Search in Google Scholar PubMed

6. Schumann G, Bonora R, Ceriotti F, Clerc-Renaud P, Ferrero CA, Férard G, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C. Part 2. Reference procedure for the measurement of catalytic concentration of creatine kinase. Clin Chem Lab Med 2002; 40:635–42.10.1515/CCLM.2002.110Search in Google Scholar PubMed

7. Schumann G, Bonora R, Ceriotti F, Clerc-Renaud P, Ferrero CA, Férard G, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C. Part 3. Reference procedure for the measurement of catalytic concentration of lactate dehydrogenase. Clin Chem Lab Med 2002; 40:643–8.10.1515/CCLM.2002.111Search in Google Scholar PubMed

8. Schumann G, Bonora R, Ceriotti F, Férard G, Ferrero CA, Franck PF, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C. Part 4. Reference procedure for the measurement of catalytic concentration of alanine aminotransferase. Clin Chem Lab Med 2002; 40:718–24.10.1515/CCLM.2002.124Search in Google Scholar PubMed

9. Schumann G, Bonora R, Ceriotti F, Férard G, Ferrero CA, Franck PF, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C. Part 5. Reference procedure for the measurement of catalytic concentration of aspartate aminotransferase. Clin Chem Lab Med 2002; 40:725–33.10.1515/CCLM.2002.125Search in Google Scholar PubMed

10. Schumann G, Bonora R, Ceriotti F, Férard G, Ferrero CA, Franck PF, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C. Part 6. Reference procedure for the measurement of catalytic concentration of γ-glutamyltransferase. Clin Chem Lab Med 2002; 40:734–8.Search in Google Scholar

11. Siekmann L, Bonora R, Burtis CA, Ceriotti F, Clerc-Renaud P, Férard G, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C. Part 7. Certification of four reference materials for the determination of γ-glutamyltransferase, lactate dehydrogenase, alanine aminotransferase and creatine kinase according to IFCC reference procedures at 37°C. Clin Chem Lab Med 2002; 40:631–4.10.1515/CCLM.2002.127Search in Google Scholar PubMed

12. Ellison SL, Rosslein M, Williams A, editors. EURACHEM/CITAC guide. Quantifying uncertainty in analytical measurement, 2nd ed. EURACHEM, 2000 (http://www.vtt.fi/ket/eurachem/quam2000-p1.pdf).Search in Google Scholar

13. Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. J Clin Chem Clin Biochem 1983; 21:709–20.Search in Google Scholar

Received: 2005-9-29
Accepted: 2005-12-7
Published Online: 2011-9-21
Published in Print: 2006-3-1

©2006 by Walter de Gruyter Berlin New York

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