Abstract
In this paper, the creation of a certified reference material for urinary creatinine is described. We used the Jaffe method and HPLC method for establishment of the certified value. Homogeneity tests are also described. We obtained material with sufficient homogeneity, stability, and with certified value (expanded uncertainty, k=2 for CI 95%) (7.77±0.27) mmol·L−1. This material was consequently used for the interlaboratory comparison (EQA Czech Republic for clinical chemistry). Twenty-nine percent of the participants obtained measurement results within the interval of the certified value ± expanded uncertainty, while 85% of the participants obtained values inside the interval of the certified value ± target measurement uncertainty. Direct use of the certified reference materials for method evaluation in EQA programs means a significant advance for monitoring and documentation traceability of results in routine measurements.
Similar content being viewed by others
References
Bardoděj Z, David A, Šedivec V, Škramovský S, Teisinger J (1980) (eds) Exposure tests in industrial toxicology, AVICENUM, pp 39, 291, 308
Narayanan S, Appleton HD (1980) Clin Chem 26:1119–1126
Van Nevel L, Ornemark U, Smeyers P, Harper C, Taylor PDP (2002) IMEP-17 Report to Participants, Part 1 International Comparability
Stokes P, O Connor GJ (2003) Chromatogr B 794:125–136
Šperlingová I, Dabrowská L, Kučera J, Tichý M (1995) Fresenius J Anal Chem 325:87–91
Jaffe M (1886) Z Physiol Chem 10:391
Schneiderka P, Pacáková V, Štulík K, Jelínková K (1993) J Chromatogr 614:221
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998on in vitro diagnostic medical devices. Official Journal of the European Communities 1998; Dec 7: L 331/1-L 331/37
Die Richtlinie der Bundesärztekammer zur Qualitätssicherung quantitativer laboratoriummedizinischer Untersuchungen. Deutsches Ärzteblatt (2003) 100/50 3335–3339
ISO 17 511:2003 Measurement of quantities in samples of biological origin – Metrological traceability of values assigned to calibrators and control materials. ISO, Geneva, Switzerland
Siekmann L (1985) Determination for creatinine in human serum by isotope dilution – mass spectrometry. J Clin Chem Clin Biochem 23:137–144
Stöckl D, Franzini C, Kratochvila J, Middle J, Ricos C, Siekmann L, Thienpont LM (1996) Analytical specification of reference methods – compilation and critical discussion. Eur J Clin Chem Clin Biochem 34:319–337
Traceability of chemical measurements. Application of reference material in chemical analysis. In: Kvalimetrie, Suchánek M (ed) EURACHEM-ČR, Prague 2004 (in Czech)
Acknowledgements
This work was supported by the Internal Grant Agency of Ministry of Health of the Czech Republic (Grant NR/7831–3) and by SEKK-EQA System Ltd Pardubice.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Kratochvíla, J., Friedecký, B., Budina, M. et al. Creatinine determination in urine from the point of view of reference values. Accred Qual Assur 12, 146–150 (2007). https://doi.org/10.1007/s00769-006-0195-8
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00769-006-0195-8