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Clinical Chemistry and Laboratory Medicine (CCLM)

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

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

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IMPACT FACTOR 2017: 3.556

CiteScore 2017: 2.34

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Source Normalized Impact per Paper (SNIP) 2017: 1.188

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1437-4331
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Volume 46, Issue 9

Issues

Trueness verification of actual creatinine assays in the European market demonstrates a disappointing variability that needs substantial improvement. An international study in the framework of the EC4 creatinine standardization working group

Joris R. Delanghe / Christa Cobbaert
  • 2Amphia Hospital, Breda and Dutch Foundation for Quality Assessment in Clinical Laboratories, Nijmegen, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Marie-Madeleine Galteau / Aimo Harmoinen / Rob Jansen / Rolf Kruse / Päivi Laitinen / Linda M. Thienpont / Birgitte Wuyts / Cas Weykamp / Mauro Panteghini
  • 11Center for Metrological Traceability in Laboratory Medicine (CIRME) and Department of Clinical Sciences, ‘Luigi Sacco’, University of Milan, Milan, Italy
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2008-07-07 | DOI: https://doi.org/10.1515/CCLM.2008.256

Abstract

Background: The European In Vitro Diagnostics (IVD) directive requires traceability to reference methods and materials of analytes. It is a task of the profession to verify the trueness of results and IVD compatibility.

Methods: The results of a trueness verification study by the European Communities Confederation of Clinical Chemistry (EC4) working group on creatinine standardization are described, in which 189 European laboratories analyzed serum creatinine in a commutable serum-based material, using analytical systems from seven companies. Values were targeted using isotope dilution gas chromatography/mass spectrometry. Results were tested on their compliance to a set of three criteria: trueness, i.e., no significant bias relative to the target value, between-laboratory variation and within-laboratory variation relative to the maximum allowable error.

Results: For the lower and intermediate level, values differed significantly from the target value in the Jaffe and the dry chemistry methods. At the high level, dry chemistry yielded higher results. Between-laboratory coefficients of variation ranged from 4.37% to 8.74%. Total error budget was mainly consumed by the bias. Non-compensated Jaffe methods largely exceeded the total error budget. Best results were obtained for the enzymatic method. The dry chemistry method consumed a large part of its error budget due to calibration bias.

Conclusions: Despite the European IVD directive and the growing needs for creatinine standardization, an unacceptable inter-laboratory variation was observed, which was mainly due to calibration differences. The calibration variation has major clinical consequences, in particular in pediatrics, where reference ranges for serum and plasma creatinine are low, and in the estimation of glomerular filtration rate.

Clin Chem Lab Med 2008;46:1319–25.

Keywords: analytical error; bias; calibration; creatinine; external quality assessment; glomerular filtration rate; reference methods

About the article

Corresponding author: Joris R. Delanghe, Department of Clinical Chemistry, De Pintelaan 185, 9000 Gent, Belgium Fax: +32-9-332-4985,


Received: 2008-03-17

Accepted: 2008-05-05

Published Online: 2008-07-07

Published in Print: 2008-09-01


Citation Information: Clinical Chemistry and Laboratory Medicine, Volume 46, Issue 9, Pages 1319–1325, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2008.256.

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©2008 by Walter de Gruyter Berlin New York.Get Permission

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