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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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1437-4331
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Volume 43, Issue 3

Issues

External Quality Assessment in The Netherlands: time to introduce commutable survey specimens. Lessons from the Dutch “Calibration 2000” project

Henk Baadenhuijsen
  • Dutch Foundation for Quality Assessment in Clinical Laboratories, University Hospital Nijmegen, Nijmegen, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Aldy Kuypers
  • Dutch Foundation for Quality Assessment in Clinical Laboratories, University Hospital Nijmegen, Nijmegen, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Cas Weykamp / Christa Cobbaert / Rob Jansen
Published Online: 2014-06-05 | DOI: https://doi.org/10.1515/CCLM.2005.052

Abstract

The performance of suitable secondary reference material for the use of trueness control of six routinely measured clinical enzymes in the Dutch External Quality Assessment (EQA) scheme is described. The reference material of choice was selected using the split-patient-sample between-field method (twin study) design as described in an earlier study of the Calibration 2000 project in The Netherlands. This material, which was proven to be commutable for all wet chemistry systems, was implemented as the national enzyme calibrator. It consisted of a cryo-protected lyophilised serum with additions of recombinant human enzymes. Various batches of the frozen version of this material without cryo-protection additive, called native EQA samples, were used in the general EQA scheme for performance evaluation. The results of Calibration 2000 calibrated and non-Calibration 2000 calibrated laboratories were compared for both the regular (spiked with non-human enzymes) and native EQA samples in terms of precision and bias with established reference method values for the native samples. The regular samples showed mean between-laboratory CV ranges for all six enzymes involved (low–high) of 5.5–10.3% for the non-calibrated users vs. 4.6–10.8% for the calibrated users. For the native samples these respective ranges were 5.2–9.9% vs. 2.2–4.9%. Without exception, the group of Calibration 2000 calibrated users showed the lowest bias against the reference method values. Regular EQA samples (spiked with non-human enzymes) showed poorer performance than native samples and are not suitable for accuracy assessment purposes, the main aim of EQA schemes. Native samples that are commutable should be used for trueness control in current EQA schemes.

Keywords: calibration; commutability; enzyme activity; External Quality Assessment; reference materials

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About the article

Corresponding author: Dr. H. Baadenhuijsen, University Hospital Nijmegen, 116 SKML, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands Phone: +31-24-3614767, Fax: +31-24-3560686,


Received: 2004-09-30

Accepted: 2004-12-15

Published Online: 2014-06-05

Published in Print: 2005-03-01


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 43, Issue 3, Pages 304–307, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2005.052.

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©2005 by Walter de Gruyter Berlin New York. Copyright Clearance Center

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