Harmonisation of seven common enzyme results through EQA

Cas Weykamp; Paul Franck; Jacqueline Klein Gunnewiek; Robert de Jonge; Aldy Kuypers; Douwe van Loon; Herman Steigstra; Christa Cobbaert

doi:10.1515/cclm-2014-0458

Article

Harmonisation of seven common enzyme results through EQA

Cas Weykamp , Paul Franck , Jacqueline Klein Gunnewiek , Robert de Jonge , Aldy Kuypers , Douwe van Loon , Herman Steigstra and Christa Cobbaert

Published/Copyright: May 29, 2014

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 52 Issue 11

Abstract

Background: Equivalent results between different laboratories enable optimal patient care and can be achieved with harmonisation. We report on EQA-initiated national harmonisation of seven enzymes using commutable samples.

Methods: EQA samples were prepared from human serum spiked with human recombinant enzymes. Target values were assigned with the IFCC Reference Measurement Procedures. The same samples were included at four occasions in the EQA programmes of 2012 and 2013. Laboratories were encouraged to report IFCC traceable results. A parallel study was done to confirm commutability of the samples.

Results: Of the 223 participating laboratories, 95% reported IFCC traceable results, ranging from 98% (ASAT) to 87% (amylase). Users of Roche and Siemens (97%) more frequently reported in IFCC traceable results than users of Abbott (91%), Beckman (90%), and Olympus (87%). The success of harmonisation, expressed as the recovery of assigned values and the inter-laboratory CV was: ALAT (recovery 100%; inter-lab CV 4%), ASAT (102%; 4%), LD (98%; 3%), CK (101%; 5%), GGT (98%; 4%), AP (96%; 6%), amylase (99%; 4%). There were no significant differences between the manufacturers. Commutability was demonstrated in the parallel study. Equal results in the same sample in the 2012 and 2013 EQA programmes demonstrated stability of the samples.

Conclusions: The EQA-initiated national harmonisation of seven enzymes, using stable, commutable human serum samples, spiked with human recombinant enzymes, and targeted with the IFCC Reference Measurement Procedures, was successful in terms of implementation of IFCC traceable results (95%), recovery of the target (99%), and inter-laboratory CV (4%).

Keywords: commutability; external quality assessment; harmonisation; recombinant human enzymes; traceability IFCC reference measurement procedures

Corresponding author: Cas Weykamp, Queen Beatrix Hospital, Department of Clinical Chemistry, Beatrixpark 1, 7101 BN Winterswijk, The Netherlands, Phone: +31 543 544774, Fax: +31 543 524265, E-mail: c.w.weykamp@skbwinterswijk.nl

Acknowledgments

The authors acknowledge Dr. Joost Swaanenburg and Dr. Hans van der Vuurst for performing assays in their laboratory, Jeffrey Sigger for the collection of sera and Liesbeth Schröer-Jansen for processing the data.

Conflict of interest statement

Author’s conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

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Supplemental Material

The online version of this article (DOI: 10.1515/cclm-2014-0458) offers supplementary material, available to authorized users.

Received: 2014-2-28

Accepted: 2014-4-30

Published Online: 2014-5-29

Published in Print: 2014-11-19

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Keywords for this article

commutability; external quality assessment; harmonisation; recombinant human enzymes; traceability IFCC reference measurement procedures

Harmonisation of seven common enzyme results through EQA

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Abstract

Acknowledgments

Conflict of interest statement

References

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