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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 / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

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1437-4331
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Volume 55, Issue 2

Issues

Commutability of proficiency testing material containing tobramycin: a study within the framework of the Dutch Calibration 2.000 project

Karen Robijns
  • Corresponding author
  • Association for Quality Assessment in Therapeutic Drug Monitoring and Clinical Toxicology (KKGT), PO Box 43100, NL 2504 AC The Hague, The Netherlands, Phone: 0031-70-3217217, Fax: 0031-70-3080140
  • section of the Dutch Foundation for Quality Assessment in Medical Laboratories (SKML), Nijmegen, The Netherlands
  • Central Hospital Pharmacy, The Hague, The Netherlands
  • Haga Teaching Hospital, The Hague, The Netherlands
  • CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands
  • Department of Clinical Pharmacy and Toxicology, Maastricht University Medical Centre+, Maastricht, The Netherlands
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Niels W. Boone
  • Department of Clinical Pharmacy and Toxicology, Zuyderland Medical Centre, Sittard-Geleen, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Rob T.P. Jansen
  • Dutch Foundation for Quality Assessment in Medical Laboratories (SKML), Nijmegen, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Aldy W.H.M. Kuypers
  • Department of Clinical Chemistry and Haematology, Maasziekenhuis Pantein, Beugen, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Cees Neef
  • CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands
  • Department of Clinical Pharmacy and Toxicology, Maastricht University Medical Centre+, Maastricht, The Netherlands
  • Association for Quality Assessment in Therapeutic Drug Monitoring and Clinical Toxicology (KKGT), PO Box 43100, NL 2504 AC The Hague, The Netherlands, Phone: 0031-70-3217217, Fax: 0031-70-3080140
  • Association for Quality Assessment in Therapeutic Drug Monitoring and Clinical Toxicology (KKGT), The Hague, The Netherlands, section of the Dutch Foundation for Quality Assessment in Medical Laboratories (SKML), Nijmegen, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Daan J. Touw
  • Association for Quality Assessment in Therapeutic Drug Monitoring and Clinical Toxicology (KKGT), PO Box 43100, NL 2504 AC The Hague, The Netherlands, Phone: 0031-70-3217217, Fax: 0031-70-3080140
  • Association for Quality Assessment in Therapeutic Drug Monitoring and Clinical Toxicology (KKGT), The Hague, The Netherlands, section of the Dutch Foundation for Quality Assessment in Medical Laboratories (SKML), Nijmegen, The Netherlands
  • Association for Quality Assessment in Therapeutic Drug Monitoring and Clinical Toxicology (KKGT), PO Box 43100, NL 2504 AC The Hague, The Netherlands, Phone: 0031-70-3217217, Fax: 0031-70-3080140
  • University of Groningen, University Medical Center Groningen, Department of Clinical Pharmacy and Pharmacology, Groningen, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2016-08-03 | DOI: https://doi.org/10.1515/cclm-2015-1254

Abstract

Background:

Results from external quality assessment schemes (EQASs) can provide information about accuracy and comparability of different measurement methods, provided that the material used in these schemes behave identical to patient samples among the different methods, a characteristic also known as commutability. The aim of this study was to assess the commutability of different matrices for the material used in an EQAS for tobramycin.

Methods:

Proficiency testing material (PTM) and patient samples containing tobramycin were prepared, collected, pooled, and distributed to participating laboratories for analysis. Low, medium, and high tobramycin concentrations in liquid human, liquid bovine and lyophilized bovine serum were tested in this study. The patient serum results of every laboratory were plotted against each of the other laboratories, and the distances of the PTM results to the patient serum regression line were calculated. For comparison, these distances were divided by the average within-laboratory standard deviation (SDwl) of the results reported in the official EQAS for tobramycin, resulting in a relative residual. The commutability decision limit was set at 3 SDwl.

Results:

With 10 laboratories participating in this study, 45 laboratory couples were formed. For human serum, only one relative residual for high concentrations of tobramycin was found outside the commutability decision limit. For liquid and lyophilized bovine sera, the number of relative residuals outside the decision limit was between 15 and 18 for low, medium, and high tobramycin concentrations.

Conclusions:

The PTM used for tobramycin is preferably prepared with human serum.

This article offers supplementary material which is provided at the end of the article.

Keywords: commutability; external quality assessment scheme; immunoassay; proficiency testing

References

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    ISO/IEC 17043:2010, Conformity assessment – general requirements for proficiency testing.

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    Robijns K, Boone N, Kuypers AW, Jansen RT, Neef C, Touw DJ. A multilaboratory commutability evaluation of proficiency testing material for carbamazepine and valproic acid: a study within the framework of the Dutch Calibration 2000 project. Ther Drug Monit 2015;37:445–50.Google Scholar

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    Shipkova M, Petrova DT, Rosler AE, Orth M, Engelmayer J, Wieland E, et al. Comparability and imprecision of 8 frequently used commercially available immunoassays for therapeutic drug monitoring. Ther Drug Monit 2014;36:433–41.Google Scholar

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    Wilson JF, Davis AC, Tobin CM. Evaluation of commercial assays for vancomycin and aminoglycosides in serum: a comparison of accuracy and precision bases on external quality assessment. J Antimicrob Chemother 2003;52:78–82.Google Scholar

About the article

Received: 2015-12-21

Accepted: 2016-06-24

Published Online: 2016-08-03

Published in Print: 2017-02-01


Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 55, Issue 2, Pages 212–217, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2015-1254.

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