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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

Online
ISSN
1437-4331
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Volume 46, Issue 9

Issues

Accuracy in clinical chemistry – who will kiss Sleeping Beauty awake?

Linda M. Thienpont
  • 1Laboratory for Analytical Chemistry, Faculty of Pharmaceutical Sciences, Gent University, Gent, Belgium
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2008-07-02 | DOI: https://doi.org/10.1515/CCLM.2008.245

Abstract

Triggered by recent criticism from parties outside the clinical chemistry community on poor analytical accuracy of measurement procedures used for evaluating the calcium-parathyroid hormone-vitamin D axis, I argue, in this opinion paper, strongly in favor of prioritizing the establishment of accuracy. I make a proposal on how the clinical chemistry profession could tackle the challenges focused at the conceptual, technical, and organizational level. The profession should “rehearse” the basic concepts of measurement, because they need to be understood before one can look for pragmatic solutions when a purist's approach cannot be realized in a foreseeable time. This is illustrated for the measurement of thyroid stimulating hormone (TSH). To solve problems encountered at the technical level of establishing reference measurement systems, in particular when this is not possible according to the point of view of purism, the profession should have the courage to agree on pragmatic solutions, without neglecting, however, the technical progress. This is exemplified by way of a solution for measurement of FT4 in serum water and TSH. Because the technical question is also inseparably connected to the specification of the analytical quality required for measurements, I propose that the profession sets realistic specifications for calibration tolerance, limits for batch acceptance, linearity, etc. Last but not least, I call upon organizing and implementing the accuracy process with utmost care, i.e., in a concerted action with all parties involved in patient care. The driving force towards accuracy should come from the test developers, while the lead should be taken by the clinical chemistry community, itself being guided by the clinical professions.

Clin Chem Lab Med 2008;46:1220–2.

Keywords: analytical quality; bias; standardization

About the article

Corresponding author: Linda M. Thienpont, Laboratory for Analytical Chemistry, Faculty of Pharmaceutical Sciences, Gent University, Harelbekestraat 72, 9000 Gent, Belgium Phone: +32-9-2648104, Fax: +32-9-2648198,


Received: 2008-03-28

Accepted: 2008-04-29

Published Online: 2008-07-02

Published in Print: 2008-09-01


Citation Information: Clinical Chemistry and Laboratory Medicine, Volume 46, Issue 9, Pages 1220–1222, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2008.245.

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