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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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Volume 48, Issue 7


Evaluating laboratory diagnostic tests and translational research

Mario Plebani
  • Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy
  • Leonardo Foundation, Abano Terme, Padova, Italy
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2010-04-21 | DOI: https://doi.org/10.1515/CCLM.2010.188


In laboratory medicine, the evaluation of an assay is reasonably straightforward and allows broad applicable standards to be established. In contrast, the evaluation of a test is more complex and inherently less susceptible to standardization. The term “test” refers to the use of an assay in the context of a particular disease, in a particular population, and for a particular purpose. Therefore, the true evaluation is to demonstrate its effectiveness in helping a clinician achieve a correct diagnosis or improve patient clinical outcomes. The debate on the current weak framework used for evaluating laboratory tests has been stimulated by recent technological developments, in particular “omics” tests. Currently, consensus has been achieved concerning the proposal to use a model based on at least four steps to be investigated. These are analytical and clinical validity, clinical usefulness and, finally, any ethical, social and legal implications, including economic implications. As the pace of technological advancements in laboratory medicine accelerates, it is time to discuss the role of laboratory testing, and the related role of clinical laboratories. In particular, we should consider whether they should evolve as focused factories of numbers and results, or as knowledge services with an emphasis on improving appropriateness in test requesting, and the interpretation and utilization of laboratory information.

Clin Chem Lab Med 2010;48:983–8.

Keywords: assay; clinical outcomes; effectiveness; laboratory testing; test evaluation; translational medicine

About the article

Corresponding author: Mario Plebani, Department of Laboratory Medicine, University-Hospital of Padova, Via Giustiniani, 2, 35128 Padova, Italy Phone: +39 049 8212792, Fax: +39 049 663240,

Published Online: 2010-04-21

Published in Print: 2010-07-01

Citation Information: Clinical Chemistry and Laboratory Medicine, Volume 48, Issue 7, Pages 983–988, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2010.188.

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