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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

Editorial Board Member: Gillery, Philippe / Kazmierczak, Steven / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Schlattmann, Peter / Whitfield, John B.

13 Issues per year

IMPACT FACTOR 2013: 2.955
Rank 5 out of 29 in category Medical Laboratory Technology in the 2013 Thomson Reuters Journal Citation Report/Science Edition

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Evaluating laboratory diagnostic tests and translational research

Mario Plebani1, 2

1Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy

2Leonardo Foundation, Abano Terme, Padova, Italy

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,

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 48, Issue 7, Pages 983–988, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2010.188, April 2010

Publication History

Published Online:
2010-04-21

Abstract

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

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