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 / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.
IMPACT FACTOR increased in 2015: 3.017
Rank 5 out of 30 in category Medical Laboratory Technology in the 2014 Thomson Reuters Journal Citation Report/Science Edition
SCImago Journal Rank (SJR) 2015: 0.873
Source Normalized Impact per Paper (SNIP) 2015: 0.982
Impact per Publication (IPP) 2015: 2.238
Evaluating laboratory diagnostic tests and translational research
1Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy
2Leonardo Foundation, Abano Terme, Padova, Italy
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
- Published Online:
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.
Here you can find all Crossref-listed publications in which this article is cited. If you would like to receive automatic email messages as soon as this article is cited in other publications, simply activate the “Citation Alert” on the top of this page.