Evaluating laboratory diagnostic tests and translational research
-
Mario Plebani
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.
©2010 by Walter de Gruyter Berlin New York
Articles in the same Issue
- HIGHLIGHT: LABORATORY DIAGNOSTICS IN THE THIRD MILLENIUM: WHERE, HOW AND WHY
- Editorial
- Foreword
- Reviews
- Roots, development and future directions of laboratory medicine
- The “hospital central laboratory”: automation, integration and clinical usefulness
- Clinical pathology services: remapping our strategic itinerary
- Stat laboratory testing: integration or autonomy?
- Point-of-care testing in critical care: the clinician's point of view
- Reproductive-endocrine point-of-care testing: current status and limitations
- Laboratory testing in pharmacies
- Laboratory testing during critical care transport: point-of-care testing in air ambulances
- Self-monitoring of blood glucose with a focus on analytical quality: an overview
- Molecular diagnostics: between chips and customized medicine
- Evaluating laboratory diagnostic tests and translational research
- Integrated diagnostics: a conceptual framework with examples
- General Clinical Chemistry and Laboratory Medicine
- The European Register of Specialists in Clinical Chemistry and Laboratory Medicine: Guide to the Register, Version 3-2010
- The prevalence of preanalytical errors in a Croatian ISO 15189 accredited laboratory
- Indicators and quality specifications for strategic and support processes related to the clinical laboratory: four years' experience
- SKML-Quality Mark for point-of-care test (POCT) glucose meters and glucose meters for home-use
- PATHFAST™ NT-proBNP (N-terminal-pro B type natriuretic peptide): a multicenter evaluation of a new point-of-care assay
- Clinical implication of plasma neutrophil gelatinase-associated lipocalin (NGAL) concentrations in patients with advanced carotid atherosclerosis
- Evaluation of the TEST 1 erythrocyte sedimentation rate system and intra- and inter-laboratory quality control using new latex control materials
- Letter to the Editor
- Phlebotomy site haemolysis rates vary inversely with workload
Articles in the same Issue
- HIGHLIGHT: LABORATORY DIAGNOSTICS IN THE THIRD MILLENIUM: WHERE, HOW AND WHY
- Editorial
- Foreword
- Reviews
- Roots, development and future directions of laboratory medicine
- The “hospital central laboratory”: automation, integration and clinical usefulness
- Clinical pathology services: remapping our strategic itinerary
- Stat laboratory testing: integration or autonomy?
- Point-of-care testing in critical care: the clinician's point of view
- Reproductive-endocrine point-of-care testing: current status and limitations
- Laboratory testing in pharmacies
- Laboratory testing during critical care transport: point-of-care testing in air ambulances
- Self-monitoring of blood glucose with a focus on analytical quality: an overview
- Molecular diagnostics: between chips and customized medicine
- Evaluating laboratory diagnostic tests and translational research
- Integrated diagnostics: a conceptual framework with examples
- General Clinical Chemistry and Laboratory Medicine
- The European Register of Specialists in Clinical Chemistry and Laboratory Medicine: Guide to the Register, Version 3-2010
- The prevalence of preanalytical errors in a Croatian ISO 15189 accredited laboratory
- Indicators and quality specifications for strategic and support processes related to the clinical laboratory: four years' experience
- SKML-Quality Mark for point-of-care test (POCT) glucose meters and glucose meters for home-use
- PATHFAST™ NT-proBNP (N-terminal-pro B type natriuretic peptide): a multicenter evaluation of a new point-of-care assay
- Clinical implication of plasma neutrophil gelatinase-associated lipocalin (NGAL) concentrations in patients with advanced carotid atherosclerosis
- Evaluation of the TEST 1 erythrocyte sedimentation rate system and intra- and inter-laboratory quality control using new latex control materials
- Letter to the Editor
- Phlebotomy site haemolysis rates vary inversely with workload
