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How to assess the quality of your analytical method?
Chair Comm Educ and Training, Croatia.
University Hospital Sestre Milosrdnice, Croatia.
University of Milan, Italy.
Linköping University, Department of Clinical and Experimental Medicine, Division of Microbiology and Molecular Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Diagnostics, Department of Clinical Chemistry.
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2015 (English)In: Clinical Chemistry and Laboratory Medicine, ISSN 1434-6621, E-ISSN 1437-4331, Vol. 53, no 11, 1707-1718 p.Article in journal (Refereed) Published
Abstract [en]

Laboratory medicine is amongst the fastest growing fields in medicine, crucial in diagnosis, support of prevention and in the monitoring of disease for individual patients and for the evaluation of treatment for populations of patients. Therefore, high quality and safety in laboratory testing has a prominent role in high-quality healthcare. Applied knowledge and competencies of professionals in laboratory medicine increases the clinical value of laboratory results by decreasing laboratory errors, increasing appropriate utilization of tests, and increasing cost effectiveness. This collective paper provides insights into how to validate the laboratory assays and assess the quality of methods. It is a synopsis of the lectures at the 15th European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Continuing Postgraduate Course in Clinical Chemistry and Laboratory Medicine entitled "How to assess the quality of your method?" (Zagreb, Croatia, 24-25 October 2015). The leading topics to be discussed include who, what and when to do in validation/verification of methods, verification of imprecision and bias, verification of reference intervals, verification of qualitative test procedures, verification of blood collection systems, comparability of results among methods and analytical systems, limit of detection, limit of quantification and limit of decision, how to assess the measurement uncertainty, the optimal use of Internal Quality Control and External Quality Assessment data, Six Sigma metrics, performance specifications, as well as biological variation. This article, which continues the annual tradition of collective papers from the EFLM continuing postgraduate courses in clinical chemistry and laboratory medicine, aims to provide further contributions by discussing the quality of laboratory methods and measurements and, at the same time, to offer continuing professional development to the attendees.

Place, publisher, year, edition, pages
WALTER DE GRUYTER GMBH , 2015. Vol. 53, no 11, 1707-1718 p.
Keyword [en]
biological variation; detection limit; IQC/EQA; measurement uncertainty; method verification/validation; methods comparability
National Category
Clinical Medicine
Identifiers
URN: urn:nbn:se:liu:diva-122429DOI: 10.1515/cclm-2015-0869ISI: 000362510000017PubMedID: 26408611OAI: oai:DiVA.org:liu-122429DiVA: diva2:866794
Available from: 2015-11-03 Created: 2015-11-02 Last updated: 2015-11-03

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Theodorsson, Elvar
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Division of Microbiology and Molecular MedicineFaculty of Medicine and Health SciencesDepartment of Clinical Chemistry
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