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Validation and verification of measurement methods in clinical chemistry
Linköping University, Department of Clinical and Experimental Medicine, Clinical Chemistry. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Diagnostics, Department of Clinical Chemistry.
2012 (English)In: Bioanalysis, ISSN 1757-6180, E-ISSN 1757-6199, Vol. 4, no 3, 305-320 p.Article, review/survey (Refereed) Published
Abstract [en]

The present overview of validation and verification procedures in clinical chemistry focuses on the use of harmonized concepts and nomenclature, fitness-for-purpose evaluations and procedures for minimizing overall measurement and diagnostic uncertainty. The need for mutually accepted validation procedures in all fields of bioanalysis becomes obvious when they implement international accreditation and certification standards or their equivalents. The guide on bioanalytical method validation published by the US FDA in 2001 represents a sensible compromise between thoroughness and cost-effectiveness. Lacking comprehensive international agreements in the field, this document has also been successfully adapted in other fields of bioanalysis. European and international efforts aiming for consensus in the entire field of bioanalysis are currently being made. Manufacturers of highly automated in vitro diagnostic methods provide the majority of measurement methods used in unmodified in clinical chemistry. Validated by the manufacturers for their intended use and fitness-for-purpose, they need to be verified in the circumstances of the end-users. As yet, there is unfortunately no general agreement on the extent of the verification procedures needed.

Place, publisher, year, edition, pages
Future Science , 2012. Vol. 4, no 3, 305-320 p.
National Category
Engineering and Technology
URN: urn:nbn:se:liu:diva-75906DOI: 10.4155/bio.11.311ISI: 000300649600015OAI: diva2:510542

Funding Agencies|County Council of Ostergotland, Sweden||

Available from: 2012-03-16 Created: 2012-03-16 Last updated: 2014-10-31

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Theodorsson, Elvar
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Clinical ChemistryFaculty of Health SciencesDepartment of Clinical Chemistry
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