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Validation and verification in clinical chemistry
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.
2017 (English)In: Klinisk biokemi i Norden, ISSN 1101-2013, Vol. 1, no 29, 8-16 p.Article, review/survey (Other academic) Published
Abstract [en]

Measurement systems used inclinical chemistry are usuallymanufactured by internationalcompanies working according toin vitro directive (IVD) – regulations.This means that medicallaboratories do not need to validatecommercially available measurement systems,but are obliged to verify that their properties foundduring the producers validation can be reproducedin the users laboratories. Developments in healthcareand accreditation standards including ISO 15189focus increasingly on customer needs which maycall for the validation of entire conglomerates oflaboratories and measurement systems catering forthe needs for the same patient population. Such validationpractices are, however, still in their infancy.The purpose of the present paper is to offer practicaldetails on the common practice of verificationof single measurement systems and add perspectiveson the validation of conglomerates of laboratoriesand measurement systems. Method validation acrossconglomerates of laboratories using verified commerciallyavailable measurement systems can only beperformed by the laboratories – users themselves intheir own circumstances. The use of patient samplesin split- sample techniques is especially valuable inthis contexts in order to avoid compatibility issues.

Place, publisher, year, edition, pages
Nordisk Forening for Klinisk Kemi , 2017. Vol. 1, no 29, 8-16 p.
National Category
Clinical Laboratory Medicine
Identifiers
URN: urn:nbn:se:liu:diva-134921OAI: oai:DiVA.org:liu-134921DiVA: diva2:1078026
Available from: 2017-03-02 Created: 2017-03-02 Last updated: 2017-03-02

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Theodorsson, Elvar

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