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Full method validation 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.
Research Institute Sweden, Sweden.
2017 (English)In: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 22, no 5, p. 235-246Article, review/survey (Refereed) Published
Abstract [en]

Clinical chemistry is subject to the same principles and standards used in all branches of metrology in chemistry for validation of measurement methods. The use of measuring systems in clinical chemistry is, however, of exceptionally high volume, diverse and involves many laboratories and systems. Samples for measuring the same measurand from a certain patient are likely to encounter several measuring systems over time in the process of diagnosis and treatment of his/her diseases. Several challenges regarding method validation across several laboratories are therefore evident, but rarely addressed in current standards and accreditation practices. The purpose of this is paper to address some of these challenges, making a case that appropriate conventional method validation performed by the manufacturers fulfils only a part of the investigation needed to show that they are fit for purpose in different healthcare circumstances. Method validation across several laboratories using verified commercially available measuring systems can only be performed by the laboratories-users themselves in their own circumstances, and need to be emphasised more by the laboratories themselves and accreditation authorities alike.

Place, publisher, year, edition, pages
SPRINGER , 2017. Vol. 22, no 5, p. 235-246
Keywords [en]
Validation; Bias; Verification; Commutability; Diagnostic uncertainty
National Category
Analytical Chemistry
Identifiers
URN: urn:nbn:se:liu:diva-141696DOI: 10.1007/s00769-017-1275-7ISI: 000411334700001OAI: oai:DiVA.org:liu-141696DiVA, id: diva2:1147348
Conference
Eurachem Workshop on Method Validation
Available from: 2017-10-05 Created: 2017-10-05 Last updated: 2018-05-05

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