Reflections and proposals to assure quality in molecular diagnostics.

Marijke Raymaekers, Marleen Bakkus, E Boone, B. De Rijke, H. El Housni, P. Descheemaeker, P Deschouwer, S. Franke, F. Hillen, Friedel Nollet, Oriane Soetens, A. Vankeerberghen

Onderzoeksoutput: Articlepeer review

9 Citaten (Scopus)

Samenvatting

Molecular diagnostic testing has become an important tool in clinical laboratories. Accreditation according to the international quality standard ISO15189:2007 for medical laboratories is required for reimbursement of several molecular diagnostic tests in Belgium.
Since the ISO15189:2007 standard applies to medical laboratories in general, the particular requirements for quality and competence are mentioned in general terms, not taking into account the specificities of molecular biology testing. Therefore, the working group "MolecularDiagnostics.be" described a consensus interpretation of chapter 5, Technical requirements, of the ISO standard for application in molecular diagnostic laboratories. The manuscript can be used as an instrument to prepare internal and external audits that meet the ISO15189:2007 (chapter 5) criteria.
Originele taal-2English
Pagina's (van-tot)33-41
Aantal pagina's9
TijdschriftActa Clinica Belgica
Volume66
Nummer van het tijdschrift2011
StatusPublished - 1 feb 2011

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