Reflections and proposals to assure quality in molecular diagnostics.

Belgium; Humans; Laboratories, Hospital/standards; Molecular Diagnostic Techniques/standards; Nucleic Acid Amplification Techniques/standards; Quality Control

Abstract :

[en] 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 15015189:2007 (chapter 5) criteria.

Disciplines :

Genetics & genetic processes

Author, co-author :

Raymaekers, M.

Bakkus, M.

Boone, E.

de Rijke, B.

El Housni, H.

Descheemaeker, P.

De Schouwer, P.

FRANKE, Sabine ; Centre Hospitalier Universitaire de Liège - CHU > Génétique

Hillen, F.

Nollet, F.

Soetens, O.

Vankeerberghen, A.

Language :

English

Title :

Reflections and proposals to assure quality in molecular diagnostics.

Publication date :

2011

Journal title :

Acta Clinica Belgica

ISSN :

0001-5512

Publisher :

Acta Clinica Belgica, Bruxelles, Belgium

Volume :

Issue :

Pages :

33-41

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 16 October 2014

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