[Method validation according to ISO 15189 and SH GTA 04: application for the detection of KRAS mutations using PCR TaqMan assay].
Fiche publication
Journal
Annales de biologie clinique
Auteurs
Membres identifiés du Cancéropôle Est :
Pr HARLE Alexandre, Pr MERLIN Jean-Louis
Tous les auteurs :
Harlé A, Dubois C, Rouyer M, Merlin JL
Lien Pubmed
Résumé
Since January 16(th) 2010, the French legislation requires that the medical laboratories must be accredited according to ISO 15189 standards. Thus, all medical laboratories in France must be accredited for at least part of their biological tests before the end of October 2013. Molecular biology tests are also concerned by the accreditation. Validation of molecular biology methods is made difficult, for reasons related to the methods, but also by the type of analytes that are basically rare. This article describes the validation of the qualitative detection of KRAS mutations in metastatic colorectal cancer using TaqMan PCR according to ISO 15189 and to the technical guide for accreditation in Human Health, SH-GTA-04, edited by the COFRAC.
Mots clés
Accreditation, legislation & jurisprudence, Cell Line, Tumor, Clinical Laboratory Services, legislation & jurisprudence, Colorectal Neoplasms, genetics, DNA Mutational Analysis, standards, France, Humans, Mutation, Neoplasm Metastasis, Polymerase Chain Reaction, methods, Proto-Oncogene Proteins, analysis, Proto-Oncogene Proteins p21(ras), Reference Standards, Sensitivity and Specificity, Specimen Handling, standards, ras Proteins, analysis
Référence
Ann. Biol. Clin. (Paris). ;71(5):603-7