Norme CEN/TS 17390-3:2020

Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les cellules tumorales circulantes (CTC) du sang total veineux - Partie 3 : Préparations pour l’analyse par coloration des CTC
Statut
:
Active
Date de publication
:
1/2020
Langues
:
EN/DE
ICS
:
11.100.10 Systèmes de diagnostic in vitro
Sommaire :
This document gives guidelines on the handling, storage, processing and documentation of venous whole blood and the CTC (Circulating Tumor Cel
l) enrichment, CTC isolation and other preparations for analytical staining (i.e., conventional cytochemical and immunocytochemical stainin
g) of CTCs during the pre-examination Phase before the cytopathological evaluation is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. This document does not cover specific staining procedures. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
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