Norm

NVN-CEN/TS 17390-1:2020 en

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA

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Over deze norm

Status Definitief
Aantal pagina's 24
Commissie In vitro diagnostica
Gepubliceerd op 01-01-2020
Taal Engels
NVN-CEN/TS 17390-1 gives guidelines on the handling, storage, processing and documentation of human venous whole blood specimens intended for the examination of RNA isolated from circulating tumour cells (CTCs) during the pre-examination phase before a molecular examination 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 the isolation of cellular RNA directly from venous whole blood containing CTCs. This is covered in EN ISO 20186-1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA.This document does not cover the isolation of specific white blood cells and subsequent isolation of cellular RNA therefrom.This document does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing.

Details

ICS-code 11.100.10
Engelse titel Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA

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