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DS CEN/TS 16835-1:2015

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA

Mar 31, 2016
95.99 Withdrawal of Standard   Apr 15, 2021

General information

95.99     Apr 15, 2021

DPS

DPS/KT 140

Technical Specification

11.100.10  

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Scope

This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for cellular RNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities).
Blood cellular RNA profiles can change significantly after collection. Therefore, special measures need to be taken to secure good quality blood samples for cellular RNA analysis and storage.
Different dedicated measures need to be taken for stabilizing blood cell free circulating RNA and RNA in exosomes circulating in blood, which are not described in this Technical Specification.
Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies. These are not described in this Technical Specification.
RNA in pathogens present in blood is not covered by this Technical Specification.

Life cycle

NOW

WITHDRAWN
DS CEN/TS 16835-1:2015
95.99 Withdrawal of Standard
Apr 15, 2021

REVISED BY

PUBLISHED
SSH EN ISO 20186-1:2019

Related project

Adopted from CEN/TS 16835-1:2015