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CEN/TS 16835-1:2015

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

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Kehtetu alates 15.04.2019
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CEN/TS 16835-1:2015
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puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
15.04.2019
Põhitekst
05.08.2015
Põhitekst
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.
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CEN/TS 16835-3:2015

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma
Kehtetu alates 01.11.2019
Põhitekst

CEN/TS 16835-2:2015

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA
Kehtetu alates 15.04.2019