ISO 20186-1:2019

Тезис

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes.

This document is applicable to any molecular in vitro diagnostic examination 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.

Different dedicated measures are taken for stabilizing blood cell free circulating RNA and RNA in exosomes circulating in blood. These are not described in this document.

Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document.

This document does not cover the isolation of specific blood cells and subsequent isolation of cellular RNA therefrom.

RNA in pathogens present in blood is not covered by this document.

Общая информация

Текущий статус
: Опубликовано

Дата публикации
: 2019-02
Версия
: 1
Технический комитет
: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
ICS
:
11.100.10 In vitro diagnostic test systems

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	Формат	Язык
std 1 124	PDF + ePub
std 2 124	Бумажный

CHF124

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Опубликовано

ISO 20186-1:2019
Этап: 60.60

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