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ISO 20186-3:2019

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma
25 sht 2019

General information

90.93     12 dhj 2024

ISO

ISO/TC 212

International Standard

11.100.10  

anglisht   frëngjisht  

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Scope

This document provides recommendations and requirements on the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before an analytical test 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 genomic DNA, which are not described in this document. Blood genomic DNA is covered in ISO 20186-2.
Different dedicated measures are taken for preserving DNA in circulating exosomes, which are not described in this document.
NOTE ccfDNA obtained from blood by the procedures cited in this document can contain DNA originally present in exosomes[8][9].
DNA in pathogens present in blood is not covered by this document.

Life cycle

NOW

PUBLISHED
ISO 20186-3:2019
90.93 Standard confirmed
12 dhj 2024

REVISED BY

IN_DEVELOPMENT
ISO/PWI 20186-3

National adoptions

Ekzaminimet diagnostike molekulare in vitro - Specifikimet për proceset e paraekzaminimit për gjakun e plotë venoz - Pjesa 3: ADN e izoluar pa qeliza qarkulluese nga plazma

60.60 Standard published

DPS/KT 140 më tepër