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Product Product ISO 20186-3:2019
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Description Description

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.



Standard Number Standard Number ISO 20186-3:2019
Title Title 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
Status Status Published
Publication Date Publication Date 25 Sep 2019
Cross References Cross References
Descriptors Descriptors
ICS ICS 11.100.10
Committee Committee ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
Publisher Publisher PECB Store
Format Format PDF
Delivery Delivery NO
Pages Pages 17
File Size File Size KB