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.
Cross References:ISO 15189:2012
ISO/IEC 17043:2010
ISO 17511:2003
ISO Guide 30:2015
ISO 15190:2003
ISO 9000:2015
ISO 20186-2:2019
ISO/TS 17822-1:2014
ISO 22174:2005
ISO/IEC 17020:2012
All current amendments available at time of purchase are included with the purchase of this document. | File Size : | 1
file
, 1.8 MB |
| ISBN(s) : | 9780539122039, 9780580919220 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 26 |
| Product Code(s) : | 30406617, 30406617, 30331317 |
| Published : | 11/27/2019 |
| Same As : | BS EN ISO 20186-3:2019 |
