This document gives guidelines on the handling, storage, processing and documentation of venouswhole blood specimens intended for the examination of human DNA isolated from circulating tumourcells (CTCs) during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratorydeveloped tests performed by medical laboratories. It is also intended to be used by laboratorycustomers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercialorganizations performing biomedical research, and regulatory authorities.Cross References:EN ISO 15189:2012ISO 15189:2012ISO 15190EN ISO/IEC 17020 (ISO/IEC 17020:2012) ASISO/IEC 17020:2012
