BS PD CEN/TS 17390-2:2020

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for the examination of human DNA isolated from circulating tumour cells (CTCs) during the pre-examination phase before a molecular examination is performed.

This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests 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.

Cross References:
EN ISO 15189:2012
ISO 15189:2012
ISO 15190
EN ISO/IEC 17020 (ISO/IEC 17020:2012) AS
ISO/IEC 17020:2012


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