BS PD CEN/TS 17390-3:2020

This document specifies guidelines on the handling, storage, processing and documentation of human venous whole blood specimens intended for staining of 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:
ISO 15189:2012
EN ISO 15189:2012
ISO 15190
ISO/IEC 17020:2012
EN ISO/IEC 17020 (ISO/IEC 17020:2012) AS


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