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 preexamination 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.
This document does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing.
NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. fetal cells).
NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.