1 Scope
This document specifies requirements and recommendations for the pre-examination phase of circulating cell free RNA ( ccfRNA ) from venous whole blood specimens , including but not limited to the collection, handling, storage , processing and documentation of venous whole blood specimens intended for ccfRNA examination . This document covers specimens collected in venous whole blood collection tubes.
The pre-examination process described in this document results in circulating cell free RNA isolated from blood plasma without prior enrichment of exosomes and other extracellular vesicles .
This document is applicable to molecular in vitro diagnostic examinations 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 need to be taken during the pre-examination phase for isolated RNA from enriched exosomes and other extracellular vesicles enriched from venous whole blood and for cellular RNA isolated from venous whole blood . These are not de...