1 Scope
This document gives guidelines on the handling, storage , processing and documentation of venous whole blood specimens intended for DNA , RNA and protein examination from exosomes and other extracellular vesicles during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes.
The pre- examination process described in this document results in isolated DNA , RNA and proteins from enriched 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 health care
institutions including facilities collecting and handling specimen , laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations
performing biomedical research, and regulatory authorities.
Different dedicated measures are taken during the pre-examination phase for venous whole blood circulating cell-free RNA (ccfRNA) examination and for venous whole blood circulating cell-...