ISO DIS 20186-3

Description / Abstract: This document recommends the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the preexamination phase before a molecular assay is performed. This document covers specimens collected in venous whole blood collection tubes.

This document is applicable to any molecular in vitro diagnostic examination 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 for stabilizing blood genomic DNA, which are not described in this document. Blood genomic DNA is covered in ISO 20186-2, Molecular in vitro diagnostic examinations — specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA.

Different dedicated measures need to be taken for preserving DNA in circulating exosomes, which are not described in this document.

NOTE 1 CcfDNA obtained from blood by the procedures suggested in this document can contain DNA present in exosomes[8][9]. DNA in pathogens present in blood is not covered by this document.

NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.