ISO DIS 20186-2

Description / Abstract: This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for genomic DNA examination during the pre-examination phase before a molecular examination is performed. This International Standard covers specimens collected in venous whole blood collection tubes.

This International Standard 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, as well as institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities.

Different dedicated measures have to be taken for stabilizing blood cell free circulating DNA, which are not described in this International Standard. Circulating cell free DNA in blood is covered in ISO 20186-3, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma. Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this International Standard.

This International Standard does not cover the isolation of specific blood cells and subsequent isolation of genomic DNA therefrom.

DNA in pathogens present in blood is not covered by this International Standard.

NOTE International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.