This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular assay is performed. This International Standard covers specimens collected in venous whole blood collection tubes. This International Standard 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, but also pertains institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities.
Blood cellular RNA profiles can change significantly after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for cellular RNA examination and storage.
Different dedicated measures need to be taken for stabilising blood cell free circulating RNA and RNA in exosomes circulating in blood, which are not described in this International Standard.
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.
RNA 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.
Registration number (WIID)
61685
Scope
This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular assay is performed. This International Standard covers specimens collected in venous whole blood collection tubes. This International Standard 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, but also pertains institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities.
Blood cellular RNA profiles can change significantly after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for cellular RNA examination and storage.
Different dedicated measures need to be taken for stabilising blood cell free circulating RNA and RNA in exosomes circulating in blood, which are not described in this International Standard.
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.
RNA 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.
