This International Standard recommends the handling, documentation, storage and processing of frozen tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed. 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 organisations performing biomedical research, biobanks, and regulatory authorities.
RNA profiles in tissues can change significantly before and after collection and can change differently in different donors’ / patients’ tissues.
Therefore, it is essential to take special measures to minimize the described profile changes and modifications within the tissue for subsequent RNA examination.
Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.
NOTE International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.
Registration number (WIID)
61694
Scope
This International Standard recommends the handling, documentation, storage and processing of frozen tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed. 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 organisations performing biomedical research, biobanks, and regulatory authorities.
RNA profiles in tissues can change significantly before and after collection and can change differently in different donors’ / patients’ tissues.
Therefore, it is essential to take special measures to minimize the described profile changes and modifications within the tissue for subsequent RNA examination.
Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.
NOTE International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.
