DIN CEN/TS 16835-1:2015-10

This Technical Specification recommends the handling, documentation and processing of clinical specimens from formalin-fixed, paraffin-embedded tissue intended for RNA analysis during the pre-analytical phase before a molecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnostic examinations (for example, in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). The fixation with formalin and the embedding in paraffin may lead to modifications of the RNA molecules which may affect the validity and reliability of the results of analytical tests. Therefore, special measures need to be taken to secure good quality blood samples for cellular RNA analysis and storage. It is therefore necessary to take specific measures to minimize the profile changes and modifications in tissue described with a view to subsequent RNA analysis.