BS PD CEN/TS 16827-1:2015

BS PD CEN/TS 16827-1:2015 gives recommendations for the handling, documentation and processing of FFPEtissue specimens intended for RNA analysis during the preanalytical phase before a molecular assay isperformed. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g.,in vitro diagnostic laboratories, laboratory customers, developers and manufacturers of in vitro diagnostics,institutions and commercial organizations performing biomedical research, biobanks, and regulatoryauthorities).The formalin fixation and the paraffin embedding process lead to modifications of the RNA molecules, whichcan impact the validity and reliability of the analytical test results.Therefore, it is essential to take special measures to minimize the described profile changes and modifications within the tissue for subsequent RNA analysis.Cross References:EN ISO 15189:2012ISO 15189:2012ISO 15190EN ISO 22174:2005 ISO 22174:2005ISO Guide 30:1992