BS PD CEN/TS 16826-1:2015

BS PD CEN/TS 16826-1:2015 gives recommendations for the handling, documentation and processing of frozentissue 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 organisations performing biomedical research, biobanks, and regulatoryauthorities).RNA profiles in tissues can change significantly before and after collection and can change differently intissues from different donors / patients.Therefore, it is essential to take special measures to minimize the described profile changes and modificationswithin the tissue for subsequent RNA analysis.Tissues that have undergone chemical stabilisation pre-treatment before freezing are not covered in thisdocument.Cross References:EN ISO 15189:2012ISO 15189:2012ISO 15190EN ISO 22174:2005 ISO 22174:2005ISO Guide 30:1992