BS PD CEN/TS 16827-3:2015

BS PD CEN/TS 16827-3:2015 gives recommendations for the handling, documentation and processing of FFPEtissue specimens intended for DNA 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).DNA integrity in tissues can change before and during formalin fixation, processing and storage. Chemicalmodifications introduced into DNA during tissue fixation might lead to fragmentation and sequence alterations, changes in the methylation status or even structural changes which can lead to e.g., spurious copynumber changes in array-CGH profiles. These modifications of the DNA molecules can impact the validityand reliability of the analytical test results. Therefore, it is essential to take special measures to minimize thedescribed modifications for subsequent DNA analysis.Cross References:EN ISO 15189:2012ISO 15189:2012ISO 15190EN ISO 22174:2005 ISO 22174:2005ISO Guide 30:1992