BS PD CEN/TS 16827-2:2015

BS PD CEN/TS 16827-2:2015 gives recommendations for the handling, documentation and processing ofFFPE tissue specimens intended for the analysis of extracted proteins during the preanalytical phase before amolecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnosticexaminations (e.g., in vitro diagnostic laboratories, laboratory customers, developers and manufacturers of invitro diagnostics, institutions and commercial organizations performing biomedical research, biobanks, andregulatory authorities).Protein profiles and protein-protein interactions in tissues can change drastically before and after collection(due to e.g., gene induction, gene down regulation, protein degradation). Protein species amounts can changedifferently in tissues from different donors / patients. The expression of genes can be influenced by the giventreatment or intervention (surgery, biopsy), or drugs administered for anaesthesia or even treatment ofconcomitant disease as well as by the different environment conditions after the tissue removal from the body.Furthermore, the formalin fixation and paraffin embedding process leads to modifications of the proteinmolecules, which can 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 modificationswithin the tissue for subsequent protein analysis.This document is not applicable for protein analysis by immunohistochemistry.Cross References:EN ISO 15189:2012ISO 15189:2012ISO 15190ISO Guide 30:1992