BS PD CEN/TS 16826-2:2015

BS PD CEN/TS 16826-2:2015 gives recommendations for the handling, documentation and processing of frozentissue 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 organisations 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 medical intervention (surgery, biopsy), or drugs administered for anaesthesia or even treatmentof concomitant disease as well as by the different environment conditions after the tissue removal from thebody.Therefore, it is essential to take special measures to minimize the described profile changes and modifications within the tissue for subsequent protein analysis.Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in thisdocument. In addition this document is not applicable for protein analysis by immunohistochemistry.Cross References:EN ISO 15189:2012ISO 15189:2012ISO 15190ISO Guide 30:1992