DANSK DSF/FPREN ISO 20184-2 PDF

This International Standard recommends the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of extracted proteins during the pre-examination phase before a molecular assay is performed. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, but also pertains institutions and commercial organisations performing biomedical research, biobanks, and regulatory authorities. Protein profiles and protein-protein interactions in tissues can change drastically before tissue collection (e.g., due to warm ischemia) and after tissue collection (e.g., due to cold ischemia). The changes are caused by e.g., gene induction, gene down regulation, protein degradation. Protein species amounts can change differently in different donors’ / patients’ tissues. The expression of genes can be influenced by the given treatment or intervention (surgery, biopsy), or drugs administered for anaesthesia or even treatment of concomitant disease as well as by the different environmental conditions after the tissue removal from the body. Therefore, it is essential to take special measures to minimize the described protein profile changes and modifications within the tissue for subsequent examination. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. In addition this document is not applicable to protein examination by immunohistochemistry. NOTE – International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.