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DIN EN ISO 20166-2:2019 Edition

DIN EN ISO 20166-2:2019 Edition

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Molecular in vitro diagnostic examinations – Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue – Part 2: Isolated proteins

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DIN 2019-04 28
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This International Standard recommends the handling, documentation, storage and processing of formalin fixed and paraffin embedded (FFPE) tissue specimens intended for the examination of isolated 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 and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, but also pertains institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities. Protein profiles, protein integrities, 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 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. The formalin-fixation and paraffin-embedding process leads to modifications of the protein molecules, which can impact the validity and reliability of the examination test results. Therefore, it is essential to take special measures to minimize the described protein profile changes and modifications within tissues for subsequent examination. This document is not applicable for protein examination by immunohistochemistry.

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