UNE-EN ISO 20184-2:2019

This International Standard recommends the handling, documentation, storage and processing of

frozen 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 any

molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology

laboratories that evaluate proteins isolated from frozen tissue. It is also intended to be used by

laboratory customers, in vitro diagnostics developers and manufacturers, as well as 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.