<p>This document gives guidelines on 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.</p>
<p>This document is applicable to any molecular <i>in vitro</i> 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, <i>in vitro</i> diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.</p>
<p>NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.</p>
Registration number (WIID)
69801
Scope
<p>This document gives guidelines on 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.</p>
<p>This document is applicable to any molecular <i>in vitro</i> 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, <i>in vitro</i> diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.</p>
<p>NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.</p>
