This document provides essential guidance for molecular in vitro diagnostic (IVD) examinations evaluating RNA extracted from frozen tissue, ensuring accuracy and reliability in medical and molecular pathology laboratories. It also supports IVD developers, manufacturers, biobanks, and research institutions in maintaining high-quality standards for RNA analysis. While it excludes chemically stabilized pre-treated tissues, it helps laboratories optimize processes for robust and reproducible results.

NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

This document is available in electronic format only.