PD CEN/TS 16827-1:2015

European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Outside the laboratory
6 Inside the laboratory
Annex A (informative) - Quality control of RNA
        extracted from formalin fixed and paraffin
        embedded tissue samples: implications for
        RT-qPCR based analyses
Bibliography

Provides recommendations for the handling, documentation and processing of FFPE tissue specimens intended for RNA analysis during the preanalytical phase before a molecular assay is performed.

This Technical Specification gives recommendations for the handling, documentation and processing of FFPE tissue specimens intended for RNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g., in vitro diagnostic laboratories, laboratory customers, developers and manufacturers of in vitro diagnostics, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). The formalin fixation and the paraffin embedding process lead to modifications of the RNA molecules, which can impact the validity and reliability of the analytical test results. Therefore, it is essential to take special measures to minimize the described profile changes and modifications within the tissue for subsequent RNA analysis.