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BSI PD CEN/TS 16827-1:2015

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue -- Isolated RNA
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BSI PD CEN/TS 16827-1:2015

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue -- Isolated RNA

PUBLISH DATE 2015
PAGES 24
BSI PD CEN/TS 16827-1:2015

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.

SDO BSI: British Standards Institution
Document Number CEN/TS 16827-1
Publication Date Aug. 31, 2015
Language en - English
Page Count
Revision Level
Supercedes
Committee CH/212
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