BS PD CEN/TS 16827-1:2015

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

BSI Group, 08/31/2015

Publisher: BS

File Format: PDF

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Description

Published:31/08/2015

Pages:22

File Size:1 file , 1.1 MB

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BS PD CEN/TS 16827-1:2015 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.

Cross References:
EN ISO 15189:2012
ISO 15189:2012
ISO 15190
EN ISO 22174:2005
ISO 22174:2005
ISO Guide 30:1992

All current amendments available at time of purchase are included with the purchase of this document.