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DS CEN/TS 16827-1:2015

Ekzaminime molekulare për diagnostikimin in vitro - Specifikime për proceset e para - ekzaminimit për indet FFPE - Pjesa 1: Qeliza ARN të veçuara

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 1: Isolated RNA
28 mar 2017
95.99 Withdrawal of Standard   15 pri 2021

General information

95.99     15 pri 2021

DPS

DPS/KT 140

Technical Specification

11.100.10  

anglisht  

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Scope

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.

Life cycle

NOW

WITHDRAWN
DS CEN/TS 16827-1:2015
95.99 Withdrawal of Standard
15 pri 2021

REVISED BY

PUBLISHED
SSH EN ISO 20166-1:2018

Related project

Adopted from CEN/TS 16827-1:2015