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  • CEN/TS 16827-1:2015

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    Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 1: Isolated RNA

    Available format(s): 

    Withdrawn date:  09-03-2023

    Language(s): 

    Published date:  12-08-2015

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/TC 140
    Document Type Technical Specification
    Publisher Comite Europeen de Normalisation
    Status Withdrawn
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 22174:2005 Microbiology of food and animal feeding stuffs Polymerase chain reaction (PCR) for the detection of food-borne pathogens General requirements and definitions
    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    EN ISO 22174:2005 Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - General requirements and definitions (ISO 22174:2005)
    ISO 15190:2003 Medical laboratories Requirements for safety
    ISO Guide 30:2015 Reference materials Selected terms and definitions
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