• PD CEN/TS 16835-2:2015

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood Isolated genomic DNA

    Available format(s):  Hardcopy, PDF

    Superseded date:  10-05-2019

    Language(s):  English

    Published date:  31-10-2015

    Publisher:  British Standards Institution

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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) - Impact of preanalytical
            workflow steps on venous whole blood
            genomic DNA quality
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies the handling, documentation and processing of venous whole blood specimens intended for genomic DNA analysis during the preanalytical phase before a molecular assay is performed.

    Scope - (Show below) - (Hide below)

    This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for genomic DNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). Blood genomic DNA can fragment or degrade after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for genomic DNA analysis. This is particularly relevant for analytical test procedures requiring high molecular weight DNA. Different dedicated measures need to be taken for preserving blood cell free circulating DNA, which are not described in this Technical Specification. Circulating cell free DNA in blood is covered in CEN/TS 16835-3, Molecular in vitro diagnostic examinations -Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma. Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for blood collected and stored by paper based technologies. These are not described in this Technical Specification. Pathogen DNA present in blood is not covered by this Technical Specification.

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

    Committee CH/212
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    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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