• PD CEN/TS 16826-2:2015

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 snap frozen tissue Isolated proteins

    Available format(s):  Hardcopy, PDF

    Superseded date:  22-02-2019

    Language(s):  English

    Published date:  31-08-2015

    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) - Quantitative protein analysis
            demonstrates changes of protein amounts
            during cold ischemia
    Bibliography

    Abstract - (Show below) - (Hide below)

    Recommends the handling, documentation and processing of frozen tissue specimens intended for the analysis of extracted proteins during the pre-analytical phase before a molecular assay is performed.

    Scope - (Show below) - (Hide below)

    This Technical Specification recommends the handling, documentation and processing of frozen tissue specimens intended for the analysis of extracted proteins 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, in vitro diagnostics developers and manufacturers, institutions and commercial organisations performing biomedical research, biobanks, and regulatory authorities). Protein profiles and protein-protein interactions in tissues can change drastically before and after collection (due to e.g., gene induction, gene down regulation, protein degradation). Protein species amounts can change differently in different donors’ / patients’ tissues. The expression of genes can be influenced by the given treatment or intervention (surgery, biopsy), or drugs administered for anaesthesia or even treatment of concomitant disease as well as by the different environment conditions after the tissue removal from the body. Therefore, it is essential to take special measures to minimize the described profile changes and modifications within the tissue for subsequent protein analysis. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. In addition this document is not applicable for protein analysis by immunohistochemistry.

    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 15189:2012 Medical laboratories — Requirements for quality and competence
    ISO 15190:2003 Medical laboratories Requirements for safety
    ISO Guide 30:2015 Reference materials Selected terms and definitions
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