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  • CLSI I/LA28 A2 : 2ED 2011

    Current The latest, up-to-date edition.

    QUALITY ASSURANCE FOR DESIGN CONTROL AND IMPLEMENTATION OF IMMUNOHISTOCHEMISTRY ASSAYS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-01-2011

    Publisher:  Clinical Laboratory Standards Institute

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

    Abstract
    Committee Membership
    Foreword
    1 Scope
    2 Introduction
    3 Standard Precautions
    4 Terminology
    Part 1 - The Scientific Theory and Principles of the Design
             and Development of Immunohistochemistry Assays
    5 Design Control Process for Immunohistochemistry Assay
       Discovery, Development, and Clinical Implementation
    6 Specimen Requirements for Immunohistochemistry Assays
    7 Analyte (Antigen)
    8 Primary Antibody
    9 Detection Methodologies and Chemistries
    10 Design Principles for Processing and Immunostaining Steps
    11 Design Principles for Interpretation of Immunohistochemistry
       Assays
    Part 2 - The Implementation of Immunohistochemistry Assays
             by Pathologists and Technologists
    12 Assay Verification and Validation in the End-User
       Laboratory
    13 Selection of Immunohistochemistry Assay by Surgical
       Pathologist

    Abstract - (Show below) - (Hide below)

    Gives guidelines for the development of validated diagnostic, prognostic, and predictive immunohistochemical assays.

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

    Development Note Supersedes NCCLS MM4 A. (03/2011)
    Document Type Miscellaneous Product
    Publisher Clinical Laboratory Standards Institute
    Status Current
    Supersedes

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    ISO/TS 17518:2015 Medical laboratories — Reagents for staining biological material — Guidance for users
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    CLSI GP28 A : 1ED 2005 MICROWAVE DEVICE USE IN THE HISTOLOGY LABORATORY
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    CLSI I/LA23 A : 1ED 2004 ASSESSING THE QUALITY OF IMMUNOASSAY SYSTEMS: RADIOIMMUNOASSAYS AND ENZYME, FLUORESCENCE, AND LUMINESCENCE IMMUNOASSAYS
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    CLSI GP15 A3 : 3ED 2008 CERVICOVAGINAL CYTOLOGY BASED ON THE PAPANICOLAOU TECHNIQUE
    CLSI EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
    CLSI I/LA2 A2 : 2ED 2006 QUALITY ASSURANCE OF LABORATORY TESTS FOR AUTOANTIBODIES TO NUCLEAR ANTIGENS: (1) INDIRECT FLUORESCENCE ASSAY FOR MICROSCOPY AND (2) MICROTITER ENZYME IMMUNOASSAY METHODS
    CLSI EP19 R : 1ED 2002 A FRAMEWORK FOR NCCLS EVALUATION PROTOCOLS
    CLSI I/LA21 A2 : 2ED 2008 CLINICAL EVALUATION OF IMMUNOASSAYS
    CLSI C24 A3 : 3ED 2006 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
    CLSI LA1 A2 : 2ED 94 ASSESSING THE QUALITY OF RADIOIMMUNOASSAY SYSTEMS
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