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  • CLSI M53 A : 1ED 2011

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    CRITERIA FOR LABORATORY TESTING AND DIAGNOSIS OF HUMAN IMMUNODEFICIENCY VIRUS INFECTION

    Available format(s):  Hardcopy, PDF

    Superseded date:  24-08-2023

    Language(s):  English

    Published date:  30-06-2011

    Publisher:  Clinical Laboratory Standards Institute

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

    Abstract
    Committee Membership
    Foreword
    1 Scope
    2 Standard Precautions
    3 Terminology
    4 Background/Natural History/Virology
    5 Initial Tests for HIV Infection
    6 Supplemental HIV Tests
    7 Special Situations
    8 Algorithms
    9 Test Results and Reporting
    10 HIV Testing Quality Control
    References
    Appendix - Reporting Comments Suggested for Initial
               and Supplemental HIV Diagnostic Test Results
    The Quality Management System Approach
    Related CLSI Reference Materials

    Abstract - (Show below) - (Hide below)

    Gives guidance for laboratorians performing human immunodeficiency virus testing and for the interpretation of results by health care providers in advanced diagnostic laboratories.

    Scope - (Show below) - (Hide below)

    This document provides an overview of the natural history and response to human immunodeficiency virus (HIV) infection, an in-depth review of initial and supplemental tests for the diagnosis of HIV infection, and initiation of a quality control (QC) program for HIV testing.

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

    Development Note Supersedes NCCLS M53 P. (07/2011)
    Document Type Miscellaneous Product
    Publisher Clinical Laboratory Standards Institute
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
    ANSI/AAMI/ISO 16142-2:2017 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
    BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards

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

    CLSI GP27 A2 : 2ED 2007 USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY
    CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
    CLSI GP44 A4 : 4ED 2010 PROCEDURES FOR THE HANDLING AND PROCESSING OF BLOOD SPECIMENS FOR COMMON LABORATORY TESTS
    CLSI MM13 A : 1ED 2006 COLLECTION, TRANSPORT, PREPARATION, AND STORAGE OF SPECIMENS FOR MOLECULAR METHODS
    CLSI QMS03 A3 : 3ED 2009 TRAINING AND COMPETENCE ASSESSMENT
    CLSI GP2 A5 : 5ED 2006 LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL
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