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  • CLSI MM12 A : 1ED 2006

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    DIAGNOSTIC NUCLEIC ACID MICROARRAYS

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    Withdrawn date:  28-03-2016

    Language(s): 

    Published date:  12-01-2013

    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
    5 Method Overview
    6 Analytical Methods
    7 Genetic Data Analysis
    8 Gene Expression Data Analysis
    9 Validation
    10 Quality Control/Quality Assurance
    References
    Appendix A - Gene Expression Data Analysis
    Appendix B - Validation
    Appendix References
    Summary of Consensus/Delegate Comments and Committee
    Responses
    The Quality System Approach
    Related CLSI/NCCLS Publications

    Abstract - (Show below) - (Hide below)

    Provides recommendations for many aspects of the array process including: a method overview; nucleic acid extraction; the preparation, handling, and assessment of genetic material; quality control; analytic validation; and interpretation and reporting of results.

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

    Development Note Supersedes NCCLS MM12 P (07/2006)
    Document Type Miscellaneous Product
    Publisher Clinical Laboratory Standards Institute
    Status Withdrawn
    Supersedes

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

    CLSI MM22 A : 1ED 2014 MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES
    CLSI MM19 P : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
    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
    CLSI MM1 A3 : 3ED 2012 MOLECULAR METHODS FOR CLINICAL GENETICS AND ONCOLOGY TESTING
    CLSI MM17 P : 1ED 2007 VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS
    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
    CLSI MM5 A2 : 2ED 2012 NUCLEIC ACID AMPLIFICATION ASSAYS FOR MOLECULAR HEMATOPATHOLOGY
    CLSI MM17 A : 1ED 2008 VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS
    CLSI MM23 : 1ED 2015 MOLECULAR DIAGNOSTIC METHODS FOR SOLID TUMORS (NONHEMATOLOGICAL NEOPLASMS)
    CLSI MM21 : 1ED 2015 GENOMIC COPY NUMBER MICROARRAYS FOR CONSTITUTIONAL GENETIC AND ONCOLOGY APPLICATIONS
    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
    CLSI MM19 A : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
    CLSI MM16 A : 1ED 2006 USE OF EXTERNAL RNA CONTROLS IN GENE EXPRESSION ASSAYS
    CLSI MM20 A : 1ED 2012 QUALITY MANAGEMENT FOR MOLECULAR GENETIC TESTING

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

    CLSI C24 A2 : 2ED 99 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENTS: PRINCIPLES AND DEFINITIONS
    CLSI GP29 A : 1ED 2002 VALIDATION OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE
    CLSI MM6 A : 1ED 2003 QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES
    CLSI EP10 A2 : 2ED 2002 PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY METHODS
    CLSI MM14 A : 1ED 2005 PROFICIENCY TESTING (EXTERNAL QUALITY ASSESSMENT) FOR MOLECULAR METHODS
    CLSI MM1 A : 1ED 2000 MOLECULAR DIAGNOSTIC METHODS FOR GENETIC DISEASES
    CLSI MM2 A2 : 2ED 2002 IMMUNOGLOBULIN AND T-CELL RECEPTOR GENE REARRANGEMENT ASSAYS
    CLSI MM3 A2 : 2ED 2006 MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES
    CLSI MM5 A : 1ED 2003 NUCLEIC ACID AMPLIFICATION ASSAYS FOR MOLECULAR HEMATOPATHOLOGY
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