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  • CLSI MM6 A2 : 2ED 2010

    Current The latest, up-to-date edition.

    QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-11-2010

    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 Update on Molecular Quantification Technologies
    6 Specimen Handling and Preparation for Molecular
       Quantification
    7 Reference Materials, Standards, Calibrators, and
       Quality Control Materials
    8 Analytical Versification and Validation
    9 Clinical Validity and Clinical Utility
    10 Reporting, Interpretation, and Limitations of results
    11 Continuing Quality Assurance
    References
    Appendix - timing of Specimen Collection
    Summary of Delegate Comments and Subcommittee Responses
    The Quality Management System Approach
    Related CLSI Reference Materials

    Abstract - (Show below) - (Hide below)

    Gives guidance for the development and use of quantitative molecular methods, such as nucleic acid probes and nucleic acid amplification techniques of the target sequences specific to particular microorganisms.

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

    Development Note Supersedes NCCLS MM6 A. (05/2011)
    Document Type Standard
    Publisher Clinical Laboratory Standards Institute
    Status Current
    Supersedes

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

    CLSI MM23 : 1ED 2015 MOLECULAR DIAGNOSTIC METHODS FOR SOLID TUMORS (NONHEMATOLOGICAL NEOPLASMS)
    CLSI MM9 A2 : 2ED 2014 NUCLEIC ACID SEQUENCING METHODS IN DIAGNOSTIC LABORATORY MEDICINE
    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
    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 MM5 A2 : 2ED 2012 NUCLEIC ACID AMPLIFICATION ASSAYS FOR MOLECULAR HEMATOPATHOLOGY
    CLSI MM19 P : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
    CLSI MM3 A3 : 3ED 2015 MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES
    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

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

    CLSI EP14 A2 : 2ED 2005 EVALUATION OF MATRIX EFFECTS
    CLSI MM16 A : 1ED 2006 USE OF EXTERNAL RNA CONTROLS IN GENE EXPRESSION ASSAYS
    CLSI MM7 A : 1ED 2004 FLUORESCENCE IN SITU HYBRIDIZATION (FISH) METHODS FOR MEDICAL GENETICS
    CLSI MM17 A : 1ED 2008 VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS
    CLSI EP21 A : 1ED 2003 ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS
    CLSI EP5 A2 : 2ED 2004 EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
    CLSI GP10 A : 1ED 95(R2001) ASSESSMENT OF THE CLINICAL ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC (ROC) PLOTS
    CLSI EP6 A : 1ED 2003 EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH
    CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
    CLSI M50 A : 1ED 2008 QUALITY CONTROL FOR COMMERCIAL MICROBIAL IDENTIFICATION SYSTEMS
    CLSI EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
    CLSI MM9 A : 1ED 2004 NUCLEIC ACID SEQUENCING METHODS IN DIAGNOSTIC LABORATORY MEDICINE
    CLSI GP41 A6 : 6ED 2007 PROCEDURES FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY VENIPUNCTURE
    CLSI EP17 A : 1ED 2004 PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION
    CLSI MM13 A : 1ED 2006 COLLECTION, TRANSPORT, PREPARATION, AND STORAGE OF SPECIMENS FOR MOLECULAR METHODS
    CLSI C24 A3 : 3ED 2006 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
    CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY
    CLSI EP9 A2 : 2ED 2002 METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
    CLSI MM3 A2 : 2ED 2006 MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES
    CLSI EP10 A3 : 2006 + A1 2014 PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES
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