• CLSI MM3 A3 : 3ED 2015

    Current The latest, up-to-date edition.

    MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES

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    Published date:  27-02-2015

    Publisher:  Clinical Laboratory Standards Institute

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

    Abstract
    Committee Membership
    Foreword
    Chapter 1 - Introduction
    Chapter 2 - Applications
    Chapter 3 - Specimen Collection, Transport, and
                Processing
    Chapter 4 - Contributors to False-Negative Results and Controls
    Chapter 5 - Methods
    Chapter 6 - Selection and Qualification of Nucleic Acid Sequences
    Chapter 7 - Establishment and Evaluation of Performance
                Characteristics of Molecular Diagnostic Tests
    Chapter 8 - Quality Assurance
    Chapter 9 - Reporting of Results
    Chapter 10 - Recommendations for Manufactures and Clinical
                 Laboratories
    Chapter 11 - Conclusion
    Chapter 12 - Supplemental Information
    References
    Additional References
    Appendix Nucleic Acid Amplification Technologies
    The Quality Management System Approach
    Related CLSI References Materials

    Abstract - (Show below) - (Hide below)

    Defines general principles for the development, evaluation, and application of tests designed for direct detection of microorganisms in clinical specimens and for identification of microorganisms grown in culture.

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

    Development Note Supersedes CLSI MM3 A2. (03/2015)
    Document Type Standard
    Publisher Clinical Laboratory Standards Institute
    Status Current
    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 AUTO4 A : 1ED 2001 LABORATORY AUTOMATION: SYSTEMS OPERATIONAL REQUIREMENTS, CHARACTERISTICS, AND INFORMATION ELEMENTS
    CLSI MM19 A : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
    CLSI MM6 A2 : 2ED 2010 QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES
    CLSI EP23 A : 1ED 2011 LABORATORY QUALITY CONTROL BASED ON RISK MANAGEMENT
    CLSI EP17 A2 : 2ED 2012 EVALUATION OF DETECTION CAPABILITY FOR CLINICAL LABORATORY MEASUREMENT PROCEDURES
    CLSI EP5 A3 : 3ED 2014 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition
    CLSI AUTO3 A2 : 2ED 2009 LABORATORY AUTOMATION: COMMUNICATIONS WITH AUTOMATED CLINICAL LABORATORY SYSTEMS, INSTRUMENTS, DEVICES, AND INFORMATION SYSTEMS
    CLSI QMS01 A4 : 4ED 2011 QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
    CLSI MM9 A2 : 2ED 2014 NUCLEIC ACID SEQUENCING METHODS IN DIAGNOSTIC LABORATORY MEDICINE
    CLSI MM17 A : 1ED 2008 VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS
    CLSI MM10 A : 1ED 2006 GENOTYPING FOR INFECTIOUS DISEASES: IDENTIFICATION AND CHARACTERIZATION
    CLSI EP12 A2 : 2ED 2008 USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE
    CLSI EP24 A2 : 2ED 2011 ASSESSMENT OF THE DIAGNOSTIC ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC CURVES
    CLSI MM14 A2 : 2ED 2013 DESIGN OF MOLECULAR PROFICIENCY TESTING/EXTERNAL QUALITY ASSESSMENT
    CLSI AUTO1 A : 1ED 2000 LABORATORY AUTOMATION: SPECIMEN CONTAINER/SPECIMEN CARRIER
    CLSI AUTO5 A : 1ED 2001 LABORATORY AUTOMATION: ELECTROMECHANICAL INTERFACES
    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 QMS05 A2 : 2ED 2012 QUALITY MANAGEMENT SYSTEM: QUALIFYING, SELECTING, AND EVALUATING A REFERRAL LABORATORY
    CLSI QMS06 A3 : 3ED 2011 QUALITY MANAGEMENT SYSTEM: CONTINUAL IMPROVEMENT
    CLSI QMS02 A6 : 6ED 2013 QUALITY MANAGEMENT SYSTEM: DEVELOPMENT AND MANAGEMENT OF LABORATORY DOCUMENTS
    CLSI M29 A4 : 4ED 2014 Protection of Laboratory Workers From Occupationally Acquired Infections
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