Skip to content
Please enter a keyword to search

  • CLSI MM22 A : 1ED 2014

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES

    Available format(s): 

    Superseded date:  31-01-2024

    Language(s): 

    Published date:  25-08-2018

    Publisher:  Clinical Laboratory Standards Institute

    Sorry this product is not available in your region.

    Add To Cart

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

    Abstract
    Committee Membership
    Foreword
    1 Scope
    2 Introduction
    3 Standard Precautions
    4 Terminology
    5 General Considerations in Developing Micoarrary Assays
    6 Platform Overview
    7 Clinical Applications
    8 Assay Performance Verification and Validation
    9 Quality Control and Quality Assurance
    10 Data Analysis and Interpretation
    References
    The Quality Management System Approach
    Related CLSI Reference Materials

    Abstract - (Show below) - (Hide below)

    Gives guidance for the laboratory development and use of qualitative nucleic acid microarray methods for the diagnosis and monitoring of infectious diseases.

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

    Document Type Miscellaneous Product
    Publisher Clinical Laboratory Standards Institute
    Status Superseded
    Superseded By

    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
    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

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

    CLSI GP27 A2 : 2ED 2007 USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY
    CLSI M6 A2 : 2ED 2006 PROTOCOLS FOR EVALUATING DEHYDRATED MUELLER-HINTON AGAR
    CLSI QMS13 A : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
    CLSI MM19 A : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
    CLSI EP17 A2 : 2ED 2012 EVALUATION OF DETECTION CAPABILITY FOR CLINICAL LABORATORY MEASUREMENT PROCEDURES
    CLSI MM5 A2 : 2ED 2012 NUCLEIC ACID AMPLIFICATION ASSAYS FOR MOLECULAR HEMATOPATHOLOGY
    CLSI QMS01 A4 : 4ED 2011 QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
    CLSI MM17 A : 1ED 2008 VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS
    CLSI EP5 A2 : 2ED 2004 EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
    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 EP9 A3 : 3ED 2013 MEASUREMENT PROCEDURE COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
    CLSI EP6 A : 1ED 2003 EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH
    CLSI GP29 A2 : 2ED 2008 ASSESSMENT OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE
    CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
    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 MM13 A : 1ED 2006 COLLECTION, TRANSPORT, PREPARATION, AND STORAGE OF SPECIMENS FOR MOLECULAR METHODS
    CLSI MM12 A : 1ED 2006 DIAGNOSTIC NUCLEIC ACID MICROARRAYS
    CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY
    CLSI MM3 A2 : 2ED 2006 MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES
    CLSI QMS03 A3 : 3ED 2009 TRAINING AND COMPETENCE ASSESSMENT
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective