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  • CLSI EP9 A2 : 2ED 2002

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES

    Available format(s): 

    Superseded date:  30-08-2013

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Clinical Laboratory Standards Institute

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    Abstract - (Show below) - (Hide below)

    Addresses procedures for determining the bias between two clinical methods or devices, and for the design of a method comparison experiment using split patient samples and data analysis.

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

    Development Note Supersedes NCCLS EP9 A (09/2002) Interim Revision of 2ED 2002 issued on 30/07/2010. (01/2011)
    Document Type Miscellaneous Product
    Publisher Clinical Laboratory Standards Institute
    Status Superseded
    Superseded By
    Supersedes

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

    CLSI EP32 R : 1ED 2006 METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION
    CLSI H56 A : 1ED 2006 BODY FLUID ANALYSIS FOR CELLULAR COMPOSITION
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    CLSI MM10 P : 1ED 2005 GENOTYPING FOR INFECTIOUS DISEASES: IDENTIFICATION AND CHARACTERIZATION
    CLSI EP18 A2 : 2ED 2009 RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES
    CSA ISO 15197 : 2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
    CLSI EP25 A : 1ED 2009 EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS
    CLSI C58 A : 1ED 2011 ASSESSMENT OF FETAL LUNG MATURITY BY THE LAMELLAR BODY COUNT
    CLSI EP27 A : 1ED 2012 HOW TO CONSTRUCT AND INTERPRET AN ERROR GRID FOR QUANTITATIVE DIAGNOSTIC ASSAYS
    CLSI POCT4 A2 : 2ED 2006 POINT-OF-CARE IN VITRO DIAGNOSTIC (IVD) TESTING
    CLSI MM19 A : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
    CLSI EP29 A : 1ED 2012 EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE
    CLSI POCT12 A3 : 3ED 2013 Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition
    CLSI POCT9 A : 1ED 2010 SELECTION CRITERIA FOR POINT-OF-CARE TESTING DEVICES
    CLSI MM1 A3 : 3ED 2012 MOLECULAR METHODS FOR CLINICAL GENETICS AND ONCOLOGY TESTING
    CLSI GP34 P : 1ED 2009 VALIDATION AND VERIFICATION OF TUBES FOR VENOUS AND CAPILLARY BLOOD SPECIMEN COLLECTION
    CLSI H47 A2 : 2ED 2008 ONE-STAGE PROTHROMBIN TIME (PT) TEST AND ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) TEST
    CLSI EP18 P3 : 3ED 2009 RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES
    CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY
    CLSI H26 P2 : 2ED 2009 VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS
    CLSI EP27 P : 1ED 2009 HOW TO CONSTRUCT AND INTERPRET AN ERROR GRID FOR DIAGNOSTIC ASSAYS
    CLSI H57 A : 1ED 2008 PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS
    CLSI MM10 A : 1ED 2006 GENOTYPING FOR INFECTIOUS DISEASES: IDENTIFICATION AND CHARACTERIZATION
    UNE-EN ISO 18113-1:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
    I.S. EN ISO 15197:2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)
    CLSI MM5 A2 : 2ED 2012 NUCLEIC ACID AMPLIFICATION ASSAYS FOR MOLECULAR HEMATOPATHOLOGY
    CLSI POCT9 P : 1ED 2009 SELECTION CRITERIA FOR POINT-OF-CARE TESTING DEVICES
    CLSI I/LA32 P : 1ED 2009 NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY
    CLSI EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
    CLSI C51 P : 1ED 2010 EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE
    ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
    EN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
    CLSI GP16-A3 : 2009 Urinalysis; Approved Guideline—Third Edition
    CLSI QMS01 A4 : 4ED 2011 QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
    CLSI H26 A2 : 2ED 2010 VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS
    CLSI EP31 A : 1ED 2008 VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM
    CLSI MM19 P : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
    CLSI C28 P3 : 3ED 2008 DEFINING, ESTABLISHING, AND VERIFYING REFERENCE INTERVALS IN THE CLINICAL LABORATORY
    CLSI C24 A3 : 3ED 2006 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
    CLSI NBS05 A : 1ED 2011 NEWBORN SCREENING FOR CYSTIC FIBROSIS
    CLSI GP37 P : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
    CLSI H57 P : 1ED 2007 PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS
    CLSI MM6 A2 : 2ED 2010 QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES
    CLSI C50 P : 1ED 2007 MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE
    CLSI POCT5 P : 1ED 2008 PERFORMANCE METRICS FOR CONTINUOUS INTERSTITIAL GLUCOSE MONITORING
    CLSI NBS04 A : 1ED 2010 NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY
    11/30208525 DC : 0 BS EN ISO 15197 - IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
    ISO 17593:2007 Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
    I.S. EN ISO 18113-1:2011 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
    CLSI EP28 A3 : 3ED 2010 DEFINING, ESTABLISHING, AND VERIFYING REFERENCE INTERVALS IN THE CLINICAL LABORATORY
    CLSI I/LA25 A2 : 2011 MATERNAL SERUM SCREENING
    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    BS EN ISO 15197:2015 In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
    EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
    CLSI H56 P : 1ED 2005 BODY FLUID ANALYSIS FOR CELLULAR COMPOSITION
    CLSI EP18 P2 : 2ED 2007 RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES
    CLSI QMS13 A : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
    CLSI H2 A5 : 5ED 2011 PROCEDURES FOR THE ERYTHROCYTE SEDIMENTATION RATE TEST
    CLSI EP22 P : 1ED 2010 PRESENTATION OF A MANUFACTURER'S RISK MITIGATION INFORMATION FOR USERS OF IN VITRO DIAGNOSTIC DEVICES
    DIN EN ISO 18113-1:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
    BS ISO 17593:2007 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
    BS EN ISO 18113-1:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements
    CLSI C50 A : 1ED 2007 MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE
    CLSI C43 A2 : 2ED 2010 GAS CHROMATOGRAPHY/MASS SPECTROMETRY CONFIRMATION OF DRUGS
    UNI EN ISO 18113-1 : 2012 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS
    PREN ISO 15197 : DRAFT 2011 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
    UNE-EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
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