• CLSI EP9 A3 : 3ED 2013

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    MEASUREMENT PROCEDURE COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES

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    Superseded date:  12-03-2020

    Language(s): 

    Published date:  09-10-2013

    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 Measurement Procedure - Familiarization Period
    6 Measurement Procedure Comparison Studies
    7 Considerations for Clinical Laboratories
    8 Visual Data Review
    9 Quantitative Analysis
    10 Comparisons Within a Measurement Procedure
    11 Interpreting Results and Comparing to Performance Criteria
    References
    Appendix A - Confidence Interval of a Median Estimate of Bias
                 Between Measurement
    Appendix B - Detecting Aberrant Results (Outliers)
    Appendix C - Ordinary Linear Regression
    Appendix D - Weighted Least Squares Regression (Weighted
                 Ordinary Linear Regression)
    Appendix E - Deming Regression
    Appendix F - Constant CV (Weighted) Deming Regression
    Appendix G - Passing-Bablok Regression
    Appendix H - Jackknife Approach for Estimating Standard Errors
                 for Bias and Regression Parameters
    Appendix I - A Practical Example Illustrating Bias Estimation and
                 Measurement Procedure Comparison Techniques
    Appendix J - Example Datasets
    The Quality Management System Approach
    Related CLSI Reference Materials

    Abstract - (Show below) - (Hide below)

    Specifies the design of measurement procedure comparison experiments using patient samples and subsequent data analysis techniques used to determine the bias between two in vitro diagnostic measurement procedures.

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

    Development Note Supersedes CLSI EP9 A2. (09/2013)
    Document Type Miscellaneous Product
    Publisher Clinical Laboratory Standards Institute
    Status Superseded
    Superseded By
    Supersedes

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

    CLSI EP19 : 2ED 2015 A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES
    CLSI H48 : 2ED 2016 DETERMINATION OF COAGULATION FACTOR ACTIVITIES USING THE ONE-STAGE CLOTTING ASSAY
    CLSI EP26 A : 1ED 2013 USER EVALUATION OF BETWEEN-REAGENT LOT VARIATION
    CLSI H60 A : 1ED 2014 LABORATORY TESTING FOR THE LUPUS ANTICOAGULANT
    CLSI POCT17 : 1ED 2016 USE OF GLUCOSE METERS FOR CRITICALLY ILL PATIENTS
    CLSI MM22 A : 1ED 2014 MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES
    CLSI EP21 : 2ED 2016 EVALUATION OF TOTAL ANALYTICAL ERROR FOR QUANTITATIVE MEDICAL LABORATORY MEASUREMENT PROCEDURES
    CLSI EP14 A3 : 2014 EVALUATION OF COMMUTABILITY OF PROCESSED SAMPLES
    CLSI C24 : 4ED 2016 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
    CLSI I/LA20 : 3ED 2016 ANALYTICAL PERFORMANCE CHARACTERISTICS, QUALITY ASSURANCE, AND CLINICAL UTILITY OF IMMUNOLOGICAL ASSAYS FOR HUMAN IMMUNOGLOBULIN E ANTIBODIES OF DEFINED ALLERGEN SPECIFICITIES
    CLSI C57 : 1ED 2015 MASS SPECTROMETRY FOR ANDROGEN AND ESTROGEN MEASUREMENTS IN SERUM
    CLSI EP36 : 1EDE 2015 HARMONIZATION OF SYMBOLOGY AND EQUATIONS
    CLSI QMS24 : 3ED 2016 USING PROFICIENCY TESTING AND ALTERNATIVE ASSESSMENT TO IMPROVE MEDICAL LABORATORY QUALITY
    CLSI POCT4 : 3ED 2016 ESSENTIAL TOOLS FOR IMPLEMENTATION AND MANAGEMENT OF A POINT-OF-CARE TESTING PROGRAM
    CLSI EP15 A3 : 3ED 2014 USER VERIFICATION OF PRECISION AND ESTIMATION OF BIAS

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

    CLSI EP14 A2 : 2ED 2005 EVALUATION OF MATRIX EFFECTS
    CLSI EP17 A2 : 2ED 2012 EVALUATION OF DETECTION CAPABILITY FOR CLINICAL LABORATORY MEASUREMENT PROCEDURES
    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 EP31 A : 1ED 2008 VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM
    CLSI EP12 A2 : 2ED 2008 USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE
    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 EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
    CLSI I/LA28 A2 : 2ED 2011 QUALITY ASSURANCE FOR DESIGN CONTROL AND IMPLEMENTATION OF IMMUNOHISTOCHEMISTRY ASSAYS
    CLSI I/LA21 A2 : 2ED 2008 CLINICAL EVALUATION OF IMMUNOASSAYS
    CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY
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