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  • CLSI EP29 A : 1ED 2012

    Current The latest, up-to-date edition.

    EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-01-2012

    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 Terminology
    4 Strategies to Estimate Measurement Uncertainty
    5 Overview of Measurement Uncertainty
    6 Bottom-up Uncertainty Estimation
    7 Top-Down Approach to Estimation of Measurement
       Uncertainty
    8 Bias Assessment
    9 Uses of Uncertainty Estimates
    10 Summary
    References
    Additional References
    Appendix A - Transformation of Type B Limit Specifications
    Appendix B - Uncertainty Estimates From Routine Quality
                 Control Results
    The Quality Management System Approach
    Related CLSI Reference Materials

    Abstract - (Show below) - (Hide below)

    Specifies a practical approach to assist clinical laboratories in developing and calculating useful estimates of measurement uncertainty, and illustrates their application in maintaining and improving the quality of measured values used in patient care.

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

    Development Note Supersedes CLSI C51 P. (02/2012) Formerly CLSI C51 A. (07/2013)
    Document Type Standard
    Publisher Clinical Laboratory Standards Institute
    Status Current
    Supersedes

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

    PD ISO/TS 17822-1:2014 In vitro diagnostic test systems. Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens General requirements, terms and definitions
    CLSI EP17 A2 : 2ED 2012 EVALUATION OF DETECTION CAPABILITY FOR CLINICAL LABORATORY MEASUREMENT PROCEDURES
    ISO/TS 17822-1:2014 In vitro diagnostic test systems Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens Part 1: General requirements, terms and definitions
    CLSI EP36 : 1EDE 2015 HARMONIZATION OF SYMBOLOGY AND EQUATIONS
    CLSI EP5 A3 : 3ED 2014 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition

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

    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 EP6 A : 1ED 2003 EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH
    CLSI EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
    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 EP10 A3 : 2006 + A1 2014 PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES
    CLSI GP2 A5 : 5ED 2006 LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL
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