Skip to content
Please enter a keyword to search

  • CLSI EP5 A3 : 3ED 2014

    Current The latest, up-to-date edition.

    Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-10-2014

    Publisher:  Clinical Laboratory Standards Institute

    Add To Cart

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

    Abstract
    Committee Membership
    Foreword
    Chapter 1 - Introduction
    Chapter 2 - Selecting and Optimizing an Appropriate
                Precision Evaluation Protocol
    Chapter 3 - Single-Site Precision Evaluation Study
    Chapter 4 - Multisite Precision Evaluation Study
    Chapter 5 - Conclusion
    Chapter 6 - Supplemental Information
    References
    Appendix A - Worked Example - Single-Site Study
    Appendix B - Worked Example - Multisite Study
    Appendix C - Advanced Models
    The Quality Management System Approach
    Related CLSI Reference Materials

    Abstract - (Show below) - (Hide below)

    This document provides guidance for evaluating the precision performance of quantitative measurement procedures.

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

    Development Note Supersedes CLSI EP5 A2. (09/2014)
    Document Type Guide
    Publisher Clinical Laboratory Standards Institute
    Status Current
    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 POCT17 : 1ED 2016 USE OF GLUCOSE METERS FOR CRITICALLY ILL PATIENTS
    CLSI H48 : 2ED 2016 DETERMINATION OF COAGULATION FACTOR ACTIVITIES USING THE ONE-STAGE CLOTTING ASSAY
    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 MM3 A3 : 3ED 2015 MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES
    CLSI EP21 : 2ED 2016 EVALUATION OF TOTAL ANALYTICAL ERROR FOR QUANTITATIVE MEDICAL LABORATORY MEASUREMENT PROCEDURES
    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 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
    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
    CLSI MM23 : 1ED 2015 MOLECULAR DIAGNOSTIC METHODS FOR SOLID TUMORS (NONHEMATOLOGICAL NEOPLASMS)
    CLSI C57 : 1ED 2015 MASS SPECTROMETRY FOR ANDROGEN AND ESTROGEN MEASUREMENTS IN SERUM
    CLSI EP36 : 1EDE 2015 HARMONIZATION OF SYMBOLOGY AND EQUATIONS
    CLSI EP15 A3 : 3ED 2014 USER VERIFICATION OF PRECISION AND ESTIMATION OF BIAS

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

    CLSI EP17 A2 : 2ED 2012 EVALUATION OF DETECTION CAPABILITY FOR CLINICAL LABORATORY MEASUREMENT PROCEDURES
    CLSI EP12 A2 : 2ED 2008 USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE
    CLSI EP29 A : 1ED 2012 EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE
    CLSI EP15 A3 : 3ED 2014 USER VERIFICATION OF PRECISION AND ESTIMATION OF BIAS
    CLSI EP25 A : 1ED 2009 EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS
    CLSI C24 A3 : 3ED 2006 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
    CLSI EP10 A3 : 2006 + A1 2014 PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES
    CLSI C56 A : 1ED 2012 HEMOLYSIS, ICTERUS, AND LIPEMIA/TURBIDITY INDICES AS INDICATORS OF INTERFERENCE IN CLINICAL LABORATORY ANALYSIS
    CLSI M29 A4 : 4ED 2014 Protection of Laboratory Workers From Occupationally Acquired Infections
    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