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  • CLSI EP6 A : 1ED 2003

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH

    Available format(s):  Hardcopy, PDF

    Superseded date:  10-06-2023

    Language(s):  English

    Published date:  12-01-2013

    Publisher:  Clinical Laboratory Standards Institute

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    Abstract - (Show below) - (Hide below)

    Covers guidelines for characterizing the linearity of a method during a method evaluation: for checking linearity as part of routine quality assurance: and for determining and stating a manufacture's claim for linear range.

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

    Development Note Supersedes NCCLS EP6 P2 (05/2003)
    Document Type Miscellaneous Product
    Publisher Clinical Laboratory Standards Institute
    Status Superseded
    Superseded By
    Supersedes

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

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    CLSI H56 A : 1ED 2006 BODY FLUID ANALYSIS FOR CELLULAR COMPOSITION
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    CLSI GP37 P : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
    CLSI H48 : 2ED 2016 DETERMINATION OF COAGULATION FACTOR ACTIVITIES USING THE ONE-STAGE CLOTTING ASSAY
    CLSI EP18 A2 : 2ED 2009 RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES
    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 EP25 A : 1ED 2009 EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS
    CLSI EP22 P : 1ED 2010 PRESENTATION OF A MANUFACTURER'S RISK MITIGATION INFORMATION FOR USERS OF IN VITRO DIAGNOSTIC DEVICES
    CLSI C58 A : 1ED 2011 ASSESSMENT OF FETAL LUNG MATURITY BY THE LAMELLAR BODY COUNT
    CLSI MM19 A : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
    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 EP29 A : 1ED 2012 EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE
    CLSI H60 A : 1ED 2014 LABORATORY TESTING FOR THE LUPUS ANTICOAGULANT
    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 POCT17 : 1ED 2016 USE OF GLUCOSE METERS FOR CRITICALLY ILL PATIENTS
    CLSI EP18 P3 : 3ED 2009 RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES
    CLSI C51 P : 1ED 2010 EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE
    CLSI MM17 P : 1ED 2007 VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS
    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
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    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)
    CLSI MM5 A2 : 2ED 2012 NUCLEIC ACID AMPLIFICATION ASSAYS FOR MOLECULAR HEMATOPATHOLOGY
    CLSI C24 : 4ED 2016 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
    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 EP30 A : 1ED 2010 CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE
    CLSI I/LA34 P : 1ED 2010 DESIGN AND VALIDATION OF IMMUNOASSAYS FOR ASSESSMENT OF HUMAN ALLERGENICITY OF NEW BIOTHERAPEUTIC DRUGS
    CLSI MM6 A2 : 2ED 2010 QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES
    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 EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
    CLSI NBS04 A : 1ED 2010 NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY
    CLSI C34 A3 : 3ED 2009 SWEAT TESTING: SAMPLE COLLECTION AND QUANTITATIVE CHLORIDE ANALYSIS
    CLSI MM17 A : 1ED 2008 VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS
    CLSI C53 P : 1ED 2008 CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE
    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 EP17 A2 : 2ED 2012 EVALUATION OF DETECTION CAPABILITY FOR CLINICAL LABORATORY MEASUREMENT PROCEDURES
    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 MM19 P : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
    CLSI NBS05 A : 1ED 2011 NEWBORN SCREENING FOR CYSTIC FIBROSIS
    CLSI I/LA20 A2 : 2ED 2009 ANALYTICAL PERFORMANCE CHARACTERISTICS AND CLINICAL UTILITY OF IMMUNOLOGICAL ASSAYS FOR HUMAN IMMUNOGLOBULIN E (IGE) ANTIBODIES AND DEFINED ALLERGEN SPECIFICITIES
    CLSI MM10 P : 1ED 2005 GENOTYPING FOR INFECTIOUS DISEASES: IDENTIFICATION AND CHARACTERIZATION
    CLSI C57 : 1ED 2015 MASS SPECTROMETRY FOR ANDROGEN AND ESTROGEN MEASUREMENTS IN SERUM
    CLSI MM22 A : 1ED 2014 MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES
    CLSI EP36 : 1EDE 2015 HARMONIZATION OF SYMBOLOGY AND EQUATIONS
    CLSI C50 P : 1ED 2007 MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE
    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    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 EP18 P2 : 2ED 2007 RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES
    CLSI H56 P : 1ED 2005 BODY FLUID ANALYSIS FOR CELLULAR COMPOSITION
    CLSI QMS13 A : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
    CLSI EP9 A3 : 3ED 2013 MEASUREMENT PROCEDURE COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
    CLSI MM16 A : 1ED 2006 USE OF EXTERNAL RNA CONTROLS IN GENE EXPRESSION ASSAYS
    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 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
    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 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
    CLSI EP15 A3 : 3ED 2014 USER VERIFICATION OF PRECISION AND ESTIMATION OF BIAS
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