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  • CLSI EP25 A : 1ED 2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 STABILITY OF IN VITRO DIAGNOSTIC REAGENTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  13-05-2023

    Language(s):  English

    Published date:  23-09-2009

    Publisher:  Clinical Laboratory Standards Institute

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

    Abstract
    Committee Membership
    Foreword
    1 Scope
    2 Standard Precautions
    3 Terminology
    4 Overview of the Stability Testing Process
    5 Real-time Stability Study Protocol
    6 Real-time Stability Monitoring (Verification)
    7 Accelerated Stability Testing
    References
    Appendix A - Measurand Drift Analysis Example
    Appendix B - Example of Use of Arrhenius Equation With
                 Accelerated Stability Testing Data to Predict
                 Shelf Life of an In Vitro Diagnostic Control
                 Product
    Appendix C - Determining the Number of Time Points and
                 Repeats of Stability Studies Based on Linear
                 Regression Analysis
    Summary of Comments and Subcommittee Responses
    Laboratory Failure Sources and CLSI Evaluation Protocols
     Documents
    The Quality Management System Approach
    Related CLSI Reference Materials

    Abstract - (Show below) - (Hide below)

    Gives guidance for establishing shelf-life and in-use stability claims for in vitro diagnostic reagents such as reagent kits, calibrators, and control products.

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

    Development Note Supersedes NCCLS EP25 P. (01/2010)
    Document Type Standard
    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    Status Superseded
    Superseded By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 MM7 A2 : 2ED 2013 FLUORESCENCE IN SITU HYBRIDIZATION METHODS FOR CLINICAL LABORATORIES
    ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
    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 EP36 : 1EDE 2015 HARMONIZATION OF SYMBOLOGY AND EQUATIONS
    UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
    BS EN ISO 23640:2015 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
    EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
    CLSI QMS01 A4 : 4ED 2011 QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
    CLSI EP5 A3 : 3ED 2014 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition
    I.S. EN ISO 23640:2015 IN VITRO DIAGNOSTIC MEDICAL DEVICES - EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS (ISO 23640:2011)
    DIN EN ISO 23640:2015-12 IN VITRO DIAGNOSTIC MEDICAL DEVICES - EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS (ISO 23640:2011)

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

    CLSI EP14 A2 : 2ED 2005 EVALUATION OF MATRIX EFFECTS
    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 EP12 A2 : 2ED 2008 USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE
    CLSI GP10 A : 1ED 95(R2001) ASSESSMENT OF THE CLINICAL ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC (ROC) PLOTS
    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 EP19 R : 1ED 2002 A FRAMEWORK FOR NCCLS EVALUATION PROTOCOLS
    CLSI EP17 A : 1ED 2004 PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION
    CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY
    CLSI EP18 A : 1ED 2002 QUALITY MANAGEMENT FOR UNIT-USE TESTING
    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
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