• CLSI I/LA32 P : 1ED 2009

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY

    Available format(s): 

    Superseded date:  27-07-2010

    Language(s): 

    Published date:  12-01-2013

    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 General Considerations
    5 Disorders Detected by Tandem Mass Spectrometry
    6 Reagents, Internal Standards, Plate and Plate Covers,
       and Specimen Preparation
    7 Mass Spectrometer Calibration and Verification
    8 Instrument Operation
    9 Method Validation
    10 Establishing and Validating Cutoffs
    11 Quality Assurance
    12 Proficiency Testing
    13 Result (Run) Acceptance Criteria
    14 Result Reporting and Interpretation
    15 External Factors Affecting Results
    16 Follow-Up (Short-Term) Activities
    17 Additional assays
    References
    Appendix A - In-House Control Preparation
    Appendix B - Scan Speed Considerations
    Appendix C - Maintenance
    Appendix D - Tubing Considerations
    Appendix E - Flow Path Blockages
    Appendix F - Troubleshooting Guides
    Appendix G - Ion Comparison
    Appendix H - Chemical Structures
    The Quality Management System Approach
    Related ClSI Reference Materials

    Abstract - (Show below) - (Hide below)

    Describes as a reference source for the numerous activities related to operating a tandem mass spectrometry laboratory as part of public and private newborn screening programs with the goal of creating greater test accuracy, performance, and consistency among laboratories, thereby ensuring data quality that will ultimately benefit all newborns worldwide.

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

    Document Type Proposed Guideline
    Publisher Clinical Laboratory Standards Institute
    Status Superseded
    Superseded By

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

    CLSI GP27 A2 : 2ED 2007 USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY
    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 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 NBS01 A5 : 5ED 2007 BLOOD COLLECTION ON FILTER PAPER FOR NEWBORN SCREENING PROGRAMS
    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 GP26 A3 : 3ED 2004 APPLICATION OF A QUALITY MANAGEMENT SYSTEM MODEL FOR LABORATORY SERVICES
    CLSI EP17 A : 1ED 2004 PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION
    CLSI I/LA27 A : 1ED 2006 NEWBORN SCREENING FOLLOW-UP
    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 C50 A : 1ED 2007 MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE
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