CLSI I/LA20 : 3ED 2016

Abstract
Committee Membership
Foreword
Chapter I - Introduction
Chapter 2 - Diagnosis of Human Immunoglobulin
            E-Mediated Allergic Disease
Chapter 3 - Human Immunoglobulin E Primer
Chapter 4 - Specimens
Chapter 5 - Immunochemical Methods
Chapter 6 - Qualification of Assay of Reagents
Chapter 7 - Calibration Systems for Assays of
            Immunoglobulin E Antibodies
Chapter 8 - Assay Performance Evaluation
Chapter 9 - Quality Assurance
Chapter 10 - Recommendation for Laboratories,
             Medical Professional, and Clinical Laboratory
             Inspectors
Chapter 11 - Design and Validation of an Immunoglobulin
             E Antibody Immunoassay for New Biotherapeutic
             Drugs in the Absence of a Drug-Specific Immunoglobulin
             E Antibody Positive Control
Chapter 12 - Conclusion
Chapter 13 - Supplemental Information
References
Appendix A - Linearity (Dilution Recovery/Parallelism
             Analysis)
Appendix B - Qualification of Anthihuman Immunoglobulin
             E Reagents by Direct Binding Dilutional Analysis
             and Competitive Inhibition Immunoassay
Appendix C - Qualification of Allergen-Containing Reagents
Appendix D - Precision/Reproducibility Testing of Assays
             of Immunoglobulin E Antibodies
Appendix E - Lower Limit of Quantitation for an Immunoglobulin
             E Antibody Assay
The Quality Management System Approach
Related CLSI References Materials

Gives guidance for the design, analytical performance, standardization, quality assurance, and clinical application of laboratory assays used in the measurement of human immunoglobulin E antibodies of defined allergen specificity.