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