CLSI I/LA34 P : 1ED 2010

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Biochemical and Clinical Properties of IgE
6 Utility of IgE in Clinical Studies of drug Safety
   and Efficacy
7 Specimens
8 Assay Protocols
9 Qualification of Assay Reagents
10 Validation and Testing Strategy
11 Assay Interference
12 Recommendations for Drug Manufactures
13 Recommendations for Academic Centers and Practitioners
   Monitoring Immunogenicity in Clinical Trials
14 Recommendations for Regulators
References
Appendix A - Drug Allergen Specificities Available for
             IgE Antibody Testing in Commercial Assays
Appendix B - Worksheet 1: Procedure Checklist
Appendix C - Worksheet 2: ELISA Plate Setup(s) for
             Drug-Specific IgE Assay - Screening
Appendix D - Worksheet 3: ELISA Plate Setup(s) for
             Drug-Specific IgE Assay - Confirmatory
Appendix E - Worksheet 4: ELISA Plate Setup(s) for
             Drug-Specific IgE Assay - End-point Titer
Appendix F - Protocol for Depletion of IgE Antibodies
             From Human Serum
Appendix G - Illustrative Protocol ELISA for IgE Antidrug
              Detection in Human Serum
The Quality Management System Approach
Related CLSI Reference Materials

Specifies guidance for the design, validation, analytical performance, standardization, and quality assurance of laboratory assays used in the measurement of human IgE antibodies specific for new biotherapeutic drugs.