CLSI I/LA20 A2 : 2ED 2009
Superseded
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ANALYTICAL PERFORMANCE CHARACTERISTICS AND CLINICAL UTILITY OF IMMUNOLOGICAL ASSAYS FOR HUMAN IMMUNOGLOBULIN E (IGE) ANTIBODIES AND DEFINED ALLERGEN SPECIFICITIES
24-10-2016
12-01-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Biochemical and Clinical Properties of IgE
6 Specimens
7 Immunochemical Methods
8 Qualification of Assay Reagents
9 Calibration Systems for Assays of IgE Antibodies
10 Assay Performance Evaluation
11 Quality Assurance
12 Assay Performance Targets
References
Appendix A - Allergen Nomenclature Addendum (Scientific Names
and Codes of Allergens)
Appendix B - Dilution-Recovery Analysis (Parallelism-Linearity)
Appendix C - Qualification of Antihuman IgE Reagents by Direct
Binding Dilutional Analysis and Competitive
Inhibition Immunoassay
Appendix D - Qualification of Allergen-Containing Reagents
Appendix E - Precision Testing of Assays of IgE Antibodies
Appendix F - Determination of the Limit of Detection for an IgE
Antibodies Assay
Summary of Consensus Comments and Subcommittee Responses
Summary of Delegate Comments and Subcommittee Responses
The Quality Management System Approach
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