CLSI I/LA20 A2 : 2ED 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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
Related CLSI Reference Materials
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