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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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ANALYTICAL PERFORMANCE CHARACTERISTICS AND CLINICAL UTILITY OF IMMUNOLOGICAL ASSAYS FOR HUMAN IMMUNOGLOBULIN E (IGE) ANTIBODIES AND DEFINED ALLERGEN SPECIFICITIES
10-24-2016
01-12-2013
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
Describes guidance for the design, analytical performance, standardization, quality assurance, and clinical application of laboratory assays used in the measurement of human IgE antibodies of defined allergen specificity.
| DevelopmentNote |
Supersedes NCCLS I/LA20 A. (03/2009)
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| DocumentType |
Miscellaneous Product
|
| PublisherName |
Clinical Laboratory Standards Institute
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| CLSI I/LA34 P : 1ED 2010 | DESIGN AND VALIDATION OF IMMUNOASSAYS FOR ASSESSMENT OF HUMAN ALLERGENICITY OF NEW BIOTHERAPEUTIC DRUGS |
| CLSI I/LA34 A : 1ED 2011 | DESIGN AND VALIDATION OF IMMUNOASSAYS FOR ASSESSMENT OF HUMAN ALLERGENICITY OF NEW BIOTHERAPEUTIC DRUGS |
| CLSI QMS01 A4 : 4ED 2011 | QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES |
| CLSI EP5 A2 : 2ED 2004 | EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS |
| CLSI EP6 A : 1ED 2003 | EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH |
| CLSI M29 A3 : 3ED 2005 | ACQUIRED INFECTIONS; APPROVED GUIDELINE |
| CLSI H26 A : 1ED 96 | PERFORMANCE GOALS FOR THE INTERNAL QUALITY CONTROL OF MULTICHANNEL HEMATOLOGY ANALYZERS |
| CLSI EP17 A : 1ED 2004 | PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION |
| CLSI I/LA30 A : 1ED 2008 | IMMUNOASSAY INTERFERENCE BY ENDOGENOUS ANTIBODIES |
| CLSI C24 A3 : 3ED 2006 | STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS |
| CLSI EP10 A3 : 2006 + A1 2014 | PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES |
| CLSI LA1 A2 : 2ED 94 | ASSESSING THE QUALITY OF RADIOIMMUNOASSAY SYSTEMS<br> |
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