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Superseded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

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Superseded date: 24-10-2016

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Published date: 12-01-2013

Publisher: Clinical Laboratory Standards Institute

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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

Abstract - (Show below) - (Hide below)

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.

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Development Note	Supersedes NCCLS I/LA20 A. (03/2009)
Document Type	Miscellaneous Product
ISBN
Pages
Published
Publisher	Clinical Laboratory Standards Institute
Status	Superseded
Superseded By	CLSI I/LA20 : 3ED 2016
Supersedes	CLSI I/LA20 A : 1ED 97(R2001)

Standards Referenced By This Book - (Show below) - (Hide below)

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

Standards Referencing This Book - (Show below) - (Hide below)

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

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