CLSI I/LA20

Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities, 3rd Edition

Give your laboratory staff the guidance they need for the design, analytical performance, standardization, quality assurance, and clinical application of laboratory assays used in the measurement of human immunoglobulin E antibodies of defined allergen specificity.

Supplemental data for I/LA20 are published in CLSI database I/LA37.

This edition of the document was corrected in December 2016. Read the full correction notice here, and learn more about our corrections process here.

This document is available in electronic format only.

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Chairholder: Robert G. Hamilton, PhD, D.ABMLI and Per N. J. Matsson, PhD

Date of Publication: October 24, 2016

Order Code PDF: CLSI ILA20Ed3E
ISBN Number: 1-56238-949-1

Order Code Print: print not available

Edition: Third

Pages: 120

CLSI I/LA20 Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

CLSI I/LA20 Abstract

Clinical and Laboratory Standards Institute report I/LA20—Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities is written for laboratorians, clinicians, manufacturers, and governmental regulators (inspectors, legislators, reviewers). The report summarizes the current state of immunoglobulin E (IgE) antibody assay technology, routinely tested biological specimens, practical methods for the evaluation of human IgE antibody assay-specific reagents, QA methods, and clinical interpretation of total and allergen-specific IgE antibody results.