Revised Human IgE Assay Report

Wayne, Pennsylvania, USA—To define the current state of reagents and serological assay technology used to measure total human immunoglobulin E (IgE) and IgE antibodies of defined allergen specificities in human blood, the Clinical and Laboratory Standards Institute (CLSI) has published a revised report that focuses on IgE assay design and calibration, validation methods, QA of assay reagents, QC strategies, and clinical applications.

The report, titled Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities (I/LA20-Ed3), provides guidance for the design, analytical performance, standardization, QA, and clinical application of laboratory assays used in the measurement of IgE antibodies of defined allergen specificity.

“IgE antibody analysis has become vital as a supplement to the clinical history for optimal diagnosis of human allergic disease,” states Robert G. Hamilton, PhD, D.ABMLI, Chairholder of CLSI’s I/LA20 Document Development Committee, and Professor of Medicine and Pathology, Johns Hopkins University School of Medicine, and Director, Johns Hopkins Dermatology, Allergy and Clinical Immunology Reference Laboratory. “I/LA20 is the only consensus document that examines all aspects of IgE antibody analysis. It is a must-have compendium for staff in clinical immunology laboratories that perform IgE antibody measurements, directors of and students in immunology training programs who study immediate-type hypersensitivity, and manufacturers of IgE antibody assay kits.”
The third edition’s enhancements include a) guidance on specifications for assay design to fulfill the US Food and Drug Administration’s rigorous 510K requirements, b) an overview of the 10 cross-reactive allergen families and the rationale for IgE anti-allergen component analysis in diagnostic allergy testing, c) new detailed guidance on IgE antibody assay QC strategies, and d) enhanced guidance for clinicians who utilize IgE antibody results to assess allergic sensitization in their patients. The most valuable enhancement is the novel database supplement, Supplemental Data for Allergen Specificity of IgE Antibody Autoanalyzers (I/LA37) (http://shop.clsi.org/immunology-documents/ILA37.html), which allows support staff to rapidly identify clinically available allergen specificities by querying their common or scientific (genus/species) name.

This document is written for laboratorians, clinicians, manufacturers, and governmental regulators (inspectors, legislators, reviewers).

For more information about I/LA20, contact Patrick McGinn at pmcginn@clsi.org or +1.484.588.5933.

CLSI sets the standard for quality in medical laboratory testing. A not-for-profit membership organization, CLSI brings together the global laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine.

For nearly 50 years, our members, volunteers, and customers have made CLSI a respected, transformative leader in the development and implementation of medical laboratory testing standards. Through our unified efforts, we will continue to set and uphold the standards that drive quality test results, enhance patient care delivery, and improve health care around the world.

By using CLSI standards, laboratorians can improve process quality, speed the development of standard operating procedures, and implement safer practices with greater ease and efficiency.