Clinical and Laboratory Standards Institute Publishes Guideline for Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities

WAYNE, PA--(Marketwire - March 11, 2009) -

Clinical and Laboratory Standards Institute (CLSI) recently published an updated document, “Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved Guideline--Second Edition” (I/LA20-A2), which provides practical 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. The primary goal of the document is to foster uniformity and enhance the quality of IgE antibody measurements that are performed in clinical laboratories throughout the world.

Robert G. Hamilton, PhD, D.ABMLI, Professor of Medicine and Pathology, Johns Hopkins University School of Medicine, and vice-chairholder of the committee that developed the document, says, “The second edition of the I/LA20 guideline is a ‘must have’ document for clinicians (especially allergists), laboratorians, and regulators who need to know about the quality and reliability of IgE antibody measurements that are performed in diagnostic allergy laboratories. Any individual who orders allergen-specific IgE measurements on their patients will want to have this comprehensive compendium for their office staff that serves as a reference guide for available allergen specificities and in which assay system they can be measured.”

Henry A. Homburger, MD, Mayo Clinic, and advisor on the subcommittee that developed the document, further explains, “I/LA20-A2 contains up-to-date information on a universe of common and rare allergens implicated in causing allergic diseases. This information is uniquely valuable to practicing allergists who wish to know more about the classification of allergenic substances, their immunoreactivity in assays for IgE antibodies, and their role in eliciting signs and symptoms of clinical allergy. All currently available allergen specificities with their scientific names and codes, as well as a listing of the strength of documentation of the substance as an allergen, are presented in a concise, well-organized appendix.”

I/LA20-A2 includes procedures for evaluating assay precision, analytical accuracy, sensitivity, parallelism, interference, and documenting the quantitative status of an assay. Guidelines for supplier validation and quality assurance, intralaboratory quality control practices, and interlaboratory proficiency testing are discussed. Finally, performance targets are outlined with recommendations for manufacturers, clinicians, and laboratorians.

This document is a revision of I/LA20-A, which was published in 1997, and includes the following updates:

-- expanded glossary of harmonized terms related to IgE antibody assays; -- discussion of clinical application and quality assurance of IgE antibody assay measurements; -- overview of causes for differences in reported IgE antibody levels among the various commercially available assay methods; and -- glossary of all currently available allergen specificities with an indication of the assay method that provides that specificity of IgE antibody analysis, their Latin and common names, and an assignment of whether the allergy specificity is well documented, poorly defined, or totally undefined based on peer-reviewed literature. 

For additional information on CLSI or for further information regarding this release, visit the CLSI website at www.clsi.org or call +610.688.0100.

CLSI, formerly NCCLS, is a volunteer-driven, membership-supported, nonprofit organization dedicated to developing standards and guidelines for the health care and medical testing community. CLSI’s unique consensus process facilitates the creation of standards and guidelines that are reliable, practical, and achievable for an effective quality system.

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Technorati: Allergen allergy assay methods analyte-specific reagents clinical utility human IgE