scope:

This report defines the current state of reagents and serological assay technology used to measure total immunoglobulin E (IgE) and IgE antibodies of defined allergen specificities in human blood. This report focuses on IgE assay design and calibration, validation methods, QA of assay reagents, QC strategies, and clinical applications.

The report is designed as a general reference for laboratorians, clinicians, manufacturers, and governmental regulators (inspectors, legislators, reviewers). It provides consensus on the current state of assay technology, the appropriate biological specimens that are routinely tested, practical methods for the validation of allergen and immunological reagents, diagnostic allergy laboratory QC strategies, consensus guidelines for clearance of allergen-containing reagents by governmental regulatory agencies, and a brief examination of the clinical interpretation of IgE antibody results. It also emphasizes achievable qualification practices that have been used by manufacturers to validate the quality and test the performance of reagents and configured assay systems. Once validated by the manufacturer, additional new lot specificity testing of allergen-containing reagents purchased by the user for one of the IgE antibody autoanalyzers does not need to be repeated. I/LA20 outlines strategies and procedures that have been successfully used by clinical laboratory workers to supplement manufacturer testing and QC practices with the goal of optimizing the laboratory's overall QA program. In addition, this report serves as a resource for inspectors and regulators who are involved in qualifying diagnostic reagents and assays and clinical immunology laboratories that perform IgE analyses.