IgE Antibody Assay-Based Allergen Database(CLSI-IL/A-37)

Abstract

There are 8 established allergen databases (IUIS/WHO ANDB, Allergome, AllFam, AllergenOnline, SDAP, COMPARE, IEDB and AllerBase).None of these provide a comprehensive listing of the internationally-accepted nomenclature codes and Linnean system descriptors of the~1000 extract and molecular allergens used world-wide in diagnostic single-and multi-plex IgE antibody assays. The new Diagnostic Allergen DataBase (DADB) has been prepared by an international scientific committee of the Clinical and Laboratory Standards Institute to specifically provide these data together in a readily-searchable Excel database. Using peanut as an example, the DADB lists the allergens’ unique assay working codes (F13), general category (food), principal IgE antibody assay method(s) where the allergen specificity is available, common name (peanut), taxonomical name (Arachis hypogaea), and the NCBI, NPU, LOINC, Allergome and IUIS/WHO descriptor codes for allergens and their assays. The DADB benefits manufacturers of allergen-specific IgE assays by providing unambiguous specificity descriptors. With the DADB, allergen extract manufacturers will have clearly defined specificity targets for allergenic product development. Government regulators will have clarity on the specificity of new allergen reagents that are being submitted for clearance. IgE antibody proficiency testing programs (e.g. CAP) will be able to clearly define the IgE antibody specificities being measured in their challenge sera. The clinician will precisely know the allergen specificity of IgE antibody that is measured in their reference laboratory. Finally, the allergic patient will be assured that their allergic sensitization is being assessed in an assay with a well-characterized allergen reagent.