BACKGROUND: Current in vitro allergen-specific IgE (sIgE) detection assays measure IgE against allergen extracts or molecules in a single- or multiplex approach. Direct comparisons of the performance of such assays among young children with common presentations of allergic diseases regardless of sensitization status are largely missing. OBJECTIVES: The aim of this study was a comparison of the analytical and diagnostic performance for common clinical questions of three commonly used technologies which rely upon different laboratory methodologies among children of the All Age Asthma (ALLIANCE) cohort (clinicaltrials.gov: NCT02496468). METHODS: Sera from 106 pediatric study participants (mean age 4 years) were assessed for the presence of sIgE by means of the ImmunoCAP™ sx1 and fx5 mixes, the ImmunoCAP ISAC™ 112 microarray, and a Euroline™ panel. RESULTS: Total and negative concordance were high (>82% - >89%), while positive concordance varied considerably (0-100%) but was also >50% for the most common sensitizations analyzed (house dust mite and birch). All three test systems showed good sensitivity and specificity (AUC consistently > 0.7). However, no significant differences with regards to identifying sIgE sensitizations associated with symptoms in children with suspected pollen- or dust-triggered wheeze or presenting with symptoms of allergic rhinoconjunctivitis or food allergy were detected. Extending the number of allergens did not change the similar performance of the three assay systems. CONCLUSION AND CLINICAL RELEVANCE: Among young children, the three sIgE assays showed good analytical and diagnostic concordance. Our results caution that the identification of larger numbers of sensitizations by more comprehensive multiplex approaches may not improve clinical utility of sIgE testing in this age group.
Institute(s)Institute of Asthma and Allergy Prevention (IAP)
GrantsFoundation for Pathobiochemistry and Molecular Diagnostics German Center for Lung Research (DZL) University Hospital Giebetaen and Marburg (UKGM) Deutsche Forschungsgemeinschaft (DFG) Thermo Fisher Scientific, Sweden Universities Giessen and Marburg Lung Center (UGMLC)