Comprehensive 17-Allergen Panel for Inhalant Specific IgE: Reliability and Validation of Optimized Quantitative Assays.

Abstract

Introduction: Atopic diseases, such as asthma and allergic rhinitis, are chronic inflammatory disorders mediated by immunoglobulin E (IgE) responses to environmental allergens. Detecting allergen-specific IgE is essential for diagnosing sensitization and guiding clinical management. Allergen-specific IgE assays have, thus, become indispensable in clinical diagnostics and allergy research. The CHORUS Specific IgE Capture assays are automated immunoassays designed to quantify up to 17 allergen-specific IgE antibodies in human serum. In this study, optimized versions of the assays have been evaluated to determine their analytical performance in terms of sensitivity, specificity, precision, and overall reliability.

Methods: Each assay was tested using human serum from patients with suspected IgE-mediated sensitization. Limits of detection (LoD) and quantitation were determined according to current guidelines. Precision and repeatability were assessed across intra-run, inter-run, intra-batch, and inter-batch conditions, with coefficients of variation (CVs) ≤15% considered acceptable. Method comparison with ImmunoCAP was performed using Spearman's correlation, Passing-Bablok regression, and Bland-Altman analysis.

Results: Across 72 replicate measurements per lot, the LoD was 0.08 kU/L, with a quantifiable range of 0.10-50.0 kU/L. Sensitivity ranged from 90.2% (Phleum pratense) to 97.0% (meadow grass), while specificity ranged from 90.2% (Dermatophagoides pteronyssinus) to 100% (Alternaria alternata, Betula verrucosa, rye grass, meadow grass). All assays demonstrated high precision (CV <15%) and strong correlation with ImmunoCAP (Spearman's r > 0.700). Outliers were rare and mostly observed above 10 kU/L.

Conclusion: CHORUS Specific IgE Capture assays exhibit high analytical accuracy and reproducibility, supporting their reliability for routine clinical determination of allergen-specific IgE.