Purpose:

The PROTIATM Allergy-Q® enzyme immunoassay (EIA) is a newly developed screening assay for specific immunoglobulin E (sIgE) for multiple allergens. The ImmunoCAP® Fluorescent EIA (FEIA) system is the most widely used method for the detection of sIgE. In this study, we evaluated the performance of the Allergy-Q® System compared to the ImmunoCAP® System.

Methods:

We compared the 2 systems using sera from 260 Korean allergic patients suffering from asthma (26.5%), allergic rhinitis (42.3%), atopic dermatitis (67.7%), and food allergy (18.1%). We compared the results of sIgE measurements for 7 inhalant allergens, 5 food allergens, and 4 microbial allergens.

Results:

Overall, 1799 matched trial results were analysed. Except for mugwort and Alternaria, most allergen-sIgE results showed intraclass correlation coefficients of >0.5. Class associations between trials were reliable for most allergens (gamma=0.858-0.987, P<0.001). Passing-Bablok regression analysis showed multiple differences in intercept and slope. Agreement between methods was moderate to substantial for most allergens (κ=0.713-0.898, P<0.001).

Conclusions:

The PROTIATM Allergy-Q® EIA System showed good detection performance compared to the ImmunoCAP® FEIA System in Korean allergic patients. However, due to methodological differences between the 2 trials, careful clinical involvement is required for interpretation of the Allergy-Q® EIA results.

Keywords:

Allergen; specific IgE; detection performance; allergic disease; Allergy-Q®; ImmunoCAP