BACKGROUND: The measurement of specific IgE to allergenic extracts and molecules in patients with allergic rhinitis (AR) is crucial for a precise diagnosis and further immunotherapy. Companies providing in vitro diagnostic methods in allergology continuously strive for the optimization and modernization of such methods. A new generation of automated allergy tests based on chemiluminescence detection and paramagnetic microparticles is now available, with possible advantages in sample volume, cost-effectiveness, and avoidance of sample-related interference. OBJECTIVES: To test whether sIgE antibody levels obtained with a new singleplex chemiluminescent method have a good agreement with the corresponding results obtained with a "gold standard" test. METHODS: We tested sera from 368 AR patients. Specific IgE sera levels (kU/L) to a comprehensive panel of 15 allergen extracts and 6 molecules were tested with ImmunoCAP(®) (Thermo Fisher Scientific Inc., Phadia AB, Uppsala, Sweden) and NOVEOS™ (HYCOR(®) Biomedical, Garden Grove, CA, USA). We evaluated the qualitative and quantitative performance of the new NOVEOS system in matching the outcome of ImmunoCAP to each of the examined allergens. RESULTS: In relation to ImmunoCAP, the overall diagnostic sensitivity and specificity of sIgE tests with NOVEOS were 90.8% (95%CI=88.6-92.7) and 96.2% (95%CI=93.9-97.8), respectively. These values were higher when only molecules were considered (sensitivity=98.7% [95%CI= 96.4-99.7%]; specificity=94.2% [95%CI= 88.4-97.6%]) and lower when only extracts were considered (sensitivity=87.6% [95%CI= 84.7-90.2%]; specificity=97% [95%CI= 94.4-98.6%]). Spearman correlation between the data set of both methods for a ≥0.1 kU/l cutoff was 0.84 (p<0.001). CONCLUSIONS: The new singleplex NOVEOS system presented good results for qualitative and quantitative comparisons when testing specific serum IgE antibodies against a range of 21 allergens. This novel immunoassay system using only 4 microliters of sample per test appears to be robust and reliable, and can, therefore, be used as an aid in allergy diagnosis.
- Potapova, E.
- Bauersachs, D.
- Villella, V.
- Meneguzzi, G.
- Scala, E.
- Sfika, I.
- Tripodi, S.
- Panetta, V.
- Dramburg, S.
- Skevaki, C.
- Matricardi, P. M.
Keywords
- Allergic Rhinitis
- IgE
- immunoassay
- inter-assay comparison
- precision medicine
- singleplex
