D3.73 - Clinical Performance of Hycor NOVEOS–Based Specific IgE Measurements for the Screening of Respiratory Allergies

The NOVEOS technology requires clinical validation for the screening of sensitization to respiratory allergens.

A retrospective study was conducted using data from the ECRHS III cohort (2011), comprising adult individuals from the French general population (Paris and Grenoble). One hundred and forty-seven subjects (median age 56 years; S/R 0.91) were selected based on the presence of asthma (n = 41), rhinitis without asthma (n = 64), or absence of respiratory symptoms (n = 42). Paraclinical and biological data collected in 2011 included skin prick tests (timothy grass, cat, dog, house dust mites, birch, olive tree, cypress, Alternaria, and cockroach) and specific IgE measurements by ImmunoCAP™ (house dust mite d1, cat e1, timothy grass g6). In 2023, these data were complemented by specific IgE measurements using the NOVEOS platform, including SX01 (mixture of 12 recombinant allergens), D. pteronyssinus (D001), cat (E001), dog (E005), rPhl p 1 (G205), rPhl p 5 (G215), rAlt a 1 (M229), rBet v 1 (T215), and rArt v 1 (W231). Agreement between skin prick tests and specific IgE results obtained by ImmunoCAP and NOVEOS was assessed, as well as the clinical utility of SX01 in patients suspected of allergic asthma or rhinitis.

Agreement between skin prick tests and NOVEOS measurements was 90% for thimothy (ImmunoCAP: 93%), 86% for D. pteronyssinus (ImmunoCAP: 87%), 94% for cat (ImmunoCAP: 94%), 90% for dog, 96% for birch, 95% for Alternaria, and 95% for SX01 when compared with the full skin test panel. The use of positivity thresholds of 0.1 or 0.35 kU_A/L did not significantly affect agreement between specific IgE measurements and skin prick tests. The positive and negative predictive values of SX01 for identifying an allergic origin of asthma or rhinitis symptoms were 54% and 85%, respectively, at an optimal threshold of 1.7 kU_A/L (AUC = 0.71).

Specific IgE measurement using the NOVEOS platform enables effective screening for respiratory sensitization, with performance comparable to skin prick testing and to ImmunoCAP™ for the allergens studied. The SX01 test demonstrates a negative predictive value for respiratory allergy in the adult general population comparable to that reported for Phadiatop in the literature (NPV 80–85%).