Validation of PROTIA™ Allergy-Q 64 Atopy® as a Specific IgE Measurement Assay for 10 Major Allergen Components.

Purpose: Component-resolved diagnostics (CRD) is expected to provide additional diagnostic information in allergic patients. PROTIA (TM) Allergy-Q 64 Atopy (R), a recently developed CRD-based multiplex specific immunoglobulin E (sIgE) assay, can quantitatively measure sIgE to major allergen components. Methods: The sIgE detection by PROTIA (TM) Allergy-Q 64 Atopy (R) and ImmunoCAP (R) assays was compared using the sera of 125 Korean allergic patients. Group 1 and 2 allergens of house dust mites (HDMs; Dermatophagoides farinae (Der f) 1 and Der f 2 in PROTIA (TM) Allergy-Q 64 Atopy (R), Dermatophagoides pteronyssinus (Der p) 1 and Der p 2 in ImmunoCAP (R)), Bet v 1, Fel d 1, Que a 1,omega-5 gliadin, alpha-lactalbumin, beta-lactoglobulin, casein and alpha-Gal were measured by both assays. Results: Comparing the results from the 2 assays, the agreement rate for all the 10 allergens was >88% (group 1 HDM allergen, 100%; group 2 HDM allergen, 94.6%; Bet v 1, 97.4%; Fel d 1, 90.5%; Que a 1, 89.2%; alpha-lactalbumin, 96%; beta-lactoglobulin, 88%; casein, 88%;omega-5 gliadin, 96%; alpha-Gal, 100%). Correlation analysis indicated that, all the 10 allergen sIgEs showed more than moderate positive correlation (Pearson correlation coefficients >0.640). Additionally, intra-class comparison showed more than high correlation for all the 10 allergens (Spearman's rank correlation coefficients >0.743). Conclusions: PROTIA (TM) Allergy-Q 64 Atopy (R) is reliable and comparable to the ImmunoCAP (R) assay for component-resolved diagnosis.