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

Abstract

Purpose Component-resolved diagnostics (CRD) is expected to provide additional diagnostic information in allergic patients. PROTIA™ Allergy-Q 64 Atopy ® , 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™ Allergy-Q 64 Atopy ® and ImmunoCAP ® 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™ Allergy-Q 64 Atopy ® , Dermatophagoides pteronyssinus (Der p) 1 and Der p 2 in ImmunoCAP ® ), Bet v 1, Fel d 1, Que a 1, ω-5 gliadin, α-lactalbumin, β-lactoglobulin, casein and α-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%; α-lactalbumin, 96%; β-lactoglobulin, 88%; casein, 88%; ω-5 gliadin, 96%; α-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™ Allergy-Q 64 Atopy ® is reliable and comparable to the ImmunoCAP ® assay for component-resolved diagnosis.

Agreement Between Predictive, Allergen-Specific IgE Values Assessed by ImmunoCAP and IMMULITE 2000 3gAllergy™ Assay Systems for Milk and Wheat Allergies

“…Since new assay methods have been developed, further studies to test compatibility across the methods needs to be performed. 20 …”

EAACIMolecular Allergology User's Guide 2.0

“…While the ImmunoCAP ISAC test, ALEX 2 ; and 100% for α-Gal. 133 More extensive cross-validation is needed to elevate this procedure to clinical use. 10 -Evolution from allergen molecules to allergen epitopes.…”

“…This is graphically overviewed by Chapman et al 71 The assay remains available but needs regulatory clearance for clinical use. The PROTIA™ Allergy‐Q 64 Atopy (Proteometech, Seoul, Korea) has been evaluated in comparison to the ImmunoCAP Specific IgE test using the sera of 125 Korean allergic patients. The agreement for the 10 allergen components tested was > 88% for group 1 house dust mite (HDM) allergen, 100%; group 2 HDM allergen, 94.6%; Bet v 1, 97.4%; Fel d 1, 90.5%; Que a 1, 89.2%; α‐lactalbumin, 96%; β‐lactoglobulin, 88%; casein, 88%; ω‐5 gliadin, 96%; and 100% for α‐Gal 133 . More extensive cross‐validation is needed to elevate this procedure to clinical use. McKenzie et al 134 has developed a novel flow cytometric assay called the CytoBas that uses fluorescent protein tetramers for direct staining of IgE antibodies on blood basophils that are then detected by flow cytometry.…”