Evaluation of major mite allergens from European standardized commercial extracts for in vivo diagnosis: addressing the need for precision medicine

BACKGROUND: Skin prick testing is the first-line interventional method to diagnose IgE mediated allergic diseases. Methodological differences in manufacturing processes and extract standardization may lead to variations in the reagent quality and potency. The current study evaluates sixteen commercially available Dermatophagoides pteronyssinus and Blomia tropicalis extracts for allergy diagnosis from different European manufacturers regarding allergen composition and content and whether these differences could influence their biological activity. METHODS: Mite-allergic subjects (n = 21) were skin-tested with the extracts and studied for immunoglobulin E reactivity. Nine extracts from D. pteronyssinus and seven from B. tropicalis were analysed for total protein content by Bradford and ELISA double sandwich was used to quantify specific antibodies for D. pteronyssinus and B. tropicalis major allergens from nine different manufacturers. RESULTS: Mite extracts showed a 10–60 fold variation regarding the total protein content. The contents of the major allergens of D. pteronyssinus and B. tropicalis differed considerably (30–53 fold change) among the extracts. Blo t 5 was quantitatively present in < 50% of the of the B. tropicalis reagents and could not be clearly detected by immunoblotting in the majority of the B. tropicalis commercial extracts. CONCLUSIONS: Certain natural D. pteronyssinus and B. tropicalis extracts lack important allergens showing a considerable variability in composition and content. A closer collaboration among clinicians, allergen manufacturing companies and regulatory agencies to improve the quality and consistency of D. pteronyssinus and B. tropicalis extracts is warranted to achieve a more precise diagnosis and treatment of house dust mite allergy.