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

Abstract

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.

Symptom patterns and comparison of diagnostic methods in ragweed pollen allergy

“…SPT has several contraindications, for example it cannot be used in patients with extensive eczema, dermographism, urticaria with or without angioedema (36), or in patients under medication that may interfere with the test results, such as antihistamines, glucocorticoids, and some classes of antidepressants (31). Another limitation is the fact that allergen extracts are biological mixtures, containing different concentrations of allergens, depending on the extraction method; therefore, results obtained with allergen extracts from different manufacturers can vary greatly (37,38). These variations are even more relevant when the biological extracts are used for allergen immunotherapy (39).…”

Diagnostic accuracy and safety of Dermatophagoides pteronyssinus extracts used for skin prick test

“…According to several studies based on Indian D. pteronyssinus products, [28,34] the contained proteins of the extracts were low, even zero, [28] and the mean wheal sizes were smaller than the standard extracts from America [34] . Even in a study of extracts from European products, the useful protein concentrations varied from product to product (Der p1 1.21 to 30.16 μg/mL, Der p2 0.55 to 20.49 μg/mL) [29] . Second, the diagnostic accuracy of the PUMCH allergen extracts was almost equivalent to that of other products on the market [Table 5] but had a larger sample.…”

Precision Medicine in Mite Allergic Rhinitis

“…In this regard, previous studies have confirmed that certain natural Dermatophagoides spp. and Blomia tropicalis extracts lack important allergens showing a considerable variability in the allergen composition and content (23)(24)(25). Moreover, it has been shown that the concentration of major allergens correlates with the biological potency and IgE reactivity of allergen extracts (26).…”