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Sensitization to Dermatophagoides siboney is a major cause of Cubans allergic rhinitis. Dermatophagoides siboney described first in Cuba and found in the Caribbean, phylogenetically close to Dermatophagoides farinae. Nasal provocation test (NPT) is indicated to confirm the diagnosis of allergic rhinitis to house dust mites. Objective: To evaluate the specificity and sensitivity of NPT with an allergenic extract of Dermatophagoides siboney. METHODS: An open, non-randomized, controlled clinical trial was carried out in 50 patients with allergic rhinitis sensitized to D. siboney mite and 50 non-allergicsubjects. Both groups were subjected to skin prick test and the NPT according to World Allergy Organization Statement. The freeze dried standardized allergic extract of D. siboney (VALERGEN-DS (BIOCEN, Cuba) was used at a different concentrations (20, 200, 2000 and 20000 BU/mL). Efficacy was evaluated through the values of sensitivity, specificity and efficiency. RESULTS: A predominance of female sex was observed in both groups (52%). Both groups were comparable with respect to demographic characteristics (p>0,05). NPT was positive in 47 out of 50 sensitized patients (94%). While, no positive response was obtained thenon-allergic group. Specificity was high: 100% (95%CI: 99-100%) and Sensitivity too: 94% (86-100%). The diagnostic efficiency was 97% (96.5-97.5%).In addition, there was a significant correlation (Spearman, r50.88; p <0.0001) between the skin reactivity and NPT response. Area under the ROC curve was 0.977 (0.93-1.0) and a p<0.0001.Only one non-specific adverse reactions were reported in allergy patients. CONCLUSIONS: Allergenic extract of Dermatophagoides siboney was specific and sensitive for its diagnostic use in NPT.

Two types of HDM SLIT-tablet formulations are currently available, a freeze-dried formulation and a compressed formulation. The impact of formulation on tablet potency and effectiveness of allergen delivery was assessed. METHODS: Three HDM-SLIT tablets, two freeze-dried (6SQ-HDM and 12SQ-HDM, respectively) and one compressed (300IR), were dissolved in assay buffer under controlled and identical conditions, and the total potency of solubilized HDM allergens was measured at various time points from 0-5 minutes by inhibition ELISA, using a pool of HDM allergic patients' sera. RESULTS: The two freeze-dried HDM SLIT-tablets dissolved completely and reached full effective potency of solubilized HDM allergens within 15 seconds. The achieved potency was proportional to the relative nominal strengths (6SQ-HDM and 12SQ-HDM) of the freeze-dried tablets. In contrast, delivery of solubilized HDM allergens from the compressed tablet was slower and incomplete, even after five minutes in solution. In the time interval that corresponds to the recommended sublingual holding times, the release of HDM allergens was higher for both the 6SQ-HDM and 12SQ-HDM freeze-dried HDM SLIT-tablet compared to the compressed 300IR tablet. CONCLUSIONS: Only the freeze-dried HDM SLIT-tablets provided fast and complete allergen delivery, and achieved full potency of soluble HDM allergens within the recommended sublingual holding time (one minute).