International, multicenter, blinded phase III clinical trial to assess the diagnostic efficacy of the skin prick test from ROXALL (SPT-RX) with different allergen extract solutions for in vivo diagnosis of IgE mediated allergies

due to the exposure to any of the allergen sources under investigation, for at least 2 years in case of seasonal allergenic sources or for at least 1 year in case of perennial allergenic sources., Patients suffering from rhinitis / rhinoconjunctivitis, with well-controlled mild-to-moderate asthma or without asthma

The primary efficacy endpoint will be related to the two main parameters for each allergenic extract that allow for distinction between allergic from non-allergic patients and which should be above 0.80 as lower limit of 90% CI each: a. Sensitivity (S). b. Specificity (E)

Positive Predictive Value (PPV): is the probability that patients who tested positive on the SPT-RX under investigation are truly allergic to a specific allergen source, Negative Predictive Value (NPV): is the probability that patients who tested negative on the SPT-RX under investigation are truly non-allergic to a specific allergen source, Positive Likelihood ratio: is the probability that a patient with the disease will have a positive test result, divided by the probability that a patient without the disease will have a positive result., Negative Likelihood ratio: is the probability that a patient with the disease will have a negative test result, divided by the probability that a patient without the disease will have a negative result., Efficiency (or Accuracy) is the percentage of patients for whom the test results coincide with the clinical history., Wheal size: the mean diameter size, in mm, induced by each allergen extract and by positive and negative tested controls. According to Ruëff et al. (2011) and Heinzerling et al. (2013), a wheal diameter ≥ 3 mm will be considered a positive result.

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