Skin prick test (SPT) is a first line diagnostic test to detect type I hypersensitivity in patients suspected of an inhalant allergy. A novel S.P.A.T. or Skin Prick Automated Test device has been developed to enable more standardised allergy testing. In two independent studies, Gorris and colleagues previously showed that test results after S.P.A.T. are less variable and more consistent compared to conventional skin prick testing (Gorris et al. Allergy. 2023; Seys et al. Rhinology 2024). In these studies conducted in volunteers, a cutoff value of 4.5 mm has been proposed based on the 97.5 percentile level of glycerol control wheals. The current study aims to determine a cutoff value corresponding to the highest accuracy to discriminate between sensitized-allergic and non sensitized, non allergic subjects for both house dust mite and birch allergens.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
75
skin prick test to detection sensitisation to aeroallergens
skin prick test to detection sensitisation to aeroallergens
nasal allergen challenge with either house dust mite allergens or birch pollen allergens
Alyatec
Strasbourg, France
Cutoff value with highest accuracy based on longest wheal diameter after SPAT
The cutoff value that corresponds to the highest F1 score of the accuracy of S.P.A.T. to detect sensitisation to both house dust mite and birch allergens by measuring the longest diameter of wheal size.
Time frame: 15 minutes after SPAT
Accuracy of SPAT compared to conventional SPT
The non-inferiority of the accuracy of S.P.A.T. compared to the conventional SPT to detect sensitisation for both house dust mite and birch allergens in allergic and non-allergic subjects will be evaluated by comparing the F1 score of SPT and SPAT, measuring the longest diameter of wheal size.
Time frame: 15 minutes after SPAT
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