To improve accuracy and take out human error opportunities, Hippo Dx developed S.P.A.T., an automated skin prick test. This study will provide a comparison between manual and automated skin prick test in allergic and non-allergic individuals with a panel of common inhalant allergens. The primary endpoint is to compare the accuracy of S.P.A.T. to detect sensitization to common aeroallergens compared to a manual skin prick test (SPT). It is a prospective monocentric study that will include 120 study participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
112
skin prick test to detection sensitisation to aeroallergens
skin prick test to detection sensitisation to aeroallergens
AZ Herentals
Herentals, Belgium
Within-test agreement (% of patients with consistent results) of wheal positivity per allergen between manual and automated test.
Each of the allergens are pricked three times via manual and automated skin prick test. Three positive or negative test results are considered consistent whereas either one or two positive or negative test results are considered non-consistent resulting in an inconclusive test result.
Time frame: 15 minutes after the diagnostic test
Allergy symptoms assessed by visual analogue scale between patients with a positive versus negative test result.
Visual analogue scale (0: best - 10: worse)
Time frame: day of the diagnostic test
Time (seconds) required to run an automated versus a manual skin prick test.
Time frame: during the diagnostic test
Amount of allergen solution that is required to run an automated versus a manual skin prick test.
Time frame: during the diagnostic test
Level of discomfort experienced by the patient as assessed by visual analogue scale after an automated versus a manual skin prick test.
Visual analogue scale (0: best - 10: worse)
Time frame: 15 minutes after the diagnostic test
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