Validation and Reproducibility of S.P.A.T. With Allergens

Study Overview
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Brief Summary
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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.

Official Title
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Validation and Reproducibility of Type I Hypersensitivity Reaction in the Diagnostic Process of the Skin Prick Test in Allergic and Non-allergic Individuals

Conditions
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Allergy to House Dust, Allergy Pollen

Intervention / Treatment
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* Device: Skin Prick Automated Test
* Diagnostic Test: Skin Prick Manual Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (18-65y) with presence or absence of self-reported symptoms of inhalant allergy will be included. Exclusion Criteria: Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment Use of antihistaminic medication < 7 days before the start of the study Use of tricyclic antidepressants (antihistamine activity) < 7 days before the start of the study Use of topical corticoids on the forearm < 7 days before the start of the study Use of Omalizumab < 6 months before the start of the study Pregnancy: there is a remote possibility of inducing a systemic allergic reaction that could induce uterine contractions or necessitate the use of epinephrine (thought to cause constriction of the umbilical artery)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Skin Prick Test<br>Study participants will receive a skin prick test by the skin prick automated test device on the right arm and manually by a health care provider on the left arm. | Device: Skin Prick Automated Test<br>* skin prick test to detection sensitisation to aeroallergens<br>Diagnostic Test: Skin Prick Manual Test<br>* skin prick test to detection sensitisation to aeroallergens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15 minutes after the diagnostic test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergy symptoms assessed by visual analogue scale between patients with a positive versus negative test result. | Visual analogue scale (0: best - 10: worse) | day of the diagnostic test | 
| Time (seconds) required to run an automated versus a manual skin prick test. |  | during the diagnostic test | 
| Amount of allergen solution that is required to run an automated versus a manual skin prick test. |  | 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) | 15 minutes after the diagnostic test |