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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin Prick Test | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin Prick Automated Test | Device | skin prick test to detection sensitisation to aeroallergens |
|
| 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 |
| 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. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Hendrik Sebrechts, MD | AZ Herentals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Herentals | Herentals | 2200 | Belgium |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Skin Prick Manual Test | Diagnostic Test | skin prick test to detection sensitisation to aeroallergens |
|
| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |