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| Name | Class |
|---|---|
| Alyatec | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDM allergic patients | Experimental | HDM allergic patients receive a nasal allergen provocation test with house dust mite allergens (der p and der f) to confirm the clinical relevance of the allergy. All patients receive a conventional skin prick test on the one arm and an automated test on the other arm. |
|
| Birch pollen allergic patients | Experimental | Birch pollen allergic patients receive a nasal allergen provocation test with birch allergen (bet v) to confirm the clinical relevance of the allergy. All patients receive a conventional skin prick test on the one arm and an automated test on the other arm. |
|
| Non allergic patients | Experimental | Non allergic patients did not receive a nasal allergen provocation test. All patients receive a conventional skin prick test on the one arm and an automated test on the other 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 |
|---|---|---|
| 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. | 15 minutes after SPAT |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 minutes after SPAT |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of allergy symptoms | The intensity of allergy symptoms will be evaluated by Lebel score and compared to wheal size after positive SPT. | 15 minutes after SPAT |
| Intensity of allergy symptoms | The intensity of allergy symptoms will be evaluated by PNIF measurement and compared to wheal size after positive SPT. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alina Gherasim, MD | Alyatec | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alyatec | Strasbourg | 67000 | France |
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| ID | Term |
|---|---|
| D000092542 | Dust Mite Allergy |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
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| Skin Prick Manual Test | Diagnostic Test | skin prick test to detection sensitisation to aeroallergens |
|
| Nasal Allergen Challenge | Diagnostic Test | nasal allergen challenge with either house dust mite allergens or birch pollen allergens |
|
| 15 minutes after SPAT |
| Longest wheal diameter measurement through S.P.A.T. web viewer compared to conventional ruler-based measurement | The concordance of wheals' size measurement by the S.P.A.T. web viewer and investigator/ trained and qualified staff member will be evaluated by correlation analysis. | 15 minutes after SPAT |
| Time to perform skin prick test | The time to perform SPAT and conventional SPT will be evaluated by timing the duration between the start of executing the test and the end of the reading of the test (without timing the 15 minutes of waiting before reading). | at time of SPAT |
| Longest wheal diameter with S.P.A.T. compared to average diameter with conventional SPT | The longest diameter of wheal size measured with S.P.A.T. will be compared to the average (D+d/2) and the longest diameter of wheal size measured by conventional SPT. | 15 minutes after SPAT |
| Cutoff value with highest accuracy based on wheal area | For the S.P.A.T., a cutoff value will be calculated similar to above by using the wheal area evaluated by F1 score. | 15 minutes after SPAT |
| Accuracy of SPAT based on wheal area compared to conventional SPT | The non-inferiority of S.P.A.T accuracy using the wheal area compared to conventional SPT longest wheal diameter will be evaluated comparing the F1 score. | 15 minutes after SPAT |
| Cutoff with highest accuracy based on histamine equivalent prick index | For the S.P.A.T., the HEP (histamine equivalent prick) index based on the wheal diameter and wheal area will be calculated. The cut-off value will be calculated similar to above. The HEP index is defined as allergen induced area/ histamine induced area or allergen induced diameter/histamine induced diameter. | 15 minutes after SPAT |
| Accuracy of SPAT based on histamine equivalent prick index compared to conventional SPT | The non-inferiority of accuracy using the HEP-index compared to conventional SPT longest wheal diameter will be evaluated comparing the F1 score. | 15 minutes after SPAT |
| D012140 |
| Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |