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The purpose of this study is to determine the accuracy of the Novel point of care test (POCT) total IgE assay in atopic patients.
120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled. Fingerstick capillary blood samples will be collected and tested in the POCT device. Venous samples will be collected and sent to a reference laboratory for measurement of serum total IgE using the reference immunoassay method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capillary Blood Sampling | Other | Capillary blood sampling, collected as two fingerprick samples with POCT device and two venous samples |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Procedure | Fingerprick and venous |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total IgE concentration | Total IgE concentration in capillary blood measured with the POCT device at Day 0 or Day 1 from enrollment. Total IgE concentration in venous blood measured with the reference method at Day 0 or Day 1 from enrollment. | Day 0 or Day 1 (Visit 2: Blood sampling) |
| Measure | Description | Time Frame |
|---|---|---|
| Device usability questionnaire response | Device usability assessment of the POCT device as per operators at the completion of the study. | Day 0 or Day 1 (Visit 2: Blood sampling) |
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Inclusion criteria: atopic patients
Exclusion criteria: healthy subjects
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Hamburg | 20354 | Germany | |||
| Novartis Investigative Site |
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| POCT device |
| Device |
Investigational device |
|
| Lübeck |
| 23552 |
| Germany |
| Novartis Investigative Site | Padova | PD | 35128 | Italy |
| Novartis Investigative Site | Pisa | PI | 56124 | Italy |
| Novartis Investigative Site | Roma | RM | 00168 | Italy |
| Novartis Investigative Site | Harderwijk | Netherlands | 3840 AC | Netherlands |
| Novartis Investigative Site | Almelo | 7609 PP | Netherlands |
| Novartis Investigative Site | Sabadell | Barcelona | 08208 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46017 | Spain |
| Novartis Investigative Site | Chertsey | Surrey | KT16 0PZ | United Kingdom |
| Novartis Investigative Site | Bradford | West Yorkshire | BD9 6RJ | United Kingdom |
| Novartis Investigative Site | Manchester | M23 9QZ | United Kingdom |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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