Trials / Completed
CompletedNCT02758548
Determination of Accuracy in Measurement of Total Immunoglobulin E Using a Test Device in Atopic Subjects
A Multicenter Clinical Evaluation Study to Determine the External Site Accuracy of Total Immunoglobulin E Measurement Using a Novel Point of Care Test Device Compared to a Reference Method in Atopic Subjects
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 193 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Blood sample | Fingerprick and venous |
| DEVICE | POCT device | Investigational device |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2016-05-01
- Completion
- 2016-05-01
- First posted
- 2016-05-02
- Last updated
- 2016-11-15
Locations
12 sites across 5 countries: Germany, Italy, Netherlands, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02758548. Inclusion in this directory is not an endorsement.