Trials / Completed
CompletedNCT03599908
Evaluation and Validation of Novel Diagnostic Tool for Allergists (AbioSCOPE)
Evaluation and Validation of Novel Diagnostic Tool for Allergists (AbioSCOPE) in Volunteer Population With Respiratory Allergies
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 105 (actual)
- Sponsor
- Centre Hospitalier Universitaire Vaudois · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
In this study, investigators evaluated for the first time the diagnostic efficacy of abioSCOPE® versus Phadia Laboratory System as an aid in the diagnosis of allergic diseases. Investigators targetted the agreement between test results obtained in abioSCOPE® and a laboratory reference method (Phadia Laboratory System, ThermoFisher Scientific, Uppsala, Sweden), considered as a quasi-gold standard in IgE (immunoglobulin E) antibody assays. Investigators also reported the medical decision taken by a panel of allergy experts who had access to patient history, skin tests and IgE antibody assay, but blinded to the method used, i,e, the reference method or the abioSCOPE® .
Conditions
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2016-11-14
- Completion
- 2016-12-21
- First posted
- 2018-07-26
- Last updated
- 2018-07-26
Source: ClinicalTrials.gov record NCT03599908. Inclusion in this directory is not an endorsement.