Trials / Completed
CompletedNCT05596032
Prospective Study to Validate the Diagnostic Performance of IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2
Prospective Field Study to Validate the Diagnostic Performance of the IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2 on abioSCOPE®
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 440 (actual)
- Sponsor
- Abionic SA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
The purpose of the study is to conduct a prospective evaluation of the diagnostic performance of the IVD CAPSULE COVID-19-NP test for antigenic determination of SARS-CoV-2 virus on the abioSCOPE® instrument. The objective of the clinical study is to demonstrate that the IVD CAPSULE COVID-19-NP test: 1. shows sensitivity: * ≥ 80% when testing unselected symptomatic participants within the first seven days of symptom onset or asymptomatic participants when diagnosis is confirmed by RT-PCR; Or * ≥ 90% for subjects with Ct ≤ 25. 2. show ≥ 98% specificity.
Conditions
Timeline
- Start date
- 2022-10-23
- Primary completion
- 2023-01-27
- Completion
- 2023-02-01
- First posted
- 2022-10-27
- Last updated
- 2023-05-03
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05596032. Inclusion in this directory is not an endorsement.