Trials / Terminated
TerminatedNCT05403346
Clinical Evaluation of a COVID-19 Antigen Self-Test (CoviDx™)
Clinical Evaluation of a SARS-CoV-2 CoviDx™COVID-19 Antigen Self-Test
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 45 (actual)
- Sponsor
- Lumos Diagnostics · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
Prospective study that will evaluate the clinical agreement of the CoviDx™ Self test compared to SARS-CoV-2 RT-PCR.
Detailed description
Subjects who are currently experiencing symptoms associated with COVID-19 will be enrolled. Each enrolled subject will either self-collect one sample from the anterior nares or have the sample collected by another lay individual. Each subject will then have a mid-turbinate nasal swab sample collected for comparator test
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CoviDx™ Covid-19 Antigen Self-Test | All patients will self-collect a mid-turbinate nasal swab for CoviDx™ Covid-19 Antigen self-testing |
Timeline
- Start date
- 2022-05-17
- Primary completion
- 2022-08-01
- Completion
- 2022-10-31
- First posted
- 2022-06-03
- Last updated
- 2022-11-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05403346. Inclusion in this directory is not an endorsement.