Trials / Completed
CompletedNCT04750629
Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™)
Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 CoviDx™ Rapid Antigen Test
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 140 (actual)
- Sponsor
- Lumos Diagnostics · Industry
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- Not accepted
Summary
Prospective study that will evaluate the clinical agreement of the CoviDx™ Rapid Antigen test compared to SARS-CoV-2 RT-PCR.
Detailed description
All patients who present with Covid-19-like symptoms within 5 days prior to consult, who consent to participate in the study, will undergo a nasopharyngeal swab (NP) collected for SARS-CoV-2 RT-PCR with EUA as per standard of care and nasal swab collection for CoviDx Rapid Antigen testing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | POC CoviDx™ Rapid Antigen Test | All patients will have a nasal swab for CoviDx™ Rapid Antigen testing |
Timeline
- Start date
- 2021-02-08
- Primary completion
- 2021-05-07
- Completion
- 2021-05-14
- First posted
- 2021-02-11
- Last updated
- 2021-06-18
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04750629. Inclusion in this directory is not an endorsement.