Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™)
Purpose
Prospective study that will evaluate the clinical agreement of the CoviDx™ Rapid Antigen test compared to SARS-CoV-2 RT-PCR.
Conditions
- SARS-CoV-2
- Covid19
Eligibility
- Eligible Ages
- Over 1 Year
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Nasopharyngeal swab collected for SARS-CoV-2 RT-PCR with EUA as per standard of care within 3 hours of CoviDx Rapid Antigen Swab collection - First onset of COVID-19-like symptoms within the last 5 days - ≥ 1 year of age - Signed Informed Consent
Exclusion Criteria
- Unable or unwilling to provide signed, Informed Consent - Less than 1 year of age - SARS-Cov-2 RT-PCR collection that occurred > 3 hours from CoviDx Rapid Antigen Swab collection - First onset of COVID-19-like symptoms occurring more than 5 days from study visit - Invalid or missing PCR test results - Use of a non-high-sensitive SARS-CoV-2 test as the qualifying SARS-CoV-2 RT-PCR test (e.g., Abbott ID NOW, rapid antigen tests, tests that do not have FDA EUA, a test that was not approved by Sponsor for use in the study) - Enrollment in another study involving the collection of a nasopharyngeal or nasal swab - Receipt of a COVID-19 vaccine or participation in a COVID-19 vaccine study
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| SARS-Cov-2 RT-PCR AND CoviDx Rapid Antigen Testing | Sequentially enrolled symptomatic patients who present for COVID-19 testing and have a swab collected for high-sensitive, SARS-CoV-2 RT-PCR testing per Standard of Care AND a swab for CoviDx™ Rapid Antigen testing. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04750629
- Status
- Completed
- Sponsor
- Lumos Diagnostics
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.