Prospective study that will evaluate the clinical agreement of the CoviDx™ Rapid Antigen test compared to SARS-CoV-2 RT-PCR.
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.
Device: POC CoviDx™ Rapid Antigen Test
All patients will have a nasal swab for CoviDx™ Rapid Antigen testing
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
Doral Medical Research
Hialeah, Florida, United States
Comprehensive Clinical Research
West Palm Beach, Florida, United States