Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lumos Diagnostics
With
Rapid Pathogen Screening
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.
Age
1–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™)
