Diagnostic Performance of an Antigen Test for SARS-CoV-2 Infection (COVID-19)

This study plans to compare a direct antigen test for severe acute respiratory syndrome
coronavirus 2 (SARS-CoV2) obtained by mid-turbinate nasal swab with a reverse transcription
polymerase chain reaction (rt-PCR) test obtained by nasopharyngeal swab (the current
reference standard) in a population of patients with symptoms suggestive of COVID-19 for
fewer than 5 days. Subjects whose physicians have already ordered an rt-PCR test at a
Carilion testing center will be screened and recruited by phone during a required scheduling
call. The study coordinator will describe the study by phone, and the subject will be
consented when they arrive at the testing center. After consenting, a mid-turbinate swab
direct antigen test will be obtained just prior to the ordered nasopharyngeal swab and any
other ordered tests. The subjects will receive their rt-PCR test results through the usual
channels of clinical notification. The subjects will not receive their nasal antigen results.
The antigen test results will be analyzed in a batch process and the results entered into
RedCap by the study staff. The rt-PCR results will be extracted from the Epic electronic
health record using patient identifiers and paired with the corresponding antigen result for
statistical analysis.