The study is a prospective, multi-site, non-inferiority trial comparing the AudibleHealth Dx to Emergency Use Authorization (EUA) approved COVID-19 RT-PCR testing to demonstrate non-inferiority of the PPA and NPA when using this device to diagnose COVID-19 illness. The AudibleHealth Dx test, the "Xpert Xpress SARS-CoV-2 RT-PCR" (brand name) test, and bidirectional Sanger sequencing will be performed for each participant during a single encounter. Participants and staff will be blinded to AudibleHealth Dx results and the RT-PCR status at the time of testing. No one will know both results in real-time except for the Site Coordinators and unblinded statistician specifically authorized to have these results for enrollment, audit, data tracking, and data compiling purposes. Unblinding of the results will occur after the AudibleHealth Dx, RT-PCR, and variant sequencing results have been obtained. Results for the RT-PCR test will be received by the participant according to the clinical site's protocol. Variant sequencing results will be handled by each site according to their protocol.
Target enrollment for this trial will be 65 COVID-19 positive cases and 247 COVID-19 negative cases, presuming a prevalence of 0.17 for a total of 312 subjects meeting all inclusion criteria.
