A clinical study was conducted across two sites, with testing performed by untrained operators. The study enrolled symptomatic subjects and subjects with recent Covid-19 exposure, each of whom self-collected two nasal swab samples (adults) or had two nasal swab samples collected by an adult caregiver (children under 14). For each subject, one swab was collected and sent to a reference laboratory and tested using a high sensitivity FDA-authorized SARS-CoV-2 RT-PCR test by trained laboratory personnel as a comparator, while the other swab was tested using the Detect Covid-19 Test™ by the untrained subject or caregiver at the clinical site. Comparing the Detect Covid-19 Test™’s results to those produced by the high sensitivity FDA-authorized SARS-CoV-2 RT-PCR test, the Positive Percent Agreement (PPA) was 90.9% (30/33) and the Negative Percent Agreement (NPA) was 100% (79/79) with expert interpretation.