Watmind USA COVID-19 Test Gets Emergency Use Authorization

The FDA has granted Emergency Use Authorization (EUA) to Watmind USA’s Speedy Swab rapid COVID-19 antigen self-test for non-prescription home use.

The immunoassay detects antigens from SARS-CoV-2 in individuals with symptoms of COVID-19 within the first six days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.

The lateral flow test, which uses anterior nasal swabs, must be administered twice over three days with 24-48 hours between tests.

The FDA said that all negative results “should be treated as presumptive,” adding that confirmation with a molecular assay may be necessary if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with a close contact with COVID-19 or in communities with a high prevalence of infection.