NEW YORK – Two SARS-CoV-2 antigen tests from Watmind USA and Genabio Diagnostics have received Emergency Use Authorization from the US Food and Drug Administration for at-home use without a prescription.
The Genabio COVID-19 Rapid Self-Test Kit and Watmind’s Speedy Swab Rapid COVID-19 Antigen Self-Test received EUA on Friday. Both lateral flow tests qualitatively detect the SARS-CoV-2 nucleocapsid protein from anterior nasal swab specimens.
Genabio’s test is intended for use with self-collected or adult-collected nasal swabs within the first week of symptom onset or for people without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours between tests.
For patients with COVID-19 symptoms, Watmind’s test is intended for use within the first six days of symptom onset. For those without symptoms, it is also intended for use when tested twice over three days with at least 24 hours between tests.