GenBody America’s COVID-19 Test Gets Expanded EUA
GenBody America’s COVID-19 antigen test kit has received an expanded Emergency Use Authorization (EUA) from the FDA for testing asymptomatic individuals.
The GenBody COVID-19 Ag is a rapid test intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal or anterior nasal swab specimens.
The test was previously authorized for individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.
The expanded EUA is for individuals without symptoms or with epidemiological reasons to suspect COVID-19, when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.