GenBody America’s COVID-19 Test Gets Expanded EUA

December 23, 2021

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.

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