NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for GenBody's over-the-counter SARS-CoV-2 antigen test.
The GenBody COVID-19 Ag Home Test is designed to detect nucleocapsid protein antigen from the SARS-CoV-2 virus in self-collected anterior nasal swab samples.
The lateral flow chromatographic immunoassay is authorized for use in individuals with COVID-19 symptoms within the first five days of symptom onset when tested at least twice over three days with at least 48 hours between tests. It is also authorized for use in asymptomatic individuals when tested at least three times over five days with at least 48 hours between tests.
In mid-2021, South Korea-based GenBody received EUA from the FDA for a point-of-care SARS-CoV-2 antigen test.