Xiamen Boson Biotech’s COVID-19 Test Gains FDA’s Emergency Use Authorization

The FDA has granted an Emergency Use Authorization (EUA) to Xiamen Boson Biotech for its Rapid SARS-CoV-2 Antigen Test Card for COVID-19.

The over-the-counter home test is authorized to detect viral antigens in individuals with symptoms of COVID-19 within the first six days of symptom onset or in asymptomatic individuals with epidemiological reasons to suspect COVID-19 infection.

The immunoassay uses self-collected anterior nasal swab samples from individuals age 14 and up or specimens from children age two to 13 collected by adults.

The rapid test does not differentiate between the SARS-CoV-2 virus, which causes COVID-19, and SARS-CoV, which caused an outbreak of respiratory illness in 2003.