The US Food and Drug Administration (FDA) has amended the initial Emergency Use Authorization (EUA) of GenBody America’s Covid-19 antigen test kit to include an indication for use in asymptomatic people or with other epidemiological reasons to suspect an infection. GenBody America CEO David Yoo said: “This new ‘claim’ allows CLIA-waived laboratories to use GenBody test kits to test individuals without symptoms when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.” The updated EUA also permits the test kit for use with anterior nasal swab samples.
