The Food and Drug Administration has granted an emergency use authorization for a at-home coronavirus testing kit. The test, made by the Australian digital diagnostics company Ellume, can be sold over-the-counter, requires users to collect a sample using a nasal swab. The sample is then placed on an analyzer, which syncs to a smartphone app that will check for COVID-19 antigens.
While antigen tests can produce erroneous results, the FDA said that Ellume’s test correctly identified 96% of positive samples in people with symptoms associated with COVID-19. The test was accurate 91% of the time in asymptomatic patients.
Ellume said the tests will cost about $30 and will be available in January at pharmacies and drug stores around the country. The tests can also be purchased online.