FDA Issues EUA for At-Home COVID-19 Test

This week, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for an at-home COVID-19 test, available to individuals without a prescription. The at-home test, Ellume, can be used by individuals ages 16 and older and children over the age of two if administered by an adult. The tests are rapid antigen tests, using a medium-length nasal swab to collect samples.

The test correctly identified 100 percent of negative samples and 96 percent of positive samples from symptomatic individuals. Among asymptomatic individuals, the test confirmed 91 percent of positive samples and 96 percent of negative samples. The test is expected to be widely available beginning in January. Additional information on the EUA is available here.