The first COVID-19 test that can be performed entirely at home was cleared by U.S. regulators on Tuesday, and it can be acquired without a prescription.
While availability will be limited initially, the new test and others in development could make virus screenings as accessible as over-the-counter pregnancy tests in the U.S. for the first time. The advance follows months of criticism that the Food and Drug Administration has been too slow to approve rapid home tests for the virus.
Manufactured by East Brisbane, Australia-based Ellume, the self-administered, single-use nasal swab test is small enough to fit in the palm of a person’s hand. It detects proteins on the virus’s surface in 15 minutes and delivers results to an app.