US federal regulators have given emergency approval for a breakthrough over-the-counter, at-home diagnostic test for the coronavirus disease 2019 (Covid-19).
The Food and Drug Administration (FDA) granted an emergency use authorization for the Covid-19 Home Test from Australian digital diagnostics company Ellume on Wednesday.
The agency found that the test correctly identified 91 percent of positive samples and 96 percent of negative samples in people without Covid-19 symptoms.
Ellume’s is the first Covid-19 home test that does not require a laboratory or a prescription. It’s FDA approval marks a “major breakthrough for Americans’ ever-expanding access to convenient Covid-19 testing options,” Health and Human Services Secretary Alex Azar said in a statement.
The nasal swab antigen test was developed with a $30-million grant from the National Institute of Health’s RADx initiative, a component of the Trump administration’s Operation Warp Speed initiative to develop a coronavirus vaccine.
“Today’s authorization is a major milestone in diagnostic testing for Covid-19,” FDA Commissioner Stephan Hahn said.
“By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes.”The $30 test kit includes a sterile nasal swab, a dropper, processing fluid and a Bluetooth-connected analyzer for use with a mobile phone app. SOVEREIGNPH