The US Food and Drug Administration issued on Tuesday an emergency use authorization for the first over-the-countertest. The test doesn’t require a doctor’s order or prescription, and it can be taken and processed by people at home, without professional assistance.
The test comes from Ellume, and the FDA describes it as, “a non-prescription home use test intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens from mid-turbinate nasal swabs that are self-collected by an individual age 16 years or older, or are collected by an adult from an individual 2 years of age and older.”
To take the test, you’ll need to download Ellume’s app to an Android or iOS device, watch an instructional video, then swab your nostril and seal the swab within a dropper filled with fluorophene. You’ll drop some of that fluid into an analyzer that pairs with your phone, then wait for the results, which take about 15 minutes to process.
“This test is intended for use in individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection,” the FDA said.
In symptomatic individuals, the test was found to be 96% effective in identifying positive cases and 100% effective in identifying negative cases. Those numbers fall slightly with asymptomatic individuals, with the test correctly identifying 91% of positive cases and 96% of negatives.
“Today’s authorization is a major milestone in diagnostic testing for COVID-19,” said FDA Commissioner Stephen M. Hahn. “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.
“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes,” Hahn adds.
Ellume says it expects to produce 3 million tests in January 2021.