The 1st Over-the-Counter Rapid COVID Test Will Soon Be Available in US Stores

Lisa Maree Williams / Getty ImagesA nurse conducts a COVID-19 test on a man on July 22, 2020, in Sydney, Australia. (Lisa Maree Williams / Getty Images)

By The Associated Press
Published December 15, 2020 at 10:11am

The first home test for COVID-19 that doesn’t require a prescription will soon be available in U.S. stores.

The Food and Drug Administration on Tuesday authorized the rapid test, which can be done entirely at home.

Regulators granted emergency use for a similar home test last month, but that one needs a doctor’s prescription.

The move allows sales of the test 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,” FDA commissioner Stephen Hahn said in a statement.

Initial supplies of the over-the-counter test will be limited. Australian manufacturer Ellume said it expects to produce 3 million tests next month before increasing production over the first half of 2021.

A company spokesperson said the test will be priced around $30 and be available at pharmacies and for purchase online.

The kit includes a nasal swab, a chemical solution and a testing strip.

The test connects digitally to a smartphone app that displays and interprets the results. Users can also connect with a health professional via the app.

Most tests still require a nasal swab performed by a health care worker that must be processed at high-tech laboratories. That typically means waiting days for results.

About 25 tests allow people to collect their own sample at home — a nasal swab or saliva — which is then shipped to a lab.

FDA officials noted that Ellume’s test can deliver a small percentage of false positive and false negative results. People who get a negative result but have COVID-19 symptoms should follow up with a health professional, the agency said.

The U.S. is currently testing nearly 2 million people daily.

Dr. Michael Mina of Harvard called the new test “a great addition” to existing options.

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