FDA Authorizes First-Ever At-Home Coronavirus Test, No Prescription Needed

The FDA's approval puts coronavirus tests entirely in the hands of ordinary people.
Brad Bergan

The U.S. Food and Drug Administration authorized the first-ever at-home coronavirus test with no prescription requirement — soon available to buy at local stores without a prescription — to allow people to discern whether they've contracted the virus, or not, according to a statement released from the FDA's official website.

The test will cost roughly $30 and enter the market by January, according to the Australian company, Ellume, developing it.


FDA has authorized first-ever at-home coronavirus test

Earlier, the FDA authorized other tests designed to help people test themselves at home to avoid long and potentially-hazardous lines of unwell patients. But these tests forced consumers to send a sample to a lab and wait for the results. A different recently-authorized test circumvents the lab, but requires a legitimate prescription.

This new test allows people to buy a viable coronavirus test without seeking a risking a trip to a doctor to acquire a prescription — putting substantially more control in the hands of potential patients. The test takes roughly five minutes to collect relevant samples, and yields a diagnosis within 15 short minutes.

UPDATE Dec. 15, 2:20 PM EST: Coronavirus test is adjustable for younglings

"Today's authorization is a major milestone in diagnostic testing for COVID-19," said FDA Commissioner Stephen Hahn in the agency's statement.

The test kit comes with a special swab allowing users to collect a sample from inside their nose. Since it can be used on adults and children no younger than 2 years old, the swab comes with an additional adapter — so users can shorten the device's length when swabbing young people.

Most Popular

UPDATE Dec. 15, 2:30 PM EST: Test ideal for pre-event check-ups before public exposure

To execute the test, users add a few drops of liquid to the sample, and place it inside a small plastic device, not unlike a home pregnancy test. Results are then wirelessly transmitted to one's smartphone app within roughly 15 minutes.

"This is the first test which is really designed to be a true at-home test yourself and obtain a result," said the company's CEO Sean Parsons to NPR in an early interview.

"This could be used for people to test themselves, for example, before going to a sporting event or a concert or going to a church to decrease the chance that they spread it [to] other people," added Parsons.

UPDATE Dec. 15, 2:35 PM EST: Experts worry cost, limited production may blunt effect on spread of virus

The company received roughly $30 million from the National Institutes of Health to scale its production capacity, and will reach a production rate of roughly 100,000 tests per day by January, said Parsons. When March 2021 hits, production should increase to roughly 250,000 tests per day, and by June production should reach as high as 1 million units per day.

Testing experts applaud the authorization, but some have warned the cost and limited production capacity will blunt the potential effect this new test might have on reducing the spread of the virus.

UPDATE Dec. 15, 2:45 PM EST: Coronavirus test is the present we need, not deserve

"It will be a game-changer, I think, to help people quickly identify if their symptoms are due to COVID," said infectious disease specialist Michael Mina of the Harvard T.G. Chan School of Public Health. "But from the perspective of truly stopping or massively slowing this pandemic, this test isn't designed for that."

On the heels of the FDA's authorization of the Pfizer vaccine and presumably days before a subsequent authorization of the Moderna equivalent, the agency has released another surprise for a global population devastated from the effects of the pandemic. While news of the at-home coronavirus test isn't exactly the Xmas present we deserve, it's probably the one we need.

message circleSHOW COMMENT (1)chevron