FDA authorizes use of at-home COVID-19 test requiring no prescription

The Food and Drug Administration issued emergency use authorization this week for the first fully at-home diagnostic test for COVID-19 that does not require a prescription. The product, from Australian company Ellume, is expected to cost around $30 and become available in drugstores sometime in January.

But some doctors and health officials are concerned that people might get a false sense of security if they test negative through the kit, which is not 100% accurate.

The antigen test kits offer results in just 15 minutes with a nasal swab that is not the “brain tickler” many may have experienced — and hated — at community testing sites.

“You don’t want to go all the way back, but you just go a little bit higher,” Dr. Johnette Crawford, urgent care doctor and Overlake Medical Center’s lab director, said. “It should just be mildly uncomfortable. Not painful at all.”

A wand analyzes the sample, connecting to a person’s phone via Bluetooth.

Crawford said people with symptoms should get a more reliable PCR test at a doctor’s or community testing site. In people without symptoms, testing shows the kit has identified 91% of COVID-19 positive samples and 96% of negative samples.

“If it’s positive, you can change your plans. You can not go out. It’s good for that kind of thing,” Crawford said. She advises anyone who tests positive to consult with a health care provider and also get a PCR test.

If it’s negative?

“We still want you to distance, social distance, wear a mask,” she said.

State health officials shared their own concerns today about tracking.

“People are having the ability to do this test at home,” State Epidemiologist for Communicable Diseases Dr. Scott Lindquist said. “How are they reporting that into our surveillance system?”

Ellume’s website stated it can provide real-time reporting of results to state health departments, doctors and others. How long it would take to connect and how reliable that would be are unclear. The company plans to roll out about 3 million kits in January and is aiming for stores like Walgreens and CVS.