The FDA Just Authorized The First At-Home COVID Test

At the clinic near me that provides COVID-19 testing, lines have been growing by the day. My friends report waiting an hour, two hours, or even longer to access a test — and they're not alone. With the holidays around the corner, many Americans are rushing to get tested, and wait times are increasing. But an easier way is on the horizon: Today, the U.S. Food and Drug Administration announced that they've issued an emergency use authorization (EUA) for the first at-home COVID-19 test. Even better, it provides results in just 30 minutes.
The test is called the Lucira COVID-19 All-In-One Test Kit, developed by California-based company Lucira Health. It's only meant to be used at home on people age 14 and older (if you're younger, a medical professional has to administer it). And while this approval is great news, the catch is that most of us can't order it up quite yet. For now, only patients of Northern California’s Sutter Health and South Florida’s Cleveland Clinic will have access to the test in the near future, according to Lucira. The rest of us are going to have to wait until the spring. The test has also been approved for use in settings such as doctor's offices, hospitals, urgent care centers and emergency rooms.
Yes, that's a big bummer. But the EUA is still good news — we just have to look at the long game. "Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them," said Jeff Shuren, MD, director of FDA’s Center for Devices and Radiological Health, in the FDA's press release announcing the EUA.
The at-home test is a nose swab, like the in-office ones. You'll swab your nose, swirl the self-collected sample in a vial, then place the vial into a battery-operated test unit that will reveal your results. The at-home test was compared to a super-reliable test that's already on the market, and the two options agreed 94.1% of the time for positive results, and 98% of the time for negative results, according to Lucira Health.
This test is a big deal. There are a handful of FDA-approved COVID tests on the market that can be administered at-home, but they all need to be shipped elsewhere for processing. This is the first option approved that shares your results at home, as well. These tests aren't quite as reliable or accurate as laboratory tests, but they are much more convenient.
While it's frustrating that we can't utilize this at-home test right away, this news — along with the positive Moderna and Pfizer vaccine results — is promising, and hopefully, a sign that we will get on the other side of this thing sooner rather than later.
COVID-19 has been declared a global pandemic. Go to the CDC website for the latest information on symptoms, prevention, and other resources.

More from Wellness

R29 Original Series