Get the Facts on the First Approved At-home COVID Test
The test promises 94% accurate results in under 30 minutes. And it will be available by Rx nationwide by early spring. by Sarah Ellis Health Writer
Big news in the fight against COVID-19: You may soon be able to test yourself for the virus from the comfort and privacy of your own home. How? On Nov. 17, the FDA granted emergency-use approval to the Lucira COVID-19 All-In-One Test Kit. It’s a self-administered nasal swab test that gives results that are 94% accurate in 30 minutes or less.
Lucira is a prescription-only test for people suspected of having COVID-19, a.k.a., folks with telltale symptoms: fever, shortness of breath, loss of taste or smell, and other well-known signs of the disease. It does require a doctor to write the prescription, so you’ll need to schedule an appointment (in-person or telehealth) to get your hands on the test, which you’ll pick up from your local pharmacy.
For now, Lucira is only available at clinics in either Northern California or Miami, but the company plans to distribute it nationwide by early spring 2021. The at-home test is expected to cost around $50, which may be covered (or partially covered) by insurance, depending on your individual plan.
First, What Does Each Test Kit Contain?
Here’s what you’ll find once you open up the box. The kit holds:
A single swab
A vial for the swab
A battery-powered unit with a lighted interface where you insert the vial to conduct the test
The unit has four possible green-lit designations: “Ready,” “Done,” “Positive,” and “Negative.” When the test is ready to begin, “Ready” lights up. When it’s finished, you’ll see “Done” light up green, as well as which result you receive—either “Positive” or “Negative.” It's a single-use device, so if you need another test later, you'd have to get a second prescription.
How Does the Test Work, Exactly?
It’s easy: You insert the swab into your nostril until you reach the nasal wall—but no further. (Definitely don’t shove it further than your natural nasal wall allows.) Rotate the swab five times, then do the same thing in your other nostril. (The swab is not like a Q-tip—you insert the same end inside both of your nostrils.) Next, place the swab inside the vial, then insert the vial into the test unit. Now, let the test work its magic.
When results are ready, the green light gives you the news—whether or not you have SARS-CoV-2 (the official name for the coronavirus). No matter the result, you’re instructed to contact your doctor immediately so they can report it to meet state and federal guidelines for tracking COVID cases. If you test negative but are still concerned about your symptoms, follow up with your doctor to get their advice. False negatives are rare with this test (only 2% of reported instances), but they can happen. You may need to be tested again a few days later.
Why Did This At-Home Test Get Emergency-Use Approval?
In early studies, Lucira’s test appears to be just as accurate as other existing forms of COVID testing, like the widely used PCR tests available at your local clinic. Again, it has a 94% effectiveness rate in community studies, and 100% of participants 14 and older were able to self-administer it correctly. Keep in mind that this is still early-stage data—the only information we have right now comes from testing reported by the manufacturer (and then vetted by the FDA). But it’s still a really good sign.
“The validation studies they did show this to be very accurate and comparable to lab-based testing … I don’t have any specific accuracy concerns,” says Amesh Adalja, M.D., infectious disease physician and senior scholar at the Johns Hopkins Center for Health Security in Baltimore. “This is a test that’s fairly simple, and to get any kind of FDA authorization for a home test, you have to do a lot of studies on laypeople to see how well they can perform the test themselves.”
What Does This Mean for You—and the Pandemic?
Experts say this new form of testing represents a major step forward. “I do think this approval is a step down the right path,” Dr Adalja says. “This is indication of a trend that I’d like to see accelerate.” Saskia Popescu, Ph.D., infection prevention epidemiologist and member of the Federation of American Scientists COVID-19 task force, agrees. “I think this is a positive first step,” she adds. “The data is promising, and I'm looking forward to seeing what we'll see when it's deployed on a larger scale in an asymptomatic population.”
Hopefully, this is only the beginning for accessible at-home COVID testing. Dr. Adalja hopes to see the advent of inexpensive, over the counter at-home tests that people can do at home daily. “If you can imagine people having COVID-19 tests that tell them whether or not they’re contagious every morning when they brush their teeth, that would go a long way to getting some control on the spread of this pandemic,” he says. “This type of program would at least give people information, and they would likely then change their behavior.”
Of course, no test is perfect, so it’s important to stick to our other safety protocols, even after the at-home testing kit becomes available. Mask up, avoid crowds, and stay home whenever you can. “Testing is not a single prevention strategy, but one of many,” Dr. Popescu says. The more tools we have at our disposal, the sooner we can bring this global pandemic to an end.
FDA News Release: Food & Drug Administration. (2020.) “Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home.” fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-self-testing-home
Lucira News Release: Lucira Health. (2020.) “FDA Authorizes First Prescription At Home Molecular Test for COVID-19.” 2nyvwd1bf4ct4f787m3leist-wpengine.netdna-ssl.com/wp-content/uploads/2020/11/FDA-Authorizes-First-Prescription-At-Home-Molecular-Test-for-COVID-19-released-20201118.pdf