Lucira’s Over-the-Counter COVID-19 and Flu Test Receives FDA Authorization

People may soon be able to test themselves for COVID-19 and flu at home, thanks to a new emergency use authorization from the Food and Drug Administration (FDA).

In a Friday news release, the FDA approved the use of the Lucira COVID-19 & Flu Test, a first-of-its-kind over-the-counter test that would tell people if they’re sick with COVID, influenza A, or influenza B.

The test is another significant step forward that will hopefully make it easier for everyday people to be in control of their own health.

“[This] is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the press release. “We remain committed to working with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them.”

Here’s what experts had to say about the test’s efficacy, who should consider purchasing one, and why a joint COVID-19 and flu test could be such a help to public health.

A Highly-Sensitive Test

The at-home Lucira COVID-19 and flu test is fairly similar to standard COVID at-home tests that have been available for the past couple of years.

Yet unlike most tests Americans may have grown accustomed to, the Lucira test requires two AA batteries to operate, which are included with the test packaging along with the nasal swab and the test itself. Once those batteries have been inserted, it's business as usual. After 30 minutes, the test results will light up to show a person’s positive or negative results for all three viruses.

Batteries aside, the biggest difference between the Lucira test and most other common at-home tests is that the former is a molecular test rather than an antigen test.

“It’s a PCR quality-type test, and it can tell you specifically what that virus is,” Ruanne Barnabas, MD, chief of infectious diseases at Massachusetts General Hospital, told Health. “It’s a qualitative test, so it doesn’t tell you how much virus, but it does tell you whether or not you’re positive or negative. And it’s considered more accurate than some of the other types of tests that we have had.”

A typical antigen test can detect a positive COVID case at least 80% of the time when someone is infected. But the FDA found that the newly-authorized joint test identified positive COVID cases over 88% of the time. For influenza A, the test identified about 90% of positive cases. There was not enough data to come to a conclusion about influenza B.

The at-home COVID and flu test also identified negative results for all three viruses nearly 100% of the time.

“Those are pretty good results for a home test—those are getting close to what we would also be able to find in a hospital,” Jill Foster, MD, director of the division of pediatric infectious diseases at the University of Minnesota and M Health Fairview, told Health. “Anything where you're greater than 90% or close to 90%, you feel pretty good.”

Access and Affordability Are Still Unknown

Despite the promise of the joint at-home test, it may be slightly difficult for Americans to actually get the product. It is not currently available in the US—and financial obstacles for both Lucira and the consumer may stall easy access.

Lucira Health filed for bankruptcy on February 22, just two days before the FDA’s announcement. The company had “produced inventory for an anticipated autumn 2022 launch,” even though they weren’t sure “when the regulatory authorization would come through,” CEO Erik Engelson said in a press release. It would come just days later. The company is now looking for a “strategic or financial partner” so that it can resume manufacturing.

There may be other barriers to accessing the test, too. In Canada, the flu and COVID at-home test was approved back in August, and it’s currently being sold for $98 CAD online. It’s not yet clear how much the test might cost in the U.S., even when physical tests do become available.

The other compilation has to do with what assistance—if any—Americans might get in purchasing this test. When the COVID public health emergency ends in May, people will no longer have access to free government COVID tests. There will likely be some cost-sharing for people, though it will likely depend on their insurance status. And obviously, those without insurance won’t have any assistance.

“It’s great to have this additional tool,” Dr. Barnabas said. “But the real value will be in how we use it—including bringing down the cost and making it more accessible to people."

Why Is Having an At-Home Flu Test Helpful?

Though there may be barriers, Drs. Barnabas and Foster agree that if it’s possible to have one or two of these flu and COVID-19 at-home tests around, it certainly wouldn’t be a bad idea. Outsourcing this kind of diagnostic testing from a hospital to people’s homes just makes everything simpler.

COVID-19 and flu symptoms are quite similar—both can cause fever, coughing, headache, sore throat, and a host of other respiratory symptoms. This test would be able to determine the actual cause of what’s making someone sick.

“If you have a test that you can afford and is accessible, you get an answer then. And I think that then supplies you with a lot more information,” Dr. Foster said. “People should view that the information is good, and something that can help them then make decisions about their health.”

The knowledge of an accurate diagnosis can have a range of benefits. For one, getting a flu or COVID diagnosis at home, rather than at an urgent care or doctor’s office, minimizes a person’s risk of spreading that virus, Dr. Barnabas said. Confirmation of what’s making someone sick can also inform whether they want to isolate themselves at home to prevent family members or roommates from getting sick, she added.

Most importantly, a confirmation of which virus a person has may also make it easier and faster to get treatment.

“It’s really recommended to go in for confirmatory testing and then for treatment. But of course, if it was in a family and someone is already diagnosed with the flu,” Dr. Barnabas said, “you can imagine that it would be possible for them to start treatment pretty quickly once they have this test.”

In some instances, it may be possible for a person to diagnose themselves with COVID or flu using this test, and then receive a prescription from their doctor over the phone or via a telehealth appointment, Dr. Foster added. That is a benefit for the providers, too.

“Hopefully it will give a little bit of relief to urgent care centers, primary care offices, emergency rooms—because a lot of times people go in just for a test,” Dr. Foster said. “[We see] clogged waiting rooms, people that have more serious issues that really demand that attention have long waits. And so I’m hoping that it will open up access a little bit.”