FDA Approves First At-Home Test for Both COVID-19 and Flu

If you or anyone in your family got sick three years ago at the start of the COVID-19 pandemic, it was hard to tell whether it was indeed the dreaded coronavirus or another similar respiratory virus, like the flu. Getting a test to confirm it was even harder. But since then, the availability of COVID tests, both in clinical settings and at home, has greatly improved.

It's about to get even easier to figure out what illness has hit your home. The Food and Drug Administration (FDA) recently issued an emergency use authorization for a test that gives even more clarity on suspected infections—and it tests for both COVID and the flu at the same time,

The New Home COVID and Flu Test

In February, the FDA approved the first over-the-counter, at-home test to check for both Influenza A and B as well as COVID in adults and children ages 2 and up. The test, manufactured by the company Lucira, is conducted the same way other at-home tests are, through self-administered nasal swabs. You'll know whether it's COVID or the flu—or neither—in just 30 minutes.

"It became clear during the pandemic that having the ability to test at home for COVID allowed parents greater freedom to make informed decisions regarding their family's health and the potential impact to those around them," says David Schaumberger, M.D., a pediatrician in New Jersey. "The emergency use authorization of a new home COVID/Flu test is another step in the same direction. It will allow parents of children 2 and older to identify these two illnesses from home, and allow them to make choices to attend school or daycare. [It will] assist in the decision-making process to seek medical care."

You don't need a prescription to buy Lucira's COVID-19 and Flu Test, and its electronic notification system makes results easy to understand. While the company did not specify the intended price point just yet, a similar, COVID-only test that Lucira produces is currently priced at around $35.

How Effective is the New COVID and Flu Test?

The FDA detailed the results of studies done on the Lucira home test. During the research process, the test was proven to correctly identify 99.3% of negative Influenza A samples and 90.1% of positive Influenza A samples. For COVID, the test detected 100% of the negative samples and 88.3% of the positive ones. Positive Influenza B samples could not be tested, as there were not enough confirmed cases of the virus circulating to include in a clinical study. The test did, however, detect 99.9% of negative Influenza B collections.

Understanding the Risks of At-Home Testing

All rapid diagnostic tests pose the risk of false positive and false negative results, so you should always err on the side of caution and seek medical attention if you are experiencing symptoms. That's especially true if you are experiencing symptoms and get a negative result, Dr. Schaumberger explains. Should a positive test appear for either of the viruses, the FDA advises people to take precautions to avoid spreading the infection. Most importantly, make sure to seek follow-up care with your healthcare provider.

"It is important to understand that the test results are just one aspect of what we as physicians are concerned about," Dr. Shcaumberger says. "Just because you don't have the flu doesn't mean you aren't sick and wouldn't benefit from being seen by your doctor."

The same is true for your children. It may not always be convenient to take your child to the doctor when they are sick, but it is important that they see their healthcare provider to receive treatment and help prevent more serious illness.

Availability of At-Home COVID and Flu Test

Though Dr. Shaumberger is concerned about at-home testing deterring people from the doctor, there are other issues he's considering as well, like accessibility.

"The current price point of this first test to market [may be] beyond the means of most families," he adds. "It would be my hope that over time the price becomes more reasonable and available to a larger patient population."

While the test has been granted emergency use authorization, it is not yet being commercially distributed. So don't head to the pharmacy just yet if you think you may need one of these self-tests for yourself or your family. The company said details about how, where, and when you can buy the test will be announced at a later time. But Lucira added that it will, for certain, be available for direct purchase from their website.