FDA Authorizes First At-Home Combo Test For COVID-19 and Flu: Who Is Eligible?

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Key Takeaways

  • The FDA has authorized the first at-home test to check for both COVID-19 and the flu with the same sample.
  • The test requires a prescription from a healthcare provider, and Quest Diagnostics will ship it to you. 
  • In addition to the time it takes to receive your kit, take the test, and ship it, test results may take as long as three days.
  • The test should only be used for people who plan on staying home to avoid potentially exposing others while they wait for their results, experts say.

You can now take an all-in-one COVID-19 and flu test in the comfort of your own home. The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Quest Diagnostics for the first combined at-home test on December 4.

An at-home test may be convenient for some people, but since the test requires a prescription from a healthcare provider, it may not be easily accessible or affordable to everyone, experts say. And the timeframe to receive results may also present some concerns.

“You may not be someone who has a primary care physician,” David Pride, MD, PhD, infectious disease specialist at UC San Diego Health, tells Verywell. “You may have to go to an urgent care and pay that urgent care fee on top of then having to pay for the test.”

Testing Logistics and Timeframe

The FDA granted the EUA for the Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu. Under this authorization, a healthcare provider may provide a prescription for the test to patients suspected of having a “respiratory viral infection consistent with COVID-19.” Quest will then ship a kit to a patient’s home so the patient can collect a nasal swab sample and then ship it back to Quest.

The time required to ship a kit to someone’s home, to ship the sample back for testing, and to get lab results back can all add up, however. “If it takes you 70 to 96 hours, or perhaps even longer, to get a result, is there value in that?” Pride says.

In the best-case scenario, the total shipping and sample collection time would be 48 hours, he explains. In a recent press release, Quest Diagnostics reports that its average turnaround time for results is two to three days but timeframes vary by a region’s demand. Quest says the fastest way to get results is through the use of its secure online portal.

A lengthy timeframe is why a physician’s decision to prescribe the test is important, Pride adds. An at-home test would only be appropriate for someone with a suspected respiratory viral illness who has taken measures to self-isolate without waiting for results of whether they have the flu, COVID-19, or both. If they have COVID-19, Pride says, “The number of people they could infect in that 96-hour time window is pretty sequential.” 

What This Means For You

If you suspect you have COVID-19 or the flu, you may be able to take an at-home test to check for both illnesses with the same sample. The test requires a prescription, so check with your health care provider to see if an at-home testing kit is right for your situation.

The Need for a Combination Test 

The EUA comes just in time for when seasonal influenza usually spikes in the U.S. and at a time when the nation is experiencing record numbers of COVID-19 cases. The Centers for Disease Control and Prevention (CDC) recommends co-testing for influenza and COVID-19 when a person is experiencing symptoms of respiratory illness.

“Unfortunately, COVID-19 and flu are two illnesses that can present the exact same way,” Pride says. “So whenever you’re in flu season, which generally we think of as between mid-November and mid-April, you’ve always got to suspect someone might have the flu.” 

Knowing whether a patient has COVID-19, the flu, or both illnesses is important, Brian Labus, PhD, MPH, REHS, assistant professor of public health at the University of Las Vegas School of Public Health, tells Verywell. 

“With COVID-19, we are isolating people who are positive," he says. "It’s important to know so you stay home and don’t infect other people. If we know that you have the flu, we can potentially give you something that will shorten your illness.”

The Quest Diagnostics combination test can detect and differentiate from SARS-CoV-2, which is the virus that causes COVID-19, and the influenza A virus and/or the influenza B virus, which are the viruses that cause the seasonal flu.

The Quest test uses reverse-transcriptase polymerase chain reaction (RT-qPCR) testing. “The flu test is a PCR test. The COVID-19 test is a PCR test,” Labus says. “They’re just packaging them together, basically.” 

The FDA has granted EUAs to five other tests to date that use the same sample to check for the presence of flu and COVID-19. However, the Quest test is the first combination test to receive an EUA from the FDA for at-home collection. Quest previously received an EUA from the FDA for an at-home test that checks for the presence of COVID-19 only. That test is available for purchase through QuestDirect after answering a few health-related questions. 

At-Home Testing During a Pandemic

Pride says taking an at-home test may help people feel more at ease about the testing process. “One of the things about the SARS-CoV-2 epidemic that we found is that sometimes people don’t test when they’re uncomfortable,” he says. “So making people comfortable doing it really is very important, and people tend to be comfortable doing things in the privacy of their own home.”

Plus, at home tests keep potentially infected people from going out in public. “You don’t have to go out and expose other people if you do have the disease,” Pride says. “You can just swab yourself, stick it in the mail, and wait for a result.”

Likewise, some people are hesitant to get tested because they are worried that if they’re not already infected, they may risk exposure while at a clinic or testing facility. “The fact that many patients are very concerned with coming to the emergency department or seeing their primary care physician will certainly increase the likelihood of compliance with this test,”  Ken Perry, MD, FACEP, an emergency physician in Charleston, South Carolina, tells Verywell.

Perry also says an at-home testing option may relieve some of the burden on healthcare professionals during the pandemic. “From having to ensure enough personal protective equipment (PPE) for the medical professionals collecting the samples, to making enough appointments for patients to be tested, there are logistical concerns to mass testing,” he says. “Allowing a test to be sent to a patient's house will help to address some of these logistical problems.”

Ease of Use

Pride says that the sample collection process using the nasal swab should be straightforward. “One of the things Quest is known for is making things pretty easy,” he says.

Paul Pagnotta, RPh, manager of pharmacy operations and clinical services at the Albany College of Pharmacy and Health Sciences, agrees. “In general, I think these tests are very simple, and much of the public should have the ability to correctly administer these tests,” he tells Verywell. However, some potential barriers may exist to administering the swab—for example, if someone cannot physically do so because of severe arthritis or a disability, he adds. 

Although the test itself may be simple, Labus says the logistics may not make sense or be all that convenient for some people—especially if they aren’t connected to a physician to easily get a prescription or if they need faster results for work purposes. “This is really something that’s more for the convenience for the patient,” he says. “And when we're talking about that sort of thing, we tend to talk about people who are insured, who are a little wealthier.”

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Article Sources
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  1. Food and Drug Administration. Coronavirus (COVID-19) update: FDA authorizes first COVID-19 and flu combination test for use with home-collected samples. Updated December 4, 2020.

  2. Quest Diagnostics. Quest Diagnostics media statement about COVID-19 testing. Updated December 7, 2020.

  3. Johns Hopkins University and Medicine. Coronavirus Resource Center: New cases of COVID-19 in world countries.

  4. Centers for Disease Control and Prevention. Testing guidance for clinicians when SARS-CoV-2 and influenza are co-circulating. Updated October 16, 2020. 

  5. Food and Drug Administration. Emergency use authorization. Updated December 7, 2020.

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