The U.S. Food and Drug Administration (FDA) authorized an emergency use authorization (EUA) for the first at-home kit that can test for both COVID-19 and the flu. The approval, announced on December 4, will allow patients to collect their own sample and send it to Quest Diagnostics for analysis and results.
In a release, the FDA said it has "authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider."
According to the Centers for Disease Control and Prevention (CDC), co-testing is recommended for people who are experiencing symptoms of either condition. The two infections share symptoms that include fever, cough, shortness of breath, fatigue and sore throat.
This test is an important step down the right road, according to Amesh Adalja, MD, assistant professor and Senior Scholar who specializes in emerging infectious disease at the Johns Hopkins Center for Health Security in Baltimore.
“Eventually, the goal should be to have to home tests available for influenza and COVID that don’t require a doctor’s prescription,” says Dr. Adalja. “I think home testing for a variety of viruses is a way to improve clinical care, improve situational awareness, and increase resiliency to pandemics,” he says.
Knowing if you have the flu, COVID-19, or both can help your doctor direct you about steps you should take to avoid infecting other people, according to the CDC. There are also different treatments for the infections, says Adalja. “For example, people with the flu might be instructed to take Tamiflu,” he says.
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“Today’s authorization for a COVID-19 plus flu test using samples collected at home is a significant step toward FDA’s nationwide response to COVID-19,” said FDA Commissioner Stephen M. Hahn, MD, in a statement. “With the authorization of this test, the FDA is helping to address the ongoing fight against COVID-19 in the middle of the flu season, which is important for many, including the most vulnerable of Americans,” he said.
What You Need to Know About the New COVID-19 and Flu Combination Test
Who Can Get the Test? To get the test, you need to have a doctor’s prescription. It’s approved for home use for people who are suspected to have a respiratory viral infection consistent with COVID-19 and home collection is determined to be appropriate.
Does the Combination Kit Test for Both Kinds of Flu? Yes, the test is approved to test for both influenza A and B, as well as COVID-19.
What Kind of Specimen Is Necessary? The combination test requires only one sample, a nasal swab. Once that’s collected, the specimen is sent to Quest Diagnostics for analysis.
What Kind of Test Is It? There are two types of diagnostic tests for COVID-19, the molecular tests, such as a RT-PCR test, that detects the virus’s genetic material, and the antigen test, which looks for specific proteins from the virus, according to the FDA.
The combination kit is an RT-PCR test, which is less likely to give a false positive than an antigen test, according to the agency.
How Long Will It Take to Get Results? The company’s website doesn’t specify how long results will take. According to the company, registering on the company’s online portal or app will provide the quickest results.
Where Can I Get the Test? The only way to get the test is through a prescription from your doctor. The company’s website instructs consumers who want the test to request it through their doctor or healthcare provider.
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