The Centers for Disease Control and Prevention has received an emergency use authorization (EUA) from the Food and Drug Administration for a new diagnostic test aimed at simultaneously detecting and differentiating between influenza and the coronavirus, according to a press release Thursday.
“With the authorization of these tests, the FDA is helping address concerns in anticipation of this upcoming flu season during the COVID-19 pandemic, which might be especially worrying for some Americans,” said FDA Commissioner Dr. Stephen M. Hahn. “This is another example of the FDA working with test developers to bring important diagnostics to Americans. With just one swab or sample, combination tests can be used to get answers to Americans faster. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”
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According to the FDA, the combination tests use a single sample from a patient to check for multiple respiratory diseases, including the flu and COVID-19.
Combination tests offer many advantages, including less discomfort to patients due to fewer samples being taken and faster, more comprehensive results. In addition, combination tests require fewer supplies, such as swabs and personal protective equipment, and reduce pressure on supply chains for reagents, or substances used to cause chemical reactions.
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The FDA has previously issued EUAs for combination tests from BioFire Diagnostics LLC and QIAGEN GmbH, which include “many other respiratory organisms in addition to the viruses that cause flu and COVID-19.”
The news comes as health officials are preparing for the upcoming flu season as well as a potential second wave of the coronavirus as cases have surged across the country in states like Florida, California, North Carolina and Arizona.
The CDC estimates that influenza has resulted in between 9 million and 45 million illnesses, between 140,000 and 810,000 hospitalizations and between 12,000 and 61,000 deaths annually since 2010.
According to the latest update from Johns Hopkins University, there are more than 2.7 million confirmed coronavirus cases and more than 128,000 deaths in the United States.
