CDC test to simultaneously detect coronavirus, influenza with FDA emergency use authorization


The Centers for Disease Control and Prevention have received an Emergency Use Authorization (US) from the Food and Drug Administration for a new diagnostic test aimed at simultaneously detecting and differentiating between influenza and coronavirus, according to a statement. press release Thursday.

“By authorizing these tests, the FDA is helping to address concerns in anticipation of this upcoming flu season during the COVID-19 pandemic, which could be especially worrisome for some Americans,” said the FDA commissioner, Dr. Stephen M. Hahn. “This is another example of the FDA working with test developers to provide important diagnoses to Americans. With just a swab or sample, combined tests can be used to get answers to Americans more quickly. This efficiency can be very effective. help to provide timely information for those sick with an unknown respiratory disease. “

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According to the FDA, combination tests use a single sample from one patient to detect multiple respiratory diseases, including the flu and COVID-19.

Combined testing offers many benefits, including less patient discomfort because fewer samples are taken and faster, more complete results. Additionally, combination testing requires fewer supplies, such as swabs and personal protective equipment, and reduces pressure in the supply chains of reagents or substances used to cause chemical reactions.

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The FDA has previously issued the US for combination testing by BioFire Diagnostics LLC and QIAGEN GmbH, which include “many other respiratory organisms in addition to the viruses that cause influenza and COVID-19.”

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The news comes as health officials are preparing for the upcoming flu season, as well as a possible second wave of the coronavirus as cases have increased nationwide in states like Florida, California, North Carolina, and Arizona. .

In this June 27, 2020 photo, people are screened in their vehicles in the western Maryvale neighborhood of Phoenix through free COVID-19 tests organized by the Equality Health Foundation, which focuses on care in underserved communities. (AP Photo

The CDC estimates that influenza has caused between 9 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 cases of coronavirus and more than 128,000 deaths in the United States.

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