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US FDA authorizes COVID-19 combination diagnostic test

US FDA authorizes COVID-19 combination diagnostic test
July 04
10:43 2020

WASHINGTON: The US Food and Drug Administration (FDA) issued an emergency use authorization for the third diagnostic test for detection and differentiation of the viruses that cause flu and the novel coronavirus in individuals suspected of COVID-19.

“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,” Xinhua news agency quoted FDA Commissioner Stephen Hahn as saying on Friday.

“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,” he said. These combination tests work by testing a single sample from a patient for multiple respiratory diseases, such as COVID-19 and the seasonal flu which can show similar symptoms.

There are several important advantages to this combination testing, according to the FDA. Taking just one sample from a patient may help alleviate the need for multiple samplings. In addition, combination tests require fewer supplies, such as swabs and personal protective equipment, and reduce pressure on the supply chain for reagents, the FDA said.

It encourages additional developers to work with the FDA on combination tests that may be useful in preserving critical testing resources in the upcoming flu season during the COVID-19 pandemic. As of Saturday, the US accounted for the world’s highest number of infections and fatalities with 2,793,425 and 129,432, respectively, according to the Johns Hopkins University.

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