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FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season

FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season

Last Reviewed : 01/05/2021
FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season

Press Release: 

The U.S. Food and Drug Administration further assisted health care providers around the country prepare for the upcoming flu season during the COVID-19 pandemic by issuing an emergency use authorization (EUA) for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19 in individuals suspected of COVID-19 by their healthcare provider to the U.S. Centers for Disease Control and Prevention (CDC). The FDA has previously issued EUAs to BioFire Diagnostics LLC and QIAGEN GmbH for their tests, which include many other respiratory organisms in addition to the viruses that cause flu and COVID-19.

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. Taking just one sample from a patient may help alleviate the need for multiple samplings, which means less discomfort for the patient with faster and more comprehensive results. 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 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. The FDA has updated the Molecular Diagnostic EUA templates to add information about these types of tests to help facilitate the preparation, submission, and authorization of EUAs of combination tests that address the COVID-19 public health emergency.

 

Source: U.S. Food and Drug Administration 

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