COVID-19-Influenza Combination Test Granted FDA Emergency Use Authorization
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By LabMedica International staff writers Posted on 06 Jul 2020 |
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The US Food and Drug Administration (FDA Silver Spring, MD, USA) has issued 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 US Centers for Disease Control and Prevention (CDC Atlanta, GA, USA).
The move aims to assist health care providers around the US in preparing for the upcoming flu season during the COVID-19 pandemic. 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.
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. Combination testing offers several advantages, such as 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 is encouraging additional developers to work with the agency 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 also 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.
"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. This is another example of the FDA working with test developers to bring important diagnostics to Americans," said FDA Commissioner Stephen M. Hahn, M.D. "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."
Related Links:
US Food and Drug Administration (FDA)
The Centers for Disease Control and Prevention (CDC)
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The move aims to assist health care providers around the US in preparing for the upcoming flu season during the COVID-19 pandemic. 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.
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. Combination testing offers several advantages, such as 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 is encouraging additional developers to work with the agency 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 also 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.
"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. This is another example of the FDA working with test developers to bring important diagnostics to Americans," said FDA Commissioner Stephen M. Hahn, M.D. "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."
Related Links:
US Food and Drug Administration (FDA)
The Centers for Disease Control and Prevention (CDC)
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