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FDA approves new CDC flu diagnostic test

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The FDA has approved an in vitro laboratory diagnostic test developed by the CDC to diagnose human infections with seasonal influenza viruses and novel influenza A viruses with the potential for a pandemic.

The test (Human Influenza Virus Real-Time RT-PCR Diagnostic Panel) utilizes a three-module design to incorporate and streamline previous versions of the CDC’s two separate FDA-cleared diagnostic test kits, according to a CDC press release.

Each module has a specific function:

• Module one identifies and distinguishes between infection with influenza A and B viruses.
• Module two further classifies influenza A viruses by subtype (H1N1, H3N2 or 2009 H1N1).
• Module three specifically detects highly pathogenic avian influenza A (H5N1) virus in human respiratory tract specimens.

“This will lead to more efficient testing, with cost savings for the federal government and for state and local public health agencies,” Nancy J. Cox, PhD, director of the Influenza Division at the CDC, and director of the CDC’s WHO Collaborating Center for Surveillance, Epidemiology and Control of Influenza, said in the press release.

The test kit is the only in vitro diagnostic test for influenza that is cleared by the FDA for use with lower respiratory tract specimens and will be given at no cost to qualified international public health laboratories, according to the release.

“As the spread of the H1N1 pandemic slowed last year, we conducted an end-to-end review of our nation’s medical countermeasure enterprise, which showed a clear need for better diagnostic tests,” Nicole Lurie, MD, assistant secretary for preparedness and response in the US Department of Health and Human Services, said in the press release. “In helping public health officials quickly identify seasonal flu, as well as the flu viruses that could become pandemic, this kit can make a real difference in protecting health and saving lives in the United States and around the world.”

For more information, please visit www.cdc.gov.

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