FDA authorizes new CDC test to detect the 2009 H1N1 influenza virus

The FDA has authorized a test developed by the Centers for Disease Control and Prevention (CDC) to diagnose human infections with the 2009 H1N1 influenza virus. The test, called the “CDC Influenza 2009 A (H1N1) pdm Real-Time RT-PCR Panel (IVD),” will help ensure the accuracy of influenza testing results among the different qualified laboratories that conduct influenza subtype testing in the United States and abroad. It uses a molecular biology technique to detect influenza A viruses, specifically the 2009 H1N1 virus. The new test will replace the previous real-time RT-PCR diagnostic test used during the 2009 H1N1 pandemic, called the “Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel),” which received an emergency use authorization by the FDA in April 2009.

The “CDC Influenza 2009 A (H1N1) pdm Real-Time RT-PCR Panel (IVD)” test is expected to be made available soon to CDC-qualified laboratories.

For more information call (301) 826-6242 or visit www.cdc.gov.