New CDC Test to Detect Human Infections with the 2009 H1N1 Influenza Virus Authorized for Use by FDA

A News & Events entry posted on August 11, 2010

According to the CDC Online Newsroom, a test developed by the U.S. Centers for Disease Control and Prevention to diagnose human infections with the 2009 H1N1 influenza virus (formerly known as swine flu or pandemic H1N1 flu) was authorized for use today by the U.S. Food and Drug Administration.

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 and 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.

To read the entire press release visit CDC Online Newsroom.