A test developed by the US 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 FDA.
"The development of this test exemplifies our dedication to improving public health surveillance for the 2009 H1N1 virus and other influenza viruses in the United States and abroad," said Dr Nancy Cox, director of CDC’s Influenza Division.
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.
"This clearance represents several months of close collaboration between the FDA and the CDC," said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. "This test is the second diagnostic cleared in recent weeks by the FDA for the 2009 H1N1 influenza virus."
Source: CDC
