FRIDAY, JUNE 22, 2018

CDC announces new H1N1 test

The U.S. Centers for Disease Control and Prevention reports that it has developed a test to diagnose human infections with the H1N1 influenza virus that can now be used by the U.S. Food and Drug Administration.

The CDC says that the purpose of the test test, dubbed the "CDC Influenza 2009 A (H1N1)pdm Real-Time RT-PCR Panel (IVD)," is to make sure there is accuracy of influenza testing results across different qualified laboratories.

The test replaces another type created with the limited number of H1N1 specimens available in April 2009, when the virus was at a pandemic stage. That test received an emergency use authorization by the FDA in April 2009.

"The development of this test exemplifies our dedication to improving public health surveillance for the2009 H1N1 virus and other influenza viruses in the United States and abroad," Dr. Nancy Cox, director of the CDC's Influenza Division, said.

The new test is able to detect the 2009 H1N1 virus at about 96 percent accuracy.

"This clearance represents several months of close collaboration between the FDA and the CDC," Jeffrey Shuren, M.D., and director of the FDA's Center for Devices and Radiological Health, said. "This test is the second diagnostic cleared in recent weeks by the FDA for the 2009 H1N1 influenza virus."