The Food and Drug Administration has approved a new test for the diagnosis of the H1N1 influenza virus.
The new test, which was developed by the Centers for Disease Control and Prevention, is said to have a sensitivity and specificity rate greater than 96%. It replaces a less specific diagnostic test that had been in use since April 2009 and was approved as part of an emergency response to the then new influenza virus strain.
“This clearance represents several months of close collaboration between the FDA and the CDC,” said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health in a news release. The test uses easily obtained nasal swab samples to make a diagnosis and the results are available in four hours.
