FDA authorizes new diagnostic test for H1N1 influenza

FDA has authorized for use a new test for the diagnosis of H1N1 influenza virus infections. This test was developed by the Centers for Disease Control and Prevention (CDC).

This new test replaces the previous real-time polymerase chain reaction (PCR) diagnostic test that was granted emergency-use authorization by FDA in April 2009. The newly approved PCR panel has been optimized by using all of the available 2009 H1N1 genetic information that CDC received during the outbreak. The test has sensitivity and specificity greater than 96% for upper respiratory specimens.