The FDA has cleared Focus Diagnostics’ Simplexa Influenza A H1N1 (2009), a test for the 2009 H1N1 Influenza Virus in patients with signs and symptoms of respiratory infection. Using specimens from nasal swabs or nasal aspirates, the Simplexa Influenza A H1N1 (2009) test simultaneously amplifies and detects two regions of the influenza virus genome and an internal control. A positive result indicates that the patient is infected with the 2009 H1N1 influenza virus, but the test does not indicate the stage of infection. A negative result does not preclude influenza virus infection.
Until this clearance, tests for 2009 H1N1 Influenza were only available through an Emergency Use Authorization (EUA).
For more information visit www.fda.gov/NewsEvents/PublicHealthFocus/ucm150305.htm.