The first test for the 2009 H1N1 influenza virus in patients with signs and symptoms of respiratory infection, known as the Simplexa Influenza A H1N1 (2009), has received clearance from the US Food and Drug Administration (FDA).

The Simplexa Influenza A H1N1 (2009) test, manufactured by Focus Diagnostics in California, uses specimens from nasal swabs or nasal aspirates to detect the virus.

The test magnifies and detects two regions of the influenza virus genome and an internal control to identify if the patient is infected with the 2009 H1N1 influenza virus.

A positive result indicates that a patient is infected with the virus, however, the test does not indicate the stage of infection.