New H1N1 Test Released
The FDA announced it has issued an Emergency Use Authorization (EUA) for a another diagnostic test for H1N1, characterized as a pandemic by the World Health Organization.
The EUA for the Focus Diagnostics Influenza H1N1 (2009) real-time reverse transcription polymerase chain reaction (RT-PCR) diagnostic test is the third diagnostic test authorized under an EUA by the FDA since Apr. 26.
The EUA allows Focus Diagnostics to distribute the test to laboratories CLIA-certified to perform high complexity tests. These tests are intended for use in the detection of the 2009 H1N1 influenza virus in patients with symptoms of respiratory infection.
The Focus Diagnostics test amplifies the viral genetic material obtained from swabs of the nose or throat, or from nasal discharges. However, the test does not indicate the stage of infection. A negative result does not preclude influenza virus infection.