New H1N1 Test Authorized for Emergency Use

The Food and Drug Administration (FDA) issued July 24 an Emergency Use Authorization (EUA) diagnostic test for the detection of H1N1 influenza virus. This is the third EUA test the FDA has released this year since declaring H1N1 a pandemic in April.

The EUA allows Focus Diagnostics to distribute the unapproved Influenza H1N1 (2009) Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) diagnostic test to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests not typically performed in a doctor’s office.

Tests of this nature are intended for use in the detection of the 2009 H1N1 flu virus in patients with respiratory infection symptoms. The Focus Diagnostics test amplifies the viral genetic material obtained from nose or throat swabs, or from nasal discharges.

For more information, read FDA’s Guidance on Emergency Use Authorization of Medical Products.

Comments are closed.