Friday, July 24, 2009

FDA authorizes emergency H1N1 test

In the primary care setting, it can be very challenging to accurately diagnose influenza. Now, we have to worry about a specific type of flu, H1N1 (also known as swine flu). Fortunately, the FDA has authorized the use of a diagnostic test for emergency use. Here are a few snippets from the FDA press release:

FDA Authorizes Emergency Use of Another Test for 2009 H1N1 Influenza Virus

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 the public health emergency involving the 2009 H1N1 influenza virus was declared on April 26, 2009. The Focus Diagnostics test amplifies the viral genetic material obtained from swabs of the nose or throat, or from nasal discharges. A positive result indicates that the patient is infected with the 2009 H1N1 influenza virus. However, the test does not indicate the stage of infection. A negative result does not preclude influenza virus infection.

The EUA authority allows the FDA, based on the evaluation of available data and other things, to authorize the use of unapproved medical products or unapproved uses of approved medical products following a determination and declaration of emergency. The Focus Diagnostics test is an unapproved device whose use is authorized by the EUA. The authorization ends when the declaration of emergency is terminated or when the FDA revokes the authorization.

Emergency Use Authorization is part of Project BioShield, which became law in July 2004.
Focus Diagnostics is based in Cypress, Calif.

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