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FDA Authorizes Emergency Use Of Another Test For Swine Flu Virus

Test for use on patients with breathing problems

By James Limbach
ConsumerAffairs.com

July 26, 2009

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The Food and Drug Administration has issued an Emergency Use Authorization (EUA) for a another diagnostic test for the 2009 H1N1 influenza, -- better known as swine flu -- virus, whose spread has caused the virus to be 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 the public health emergency involving the virus was declared on April 26, 2009.

The EUA allows Focus Diagnostics to distribute the test to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests.

This test is not typically utilized in a doctor's office -- it is a complex laboratory test performed in an environment that has the necessary equipment. These tests are intended for use in the detection of the 2009 H1N1 influenza virus in patients with symptoms of respiratory infection.

"This authorization will contribute to the nation's capacity for accurate testing for the 2009 H1N1 influenza virus," said Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health.

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 swine flu virus. However, the test does not indicate the stage of infection. A negative result does not preclude flu 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.

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