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FDA issues EUA for H1N1 diagnostics test

The US FDA has issued an Emergency Use Authorisation for another H1N1 influenza virus diagnostic test

The US Food and Drug Administration (FDA) has issued an Emergency Use Authorisation (EUA) for another H1N1 influenza virus diagnostic test. 

The Focus Diagnostics Influenza H1N1 (2009) Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) diagnostic test is the third diagnostic test authorised under an EUA by the FDA since the H1N1 influenza public health emergency was declared on April 26.

EUA is part of Project BioShield, which became law in July 2004. Through it the FDA can authorise 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 authorised by the EUA. Its authorisation will, however, end when the declaration of emergency is terminated or when the FDA revokes the authorisation.

Following allocation of the EUA, Focus Diagnostics can distribute the RT-PCR diagnostic test to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests intended for use in the detection of the 2009 H1N1 influenza virus in patients with symptoms of respiratory infection.

"This authorisation will contribute to the nation's capacity for accurate testing for the 2009 H1N1 influenza virus," said Dr Daniel G Schultz, 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 2009 H1N1 influenza virus. The test does not, however, indicate the stage of infection and a negative result does not preclude influenza virus infection.

27th July 2009

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