Quest Diagnostics gets emergency use authorization for Focus Diagnostics to detect H1N1 flu virus

Quest Diagnostics Incorporated, the world's leading provider of diagnostic testing, information and services, announced that the US Food and Drug Administration (FDA) has granted an emergency use authorization to the company's Focus Diagnostics business for its test for detecting the 2009 H1N1 influenza virus (the pandemic flu virus), a strain of influenza A virus initially referred to as the swine flu virus.

The Influenza A H1N1 (2009) Real Time RT-PCR test is the first commercial lab test to be granted an emergency use authorization by the FDA for testing for the 2009 H1N1 influenza virus. It is also the first test to qualitatively detect RNA of the pandemic flu virus in a patient's nasal or nasopharyngeal specimens. The test targets two separate regions of the hemagglutinin gene of the 2009 H1N1 influenza virus to differentiate the presence of the pandemic virus from seasonal human influenza A virus. Turnaround time for reporting results is typically within 24 hours of receipt of specimen.


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