New 2009 H1N1 Influenza Virus Test Authorized by FDA

Test developed by CDC has sensitivity and specificity greater than 96 percent
By Jeff Muise
HealthDay Reporter

WEDNESDAY, June 23 (HealthDay News) -- The U.S. Food and Drug Administration has authorized a new test that uses molecular biology techniques to diagnose 2009 H1N1 influenza virus infection in humans.

The "CDC Influenza 2009 A (H1N1)pdm Real-Time RT-PCR Panel (IVD)," developed by the U.S. Centers for Disease Control and Prevention over the past several months, can isolate and detect viral genetic material from sputum samples taken from a patient's upper or lower respiratory tract in a doctor's office or hospital. The H1N1 virus genetic material is amplified to generate a fluorescent signal which is detected with the Applied Biosystems 7500 Fast DX Real-Time PCR Instrument. The test can produce a result within four hours.

The new test replaces a former test developed with limited H1N1 specimens and authorized by the FDA for emergency use in April 2009. With the large amounts of genetic material gathered since the 2009 pandemic, the new test has been improved to detect 2009 H1N1 virus with sensitivity and specificity greater than 96 percent using upper respiratory specimens. The test is expected to be available to CDC-qualified laboratories soon.

"This clearance represents several months of close collaboration between the FDA and the CDC," Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said in a statement. "This test is the second diagnostic cleared in recent weeks by the FDA for the 2009 H1N1 influenza virus."

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