New H1N1 Flu Test Wins FDA Approval


The FDA announced this week its approval of a new test to detect the 2009 H1N1 influenza virus in humans. Developed by the US Centers for Disease Control and Prevention (CDC), the test promises to improve the accuracy of flu testing in the United States and overseas.

The test will soon replace an earlier version, which was created using the limited number of H1N1 specimens that were available when the pandemic first began in April 2009. Thanks to the wealth of genetic material that was generated as the virus progressed since then, the new test—called the “CDC Influenza 2009 A (H1N1) pdm Real-Time RT-PCR Panel (IVD),"—can detect the 2009 H1N1 virus with more than 96% accuracy in upper respiratory specimens.

The test uses secretions from a patient’s upper or lower respiratory tract, which can be sampled in physicians’ offices or hospitals. A diagnostic instrument recognizes fluorescent signals produced by viral genetic material present in the specimens, and results are delivered within 4 hours.

"The development of this test exemplifies our dedication to improving public health surveillance for the 2009 H1N1 virus and other influenza viruses in the United States and abroad," Nancy Cox, PhD, director of CDC's influenza division, said in a press release.

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