New Test Improves Detection of 2009 H1N1

Physicians will soon have a new test they can use to diagnose patients with the 2009 H1N1 influenza virus. Developed by the U.S. Centers for Disease Control and Prevention (CDC) and authorized for use June 22 by the U.S. Food and Drug Administration (FDA), the new test will replace the previous real-time RT-PCR diagnostic test used during the 2009 H1N1 pandemic.

The new test, called the CDC Influenza 2009 A(H1N1)pdm Real-Time RT-PCR Panel (IVD), can detect human infections with 2009 H1N1 virus with sensitivity and specificity greater than 96 percent for upper respiratory specimens, according to the CDC. Upper respiratory specimens are easily obtainable in a doctor’s office.

Here’s how it works: Amplified viral genetic material generates a fluorescent signal, which is then detected and analyzed by a diagnostic instrument called the Applied Biosystems 7500 Fast DX Realtime PCR Instrument. The test panel and diagnostic system can provide results within four hours, and multiple samples can be tested at the same time.

The CDC did not give a specific date for when physicians will be able to order the new test from CDC-qualified laboratories for detecting 2009 H1N1 flu, but in all likelihood it will be available by the start of the next flu season.

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