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FDA Approves Rapid Diagnostic Test for Seasonal and Pandemic Flu

By Christine SooHoo, October 20, 2008

On September 30, 2008, the U.S. Department of Health and Human Services (HHS) announced that the U.S. Department of Food and Drug Administration (FDA) has approved a rapid diagnostic test for flu virus infections called Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel^TM).¹ According to HHS, this new PCR-based test can simultaneously test multiple nasal or throat samples, and within 4 hours it can identify human influenza virus strains (including H5N1 influenza) with 99% accuracy.^1,2 The U.S. Centers for Disease Control and Prevention (CDC), in cooperation with Applied Biosystems Inc., developed rRT-PCR Flu Panel^TM, and the diagnostic will be available for use sometime this fall in 20–30 CDC-approved state public health laboratories across the nation.²

References

1. FDA clears new CDC test to detect human influenza [news release]. Washington, DC: U.S. Department of Health and Human Services. September 30, 2008. http://www.hhs.gov/news/press/2008pres/09/20080930a.html. Accessed October 15, 2008.
2. Stobbe M. Faster genetic test for flu virus approved. Associated Press. September 30, 2008. http://ap.google.com/article/ALeqM5iQ5JyawoD9AGzG5jesJuF17EiJnQD93HD0PO0. Accessed October 15, 2008.