Posted on 08/29/2009 4:43:40 PM PDT by neverdem
By John Gever, Senior Editor
Military doctors can use a portable polymerase chain reaction (PCR) testing device to diagnose novel H1N1 flu infections in troops overseas, the FDA announced.
The emergency authorization was approved "to better protect our troops," said FDA Commissioner Margaret A. Hamburg, MD, in a statement.
The device, called JBAIDS (Joint Biological Agent Identification and Diagnostic System), is a rugged, suitcase-sized instrument that can run PCR-based molecular diagnostic tests. It has been under development for several years by a consortium of military health research centers, the CDC, and academic medical laboratories.
The development program began in the wake of the Sept. 11, 2001, terrorist attacks and was mainly focused on biological warfare and bioterrorism threat detection, but the mission also included the ability to test for naturally occurring infectious pathogens.
The H1N1 flu testing on the device will use the PCR primers developed by the CDC for use in public health laboratories.
Deployment will begin in September to combat units in the Middle East and Navy ships, according to the U.S. Army's Joint Project Management Office for Chemical Biological Medical Systems. The FDA granted approval less than three months after testing of the H1N1 panel began.
In early 2010, according to the office, military health officials will request FDA approval to use the JBAIDS device for diagnosing H5N1 avian flu.
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