The FDA has cleared the first nucleic acid amplification
test to diagnose the early stages of Q fever infections in military personnel
serving overseas, according to an FDA press release.
Its important that the FDA protect our
troops from biothreats using innovative diagnostics, Jeffrey Shuren,
MD, director of the FDAs Center for Devices and Radiological Health,
said in a press release. Q fever bacteria are considered a biothreat
agent in part due to the fact that fewer than 10 organisms need to be inhaled
to cause infection and its ability to withstand open environments.
The test developed by Idaho Technology Inc. and
funded by the Chemical Biological Medical System Joint Project Management
Office within the US Department of Defense identifies and detects
Coxiella burnetii in a patients blood sample within 4 hours. Use
of the test is limited to designated Department of Defense laboratories
equipped with the departments Joint Biological Agency Identification and
According to the CDC, Q fever was first recognized as a
human disease in Australia in 1935 and in the US during the early 1940s.