FDA cleared the first nucleic acid amplification test to diagnose the early stages of Q fever infections in military personnel serving overseas. The Chemical Biological Medical System Joint Project Management Office within the U.S. Department of Defense funded the development of this test, which identifies and detects the bacteria that cause Q fever (Coxiella burnetii) within four hours. The test was developed by Idaho Technology Inc.

FDA cleared this test to be used on the Defense Department’s Joint Biological Agency Identification and Diagnostic System (JBAIDS), a multiple use instrument that can be used for the rapid detection of numerous bacteria and viruses, such as the bacteria that cause Q fever. The test is performed on the JBAIDS instrument and determines if Coxiella burnetii DNA is present in a patient’s blood sample. Use of the test is limited to designated Department of Defense laboratories equipped with the JBAIDS.

“It’s important that FDA protect our troops from biothreats using innovative diagnostics,” said Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health. “Q fever bacteria is 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.”