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FDA Clears Idaho's Q Fever MDx Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration today cleared the first nucleic acid amplification test for the diagnosis of Q fever infection in military personnel serving overseas.

The test, which was developed by Idaho Technology, was funded by the Chemical Biological Medical System Joint Project Management Office within the US Department of Defense, and identifies and detects the bacteria that cause Q fever, or Coxiella burnetii. It does so by determining whether Coxiella burnetii DNA is present in a patient's blood sample. Results can be achieved within four hours, FDA said.

FDA cleared the test for use on DOD's Joint Biological Agency Identification and Diagnostic System, or JBAIDS, a multiple use platform for the rapid detection of bacteria and viruses. Use of the test is limited to designated DOD laboratories equipped with JBAIDS.

FDA said that Q fever is an emerging infectious disease among servicemen and servicewomen in Iraq and worldwide. It can cause acute or chronic illness and is acquired primarily from contact with infected animals or exposure to contaminated environments. Early treatment with antibiotics normally leads to full recovery.

The disease was first recognized as a human disease in Australia in 1935 and in the US in early 1940s. The "Q" stands for "query," FDA said, as the causative agent was unknown at the time.

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