Entries in Cleared (2)


New Test Cleared for Diagnosing Q Fever in Soldiers

Jupiterimages/Comstock(WASHINGTON) -- The first nucleic acid amplification test for diagnosing early stages of Q fever infections in military personnel serving abroad has been cleared by the U.S. Food and Drug Administration (FDA).

Q fever (Coxiella burnetii) is an infectious disease that affects U.S. soldiers serving in Iraq and other parts of the world. FDA officials say the new test is capable of indentifying and detecting the bacteria that causes the fever within four hours.

“It’s important that the FDA protect our troops from biothreats using innovative diagnostics,” said Jeffrey Shuren, M.D., director of the 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.”

The test’s development was funded by the U.S. Department of Defense and developed by Idaho Technology Inc.

Copyright 2011 ABC News Radio


Test to Help Speed-Up Distinguishing Between MRSA and MSSA

Siri Stafford/Photodisc/Thinkstock(WASHINGTON) -- Health experts will now be able to save time when trying to determine whether Staphylococcus aureus infections in patients are methicillin resistant (MRSA) or methicillin susceptible (MSSA), as the U.S. Food and Drug Administration (FDA) announced on Friday that it has cleared a test that will allow a speed-up in the process.

There are various types of Staphylococci bacteria, some of which are easily treated with antibiotics and some that are resistant to this treatment, such as MRSA.

The FDA has cleared the KeyPath MRSA/MSSA Blood Culture Test for use by doctors, with officials saying that the test makes it possible to determine whether bacteria in a patient’s positive blood culture sample are MRSA or MSSA within about five hours.

“This not only saves time in diagnosing potentially life-threatening infections but also allows health care professionals to optimize treatment and start appropriate contact precautions to prevent the spread of the organism,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health.

Copyright 2011 ABC News Radio

ABC News Radio