FDA approves quicker test for MRSA

Hospitals trying to get a step ahead in tackling Staphylococcus aureus infections within their facilities now may have another tool in their arsenal with the approval by the U.S. Food and Drug Administration (FDA) late last week of a new test that is able to quickly identify whether the bacteria are methicillin resistant (MRSA) or methicillin susceptible (MSSA).

The new test--the KeyPath MRSA/MSSA Blood Culture Test--determines whether bacteria growing in a patient's positive blood culture sample are MRSA or MSSA usually within five hours of when any bacterial growth is first detected. The test, manufactured by MicroPhage of Longmont, Colo., does not require specific instruments beyond blood culture equipment, according to the FDA.

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

The FDA based its clearance on a clinical study that evaluated 1,116 blood samples at four major hospital centers. When the organisms were determined to be Staphylococcus aureus, the MRSA determination was 98.9 percent accurate; the MSSA determination was 99.4 percent accurate.

For more details:
- here's the FDA's announcement
- view the Medpage Today article

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