FDA approves rapid MRSA/MSSA test

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The U.S. Food and Drug Administration has approved a blood culture test that can determine if Staphylococcus aureus bacteria infections are methicillin resistant (MRSA) or methicillin susceptible (MSSA).

The KeyPath MRSA/MSSA Blood Culture Test, which does not require any specific instruments aside from blood culture equipment, can distinguish between the diseases within approximately five hours after any bacterial growth is first detected in a sample, the FDA said. The distinction between MSSA and MRSA is important: Some MSSA infections can be treated using certain antibiotics, whereas MRSA infections are resistant to most antibiotics.

This is good news for nursing homes and hospitals, where infections among patients with weakened immune systems can be deadly and spread rapidly.

“Clearing this test gives healthcare professionals a test that can confirm S. aureus and then identify whether the bacteria is MRSA or MSSA,” 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. “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.”
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