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FDA clears new test to distinguish between MRSA, MSSA
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The FDA has announced the clearance of the first test to identify whether infections are methicillin-resistant or methicillin-susceptible Staphylococcus aureus, according to an FDA press release.
The KeyPath MRSA/MSSA Blood Culture Test (MicroPhage Inc.) determines whether bacteria growing in a patient’s positive blood culture sample are methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-susceptible Staphylococcus aureus (MSSA) within about 5 hours after any bacterial growth is first detected in the sample, according to the release.
Clearance was based upon 1,116 blood samples evaluated at four U.S. hospital centers. Among the organisms determined to be S. aureus, MRSA determination was 98.9% accurate and MSSA was 99.4% accurate. The test does not require any specific instruments to obtain results.
“Clearing this test gives health care professionals a test that can confirm S. aureus and then identify whether the bacteria is MRSA or MSSA,” Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health, stated in the release. “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.”