The Food and Drug Administration cleared the first test able to quickly determine whether Staphylococcus aureus infection bacteria are methicillin resistant, known as MRSA, or methicillin susceptible, known as MSSA, the agency announced.
FDA approves first quick test for MRSA/MSSA bacteria
Hospital executives and regulators are working hard to prevent healthcare-acquired infections, particularly those caused by MRSA because of the difficulty and costs in treating MRSA infections.
“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, director of the Office of In Vitro Diagnostics Device Evaluation and Safety in the FDA's Center for Devices and Radiological Health, in the announcement. “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,” Gutierrez said.
The KeyPath MRSA/MSSA Blood Culture Test is manufactured by MicroPhage of Longmont, Colo., according to the FDA.
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