FDA approves quick MRSA test
The FDA approved the KeyPath MRSA/MSSA Blood Test (Microphage Inc.), a test that will enable clinicians to distinguish whether cultured Staphylococcus aureus bacteria are methicillin resistant or methicillin susceptible 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,” Alberto Gutierrez, PhD, of the FDA's Center for Devices and Radiological Health, said in a press release.
The test was deemed 98.9% accurate in determining MRSA status (178 of 180 samples), and 99.4% accurate in determining MSSA status (153 of 154) in a clinical study that involved 1,166 blood samples from four major U.S. centers.
The test can be used in any laboratory setting, according to the FDA, as it does not require any specific instrument aside from blood culture equipment to obtain results.