KeyPath MRSA/MSSA Blood Culture Test Approved

The FDA has cleared the KeyPath MRSA/MSSA Blood Culture Test to determine whether bacteria growing in a patient's positive blood culture sample are MRSA or MSSA. Test results are available within about five hours after any bacterial growth is first detected in the sample. This approval was based on a clinical study of 1,116 blood samples evaluated at four major U.S. hospital centers. Within the organisms determined to be Staphylococcus aureus, the MRSA determination was 98.9% accurate (178/180) and the MSSA determination was 99.4% accurate (153/154).

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