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FDA Clears First Test to Quickly Diagnose/Distinguish MRSA / MSSA

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  • FDA Clears First Test to Quickly Diagnose/Distinguish MRSA / MSSA

    The U.S. Food and Drug Administration today cleared the first test for Staphylococcus aureus (S.aureus) infections that is able to quickly identify whether the bacteria are methicillin resistant (MRSA) or methicillin susceptible (MSSA)...

    The KeyPath MRSA/MSSA Blood Culture Test determines whether bacteria growing in a patient?s positive blood culture sample are MRSA or MSSA within about five hours after any bacterial growth is first detected in the sample. Aside from blood culture equipment, the test does not require any specific instruments to get results, which makes it useful in any laboratory...

    The FDA based its clearance on a clinical study of 1,116 blood samples evaluated at four major U.S. hospital centers. Within the organisms determined to be S.aureus, the MRSA determination was 98.9% accurate (178/180) and the MSSA determination was 99.4% accurate (153/154).

    The KeyPath MRSA/MSSA Blood Culture Test is manufactured by MicroPhage Inc. of Longmont, Colo.
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