Rapid MRSA test gets FDA OK
Link: AMNews: Jan. 28, 2008. Rapid MRSA test gets FDA OK ... American Medical News.
Those working to control the spread of methicillin-resistant Staphylococcus aureus say this task is about to get easier. In January, the Food and Drug Administration approved the first blood test that can differentiate it from the methicillin-susceptible variant in two hours, rather than the 24 to 48 hours or longer that currently available technology takes. "[This] test is good news for the public health community," said Daniel G. Schultz, MD, director of the FDA's Center for Devices and Radiological Health. The BD GeneOhm StaphSR Assay assesses a blood sample for genetic material specific to the two main forms of these bacteria. Studies leading to the test's approval found that it could identify 100% of MRSA samples and 98% of the susceptible types. According to an FDA statement, this test should be used in patients already suspected of having a staph infection but not to monitor treatment or initially detect it. Doctors still might have to conduct follow-up testing to pin down precisely what will kill particular bacteria, but physicians say the information provided by this product will be enough to narrow down treatment choices early on.
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