FDA approves rapid staph test

Published: Jan. 2, 2008 at 5:44 PM

WASHINGTON, Jan. 2 (UPI) -- The U.S. Food and Drug Administration has approved the first rapid blood test for potentially deadly drug-resistant staph bacterium.

The BD GeneOhm StaphSR Assay uses molecular methods to identify whether a blood sample contains genetic material from the Methicillin-resistant Staphylococcus aureus (MRSA) bacterium or a less dangerous staph bacterium that can still be treated with methicillin.

"The BD GeneOhm test is good news for the public health community," Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, said Wednesday in a release. "Rather than waiting more than two days for test results, healthcare personnel will be able to identify the source of a staph infection in only two hours, allowing for more effective diagnosis and treatment."

MRSA staph bacterium can cause potentially life-threatening conditions such as blood stream infections, surgical site infections or pneumonia.

In a clinical trial at five locations, the new test identified 100 percent of the MRSA-positive specimens and more than 98 percent of the more common, less dangerous staph specimens, the FDA said.

© 2008 United Press International, Inc. All Rights Reserved.
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