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FDA approves new blood test for rapidly identifying MRSA infections
The new test would allow identifying the source of a staph infection in 2 hours.
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The U.S. Food and Drug Administration has approved the first rapid blood test for identifying methicillin-resistant Staphylococcus aureus, the agency announced in a press release.
The device — the BD GeneOhm StaphSR Assay (BD Diagnostics) — uses molecular methods to determine whether a blood sample contains genetic material from either methicillin-resistant S. aureus (MRSA) or the more common, less dangerous S. aureus bacterium, which is still susceptible to treatment with methicillin.
"The BD GeneOhm test is good news for the public health community. Rather than waiting more than 2 days for test results, health care personnel will be able to identify the source of a staph infection in only 2 hours, allowing for more effective diagnosis and treatment," Daniel G. Schultz, MD, director of the FDA's Center for Devices and Radiological Health, stated in the release.
The FDA cleared the BD GeneOhm StaphSR assay based on the results of a five-center clinical trial. In the study, the test identified 100% of MRSA-positive specimens and more than 98% of the S. aureus specimens.
However, in order to preserve the integrity of positive test results, the test should be used only in patients who are suspected of having a staph infection and should not be used to monitor treatment for such infections because it cannot quantify a patient's treatment response, according to the FDA press release.
Physicians should also not use the test results as the sole basis for a diagnosis because the test may reflect the bacteria's presence in patients who have been successfully treated. Also, the test does not rule out other potential complicating conditions or infections, the release said.
BD has recently submitted subsequent applications to the FDA, which seek to gain approval for using its BD GeneOhm StaphSR assay to detect staph infections from nasal and wound swabs.
The company is also developing rapid tests for detecting two other organisms that cause severe health care-associated infections. These tests will identify the vanA and vanB genes associated with vancomycin-resistant enterococci and the toxin gene associated with Clostridium difficile, according to a press release from BD.