The FDA has approved the first rapid blood test for methicillin-resistant Staphylococcus aureus (MRSA). It is the two-hour BD GeneOhm StaphSR Assay, which identified 100% of the MRSA-positive specimens and more than 98% of the more common, less dangerous staphylococcus specimens in a multisite clinical trial. Distinguishing between the two types of infection is critical to successful treatment.
“Rather than waiting more than two days for test results, health-care personnel will be able to identify the source of a staph infection in only two hours,” an FDA official says.
Whereas the more common, less dangerous strain of S. aureus causes generally mild skin infections and can be treated with methicillin, MRSA can lead to blood and surgical-site infections, pneumonia, and a number of other life-threatening conditions. This strain is difficult to treat with ordinary antibiotics.
Clinicians should use the new test only in patients who are suspected of having a staph infection, and should be aware that a positive result may reflect the presence of bacteria in a person who has already been successfully treated. In addition, since the test will not rule out other complicating infections, it shouldn’t be used as the sole basis for diagnosis.
The new test is manufactured by BD Daignostics of Franklin Lakes, N.J.