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FDA Approves Quick Test to Thwart Spread of MRSA By Amanda Sounart, associate editor

The U.S. Food and Drug Administration (FDA) announced approval of a new rapid-results test that detects Methicillin-resistant Staphylococcus aureus (MRSA), the drug-resistant strain of the highly contagious staph infection. The test is the first of its kind that can deliver results within two hours, allowing hospitals to quickly treat and hopefully prevent the spread of the infection.

MRSA made headlines in the past year after the Centers for Disease Control and Prevention (CDC) reported that bacteria may kill more people per year than the AIDS virus. Around the same time, outbreaks of the infection were reported by school districts in several states and claimed the lives of a high school student and junior high school teacher.

While community associated MRSA has been well reported, the majority of infections occur in health care settings including hospitals, nursing homes and dialysis centers. Patients in these facilities often have weakened immune systems and are being attended to by medical personnel who have been in contact with other patients who are carriers of the bacteria.

“Hospitals have been screening patients for staph as they come in,” said Barbara Kalavik, director of public relations for BD Diagnostics, a segment of Becton, Dickinson and Company, creators of the test. “MRSA spreads easily through hand-to-hand, hand-to-bedrail or any type of direct contact. A person going into the emergency department or intensive care has a high probability of an invasive procedure, such as having a catheter inserted, which may provide and then the bacteria on the skin with a pathway finds a way into the body whereby it may and infects the patient.”

Traditional microbiology tests currently in use require anywhere from 24 to 72 hours. The new test, called BD GeneOhm StaphSR Assay is a rapid, molecular assay which is performed on a positive blood culture to tell if patients are infected with SA or MRSA, in which case they can begin the appropriate treatment immediately. Furthermore, test results show which strain of the bacteria the patient is infected with, which should prevent overmedication of non-MRSA staph infections.

“If the patient is infected with MRSA, you have to bring in the heavy-hitter antibiotics and you have to bring them in immediately,” added Kalavik. “But you only want to spend that power if it’s that bug. That’s how we got into this trouble in the first place. We were using powerful antibiotics when it wasn’t necessary and the bacteria began to mutate to survive.”

With faster results, the new test can not only prevent the spread of MRSA, it can allow hospitals to offer quicker treatment that is critical to helping an infected patient.

For more information, visit the FDA Web site at www.FDA.gov.

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