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FDA Clears First Quick Test For 'Super Staph'

New test can give results in two hours, instead of two days

January 2, 2008

• Public Citizen Proposes Basic Safety Reforms • Medicare Penalizes Hospitals for Treating Disadvantaged Patients • CDC Steps Up Efforts to Fight MRSA Infections • FDA Clears First Quick Test For 'Super Staph' • Drug-Resistant Bugs Growing, Study Finds • CDC Slow to Act Against Hospital Infections, Critic Charges • Study: Cell Phones Reduce Hospital Errors • Hospitals Slow to Improve Patient Safety • Hospital Sloppiness Costing Taxpayers Billions • States Take Aim at Hospital Infections • Hospital Computer Keyboards Can Spread Germs, Study Finds • Medicare Launches Hospital Comparison Site

The U.S. Food and Drug Administration has greenlighted the first "fast results" blood test for the bacterium known as MRSA - the drug resistant staph germ that can cause potentially deadly infections.

Methicillin is an antibiotic that has been used successfully to treat infections from the Staphylococcus aureus bacterium. Over the years, the staph bacterium mutated and spawned MRSA, a strain of staph bacterium that is resistant to methicillin and which has a higher rate of being fatal.

The new test - BD GeneOhm StaphSR Assay - uses molecular methods to identify whether a blood sample contains genetic material from the MRSA bacterium or the more common, less dangerous staph bacterium that can still be treated with methicillin.

"The BD GeneOhm test is good news for the public health community. 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, allowing for more effective diagnosis and treatment," said Daniel G. Schultz, M.D., director, FDA's Center for Devices and Radiological Health.

Staph infections occur most frequently in hospitals and other health care facilities, such as nursing homes and dialysis centers, and among those who have weakened immune systems. Both types of bacteria also can infect healthy people.

Distinguishing between the two sources of infection is critical to successful treatment, the FDA said. The more common, less dangerous strain of staph results in infections that are generally mild and affect the skin with pimples or boils that can be swollen, painful and drain pus.

However, the MRSA staph bacterium is difficult to treat with ordinary antibiotics. It can cause potentially life-threatening conditions such as blood stream infections, surgical site infections or pneumonia.

FDA said it cleared the BD GeneOhm StaphSR assay based on the results of a clinical trial at five locations. The new assay identified 100 percent of the MRSA-positive specimens and more than 98 percent of the more common, less dangerous staph specimens.

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