FDA approves rapid MRSA diagnostic test

By ACSH Staff — May 10, 2011
The FDA has just approved a new diagnostic test that will expedite the time needed to confirm a methicillin-resistant Staphylococcus aureus (MRSA) infection. Whereas current MRSA tests take up to 48 hours to generate results, the BD GeneOhm StaphSR test, developed by BD Diagnostics, can detect MRSA within five hours of culturing a sample.

The FDA has just approved a new diagnostic test that will expedite the time needed to confirm a methicillin-resistant Staphylococcus aureus (MRSA) infection. Whereas current MRSA tests take up to 48 hours to generate results, the BD GeneOhm StaphSR test, developed by BD Diagnostics, can detect MRSA within five hours of culturing a sample. The FDA based its decision on a study in which the test correctly identified 98.9 percent of MRSA-containing blood samples among approximately 1,100 total samples. MRSA is currently the leading cause of hospital-acquired infections and is resistant to multiple antibiotics. ACSH's Dr. Gilbert Ross says that this test is a “welcome and potentially major advance in the rapid characterization of bacterial infections.”

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