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Updated MRSA blood culture test receives FDA clearance

The FDA cleared for marketing today a test for the detection of methicillin-resistant Staphylococcus aureus and Staphylococcus aureus, according to an FDA spokesperson.

The updated Xpert MRSA/SA Blood Culture (BC) test runs on the GeneXpert System and processes positive blood culture specimens to determine whether a patient’s blood is infected with S. aureus or MRSA. The test produces results in about an hour, according to a press release from the manufacturer.

Current testing methods require physicians to order a set of blood culture bottles drawn from patients who present with symptoms of systemic infections. Positive cultures can appear in as little as 16 to 24 hours, but further testing is required to identify the specific cause of the infection. Gram’s stain results can be helpful for guiding empiric therapy, but many physicians traditionally rely on other culture methods that require an additional 24 to 48 hours.

The GeneXpert System combines on-board sample preparation with real-time PCR amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences, thereby delivering answers directly from unprocessed samples, according to the press release.