Blood culture panel cleared by FDA
Staphylococcus infection
Photo by Bill Branson
The US Food and Drug Administration (FDA) has granted 510(k) clearance for a blood culture panel that detects sepsis caused by methicillin-resistant Staphylococcus aureus (MRSA) and other Staphylococcus species.
The Staph ID/R Blood Culture Panel is a product of Great Basin Scientific, Inc.
It is an automated, DNA multiplex assay used to identify Staphylococcus species directly from positive blood cultures in about 2 hours.
The panel also detects the mecA gene, a drug-resistance marker that confers resistance to methicillin and other beta-lactams and creates MRSA.
In addition, the Staph ID/R Blood Culture Panel identifies coagulase-negative staphylococci.
According to the US Centers for Disease Control and Prevention, 20% to 50% of all positive blood cultures are likely false positives due to contamination caused by coagulase-negative staphylococci, many of which are part of the normal flora of human skin and are not dangerous.
The Staph ID/R Blood Culture Panel is run on the Great Basin Analyzer. The company says the assay requires less than a minute of hands-on time and no results interpretation due to electronic results reporting. 