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Blood culture panel cleared by FDA

Blood culture positive for

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.

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Blood culture positive for

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.

Blood culture positive for

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.

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Blood culture panel cleared by FDA
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