Medliorate

Improving medical students

2 Hour MRSA Test

Posted by medliorator on January 15, 2008

[The FDA] announced it has cleared for marketing the first rapid blood test for the drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus)

 

The 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.

 

FDA 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.

 

In order to preserve the integrity of positive test results, this test should be used only in patients suspected of a staph infection. The test should not be used to monitor treatment for staph infections because it cannot quantify a patient’s response to treatment. Test results should not be used as the sole basis for diagnosis as they may reflect the bacteria’s presence in patients who have been successfully treated for staph infections. Also, the test will not rule out other complicating conditions or infections.

 

The BD GeneOhm StaphSR test is manufactured by BD Diagnostics, a subsidiary of BD of Franklin Lakes, N.J.

FDA Clears First Quick Test For Drug-Resistant Staph Infections [FDA]

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