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FDA Approves Test to Detect MRSA Rapidly

by Kathy Jones on May 9, 2011 at 6:18 PM
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 FDA Approves Test to Detect MRSA Rapidly

The US Food and Drug Administration has given its approval for the first test that could identify whether the Staphylococcus aureus bacteria is either methicillin resistant (MRSA) or methicillin susceptible (MSSA).

Manufactured by Colorado's MicroPhage Inc, the test, known as KeyPath Test, will take just over five hours to identify whether the bacteria is MRSA or MSSA and allow the doctors to provide efficient treatment.

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Clinical studies of the test on 1,116 blood samples found that it was 99.4 percent accurate in identifying MSSA infections and 98.9 percent accurate in identifying MRSA infections when Staphylococcus aureus bacteria was involved.

"The test not only saves time in diagnosing potentially life-threatening infections but also allows healthcare professionals to optimize treatment and start appropriate contact precautions to prevent the spread of the organism", Alberto Gutierrez at the FDA's Center for Devices and Radiological Health said.



Source: Medindia
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