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FDA Clears First Quick Test for Resistant Staph

The U.S. Food and Drug Administration Friday cleared the first test for Staphylococcus aureus (S. aureus)  infections that can quickly discern whether the bacteria are methicillin resistant (MRSA) or methicillin susceptible (MSSA).

In a news release, FDA said the KeyPath Test, manufactured by MicroPhage Inc. of Longmont, CO, takes only about five hours to identify whether bacteria in a positive blood culture sample are MRSA or MSSA, and does not require any additional instruments to get results.

The FDA said it based its clearance on a clinical study of 1,116 blood samples evaluated at four major U.S. hospital centers. Within the organisms determined to be S.aureus, the MRSA determination was 98.9 percent accurate and the MSSA determination was 99.4 percent accurate.

There are many different types of Staphylococci bacteria, which cause skin infections, pneumonia, food and blood infections. While some S. aureus infections are treated easily with antibiotics, others are resistant (MRSA) to commonly prescribed antibiotics such as penicillin and amoxicillin.

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