FDA approves rapid MRSA test

The U.S. Food and Drug Administration recently cleared the first Staphylococcus aureus test capable of rapidly identifying whether an infection is methicillin resistant or methicillin susceptible.

There are a variety of kinds of Staphylococci bacteria that are capable of causing skin infections, pneumonia, food or blood poisoning. Some are treated easily with an array of antibiotics, but others, referred to as methicillin resistant, defy commonly prescribed antibiotic treatments such as penicillin and amoxicillin.

The KeyPath MRSA/MSSA Blood Culture Test can determine whether the bacteria growing in a patient’s blood culture test is MRSA or MSSA within approximately five hours after growth is first detected. The test requires no outside instruments, aside from those used in obtaining the blood culture sample, so it can be considered useful in any laboratory setting.

“Clearing this test gives health care professionals a test that can confirm S.aureus and then identify whether the bacteria is MRSA or MSSA,” Alberto Gutierrez, the director of the Office of In Vitro Diagnostics Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health, said. “This not only saves time in diagnosing potentially life-threatening infections but also allows health care professionals to optimize treatment and start appropriate contact precautions to prevent the spread of the organism.”

MRSA infections can occur anywhere, but those that appear in healthcare settings can be especially dangerous due to the weakened immune systems of patients and the possibility of the bacteria being spread directly into the body through surgical procedures.

In a clinical study of the test, MSRA determination was 98.9 percent accurate and MSSA determination was 99.4 percent accurate.