Do I Have MRSA? FDA Approves Superbug Diagnostic Test

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MRSA bacteria, artwork

A newly approved diagnostic test can rapidly identify whether a patient’s Staphylococcus aureus infection is resistant to commonly prescribed antibiotics.

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That’s important because antibiotic-resistant strains of Staph — known as methicillin-resistant Staphylococcus aureus, or MRSA — can cause pneumonia or infections of the skin, blood and joints if left untreated. And the longer doctors take to diagnose MRSA, the greater the chances of life-threatening illness and contagion among patients.

Last week, the Food and Drug Administration (FDA) announced the approval of the KeyPath MRSA/MSSA Blood Culture Test, the first test to rapidly distinguish between MRSA and methicillin-susceptible Staphylococcus aureus, or MSSA, the strains that are treatable with antibiotics. The KeyPath test was able to diagnose and distinguish the two types of infections in just five hours; it identified MRSA with 98.9% accuracy and pinpointed MSSA 99.4% of the time.

(More on “Can We Protect Ourselves from the ‘Superbug’ MRSA?”)

The FDA approved the test after reviewing four clinical trials involving 1,116 blood samples from patients at major hospitals. MRSA infections have been on the rise for years, and have moved from the hospital setting into the community, appearing in professional sports locker rooms, school gyms and even airplane tray tables. The infection kills 19,000 Americans each year.

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