Last Friday, the FDA cleared a diagnostic test that will be able to quickly determine staph infections and their resistance to antibiotics. Staphylococci bacteria are common in infections, but many are methicillin resistant (MRSA) or methicillin susceptible (MSSA) and required altered treatment protocols. Being able to rapidly diagnose and correctly treat the infection, can save life and limb.
Cases of MRSA, a drug-resistant bacterial infection, were once thought to exist primarily in hospitals settings, but such is not the case. MRSA has been found to originate outside hospitals, and are different strains of the infection than those originating inside hospitals. Since 1999, the number of cases of the bacterial infection have grown by 90 percent.
Approximately 20,000 people in the United States die annually from MRSA. Some symptoms such as abscesses may be easily detectable, but there are difficult to detect symptoms, such as blood infections, that can kill very rapidly. Treatment for MRSA can be very costly, ranging from $3,000 to $35,000 per individual case.
The test, called the KeyPath MRSA/MSSA Blood Culture Test, is produced by MicroPhage Inc. and can determine whether bacteria in a patient’s positive blood culture sample are MRSA or MSSA within about five hours and does so with a 98.9 percent accuracy rate. The MicroPhage test, done through nasal screening, is expected to have significant cost and performance advantages over molecular tests like polymerase chain reaction (PCR) and other methodologies.
“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,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health.
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