FDA OK's Test to Spot Drug-Resistant Staph
FRIDAY, May 6 -- The first Staphylococcus aureus diagnostic that can quickly identify the staph bacterium and whether it's resistant to methicillin and similar antibiotics has been approved by the U.S. Food and Drug Administration.
Staphylococci bacteria can cause a number of maladies, including pneumonia, blood poisoning and certain skin infections. Some of the infections may respond to antibiotics such as methicillin and are called methicillin susceptible (MSSA), while other strains are known as methicillin resistant (MRSA).
The KeyPath MRSA/MSSA Blood Culture Test is able to distinguish between the two types of infection within about five hours, the FDA said in a news release.
MRSA infections, while they can develop anywhere, often appear in hospital and other health care settings, where many patients have weakened immune systems.
The new diagnostic was evaluated in clinical studies involving 1,116 people at four major U.S. hospital centers. The test was 98.9 percent accurate in identifying MRSA, and 99.4 percent accurate in identifying MSSA, the FDA said.
The test is produced by MicroPhage Inc., based in Longmont, Colo.
To learn more about MRSA infections, visit the U.S. Centers for Disease Control and Prevention.
Posted: May 2011