【分享】美国FDA批准首个鉴定超级细菌的快速诊断试剂

               

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FDA NEWS RELEASE

For Immediate Release: May 6, 2011
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA clears first test to quickly diagnose and distinguish MRSA and MSSA

TheU.S. Food and Drug Administration today cleared the first test forStaphylococcus aureus (S.aureus) infections that is able to quicklyidentify whether the bacteria are methicillin resistant (MRSA) ormethicillin susceptible (MSSA).

There are many different types ofStaphylococci bacteria, which cause skin infections, pneumonia, foodand blood infections (blood poisoning). While some S.aureus infectionsare treated easily with antibiotics, others are resistant (MRSA) tocommonly prescribed antibiotics such as penicillin and amoxicillin.

TheKeyPath MRSA/MSSA Blood Culture Test determines whether bacteriagrowing in a patient’s positive blood culture sample are MRSA or MSSAwithin about five hours after any bacterial growth is first detected inthe sample. Aside from blood culture equipment, the test does notrequire any specific instruments to get results, which makes it usefulin any laboratory.

“Clearing this test gives health careprofessionals a test that can confirm S.aureus and then identifywhether the bacteria is MRSA or MSSA,” said Alberto Gutierrez, Ph.D.,director of the Office of In Vitro Diagnostics Device Evaluation andSafety in the FDA’s Center for Devices and Radiological Health. “Thisnot only saves time in diagnosing potentially life-threateninginfections but also allows health care professionals to optimizetreatment and start appropriate contact precautions to prevent thespread of the organism.”

MRSA infections can occur anywhere;however, infections appearing in health care settings are usually moresevere and potentially life-threatening given patients being treated inthose facilities may have weakened immune systems and frequentlyundergo procedures such as surgery, which allows an easier spread ofbacteria directly into the body.

The FDA based its clearance on aclinical study of 1,116 blood samples evaluated at four major U.S.hospital centers. Within the organisms determined to be S.aureus, theMRSA determination was 98.9% accurate (178/180) and the MSSAdetermination was 99.4% accurate (153/154).

The KeyPath MRSA/MSSA Blood Culture Test is manufactured by MicroPhage Inc. of Longmont, Colo.