Rapid test for MRSA cleared by FDA

Kathleen Blanchard's picture
MRSA test, FDA

The FDA has cleared a rapid test for detecting MRSA that is also in line with recommendations from infectious disease specialists.

The test, approved today, can quickly detect infection from methicillin resistant (MRSA) or methicillin susceptible (MSSA) staphylococcus aureus.

Staphylococcus infections are easily treated with penicillin (methicillin) derivatives, but without the ability to detect resistant strains early, the chance of poor health outcomes and spread of drug resistant bacteria increase.

According to the FDA press release, the test can be performed in any lab without special equipment. Results are available in 5 hours, as soon as any MRSA shows up in a patient's blood culture.

Rapid MRSA culture 98.9 percent accurate

The FDA approval follows a study that included 1,116 blood samples evaluated at four major U.S. hospital centers. Detection of MRSA was 98.9 percent accurate. MSSA identification was correct in 99.4 percent of the blood samples.


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

According to 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, “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.”

The rapid MRSA blood culture follows concerns and a release from the Infectious Diseases Society of America (IDSA) last month. The group suggested the need for supporting development of rapid testing to identify infections at point of patient care.

The KeyPath MRSA/MSSA Blood Culture Test only requires blood culture equipment and will allow for rapid identification of MRSA, early implementation of precautionary measures in hospitals where infections are most severe and targeted treatment that can be initiated sooner than conventional blood cultures that take 48 to 72 hours.

Source: FDA.gov
Image credit: Morguefile