FDA Clears Test for C. Difficile Infection

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Yesterday, the U.S. Food and Drug Administration (FDA) cleared Cepheid Xpert C. difficile/Epi assay for use in rapid detection of the toxin B gene associated with Clostridium difficile infection (CDI).

Clostridium difficile is often called C. difficile or C. diff. Infection from C. diff (CDI) may develop due to the prolonged use of antibiotics during healthcare treatment. Symptoms of CDI range from diarrhea to life-threatening inflammation of the colon (colitis).

Clostridium difficile (C. difficile) bacteria are found in the stool of an infected person. The infection can be spread when others (family, care givers, etc) touch items or surfaces contaminated with the bacteria or spores and then touch their mouth.

The Cepheid Xpert C. difficile/Epi assay is automated and works on the Cepheid GeneXpert Dx System to detect toxin gene sequences associated with toxigenic C. difficile. The Cepheid GeneXpert Dx System consists of an instrument that houses single-use disposable cartridges, a personal computer, and software that allow a laboratory technician to run tests and view test results quickly.

The test, Cepheid Xpert C. difficile/Epi assay, determines if C. difficile is in a patient’s stool. It can also detect if the C. difficile is the epidemic 027/NAP1/BI strain, which has been associated with a marked increase in the severity and incidence of CDI in North America and Europe over the past decade.

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The test is intended for use as an aid in the diagnosis of CDI. The detection of the 027/NAP1/B1 strain is for epidemiological purposes only and should not be used to determine or monitor treatment. Health care facilities should monitor the number of C. difficile infections and, especially if rates at the facility increase, the severity of disease and patient outcomes.

“Health care professionals in the infectious disease community who have seen various outbreaks of CDI associated with aggressive strains in recent years now have a new testing tool to detect this disease,” 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.

People at risk of developing the bacterial infection include the elderly, patients in hospitals or living in a nursing home, and people taking antibiotics for another infection. The most effective way to prevent CDI is thorough hand-washing with soap and warm water.

In recent years, C. difficile infections have become more frequent, more severe and more difficult to treat. Each year, tens of thousands of people in the United States get sick from C. difficile, including some otherwise healthy people who aren't hospitalized or taking antibiotics.

In about 20% of patients, Clostridium difficile infection will resolve within 2-3 days of discontinuing the antibiotic to which the patient was previously exposed. The infection can usually be treated with an appropriate course (about 10 days) of antibiotics including metronidazole or vancomycin (administered orally). After treatment, repeat Clostridium difficile testing is not recommended if the patients’ symptoms have resolved, as patients may remain colonized.

The Cepheid Xpert C. difficile/Epi test is made by Cepheid of Sunnyvale, Calif.

Sources
Food and Drug Administration
CDC: Prevent Clostridium difficile Infection

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