SILVER SPRING, Md., April 8, 2011 /PRNewswire-USNewswire/ — The
U.S. Food and Drug Administration today cleared a test called the
Cepheid Xpert C. difficile/Epi assay that is designed to
rapidly detect the toxin B gene associated with Clostridium
difficile infection (CDI), a cause of diarrhea that can lead to
colitis, other serious intestinal conditions and death in severe
cases.
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Clostridium difficile (C. difficile) bacteria are
found in the stool of an infected person. Others can become
infected if they 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 and also
detects 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.
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 out
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