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Vivalytic C. difficile
– Instructions for Use
Introduction
Clostridioides difficile (C. difficile) is a gram-positive, spore-forming
anaerobic bacillus consisting of toxigenic and non-toxigenic strains.
C. difficile is one of the most common pathogens of nosocomial diarrhea,
especially in patients with antibiotic-associated diarrhea. In recent years, the
number and severity of cases has increased in Europe and worldwide.
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The symptoms of C. difficile infection (CDI) ranges from mild diarrhea to
severe life-threatening pseudomembranous colitis, although colonization
of C. difficile does not necessarily lead to a symptomatic infection. The
disruption of the balance of gut microorganisms e.g. due to antibiotically
treatment may cause toxigenic C. difficile to establish, dominate colonization
and might be the start of CDI.
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Factors involved in the pathogenesis of C. difficile, are the genes tcdA and
tcdB that code for toxin A (enterotoxin) and toxin B (cytotoxin) which are
located in a 19.6 kb chromosomal region called the pathogenicity locus
(PaLoc). Most pathogenic strains are toxin A and B positive (A+B+), but some
pathogenic variant isolates may be toxin A negative and B positive (A-B+).
They are the cause of C. difficile-associated diseases.
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Some strains of toxigenic C. difficile also produce a toxin called C. difficile
transferase (CDT), or binary toxin.
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Package Contents
15 Vivalytic C. difficile test cartridges for the qualitative detection of
Clostridioides difficile specific tcdA/tcdB toxin gene sequences.
Intended Use
The Vivalytic C. difficile test is an automated qualitative in vitro diagnostic
test based on real-time polymerase chain reaction (PCR) for the detection of
nucleic acids from toxigenic C. difficile (toxin genes tcdA/tcdB) from liquid
or soft human stool swabs to aid in the diagnosis of acute gastrointestinal
infections of symptomatic individuals.
Results should not be used as the sole basis for diagnosis, treatment,
or other patient management decisions. Positive results do not exclude
co-infection with other pathogens. The agent(s) detected may not be the
definite cause of disease. Negative results do not exclude a C. difficile
infection or another gastrointestinal infection. Results must be clinically
correlated with patient history, clinical observations, and epidemiological
information. Other diagnostic information is necessary to determine patient
infection status. Intended for use with a Vivalytic one analyser by healthcare
professionals only in laboratory settings such as hospital laboratories and
reference laboratories.
Safety Information
These Instructions for Use contain test-specific information only. For
additional warnings and instructions refer to the Instructions for Use
provided with your Vivalytic one analyser (chapter device safety information).
Only use Vivalytic cartridges and accessories approved for the Vivalytic
one analyser. Take care to avoid any contamination when handling patient
samples and cartridges. When sample was spilled on the cartridge, do not
use the cartridge, and dispose it.
For in vitro diagnostic use by trained healthcare professional.
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