Intended use:
For in vitro diagnostic use. The RIDA®UNITY C. difficile test, which can be performed
automatically or manually, is a multiplex real-time PCR for the direct qualitative
detection of
– Clostridioides difficile DNA
– Clostridioides difficile toxin A/B DNA
in untreated human stool samples from persons with signs and symptoms of acute
gastroenteritis.
The RIDA®UNITY C. difficile test is intended to support the differential diagnosis of
Clostridioides difficile infections in patients with symptoms of gastroenteritis in
connection with other clinical and laboratory findings.
Negative results do not rule out infection with Clostridioides difficile and should not be
used as the sole basis for diagnosis. The product is intended for professional use.
General information:
Clostridioides difficile (formerly Clostridium difficile) is a pathogen associated with
both nosocomial and community-associated diarrhea. It is a Gram-positive,
spore-forming bacillus whose colonization leads to the release of toxin A
(enterotoxin) and toxin B (cytotoxin). The bacterium can be transmitted via the
fecal-oral route or from the environment. The clinical findings of C. difficile
infections range from asymptomatic colonization to pseudomembranous colitis that
causes fever, abdominal pain, and bloody diarrhea. Around 5 % of adults and 15 %
to 70 % of infants are colonized with C. difficile, and the prevalence of colonization in
hospital patients or nursing home residents is much higher. Important, patient-related
risk factors for C. difficile infections are exposure to antibiotics, advanced age, and
hospitalizations. Infections with C. difficile in hospitalized pediatric patients
increased worldwide in recent years.
Accessories:
| Art. No. | UN0835 |
|---|---|
| Test format | real-time PCR with 96 reactions |
Dear customers,
we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2023, you can find our documents on the eIFU portal eifu.r-biopharm.com/clinic.
