Intended use:
For in vitro diagnostic use. RIDA®GENE Clostridium difficile is a multiplex real-time PCR for the direct, qualitative detection of Clostridium difficile (16s-rDNA) and Clostridium difficile toxin A (tcdA) / B (tcdB) genes from human stool samples and cultures.
The RIDA®GENE Clostridium difficile multiplex real-time PCR can be used as an aid in diagnosis of Clostridium difficile associated diarrhea (CDAD).
General information:
Clostridioides difficile (before Clostridium difficile), a gram-positive, spore-forming anaerobic bacterium was first described in 1935 by Hall and O’Toole as a component of the intestinal microflora in healthy neonates. In the late 1970s, however, Clostridioides difficile was identified as the cause of antibiotica-associated diarrhea and pseudomembranous colitis. Today Clostridioides difficile is one of the most common causes of nosocomial diarrhea.
Clostridioides difficile is responsible for 15 – 25 % of antibiotica-associated diarrhea and nearly all cases of pseudomembranous colitis. The predisposing risk factors for CDAD are for example antibiotica exposure, advanced age as well as number and duration of hospitalization. However, Clostridioides difficile infection is also seen in an increasing number of non-antibiotic-treated and non-hospitalized individuals.
The symptoms range from mild diarrhea to intestinal infections of variable severity, including pseudomembranous colitis, the most severe form of antibiotic-induced inflammatory bowel disease. Clinically symptomatic cases are caused by toxigenic Clostridioides difficile strains that produce toxin A and toxin B. In recent years the incidence and severity of Clostridioides difficile infections increased worldwide.
Real-time PCR permits a rapid, highly sensitive and specific detection of Clostridioides difficile infection. An early and reliable diagnosis of Clostridioides difficile infection makes it possible to administer specific treatment of CDAD patients and also to initiate hygiene measures to prevent nosocomial transmission.
Advantages
- Reliable detection of Clostridioides difficile plus additional differentiation between toxigenic and non-toxigenic strains
- Ready-to use reagents
- Harmonized Workflow and PCR profile allows parallel processing of multiple RIDA®GENE assays (DNA and RNA assays)
- PCR results in less than 1.5 hours
- All necessary controls included (Internal Control, Positive Control and No Template Control)
- Simplified sample analysis through RIDA®SEEK Software
Accessories:
| Art. No. | PG0835 |
|---|---|
| Test format | 100 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.
