For in vitro diagnostic use. RIDA®GENE CD Toxin A/B is a real-time PCR for the direct, qualitative detection of Clostridium difficile toxin A (tcdA) and toxin B (tcdB) genes from human stool samples and culture.
The RIDA®GENE CD Toxin A/B real-time PCR is intended for use as an aid in diagnosis of Clostridium difficile associated diarrhea (CDAD).
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, Clostridium difficile was identified as the cause of antibiotica-associated diarrhea and pseudomembranous colitis. Today Clostridium difficile is one of the most common causes of nosocomial diarrhea.
Clostridium 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, Clostridium 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 Clostridium difficile strains that produce toxin A and toxin B. In recent years the incidence and severity of Clostridium difficile infections increased worldwide.
Real-time PCR permits a rapid, highly sensitive and specific detection of Clostridium difficile infection. An early and reliable diagnosis of Clostridium difficile infection makes it possible to administer specific treatment of CDAD patients and also to initiate hygiene measures to prevent nosocomial transmission.
|Test format||real-time PCR with 100 reactions|
|Shelf life||24 months after production|
|Sensitivity||≥ 10 DNA copies per reaction|
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.