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 in human stool samples. The RIDA®GENE CD Toxin A/B is intended for use as an aid in diagnosis of Clostridium difficile associated diarrhea (CDAD).
Clostridium difficile associated diarrhea (CDAD) is one of the most common causes of nosocomial infections in industrialized countries. CDAD typically occurs after antibiotic medications. The clinical spectrum of CDAD ranges from diarrhea to severe life-threatening pseudomembranous colitis. The clinical signs of toxic Clostridium difficile (C. difficile) strains are caused due to the production of the enterotoxin A and/or cytotoxin B. C. difficile are highly contagious and are transmitted through the faecal-oral route by person to person or from environmental contaminated surfaces. Outbreaks can occur in hospitals, nursing homes and other extended-care facilities. The cost of CDAD on the health care system is estimated to be €3 billion per year for the European Union and $1.1 billion per year in the United States. In the recent years the morbidity and severity of C. difficile infection has increased significantly. To prevent complications from severe CDAD and transmission, diagnosis followed by appropriate patient treatment and hygiene interventions is crucial.
|Test format||real-time PCR with 100 reactions|
|Shelf life||24 months after production|
|Sensitivity||Analytical sensitivity: ≥ 10 DNA copies per reaction|