Intended use:

For in vitro diagnostic use. RIDA®GENE Clostridium difficile is a real-time multiplex PCR for the direct, qualitative detection of Clostridium difficile (16S-rDNA) and Clostridium difficile toxin A (tcdA) and toxin B (tcdB) genes from human stool samples and cultures. The RIDA®GENE Clostridium difficile real-time multiplex PCR can be used as an aid in diagnosis of Clostridium difficile associated diarrhea (CDAD).

General Information:

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.

Specifications
Art. No. PG0835
Test format real-time PCR with 100 reactions
Shelf life 24 months after production
Sensitivity Analytical Sensitivity : ≥ 5 DNA copies per reaction
Files
InstructionsEnglish
German
German - valid with new lot XXXXXN
English - valid with new lot XXXXXN
Spanish - valid with new lot XXXXXN
French - valid with new lot XXXXXN
Italian - valid with new lot XXXXXN
All - valid with new lot XXXXXN
SDSPG0835_german.zip (German)
PG0835_english.zip (English)
PG0835_french.zip (French)
PG0835_italian.zip (Italian)
PG0835_spanish.zip (Spanish)
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