Description
Clostridium difficile Toxin/GDH with Reflex to PCR - After treatment with antibiotics, many patients develop gastrointestinal problems ranging from mild diarrhea to severe pseudomembranous colitis. This organism is an opportunistic anaerobic bacterium that grows in the intestine once the normal flora has been altered by the antibiotic. For diagnosis of toxigenic C. difficile, current practice guidelines from the CDC recommend confirmation by Nucleic Acid Amplification Testing (NAAT) if the glutamate dehydrogenase of C. difficile (GDH) Antigen is positive, and toxin is not detected by Enzyme immunoassay. Additionally, if toxin is detected without the presence of GDH antigen, confirmation by NAAT is also recommended.
C difficile is an opportunistic, toxin-producing bacterial pathogen of the gastrointestinal tract that is the most common cause of healthcare-associated diarrhea. It causes 25% to 30% of antibiotic-associated diarrhea and 95% of pseudomembranous colitis cases.Disease-causing C difficile strains produce 1 or both of 2 toxins: toxin A is an enterotoxin and toxin B is a cytotoxin. Other strains produce neither toxin and are thought to be avirulent.
This new test is a rapid, membrane enzyme immunoassay that simultaneously detects C difficile glutamate dehydrogenase (GDH) antigen and toxins A and B in a single reaction well. It is a manual cartridge-based test that requires no instrumentation. GDH antigen is a metabolic enzyme expressed at high levels by all strains of C difficile and some other Clostridium species.
