Test : Clostridium difficile Toxin Assay
Indications : Diagnose antibiotic related colitis caused by C. difficle toxin. Antibiotic associated pseudomembranous colitis is produced primarily by toxigenic C. difficile.
Physiology : Toxigenic strains usually produce two toxins: toxin A, an enterotoxin that is responsible for much of the pathology of pseudomembranous colitis; and toxin B, a cytotoxin which is detected by cell culture and whose role in clinical disease is unclear. Not all C. difficile strains are toxigenic, and even toxigenic strains may not produce disease if present in insufficient numbers.
Normal Range : Presence of toxin is suggestive of disease. Isolation of organism may occur in a small percentage of normal adults and in normal newborns. Isolation of the organisms without demonstration of toxin production is a nonspecific finding since all isolates are not toxigenic.
Sample : stool or proctoscopic specimen
Test Method : Latex agglutination