Pay with Crypto and get 10% off your order!
Aid in the diagnosis of antibiotic-associated diarrheal disease and pseudomembranous colitis. Toxigenic C difficile is a major cause of antibiotic-associated diarrhea and colitis and is the causative agent for virtually all cases of pseudomembranous colitis. Although about 2% of normal healthy adults are colonized with C difficile, many patients acquire this organism through nosocomial infection. Exposure to most antibiotics is thought to allow proliferation of toxigenic C difficile by disrupting the normal intestinal flora. Two large toxin proteins, toxin A and toxin B, encoded by two separate genes, named tcdA and tcdB, are believed to be the primary virulence factors of C difficile. Together, with three additional genes, they form a 19.6-kb pathogenicity locus called PaLoc, which is found in all known toxigenic strains of C difficile.
• This test does not distinguish between viable and nonviable organisms.
• Test results are to be used in conjunction with information available from the patient's clinical evaluation and other diagnostic procedures.
• This test is for use with unformed (ie, soft, loose) stool samples only.
• This test detects/presumptively differentiates the BI/NAP1/027 strain from other toxigenic strains of C difficile. Detection of BI/NAP1/027 strains of C difficile is presumptive and is solely for epidemiological purposes and is not intended to guide or monitor treatment for C difficile infections.
• The detection of bacterial nucleic acid is dependent on proper specimen collection and handling (including transportation and storage).
• Performance characteristics have not been established for patients less than two years of age.
During the last several years, increased rates of C difficile infection have been reported, noting more severe disease and an associated increase in mortality. C difficile infection remains a disease mostly associated with health care (at least 80%), with the elderly remaining at greatest risk. More disease has been reported in traditionally "low-risk" individuals, such as healthy persons in the community and peripartum women. Severe disease outbreaks of C difficile infection in health care facilities have been attributed to the emergence of a hypervirulent epidemic strain, known by its names—assigned by various typing schemes—as restriction enzyme analysis type BI, North American Pulsed Field type 1 (NAP1), or PCR ribotype 027. BI/NAP1/027 has spread widely, and it appears more virulent due to its increased production of toxins A and B and its production of an additional toxin known as binary toxin. This strain is also believed to produce more spores, leading to enhanced persistence in the environment.
