10 individually packed test cassettes for detection of Clostridium difficile glutamate dehydrogenase (C. difficile GDH) antigens in human faecal specimens
Package contents:
10 Test cassettes
10 specimen collection tubes with buffer
1 package insert
Exclusively for professional users
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The NADAL® C. difficile GDH Ag Test is a rapid chromatographic immunoassay for the qualitative detection of Clostridium difficile glutamate dehydrogenase (C. difficile GDH) antigens in human faecal specimens. The test is intended for use as an aid in the diagnosis of Clostridium difficile infection and is designed for professional use only.
Clostridium difficile (C. difficile) is an anaerobic gram-positive, spore-forming bacterium. The ability of C. difficile to form spores is the key feature which enables this bacterium to persist in patients and the physical environment for long periods and thereby facilitates its transmission. C. difficile is transmitted by the fecal-oral route. C. difficile is the principal pathogen related to antibiotic associated diarrhea and/or pseudomembranous colitis in hospitalised patients. Mature colonic bacterial flora in a healthy adult is generally resistant to C. difficile colonisation. However, if the normal enteric flora is altered, resistance to colonisation is lost. Any factor associated with alteration of the normal enteric flora increases the risk of C. difficile colonisation after exposure to antibiotics, especially those with broad-spectrum activity such as penicillins, cephalosporins and clindamycin. C. difficile can release two high-molecular-weight toxins: toxins A and B, which are responsible for the clinical manifestations ranging from mild, self-limited watery diarrhea to fulminant pseudomembranous colitis, toxic megacolon and death. Clostridium difficile glutamate dehydrogenase (C. difficile GDH) is an enzyme produced in large quantities by all toxigenic and non-toxigenic strains, making it an excellent biomarker.
