C. Difficile Toxin A and B and GDH Combo Test

C. difficile Toxin A and B and GDH Combo Test (Feces) is a rapid chromatographic immunoassay for the simultaneous qualitative detection of Clostridium difficile Toxin A,Toxin B and glutamate dehydrogenase (GDH) antigen in human feces.

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Description

Intended Use

C. difficile Toxin A and B and GDH Combo Test offers a simple and highly sensitive screening assay to make a presumptive diagnosis of Clostridium difficile infection.

Introduction

C. difficile is a gram-positive, spore-forming anaerobic bacillus. Toxigenic strains of C. difficile produce two different toxins constituting the essential virulence factors for C. difficile infection (CDI). CDI is considered responsible for approximately 25% of the diarrhea incidents related to the consumption of antibiotics, and CDI can lead to pseudomembranous colitis (PMC), requiring urgent treatment with antibiotics effective against C. difficile and which, without treatment, may severely compromise the life of patients. In the case of PMC, CDI mortality can be as high as 6% to 30%1,2.

Disease due to C. difficile develops when the organism is allowed to proliferate in the colon, most commonly after antibiotic use has eliminated competing flora. C. difficile can release two high-molecular-weight toxins, toxin A and toxin B, which are responsible for the clinical manifestations, which range from mild, self-limited watery diarrhoea to fulminant pseudomembranous colitis, toxic megacolon, and death. Clostridium difficile Glutamate Dehydrogenase (GDH) is an enzyme produced in large quantities by all toxigenic and non-toxigenic strains, making it an excellent marker for the organism. The greatest utility of GDH tests is their use as a screen to rule specimens negative and to select specimens for further testing.

Asymptomatic population may be carriers of toxigenic C. difficile, among which, some may be epidemic strains. Diagnosis and differentiation of C. difficile toxin A and toxin B play essential role with regard to both rapid treatment and disease transmission control3.

Current diagnostic methods of CDI are mostly qualitative detection of the bacteria, toxins, or toxin genes. Rapid immunoassay of CDI has become more important due to the availability of direct diagnosis and effective treatment. Rapid diagnosis of CDI can lead to reduced hospital stays and cost of hospital care.

Test Procedure