C. Difficile GDH Rapid Test

Intended Use

C. difficile GDH Rapid Test (Feces) is a rapid chromatographic immunoassay for the qualitative detection of Clostridium difficileglutamate dehydrogenase (GDH) antigenin human feces. It is intended to be used as a screening marker for the presence of C. difficile. Confirmed by further tests such as toxin assays or molecular tests that detect the presence of toxin A or toxin B, an accurate, rapid diagnosis of C. difficile infections can be obtained. 

Principle

C. difficile GDH Rapid Test detects C. difficile GDH antigens through visual interpretation of color development. Anti-GDH antibody is immobilized on the test region of the nitrocellulose membrane. A fecal sample is added to the sample diluent buffer which is optimized to extract the GDH antigens from specimen. During testing, the exposed antigens, if present, will bind to anti-GDH antibody conjugated to colored particles on the sample pad. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by anti-GDH antibody at the detection zone of the strip. Excess colored particles are captured at the internal control zone. 

The presence of a colored band in the test region indicates a positive result for the particular GDH antigens, while its absence indicates a negative result. A colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking is working.

Test Procedure

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