Clostridium Difficile GDH+ToxinA+ToxinB Antigen Rapid Test Kit

PRODUCT NAME

Clostridium Difficile GDH+ToxinA+ToxinB Antigen Rapid Test Kit (Colloidal Gold) SPECIFICATION 25 tests/kit, 5 tests/kit, 1 test/kit

INTENDED USE

The Clostridium Difficile GDH+ToxinA+ToxinB Antigen Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of Clostridium Difficile GDH,ToxinA and Toxin B in human Fecal Specimen. It is suitable for the auxiliary diagnosis of Clostridium Difficile infection.

INTRODUCTION

Clostridium Difficile(C.difficile), a Gram-positive spore bearing anaerobic bacterium is the major aetiological agent of diarrhoea and colitis associated with antibiotics.C.difficile is the most common cause of health care-associated diarrhoea in developed coutries and is a major source of nosocomial morbidity and mortality worldwide. Diease 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 toxigenic culture(TC) is used as the gold standard technique to determine Clostridium difficile infection.This method consists in culture and isolation of C.difficile from faeces,followed by toxin testing of the isolate,a labour-intensive assay to obtain a result.