INTRODUCTION

The Clostridium Difficile Toxin A/B Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative and simultaneous detection of Clostridium difficile toxin A and Clostridium difficile toxin B in human fecal specimens. It is intended to be used by healthcare professionals as a screening test to aid in the diagnosis of infection with C. difficile. The test only provides preliminary analysis results but not critical diagnosis criteria. Any use or interpretation of the test must be analyzed and confirmed with alternative testing method(s) and clinical findings based on professional judgment of healthcare providers.

INTENDED USE

The gram-positive anaerobic bacillus C. difficile is the leading causative agent of antibiotic-associated diarrhea and pseudomembranous colitiss1 . If C. difficile is not diagnosed on time and treated, this pathogen can cause disease resulting in severe symptoms or even death. The major risk factor for C. difficile infection is exposure to antibiotics related medicine and treatment. C. difficile infection is usually transmitted through the fecal-oral route, and it can develop rapidly if the normal gastrointestinal flora is disrupted by antibiotic therapy as well as a person acquires toxin-producing C. difficile2 . It’s reported that toxin A and toxin B are the key virulence factors for difficile infcetion.

These toxins show high sequence and functional homology. Toxin A has been described as a tissue damaging enterotoxin which attracts neutrophils and monocytes and toxin B as a potent cytotoxin that degrades the colonic epithelial cells5 . Most virulent strains produce both toxins, however, toxin A negative/toxin B positive strains can also lead to disease6, 7 . The Clostridium Difficile Toxin A/B Combo Rapid Test utilizes a double antibody sandwich assay to selectively detect C.  difficile Toxin A and C. difficile Toxin B antigens, respectively, in human fecal specimens. The test can be performed without cumbersome laboratory equipment, and the results are available at 15-20 minutes.