C. Difficile Toxin A and B Rapid Test

Intended Use

C. difficile Toxin A and B Rapid Test is a rapid chromatographic immunoassay for the simultaneous qualitative detection of Clostridium difficile Toxin A and Toxin B in human feces.

C. difficile Toxin A and B Rapid Test is intended to aid in the diagnosis and differentiation of C. difficle toxin A and toxin B infections.

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.

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. The C. difficile Toxin A/B Rapid Test Device is a lateral flow immunoassay using highly sensitive monoclonal antibodies that are specific for C. difficile toxin A and toxin B antigens. The test provides a simple, fast and separate detection of toxin A and toxin B in a single test.

Test Procedure

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