VIASURE Clostridium difficile toxB Real Time PCR Detection Kit is designed for specific identification of Clostridium difficile Toxin B in human stool samples from patients with signs and  symptoms of gastrointestinal infection.

This test is intended for use as an aid in the diagnosis of Clostridium difficile infection in humans in combination with clinical and epidemiological risk factors.

DNA is extracted from stool specimens, multiplied using Real Time amplification and detected using specific primers and a fluorescent reporter dye probe for Toxin B.

Clostridium difficile is a gram-Positive, sporogenic, anaerobic bacillus that belongs to the Clostridiaceae family. Initially, C. difficile was described as a member of the commensal microbiota of neonates. However, later it was identified as a causal agent of antibiotic-associated diarrhea (AAD) and its infection is associated with high morbidity and mortality in the elderly.

The major risk factors for C. difficile infection are broad spectrum antibiotics exposure, hospitalization, and advanced age. The severity of its infection ranges from mild diarrhea and pseudomembranous colitis to toxic megacolon, perforations of the colon and occasionally, sepsis and even death. The main routes of transmission are the fecal-oral or aerosols. In fact, infected persons with acute diarrhea can lead to heavy contamination of the environment with spores, which can persist in dust or on surfaces for months and be transmitted to other hospitalized patients or to healthcare workers once again.

Toxigenic strains of C. difficile can colonize the gut, replicate and produce enterotoxin A and cytotoxin B, encoded by tcdA and tcdB genes which are included in a 19,6 kb pathogenicity locus. Toxins A and B share significant sequence homology and have similar domains, except the carboxyl terminal that differs significantly between the two toxins and it is the receptor binding portion. Toxin B appears to be more clinically relevant for C. difficile virulence than toxin A and it is invariably associated with clinically isolated pathogenic strains.

A Real-Time PCR based diagnosis has been described as a sensitive test for identification of Clostridium difficile toxin B.