Toxigenic C. diff causes 15-25% of antibiotic-associated diarrhea. Toxigenic C. diff intestinal colonization can cause Clostridium difficile infection (CDI) when antibiotic use disrupts normal intestinal flora. According to the Association for Professionals in Infection Control and Epidemiology, the prevalence and mortality rate of CDI has risen markedly since 2003. Early recognition of CDI with accurate and timely diagnosis is essential to aid vital patient management decisions.
The Great Basin Toxigenic C. difficile test is a qualitative in vitro diagnostic test, that detects toxigenic Clostridium difficile in human stool samples collected from patients suspected of having CDI. This test targets C. difficile Toxin B gene (tcdB) and is intended as an aid in the diagnosis of CDI.
This in vitro diagnostic test is configured for use on Great Basin Analyser with toxigenic Great Basin C. difficile Assay Test Cartridge Kit.
The test is intended for clinical laboratories, hospital laboratories and reference laboratories. The toxigenic C. difficile Assay is not intended for point-of-care use.
Faster Clinical Decision Making and Improved Patient Outcomes
Increasing Laboratory Effectiveness
|Analytical Sensitivity (95% CI)||
Able to detect 100% of all strains and toxinotypes
|Analytical Specificity||No cross-reactivity with medically relevant bacteria, viruses and fungus|
|Sample Type(s)||Liquid or soft stool|
|Product||Pack Size||Item Number|
|Great Basin Toxigenic C. difficile Test||300784|