Great Basin Toxigenic C. difficile Test

Sample-to-result molecular test for the detection of Clostridium difficile


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

  • Easy-to-use sample-to-result solution delivers more diagnostic data per sample than low-plex technologies
  • On-demand testing; no batching of tests that delay results
  • Accurate and timely detection
  • High Sensitivity
  • Fast turnaround time (~90 mins)
  • Saves time over culture with fewer steps than other molecular methods

Increasing Laboratory Effectiveness

  • Sample-to-result with less than <2 mins hands-on-time per sample
  • Efficiency benefits to hospitals and potentially shorter stays for patients
  • Small instrument footprint



Analytical Sensitivity (95% CI)

39 CFU/mL

Analytical Reactivity

Able to detect 100% of all strains and toxinotypes

Analytical Specificity No cross-reactivity with medically relevant bacteria, viruses and fungus
Clinical Sensitivity


Clinical Specificity


Reproducibility ≥98%
Sample Type(s) Liquid or soft stool


ProductPack SizeItem Number
Great Basin Toxigenic C. difficile Test 300784