C. difficile
For Investigational Use Only. Performance characteristics of this product have not been established.
| Verigene® C. difficile Test | |||
|---|---|---|---|
| Targets | tcdA gene | ||
| tcdB gene | |||
| BI/NAP1/027 hypervirulent strain differentiation | |||
| Automation | Sample-to-Result | ||
| Instrumentation | Verigene Reader and Processor SP | ||
| Workflow | Random Access | ||
| Sample Type | Stool | ||
| Pipetting Steps | 1 | ||
| Hands-On Time | <5 minutes | ||
| Run Time | <2 hours | ||
Background
Clostridium difficile is a major nosocomial pathogen causing a range of symptoms from mild to severe diarrhea and is the etiological agent of pseudomembranous colitis. The incidence of C. difficile infection has increased markedly in recent years, notably associated with the epidemic spread of the BI/NAP1/027 hypervirulent strain. Accurate diagnosis of C. difficile is essential to ensure patients receive appropriate treatment and that correct infection control measures are put in place.
Nanosphere’s automated Verigene System is uniquely suited to deliver an easy-to-use, multiplexed, cost-effective solution for molecular C. difficile testing. The Verigene C. difficile Test requires less than 5 minutes of user hands-on time to run, and delivers comprehensive results directly from a stool sample in less than two hours.
Workflow
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STEP 1
Load Test Cartridge, test consumables, and sample into Processor SP
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STEP 2
Automated sample preparation and test processing on Processor SP
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STEP 3
Place slide from Test Cartridge in Verigene Reader for results
