The European Centre for Disease Prevention and Control (ECDC) reports that the burden of healthcare-associated C. difficile infection (CDIs) in acute care hospitals in the EU/EEA was estimated at 123.997 cases annually1. In the ECDC point prevalence survey of healthcare-associated infections (HAIs) and antimicrobial use in European acute care hospitals 2011-2012, C. difficile was the 8th most frequently detected microorganism among HAIs. Using a conservative figure of 3% attributable mortality, the number of deaths occurring as the direct consequence of healthcare-associated CDI can be estimated at 3.700 per year in the EU/EEA.
1. ECDC SURVEILLANCE REPORT Point prevalence survey of healthcare associated infections and antimicrobial use in European acute care hospitals 2011–2012
Why to choose it
A CLIA moderate complexity assay with greater than 4.4X fewer invalid rates that fits into any testing algorithm. The assay allows you to improve your efficiency with a true sample-to-answer workflow without DNA extraction and provides results in about an hour.
Reduce result delays and costly repeat testing with ease of use and a low invalid rate
SimplexaTM C. difficile Direct has shown greater than 4.4X fewer invalids than other commercial NAATs.
Clinical Study Invalid Rates
The Simplexa™ C. difficile Direct assay delivers diagnostic confidence
In a thorough study of over 2,300 prospective samples, our Simplexa™ C. difficile Direct assay demonstrated excellent clinical agreement against three US on-market assays.
Simplexa® C. difficile Direct Clinical Agreement Summary
|Method||N||Positive % agreement||Negative % agreement|
|Method NAAT 1||N829||Positive % agreement93.4%||Negative % agreement96.6%|
|Method NAAT 2||N776||Positive % agreement93.9%||Negative % agreement94.0%|
|Method NAAT 3||N721||Positive % agreement84.8%||Negative % agreement99.2%|
|MethodDirect Culture||N2330||Positive % agreement95.7%||Negative % agreement92.1%|
SimplexaTM C. difficile Direct Assay
* Direct Amplification Discs included in kit
|Code MOL2950||Reactions 24|
SimplexaTM C. difficile Direct Positive Control Pack
|Code MOL2960||Reactions 10|
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