Simplexa™ C. difficile Direct Kit
An essential component of Clostridium difficile infection testing
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KIT for Infectious Diseases Overview
Background
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.
For use on
Benefits
Invalid
Rates
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
Specific
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% |
Ordering info
| Product | Code | Reactions |
|---|---|---|
| Product SimplexaTM C. difficile Direct Assay
* Direct Amplification Discs included in kit |
Code MOL2950 | Reactions 24 |
| Product SimplexaTM C. difficile Direct Positive Control Pack |
Code MOL2960 | Reactions 10 |
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Our repository
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assay protocols and more.