According to the CDC, Clostridium difficile is now the most common microbial healthcare associated infection with annual health care cost exceeding $4.8 billion.
Approximately 15,000 deaths are attributable to C. difficile infection each year in the U.S.A.
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
Simplexa® 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%|
Simplexa® C. difficile Direct Assay
* Direct Amplification Discs included in kit
|Code MOL2950||Reactions 24|
Simplexa® C. difficile Direct Positive Control Pack
|Code MOL2960||Reactions 10|