Simplexa® C. difficile Direct Kit
An essential component of Clostridium difficile infection testing
KIT for Infectious Diseases Overview
Background
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.
For use on
Benefits
Invalid
Rates
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
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 Simplexa® C. difficile Direct Assay
* Direct Amplification Discs included in kit |
Code MOL2950 | Reactions 24 |
| Product Simplexa® C. difficile Direct Positive Control Pack |
Code MOL2960 | Reactions 10 x 100 μL |
Our repository
All the answers you need.
Access our database to find:
instructions for use, safety data sheets,
assay protocols and more.