Simplexa® C. difficile Direct Kit
In vitro qualitative assays for the direct detection of C. difficile
The Direct Kit allows up to 8 samples per run in a moderate complexity format.
Disease state
According to the CDC, Clostridium difficile is now the most common microbial healthcare associated infection (HAI), with annual healthcare costs exceeding $4.8 billion. Approximately 15,000 deaths are attributable to C. difficile infection each year in the USA.
C. difficile is a common but expensive to treat infection
The Value of Simplexa® C. difficile Direct Kit
Empower clinicians to quickly treat and isolate patients
Reduce result delays
Simplexa® C. difficile Direct has shown greater than 4.4X fewer invalids than other commercial NAATs.
Delivers diagnostic confidence
97.1% predictive value of the assay based on a study of over 2300 samples, demonstrating excellent clinical agreement against three on-market assays.
How the Simplexa® C. difficile Direct Kit works
Simplexa® C. difficile Direct is an in-vitro qualitative real-time PCR assay with a simple workflow, enabling unextracted primary sample and ready-to-use PCR reagent loading on a re-usable Direct Amplification Disc on the compact LIAISON® MDX system designed for operational simplicity, flexibility, and quality assurance for utility across any clinical lab.
Sample-to-answer
Consumables arrive at the laboratory ready to use with no further reagent preparation.
One target, two consumables
Select the kit that fits your workflow needs. The 8-well, moderate complexity Direct Kit allows for smaller runs on a reusable disc.
To be used on the LIAISON® MDX Instrument
The LIAISON® MDX is an innovative and powerful real-time PCR instrument with two consumable disc options: the 8-well Direct Amplification Disc and the 96-well Universal Disc for higher volume testing.
Supported by an expanding menu of molecular assays, the system provides easy-to-understand results with the ability to check amplification curves after a run. All of this in a compact footprint measuring only 12″ by 8″ by 12″ so that it can fit into laboratories of any size.
Simplexa® C. difficile Direct Kit ordering info
Part Name |
Kit Size |
Registration Status |
Part Number |
---|---|---|---|
Simplexa® C. difficile Direct Kit |
24 |
IVD | MOL2950 |
Simplexa® C. difficile Direct Positive Control Pack |
10 |
IVD | MOL2960 |