DiaSorin Molecular Simplexa® C-difficile kit

SimplexaTM 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.

Benefits

DiaSorin Molecular Simplexa® C-difficile kit
Low
Invalid
Rates

Reduce result delays and costly repeat testing with ease of use and a low invalid rate

4.4X FEWER INVALIDS

SimplexaTM C. difficile Direct has shown greater than 4.4X fewer invalids than other commercial NAATs.

Clinical Study Invalid Rates

Highly
Specific

The Simplexa™ C. difficile Direct assay delivers diagnostic confidence

97.1% PREDICTIVE VALUE

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 x 100 μL

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