DiaSorin Molecular Simplexa® C-difficile kit

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.

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

Simplexa® 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

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

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assay protocols and more.

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