ARIES® C. difficile Assay | CE Marked for IVD Use

The ARIES® C. difficile Assay offers rapid detection of toxin A and toxin B genes

ARIES® C. difficile Assay (IVD) Overview

Clostridium difficile infections (CDI) are potentially life-threatening health risks that tend to occur in people who have taken antibiotics or been admitted to hospitals.

In fact, CDI accounts for 15-25% of all antibiotic-associated diarrhea and is the most common cause of infectious diarrhea in a healthcare setting.¹ The rising prevalence of these colitis-inducing infections is cause for concern, as is the estimated $1 billion in healthcare costs they cause.²

For patients suspected of having a CDI, the ARIES® C. difficile Assay targets the C. difficile toxin A gene (tcdA) and toxin B gene (tcdB) with real-time PCR chemistry and is able to detect the presence of this bacterium from stool samples in just two hours. The assay is FDA Cleared and CE Marked for IVD use.

The ARIES® C. difficile Assay Offers:

Ease of Use—A simple, fully closed sample-to-answer system that can be easily operated with minimal risk of contamination
Fast Time to Results—Answers in just two hours with minimal hands-on time
Comprehensive Detection—Targets both toxin A and toxin B, increasing confidence in results by reducing the chance of a false negative from strains that only produce toxin A
Fully Integrated—All aspects of testing are automated, from sample extraction through analysis, to enable easy implementation across multiple shifts
Flexibility—Run both IVD and LDT assays on the same system simultaneously, when using a Universal Assay Protocol
Error-reducing Safeguards—Internal barcode scanning and bidirectional LIS connectivity helps to increase efficiency and reduce data input errors

Performance of the ARIES® C. difficile Assay

Performance of the ARIES® C. difficile Assay was evaluated at four geographically distinct sites using leftover, de-identified, unpreserved, unformed stool specimens.

ARIES® C. difficile Assay Performance Compared to Direct and Enriched Toxigenic Culture
ARIES® C. difficile Assay	Direct and Enriched Toxigenic Culture
ARIES® C. difficile Assay	Positive	Negative	Total
Positive	133	35^b	168
Negative	14^a	797	811
Total	147	832	979^c
		95% CI
Sensitivity	90.5%	84.6% – 94.2%
Specificity	95.8%	94.2% – 97.0%
a. Thirteen (13) of the ARIES® C. difficile Assay negative specimens that were positive by direct and enriched toxigenic culture (i.e., False Negative) were C. difficile negative by bidirectional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® C. difficile Assay. b. Fifteen (15) of the ARIES® C. difficile Assay positive specimens that were negative by enriched toxigenic culture (i.e., False Positive) were positive by bidirectional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® C. difficile Assay. c. Five (5) specimens generated invalid results by the ARIES® C. difficile Assay after allowable re-run. Four (4) of these were negative and one (1) was positive by direct and enriched toxigenic culture. All 5 of these specimens were excluded from the device performance calculations.

Please see the Package Insert for more detailed information.

Workflow

The operator prepares the sample, adds it to the cassette, puts the cassette in the magazine, loads the magazine into the ARIES® System, and the run will start automatically.

Step 1

Prepare the sample using the provided stool resuspension kit

Step 2

Load the sample into the cassette

Step 3

Insert up to six cassettes into the magazine

Step 4

Insert the magazines into the instrument

Step 5

Review & release results

The ARIES® C. difficile Assay offers rapid detection of toxin A and toxin B genes ARIES® C. difficile Assay (IVD) Overview Clostridium difficile infections (CDI) are potentially life-threatening health risks that tend to occur in people who have taken antibiotics or been admitted to hospitals. In fa

References:

Schroeder LF, Robilotti E, Peterson LR, et. al. Economic evaluation of laboratory testing strategies for hospital-associated Clostridium difficile infection. J Clin Microbiol 2014 Feb;52(2):489-96.
Antibiotic Resistance Threats in the United States, 2013. CDC (Internet). Cited 2017 March. Available from: https://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf.

Intended Use

The ARIES® C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of toxigenic Clostridium difficile (C. difficile) nucleic acid in unpreserved, unformed (liquid or soft) stool specimens obtained from patients suspected of having Clostridium difficile infection (CDI).

The test targets the C. difficile toxin A gene (tcdA) and toxin B gene (tcdB) and is indicated for use as an aid in the diagnosis of C. difficile infection (CDI).

The ARIES® C. difficile Assay is indicated for use with ARIES® Systems.

Validation of the LIS compatibility must be performed by the end user.

ARIES® C. difficile Assay (RUO) Overview

The ARIES® C. difficile Assay is a rapid method for the detection of toxigenic C. difficile (including 027/BI/NAP1) in research labs.

Detects both toxin A and toxin B
Rapid results in less than 2 hours
Simplified workflow for minimal hands-on time
Integrated internal control for maximum confidence in results
Automated data analysis and bidirectional connectivity to streamline reporting

Workflow

The operator prepares the sample, adds it to the cassette, puts the cassette in the magazine, loads the magazine into the ARIES® System, and the run will start automatically.