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ARIES® C. difficile ASSAY

ARIES C. difficile Assay (IVD)

The ARIES® C. difficile Assay is an easy to use molecular assay for the direct detection of toxigenic Clostridium difficile nucleic acid in stool samples using a sample to answer platform

ARIES® C. difficile Assay 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 CE Marked for IVD use.

 

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

 

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 Culture
ARIES® C. difficile Assay Direct Toxigenic Culture
Positive Negative Total
Positive 103 65b 168
Negative 2a 809 811
Total 105 874 979c
  95% CI  
PPA 98.1% 93.3% – 99.5%
NPA 92.6% 90.6% – 94.1%
a. One of the ARIES® C. difficile Assay negative specimens that was positive by direct toxigenic culture (i.e. False Negative) was C. difficile negative by bidirectional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® C. difficile Assay.
b. Of the 65 ARIES® C. difficile Assay positive specimens that were negative by direct toxigenic culture (i.e. False Positive), 30 were positive by enriched toxigenic culture. An additional 15 specimens 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 toxigenic culture. All 5 of these specimens were excluded from the device performance calculations.

 

 

ARIES® C. difficile Assay Performance Compared to Direct and Enriched Toxigenic Culture
ARIES® C. difficile Assay Direct and Enriched Toxigenic Culture
Positive Negative Total
Positive 133 35b 168
Negative 14a 797 811
Total 147 832 979c
  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.

ARIES® C. diff IVD Assay Workflow - Step 1

Step 1

Prepare the sample using the provided stool resuspension kit

ARIES® C. diff IVD Assay Workflow - Step 2

Step 2

Load the sample into the cassette

ARIES® C. diff IVD Assay Workflow - Step 3

Step 3

Insert up to six cassettes into the magazine

ARIES® C. diff IVD Assay Workflow - Step 4

Step 4

Insert the magazines into the instrument

ARIES Workflow - Step 5

Step 5

Review & release results

Ordering Information

 

Luminex Online Order Management
Email: [email protected]
Phone: +31 (0)73 800 1900
Fax: +31 (0)73 800 1998
Product Name Kit Size Registration Status Part Number
ARIES® C. difficile Assay Complete Kit

Includes:
24 C. difficile Test Cassettes
ARIES® Stool Resuspension Kit (30-00095)
These two components ship separately. Does not include assay protocol file kit (CN-0334-01).

24 tests CE Marked 50-10023
ARIES® C. difficile Assay Protocol File Kit
(one time order only)
  CE Marked CN-0334-01
ARIES® Two Module System

Includes instrument, system operation manual, two magazines, quick guide (IVD), two sample prep trays, power cord, and handheld barcode scanner and stand

1 unit CE Marked ARIES-M12V1-IVD
ARIES® M1 System

Includes instrument, system operation manual, one magazine, quick guide (IVD), two sample prep trays, power cord, and handheld barcode scanner and stand

1 unit CE Marked ARIES-M6V1-IVD
SYNCT™ Software   CE Marked CN-SW47
  1. 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.
  2. 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.

 

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

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.

ARIES® Systems are class 1(I) laser products.

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