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.
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. |
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| 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. |
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Please see the Package Insert for more detailed information.
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.
Prepare the sample using the provided stool resuspension kit
Load the sample into the cassette
Insert up to six cassettes into the magazine
Insert the magazines into the instrument
Review & release results
| 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
|
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
|
1 unit | CE Marked | ARIES-M12V1-IVD |
ARIES® M1 System
|
1 unit | CE Marked | ARIES-M6V1-IVD |
| SYNCT™ Software | CE Marked | CN-SW47 | |
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.