Simplexa® C. auris Direct
The FIRST FDA De Novo granted assay for the in vitro qualitative detection of Candida auris colonization
Pivotal aid in the prevention and control of a rapidly emerging multidrug-resistant fungal pathogen in healthcare settings.
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Disease state
Candida auris is an emerging multidrug-resistant fungal pathogen associated with severe nosocomial infections and is considered a serious global health threat.
The WHO and US Centers for Disease Control (CDC) have identified C. auris as a critical fungal pathogen causing outbreaks in more than 35 countries in the last decade and emerging as a significant healthcare concern associated with an urgent antimicrobial resistance threat.1,2
C. auris is also associated with high mortality rates – one in three patients die within a month of being diagnosed with the infection.3 Like other potentially invasive fungal infections, immunocompromised patients are the most vulnerable to the dangers of C. auris infections.
Asymptomatic carriers must be identified to evaluate the risk of acute infection and potential spread in healthcare facilities.3,4 Screening asymptomatic patients or those at risk for C. auris colonization is key to preventing the spread in healthcare facilities and is best conducted by testing swabs taken from the axilla and groin areas of hospitalized patients.5
1. Centers for Disease Control and Prevention, “Fact sheets” (2023). Available at: https://www.cdc.gov/fungal/candida- auris/fact-sheets/index.html
2. https://www.who.int/news/item/25-10-2022-who-releases-first-ever-list-of-health-threatening-fungi
3. Tracking Candida auris | Candida auris | Fungal Diseases | CDC
4. Saris K., Meis J.F., Voss A. Candida auris. Curr. Opin. Infect. Dis. 2018;31:334–340.
Candida auris is an emerging multidrug-resistant fungus that presents a serious global health threat
The value of Simplexa® C. auris Direct
The first FDA De Novo granted PCR assay for helping to prevent C. auris infection in the healthcare setting
Preventing outbreaks and protecting at-risk patients
Accurate and fast results help prevent C. auris hospital outbreaks and can protect fragile patients from potentially deadly outcomes.
Operational efficency with simple workflow
Less chance for error with CLIA moderate complexity, no DNA extraction required.
Excellent clinical performance
High performance in clinical trials: 94.8% sensitivity (PPA) and 98.7% specificity (NPA).
Clinically impactful
Timely and accurate identification of patients with suspected C. auris colonization supports infection and prevention control strategies in healthcare settings.
How the Simplexa® C. auris Direct works
Simplexa® C. auris Direct is a qualitative real-time PCR assay with a simple workflow for the in vitro qualitative detection of C. auris DNA from a composite swab of bilateral axilla/groin from patients suspected of C. auris colonization. Includes ready-to-use Sample Prep Solution and PCR reagent for loading onto a reusable Direct Amplification Disc on the compact LIAISON® MDX system. Designed for operational simplicity, flexibility, and quality assurance for utility across any clinical lab.
Sample-to-Answer
Scan 1-8 primary unextracted samples per run, ready-to-use single use reaction mix vials, and the 8-well Direct Amplification Disc. Simply load samples mixed in proprietary sample preparatory solution and reagents directly onto the disc, place the disc on the LIAISON® MDX system, and press run for results in less than 2 hours.
Intuitive LIAISON® MDX Studio Software
Preinstalled with bidirectional connectivity allowing for simple run set-up, data analysis, and information management.
Broad clade coverage
Comprehensive coverage across all six global C. auris clades identified across the world.
To be used on the LIAISON® MDX System
The LIAISON® MDX is an innovative and powerful real-time PCR instrument with two consumable disc options: the 8-well Direct Amplification Disc and the 96-well Universal Disc for higher volume testing.
Supported by an expanding menu of molecular assays, the system provides easy to understand results with the ability to check amplification curves after a run. All of this in a compact footprint measuring only 12″ by 8″ by 12″ so that it can fit into laboratories of any size.
Simplexa® C. auris Direct ordering info
Part Name |
Kit Size |
Registration Status |
Part Number |
|---|---|---|---|
|
Simplexa® C. auris Direct Kit* |
24 |
IVD | MOL3950 |
|
Simplexa® C. auris Positive Control Pack |
10 |
IVD | MOL3960 |
* Direct Amplification Discs and Simplexa C. auris Sample Prep Kit (MOL5390) are included with kit.