Novel Molecular Test to Help Prevent and Control Multi Drug-Resistant Fungal Pathogen in Healthcare Settings

Candida auris (C. auris) is a rapidly emerging multi drug-resistant fungal pathogen that is commonly found in healthcare environments, where it presents a challenge due to its ability to asymptomatically colonize patients, facilitating its spread within these settings. Known to be a significant risk factor for invasive infections, C. auris is associated with high mortality rates and is resistant to many antifungal medications typically used for treatment. It has been responsible for outbreaks in over 35 countries in the past decade, marking it as a critical antimicrobial resistance threat. Given this, it is crucial to screen for C. auris to enable the timely implementation of contact precautions and infection control measures that can curb its spread within healthcare facilities and prevent potential outbreaks. Traditional testing methods can take days to yield results and often require sending samples to a reference laboratory. Now, a real-time polymerase chain reaction (RT-PCR) assay for the direct in vitro qualitative detection of C. auris DNA from a swab of patients suspected of C. auris colonization delivers results in less than two hours with excellent clinical performance.

Diasorin’s (Saluggia, Italy) Simplexa C. auris Direct kit is specifically designed to quickly identify patients suspected of C. auris colonization and help prevent its spread in healthcare settings. This RT-PCR assay provides direct in vitro qualitative detection of C. auris DNA from axilla/groin swabs of patients suspected of colonization, accurately identifying the six known global clades of C. auris. Performed on the LIAISON MDX system, this kit features a user-friendly, sample-to-answer system with a streamlined workflow that delivers results in less than two hours.

The Simplexa C. auris Direct kit 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, users can simply load samples mixed in the 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 two hours. The test provides a comprehensive coverage across all six global C. auris clades identified across the world. The accurate and fast results can help prevent C. auris hospital outbreaks and can protect fragile patients from potentially deadly outcomes. Diasorin has received FDA De-Novo grant for the Simplexa C. auris Direct on the LIAISON MDX instrument, making it the first FDA De Novo granted PCR assay for helping to prevent C. auris infection in the healthcare setting.

"The FDA de-novo authorization for the Simplexa C. auris Direct kit fills a much-needed gap in C. auris molecular detection and uniquely positions Diasorin as the first molecular diagnostic vendor to commercialize a PCR test for the prevention and control of Candida auris infection in healthcare settings," said Angelo Rago, President of Luminex. "This de-novo molecular test is the first easy, fast, and moderate complexity assay empowering laboratories with diagnostic confidence in managing patients suspected of C. auris infection, thereby promoting better patient outcomes."

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