Summary:
Diasorin has launched the Simplexa C. auris Direct kit in CE-mark-accepting countries to aid in identifying Candida auriscolonization and enhance infection control in healthcare settings.

Takeaways:

  1. The Simplexa C. auris Direct kit is an RT-PCR assay that detects C. auris DNA from patient swabs, providing results in under two hours.
  2. The infection is a significant global healthcare challenge due to its high resistance to antifungal drugs and rapid spread in medical facilities.
  3. Screening colonized patients is crucial for infection control, as the fungal infection is responsible for outbreaks in over 35 countries and poses a major antimicrobial resistance threat.

Diasorin announces the launch of its Simplexa C. auris Direct kit in all countries accepting the CE mark. The assay aids in the identification of patients suspected of Candida auris colonization to enable infection control in healthcare settings, and prevent potentially deadly infections in vulnerable patients.

This real-time polymerase chain reaction (RT-PCR) assay is used for the direct in vitro qualitative detection of C. auris DNA from a composite swab of axilla/groin from patients suspected of C. auris colonization, and detects all six C. auris clades identified globally. This targeted molecular diagnostic test is performed on the LIAISON MDX, yielding patient results in less than two hours with excellent clinical performance.

C. Auris Is Global Challenge

C. auris is a global challenge for healthcare facilities since asymptomatically colonized patients can easily spread the fungus in hospital environments and to other patients. Furthermore, patient colonization is a known risk factor for invasive infections that are associated with high mortality rates.

These infections are known to be resistant to one or more classes of antifungal drugs. Because of this, the World Health Organization, U.S. Center for Disease Control and Prevention, and European Centre for Disease Prevention and Control have all identified it as a fungal pathogen of critical importance.

Responsible for outbreaks in more than 35 countries over the last decade and emerging as a significant healthcare concern, C. auris is considered to be an urgent antimicrobial resistance threat. Therefore, screening to identify colonized patients is key to implementing timely contact precautions and infection control measures to limit the spread of the organism within healthcare facilities and to prevent outbreaks.

“Diasorin is committed to develop impactful diagnostic solutions to combat deadly and emerging infections,” said Angelo Rago, President of Luminex. “The Simplexa C. auris Direct kit fills a much-needed gap in C. auris molecular detection and will help to empower labs to easily, accurately and rapidly control and prevent Candida auris infections in healthcare settings.”

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