By Chiara Seletti

Testing patients suspected of being colonized with this fungal pathogen can help prevent potentially deadly outbreaks in healthcare settings

Since it was first identified in 2009, Candida auris (C. auris) is now regarded as a severe threat to public health. The fungus is a significant pathogen possessing a deep reservoir of drug-resistance mechanisms. C. auris isolates can be multidrug-resistant, with some isolates showing pan resistance. Alarmingly, 90% of C. auris isolates are resistant to at least one of four drug classes.

The presence of C. auris poses a risk to many patients in healthcare settings

The Centers for Disease Control and Prevention classified C. auris as an urgent microbial resistance threat, noting the alarming rate at which it has spread in healthcare facilities. Additionally, the World Health Organization categorized it as a critical priority pathogen.

This challenging pathogen is difficult to eradicate, as it persists on environmental surfaces for as long as three months and cannot be removed with standard disinfectants. In hospitals and other healthcare facilities, the presence of C. auris can be a risk to many patients.

Colonization poses a significant risk for spreading infection, and studies suggest that 10% of colonized patients are susceptible to developing an invasive infection. Infections caused by C. auris can be particularly severe, leading to bloodstream infections, wound infections, and ear infections. The mortality rate from bloodstream infections is alarmingly high, reaching up to 60%, especially among vulnerable patients, such as those who are immunocompromised.

To reduce the risk of spread, rapid identification of colonized patients is key

For the best chance of preventing C. auris outbreaks in healthcare settings, infection prevention experts recommend testing anyone with risk factors associated with colonization with this pathogen. Patients who test positive can then be isolated and cared for with proper infection control measures to reduce the risk of spreading C. auris to other patients in the facility.

To meet this need, Diasorin developed the Simplexa^® C. auris Direct assay for the in vitro qualitative detection of C. auris DNA directly from a composite swab of bilateral axilla/groin from patients suspected of colonization. The test runs on the LIAISON^® MDX platform, generating results in less than two hours with excellent clinical performance —achieving 94.8% sensitivity and 98.7% specificity in clinical trials. The assay has broad coverage to detect the known C. auris clades that have been detected globally.

The Simplexa^® C. auris Direct assay: your solution for rapid identification of colonized patients

In 2024, the Simplexa^® C. auris Direct assay was granted De Novo authorization from the US Food and Drug Administration. Now, it has also received CE-IVDR marking, allowing it to be used as a clinical test in all countries accepting the CE mark.

The Simplexa^® C. auris Direct assay enables rapid identification of colonized patients, which ultimately empowers healthcare teams to manage this dangerous pathogen more effectively through infection control and prevention efforts, thereby achieving better patient outcomes.

For more information on the Simplexa^® C. auris Direct assay:

• Watch the video, from IDWeek 2024, where Dr. Berry elaborates on C. auris and reviews the clinical and analytical data of the Simplexa^® C. auris Direct assay.
• Click here to request additional information