Evaluation of Rapid Diagnostic Device for the Detection of Candida Auris

"Candida auris is an emerging fungus that can cause severe infections, particularly in hospitalized patients, and is often resistant to multiple antifungal treatments. Rapid and accurate detection of this pathogen is essential to control its spread in healthcare settings. This study aims to evaluate the clinical performance of the NG-Test® Candida auris rapid diagnostic test (RDT), developed by CEA and NG Biotech. The test uses immunochromatography and can detect Candida auris in about 15 minutes. Its results will be compared to the reference method, MALDI-TOF, performed on colonies grown from routine patient samples. Both retrospective (using stored isolates) and prospective (using new isolates) evaluations will be conducted. The study will measure the sensitivity and specificity of the test, and also include an assessment of its ease of use by laboratory staff. No additional samples will be collected from patients, and all testing will use de-identified isolates to ensure confidentiality."

NCT Number	NCT07253311
Lead Sponsor	Assistance Publique - Hôpitaux de Paris Collaborators: NG Biotech, Commissariat A L'energie Atomique
Conditions	Candida Auris Infection, Candida Auris Colonization, Nosocomial Infections
Enrollment	554 participants
Start Date	2026-05-25
Primary Completion	2026-10-31 (estimated)
Study Completion	2026-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-24