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Study identifier: NCT07253311 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Evaluation of Rapid Diagnostic Device for the Detection of Candida Auris

Condition: Candida Auris Infection · Candida Auris Colonization · Nosocomial Infections  ·  Sponsor: Assistance Publique - Hôpitaux de Paris

PhaseN/A
Planned participants554
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

"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."

This description comes directly from the study's public registry record.

Talk to the study team

Thierry NAAS, PhD  ·  1 45 21 29 86  ·  thierry.naas@aphp.fr

Saoussen OUESLATI, PhD  ·  1 45 21 29 86  ·  saoussen.oueslati@aphp.fr

Always discuss trial participation with your own doctor first.

Locations (1)

Attikon University HospitalAthens, GreeceRecruiting

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Source record: clinicaltrials.gov/study/NCT07253311