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Evaluation of Rapid Diagnostic Device for the Detection of Candida Auris

NCT07253311 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 554

Last updated 2025-11-28

No results posted yet for this study

Summary

"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."

Conditions

  • Candida Auris Infection
  • Candida Auris Colonization
  • Nosocomial Infections

Interventions

DIAGNOSTIC_TEST

NG-TestⓇ C.auris kit

Evaluation of the performance of the rapid diagnostic test (RDT) for the detection of the Candida auris and comparision with MALDI-TOF result (reference test)

Sponsors & Collaborators

  • NG Biotech

    collaborator UNKNOWN

  • Commissariat A L'energie Atomique

    collaborator OTHER_GOV

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-03-31
Completion
2026-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07253311 on ClinicalTrials.gov