Evaluation of Rapid Diagnostic Device for the Detection of Candida Auris

NCT07253311 | Not Yet Recruiting

• 1 other identifier: APHP 250168
• Study Type: observational
• Target: 554
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Candida auris; Diagnostic Tests; Routine; Immunochromatography; Microbiological Techniques; Sensitivity and Specificity; Microbial Drug Resistance, Fungal; Infection; Control

Outcome Measures

Primary Outcomes (1)

• to evaluate the clinical performance of the NG-Test® Candida auris rapid diagnostic test (RDT), developed by CEA and NG Biotech, for detecting this pathogen using immunochromatography.

  Sensitivity and specificity of the NG-Test® Candida auris rapid diagnostic test (RDT) will be assessed by comparison with the reference method (MALDI-TOF, Bruker) using colonies isolated prospectively from patients suspected of infection or colonization. The evaluation will also include a retrospective analysis using well-characterized isolates previously conserved by the microbiology department. Specificity will be assessed by testing a variety of non-Candida auris strains.

  1 day

Interventions

NG-TestⓇ C.auris kit DIAGNOSTIC_TEST

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes hospitalized patients suspected of Candida auris infection or cutaneous colonization.

You may qualify if:

• From patients with suspected Candida auris infection:
• \- All isolates from the population that grow on the selective media: Sabouraud-dextrose (40g/L dextrose, 5.0g/L of peptic digest of animal tissue, 5.0 g/L of pancreatic digest of casein, 15.0 g/L of agar and final pH 5.6 ± 0.2) and CHROMagar™ Candida plus (manufactured by CHROMagar™, France). used in the hospital's routine diagnostic process.
• From patients with suspected Candida auris cutaneous colonization:
• \- All isolates from the population that grow on the selective media: Salt-Sabouraud Dulcitol Broth (SSDB) with chloramphenicol and gentamicin (manufactured by S2 Media, United States), And the media used in the hospital's routine diagnostic process: Sabouraud Dextrose Liquid Medium containing NaCl 10%, chloramphenicol 50 mg/L.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• NG Biotech: collaborator
• Commissariat A L'energie Atomique: collaborator

MeSH Terms

Conditions

Candida auris infection; Cross Infection; Hypersensitivity; Infections

Condition Hierarchy (Ancestors)

Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Central Study Contacts

Thierry NAAS, PhD

CONTACT

1 45 21 29 86; thierry.naas@aphp.fr

Saoussen OUESLATI, PhD

CONTACT

1 45 21 29 86; saoussen.oueslati@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: December 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share