Evaluation of Rapid Diagnostic Device for the Detection of Candida Auris (DiagRaMIE Caur)

Evaluation of Rapid Diagnostic Device for the Detection of Candida Auris DiagRaMIE C 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."

Study Overview

• Status: Not yet recruiting
• Conditions: Nosocomial Infections; Candida Auris Infection; Candida Auris Colonization
• Intervention / Treatment: Diagnostic test: NG-TestⓇ C.auris kit

Detailed Description

This monocentric, non-randomized diagnostic accuracy study aims to evaluate the NG-Test® Candida auris, a lateral flow immunoassay developed by CEA and NG Biotech, for the qualitative detection of Candida auris. Isolates will be obtained from patients with suspected infection or cutaneous colonization, grown on selective media from routine clinical samples, with no additional sampling. Test results will be compared with the reference method, MALDI-TOF. Approximately 224 isolates from infected patients and 330 isolates from colnized patients will be included, allowing precise estimation of sensitivity and specificity with 95% confidence intervals. Results from the rapid test, MALDI-TOF identifications, and pictures of the test cassettes will be entered into an electronic case report form under unique pseudonymized identifiers. Statistical analysis will include contingency tables, calculation of sensitivity, specificity, positive and negative predictive values, and likelihood ratios with 95% confidence intervals. Inter-observer agreement will be measured using Cohen's kappa coefficient. The study will be conducted over a six-month inclusion period in a single center, the Clinical Microbiology Laboratory of Attikon University Hospital in Athens. The validation of this rapid test is expected to provide a reliable tool to support infection control measures and limit the nosocomial spread of Candida auris.

• Study Type: Observational
• Enrollment (Estimated): 554

Contacts and Locations

• Study Contact: Name: Thierry NAAS, PhD; Phone Number: 33 1 45 21 29 86; Email: thierry.naas@aphp.fr
• Study Contact Backup: Name: Saoussen OUESLATI, PhD; Phone Number: 1 45 21 29 86; Email: saoussen.oueslati@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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.

Exclusion Criteria:

• NA

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Commissariat A L'energie Atomique; NG Biotech

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Infection; Candida auris; Control; Sensitivity and Specificity; Diagnostic Tests; Routine; Immunochromatography; Microbiological Techniques; Microbial Drug Resistance, Fungal
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Immune System Diseases; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Hypersensitivity; Infections; Cross Infection; Candida auris infection
• Other Study ID Numbers: APHP 250168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No