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

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Candida Auris Infection; Candida Auris Colonization; Nosocomial Infections

Treatments: Diagnostic Test: NG-TestⓇ C.auris kit

Study type: Observational

Funder types: Other

Identifiers

NCT07253311

APHP 250168

Details and patient eligibility

About

"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."

Full 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.

Enrollment: 554 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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