Evaluation of Rapid Diagnostic Device for the Detection of Candida Auris

Официальное название

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

Обзор

"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."

Подробное описание

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.

Вмешательства

• Диагностический тест 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)

Первичные конечные точки

• 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. [Срок оценки: 1 day]

Критерии участия

Критерии включения

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.

Критерии исключения

• NA

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Греция · 1 центр

• Attikon University Hospital — Athens

Идентификаторы

NCT: NCT07253311 · APHP 250168

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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