Evaluation of Rapid Diagnostic Device for the Detection of Candida Auris
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
"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."
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
NA
Trial population
The study population includes hospitalized patients suspected of Candida auris infection or cutaneous colonization.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
NG-TestⓇ C.auris kit
Diagnostic testEvaluation of the performance of the rapid diagnostic test (RDT) for the detection of the Candida auris and comparision with MALDI-TOF result (reference test)
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
1 daySponsors and contacts
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
NG Biotech
Collaborator
Commissariat A L'energie Atomique
Collaborator
Source ClinicalTrials.gov