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Molecular Detection of Candida auris Using DiaSorin Molecular Simplexa® Detection Kit: A Diagnostic Performance
Juan David Ramírez1,2, Chin Yi Wang1, Deandra Bolton1
1Department of Pathology, Molecular and Cell-Based Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.
Abstract:
Candida auris is a globally emerging fungal pathogen that is associated with healthcare-related infections. The accurate and rapid detection of C. auris is crucial for effective infection prevention, control, and patient management. This study aimed to validate the analytical and diagnostic performance of the DiaSorin Molecular C. auris Detection Kit. The analytical specificity, sensitivity, and reproducibility of the assay were evaluated. The limit of detection (LOD) was determined to be 266 CFU/µL using the ZeptoMetrix Candida auris Z485 strain and standard calibration curves. The assay demonstrated high analytical specificity and showed no amplification against a diverse panel of bacteria and fungi. Clinical validation was conducted using deidentified residual axillary/groin surveillance culture specimens from C. auris culture-positive and culture-negative patients. The DiaSorin Molecular Detection Kit exhibited 100% agreement in sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) when compared to cultures coupled with MALDI-TOF identification. Intra- and inter-reproducibility testing demonstrated consistent and reliable diagnostic performance. This validated assay offers rapid and accurate detection of C. auris, facilitating timely implementation of infection control measures and appropriate patient care. The DiaSorin Molecular C. auris Detection Kit has the potential to aid in controlling the outbreaks caused by this emerging fungal pathogen. Providing a reliable diagnostic tool can contribute to the effective management and containment of C. auris infections in healthcare settings and ultimately improve patient outcomes.
Insights
The DiaSorin Molecular Candida auris Detection Kit accurately identifies the emerging fungal pathogen Candida auris. This rapid diagnostic tool aids in controlling healthcare-associated infections and improving patient outcomes.
Area of Science:
- Medical Mycology
- Clinical Diagnostics
- Infectious Diseases
Background:
- Candida auris is a significant emerging fungal pathogen causing healthcare-associated infections.
- Rapid and accurate detection of Candida auris is critical for infection control and patient management.
- Existing diagnostic methods require validation for emerging pathogens.
Purpose of the Study:
- To validate the analytical and diagnostic performance of the DiaSorin Molecular Candida auris Detection Kit.
- To assess the sensitivity, specificity, and reproducibility of the assay.
- To evaluate the kit's potential in controlling Candida auris outbreaks.
Main Methods:
- Analytical validation included specificity, sensitivity, and reproducibility testing.
- Limit of Detection (LOD) determined using a standard Candida auris strain.
- Clinical validation performed on surveillance culture specimens compared to MALDI-TOF identification.
Main Results:
- The assay's Limit of Detection (LOD) was 266 CFU/µL.
- High analytical specificity was observed, with no cross-reactivity against other microbes.
- Clinical validation showed 100% agreement in sensitivity, specificity, PPV, and NPV compared to culture and MALDI-TOF.
Conclusions:
- The DiaSorin Molecular Candida auris Detection Kit provides rapid and accurate detection of Candida auris.
- The validated assay facilitates timely infection control measures and patient care.
- This diagnostic tool can aid in managing and containing Candida auris outbreaks in healthcare settings.
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