Molecular Detection of <i>Candida auris</i> Using DiaSorin Molecular Simplexa<sup>®</sup> Detection Kit: A Diagnostic Performance Evaluation

oleh: Juan David Ramírez, Chin Yi Wang, Deandra Bolton, Bernadette Liggayu, Sarah Schaefer, Gopi Patel, Waleed Javaid, Carlos Cordon-Cardo, Adolfo Firpo-Betancourt, Emilia Mia Sordillo, Alberto Paniz-Mondolfi

Format: Article
Diterbitkan: MDPI AG 2023-08-01

Deskripsi

<i>Candida auris</i> is a globally emerging fungal pathogen that is associated with healthcare-related infections. The accurate and rapid detection of <i>C. auris</i> is crucial for effective infection prevention, control, and patient management. This study aimed to validate the analytical and diagnostic performance of the DiaSorin Molecular <i>C. auris</i> 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 <i>Candida auris</i> 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 <i>C. auris</i> 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 <i>C. auris</i>, facilitating timely implementation of infection control measures and appropriate patient care. The DiaSorin Molecular <i>C. auris</i> 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 <i>C. auris</i> infections in healthcare settings and ultimately improve patient outcomes.