Evaluating a Flexible Workflow for Candida auris Surveillance on the AltoStar Automation System AM16 with Commercial and In-House Real-Time PCR Assays

Background: , responsible for healthcare-associated outbreaks and high mortality, is a major global health threat. Rapid and scalable molecular diagnostics is essential; however, few automated platforms can accommodate both commercial assays and laboratory-developed tests (LDTs). We evaluated the analytical and clinical performance of two real-time PCR assays for C. auris detection using the AltoStar Automation System AM16. Methods: Direct assay (DiaSorin Molecular LLC), with culture as the reference standard. Results: Both assays demonstrated excellent reproducibility, with CVs below 5%, and 100% analytical specificity. The in-house LDT showed greater sensitivity, with LoDs of 25-191 colony-forming units (CFU)/mL (1.56-12 CFU/reaction) versus 52-235 CFU/mL (3.25-15 CFU/reaction) for the Altona assay. Regarding clinical accuracy, the LDT, Altona assay, and DiaSorin assay showed 100% positive and negative agreement with the culture results (Cohen's kappa=1.00). Conclusions: , a critical fungal pathogen.