Comprehensive performance evaluation of a high-throughput automated system for pathogen nucleic acid detection in clinical settings

The system demonstrated excellent performance in terms of concordance, accuracy, precision, linearity, interference testing, and cross-reactivity. It is highly suited for large-scale pathogen screening and routine nucleic acid testing in clinical laboratories, both for qualitative and quantitative analyses. Additionally, this study introduces a comprehensive and standardized performance validation framework that addresses critical gaps in existing methodologies, offering a robust foundation for the rigorous evaluation of diagnostic systems and serving as a valuable reference for future research.