Performance evaluation of GenXplore q4800: a novel open-platform automated nucleic acid testing system

ABSTRACT The emergence of diverse infectious diseases has led to the development of numerous molecular diagnostic kits for pathogen detection. These nucleic acid testing kits are typically categorized as manual or automated, with most automated kits requiring proprietary instruments, thereby limiting flexibility. GenXplore q4800 is a newly developed, open-platform, fully automated nucleic acid testing system designed to be compatible with a wide range of manual testing kits from different manufacturers. In this study, we evaluated the analytical and clinical performance of the GenXplore q4800 using manual molecular kits targeting sexually transmitted infections and respiratory viruses. The automated detection of inactivated pathogen controls demonstrated high repeatability, reproducibility, and sensitivity. The result of the contamination assessment was acceptable. For clinical validation, 120 urine specimens were tested for Neisseria gonorrhoeae and Chlamydia trachomatis. Results from the GenXplore q4800 were compared with those obtained using a semi-automated reference method. The GenXplore q4800 achieved 100% positive percent agreement, 100% negative percent agreement, and a Cohen’s kappa coefficient of 1.0 in these two pathogens, indicating strong concordance. Additionally, feedback from 16 professional users confirmed a high level of satisfaction with the system’s usability.IMPORTANCEMost fully automated nucleic acid testing systems rely on proprietary reagent kits, which limit flexibility during supply shortages or emerging outbreaks. The GenXplore q4800 is a newly developed open-platform system that allows integration of third-party nucleic acid extraction and nucleic acid testing reagents, enabling laboratories to adapt quickly to diagnostic needs. The findings demonstrate that GenXplore q4800 can serve as a reliable and flexible alternative for routine molecular diagnostics, supporting more resilient laboratory workflows and expanding options beyond closed-platform systems.