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

Area of Science:

• Molecular Diagnostics
• Infectious Disease Detection
• Laboratory Automation

Background:

• Automated nucleic acid testing (NAT) systems often require proprietary instruments, limiting laboratory flexibility.
• The emergence of new infectious diseases necessitates adaptable diagnostic solutions.
• The GenXplore q4800 aims to address these limitations with an open-platform approach.

Purpose of the Study:

• To evaluate the analytical and clinical performance of the GenXplore q4800 automated NAT system.
• To assess the system's compatibility with various manual molecular testing kits.
• To determine the GenXplore q4800's suitability as a flexible alternative for routine molecular diagnostics.

Main Methods:

• Analytical validation using inactivated pathogen controls for repeatability, reproducibility, and sensitivity.
• Clinical validation testing 120 urine specimens for *Neisseria gonorrhoeae* and *Chlamydia trachomatis*.
• Comparison with a semi-automated reference method and user feedback collection.

Main Results:

• High repeatability, reproducibility, and sensitivity in automated pathogen detection.
• 100% positive and negative percent agreement for *N. gonorrhoeae* and *C. trachomatis* detection, with a Cohen's kappa of 1.0.
• High user satisfaction regarding system usability and flexibility.

Conclusions:

• The GenXplore q4800 demonstrates excellent analytical and clinical performance for molecular diagnostics.
• Its open-platform design provides flexibility, enabling adaptation to various diagnostic needs and reagent compatibility.
• The system offers a reliable and adaptable alternative to closed-platform NAT systems, enhancing laboratory workflow resilience.