Title : Clinical trials of the fully automated nucleic acid testing system (LabGenius) for VRE infectious disease
Abstract:
LabGenius is a newly developed in Biomedux Co(Republic of Korea) for Fully Automated Nucleic Acid Testing System(FANATS). It can be operated as, so-called, Sample-to-results, a Point of care Testing. Using this FANATS, we have performed the clinical trials to assess clinical sensitivity and specificity at Kosin University Gospel Hospital (IRB No. KUGH 2024-03-002). Total 400 samples of were tests and composed of 200 VRE Van A positives and 200 negatives. The clinical sensitivity and specificity were 99.5% identicaly.