Clinical trials of the fully automated nucleic acid testing system (LabGenius) for CT/NG STI diseases

Title : Clinical trials of the fully automated nucleic acid testing system (LabGenius) for CT/NG STI diseases

Abstract:

LabGenius is a newly developed in Biomedux Co(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 for clinical trials for CT/NG STI infection disease at Chung-Ang University Hospital (IRB No. 2409-009-614). Total 450 samples of women’s vaginal swabs were tests. The test samples composed of 150 CT positives, 150 NG positives and 150 negatives and collected by GC Laboratory (YongIn-City, Korea, IRB No. GCL-2024-1057-03). The clinical sensitivity and specificity of NG were 100% and 99.7 % respectively. The clinical sensitivity and specificity of CT were 98.7% and 100% respectively.

Biography:

Ms. HJ Yang studied Life Science at the Geonggi University, Korea and graduated as BS in 2019. She then joined the research group of Dr. Ae Ja Park at the R&D Center of Biomedux Co. She has mainly focused on the development of the FANATS at the Biomedux R&D Center.