A-228 Performance Evaluation of the LabGenius C-CT/NG-BMX Assay for Detection of <i>Chlamydia trachomatis</i> and <i>Neisseria gonorrhoeae</i>

Abstract Background The LabGenius C-CT/NG-BMX assay (LabGenius CT/NG; BIOMEDUX, Gyeonggi-do, Republic of Korea) is a recently developed real-time polymerase chain reaction that can simultaneously detect sexual transmitted pathogens (Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG)) in vaginal swab specimen or urine specimen. Methods To evaluate the analytical performance, total 343 167 specimens were selected to compare CT/NG with BD MAX™ CT/GC/TV (Becton, Dickinson Company, NJ, USA). In addition, using binomial logistic regression analysis, we estimated limit detection which 95% (Lod95) rate achieved CT/NG. Results showed almost perfect agreement (κ = 0.826 for CT, κ 0.944 NG), overall agreements between two assays 91.6% CT 97.8% NG, respectively. LoD95 values 9.9 7.8 copies/uL 7.6 5.1 Conclusion this study, demonstrated acceptable performance compared CT/GC/TV, could be cost-effective option routine follow-up test pathogens.