Performance Evaluation of the LabGenius C-CT/NG-BMX Assay for Chlamydia trachomatis and Neisseria gonorrhoeae Detection

Ann Lab Med. 2024 Nov 8. doi: 10.3343/alm.2024.0118. Online ahead of print.

Abstract

The LabGenius C-CT/NG-BMX assay (LabGenius CT/NG; BIOMEDUX, Gyeonggi, Republic of Korea) is a recently developed real-time PCR assay that can simultaneously detect the sexually transmitted pathogens Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in genitourinary specimens. We evaluated the analytical performance of this assay in comparison with BD MAX CT/GC/TV (Becton Dickinson, Franklin Lakes, NJ, USA). The results of both assays were in nearly perfect agreement for the detection of CT and NG. LabGenius CT/NG demonstrated acceptable analytical performance, comparable with that of another commercially available kit, and provides a cost-effective option for detecting sexually transmitted pathogens in routine and follow-up testing.

Keywords: Chlamydia trachomatis; Diagnostic tests; Evaluation; Neisseria gonorrhoeae; PCR; Sexually transmitted pathogens.