Ann Lab Med.  2025 Mar;45(2):218-222. 10.3343/alm.2024.0118.

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

Affiliations
  • 1Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea
  • 2Department of Laboratory Medicine, Chung-Ang University Hospital, Seoul, Korea
  • 3Department of Laboratory Medicine, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong, Korea
  • 4BIOMEDUX Co., Suwon, Korea
  • 5Department of Urology, Chung-Ang University College of Medicine, Seoul, Korea

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.

Keyword

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

Figure

  • Fig. 1 Binomial logistic regression analysis of the percent positive results of LabGenius CT/NG according to (A) Chlamydia trachomatis (CT) and (B) Neisseria gonorrhoeae (NG) DNA concentrations.


Reference

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