A Rapid Multiplex LAMP Assay for Point-of-Care Detection of CT, NG, TV, and Fluoroquinolone Resistance in NG.

Rapid point-of-care (POC) diagnostics are essential tools for improving timely treatment and reducing the transmission of sexually transmitted infections (STIs). The STI NG Plus Assay is a rapid multiplex LAMP (loop-mediated isothermal amplification) NAAT (nucleic acid amplification test) capable of simultaneously detecting Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and fluoroquinolone resistance-associated mutations in NG ( gyrA S91F). In this study, we assessed the STI NG Plus assay primer design and analytical sensitivity. Using a bioinformatically optimized primer design pipeline and empirical screening, the assay demonstrated high inclusivity and specificity, with no cross-reactivity to 48 urogenital organisms or the human genome. Analytical sensitivity testing showed reliable detection of all targets in both lysis buffer and clinical matrix. Limits of detection were lower than those of an existing FDA-cleared test. The assay's robustness, speed, and sensitivity support its potential for decentralized STI testing with integrated antimicrobial resistance profiling.