Bead-based multiplex sexually transmitted infection profiling

Abstract

Sexually transmitted infections are a significant cause of genital disease, infertility and hospital admissions. The economic impact is high. An accurate diagnosis is often difficult and time consuming. We report the development and validation of a novel bead-based multiplex sexually transmitted infection profiling (STIP) assay that detects 18 sexually transmitted infections using a multiplex PCR followed by Luminex bead-based hybridisation. STIP was validated using urogenital samples pretested by commercially available quantitative PCR, microscopy or by culturing methods. STIP specifically detects Chlamydia trachomatis, Herpes simplex virus 1 and 2, Treponema pallidum, Trichomonas vaginalis, Neisseria gonorrhoeae, Mycoplasma (M.) genitalium, M. hominis, M. pneumonia, M. spermatophilum, Ureaplasma urealyticum and U. parvum, and quantifies bacterial vaginosis-associated Atopobium vaginae and Gardnerella vaginalis as well as three Candida species and normal genital flora-associated Lactobacillus species. STIP reached an overall concordance of 95-100% with commercially available quantitative PCR tests. Compared to Nugent score, STIP reached a sensitivity of 95% and a specificity of 86% for bacterial vaginosis detection. Candida specimens, pretested by direct culturing, were identified with a sensitivity of 97% and a specificity of 99%. STIP is a powerful high-throughput tool in assessing a broad spectrum of urogenital infections.