Performance of rapid immunochromatographic assay in the diagnosis of Trichomoniasis vaginalis.

Trichomonas vaginalis accounts for nearly half of all curable sexually transmitted diseases worldwide with serious health consequences. Effort to increase the sensitivity of its diagnosis is critical to both control measures and epidemiologic studies. This study was conducted to evaluate the OSOM® Trichomonas Rapid Test (Sekisui Diagnostics, Framingham, MA, USA), a qualitative antigen-detection immunochromatographic (IC) assay in the diagnosis of vaginal trichomoniasis comparable to the conventional methods. The study enrolled 258 females aged 18-50 years classified into symptomatic (185) and asymptomatic (73) groups. Vaginal swab specimens were obtained for wet mount, stained preparation (Giemsa, acridine-orange), culture (InPouch TV™, modified Diamond's), and for rapid OSOM testing. Trichomonas vaginalis was detected in 67, 66, 71, 99, 96, and 97 using wet mount, acridine-orange stain, Giemsa stain, modified Diamond's, InPouch media, and OSOM test, respectively. In comparison to a composite reference standard (CRS) of wet mount microscopy and culture, OSOM test reported 97.98%, 99.37%, 98.98%, 98.75%, and 98.84% for sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy, respectively. The OSOM test proved to be a simple and objective test. This rapid point-of-care-test will contribute significantly in the diagnosis of vaginal trichomoniasis and will increase the understanding of its still vague epidemiology.