Ease of use and validity testing of a point-of-care fast test for parasitic vaginosis self-diagnosis.

Abstract

There is a demand for patients to self-diagnose their sexually transmitted infections (self- testing), particularly during the coronavirus pandemic to prevent infection spread. We enrolled a cohort of Saudi women in a single-visit prospective study, which was the first of its kind performed in the country. Our aim was to evaluate the OSOM® Trichomonas (OSOM) test, a single-use, point-of-care rapid test, for its efficacy and accessibility as a self-test for Trichomonas vaginalis (Trichomonas) infection. At a public hospital's gynecology clinic, women received sufficient training on specimen collection and OSOM self-testing. The women's infection status was re-evaluated using direct wet mount microscopy and clinician performed OSOM using additional swabs. Specimens with discordant results were sorted using an in- house polymerase chain reaction (PCR). 174 women aged 18 to 35 were registered and self- tested at the clinic under the supervision of a gynecologist between June and December 2020, with 84.4 percent (147/174) having a valid result on the first or repeat OSOM. Infection was detected in 12.2% (18/147) of participants, with two-thirds of them symptomatic. Young age, low education, the existence of vaginitis symptoms, and unemployment were identified as key risk factors for infection in the study population, with statistically significant differences seen among women only in terms of education level and employment status (p<0.001). The OSOM self-test performed well (83.3% sensitivity and 98.4% specificity), outperforming the wet mount microscopy (72.2% sensitivity and 100% specificity) and comparable to the clinicians' OSOM (88.8% sensitivity and 100% specificity). The patients' and clinicians' OSOM tests were strongly correlated, with a kappa of 0.89 and a 97.9% agreement. Self-collection of vaginal swabs was accepted and preferred by most women (94%) over the clinician-collection. Overall, our study's findings may have important consequences for the implementation of Trichomonas screening based on OSOM self-testing approach in the study's population.