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-testi ng), parti cul arl y duri ng the coronavi rus pandemi c to prevent i nfecti on 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 recei ved suffici ent trai ni ng on speci men coll ecti on and OSOM self-testi ng. 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 ri sk factors for i nfecti on i n the study popul ati on, wi th stati sti cal l y si gni fi cant differences seen among women only in terms of education level and employment status (p<0.001). The OSOM sel f-test performed wel l (83.3% sensi ti vi ty and 98.4% speci fi ci ty), outperformi ng the wet mount mi croscopy (72.2% sensi ti vi ty and 100% speci fi ci ty) and comparable to the clinicians’ OSOM (88.8% sensitivity and 100% specificity). The patients’ and cl i ni ci ans’ OSOM tests were strongl y correl ated, wi th 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 cl i ni ci an-col l ecti on. Overal l, our study’s fi ndi ngs may have i mportant consequences for the implementation of Trichomonas screening based on OSOM self-testing approach in the study’s population.