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Ease of use and validity testing of a point-of-care fast test for parasitic vaginosis self-diagnosis.
Trop Biomed. 2021 Dec 01; 38(4):491-498.TB

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.

Authors+Show Affiliations

Department of Microbiology, College of Medicine, Taif University, P.O. Box 11099, Taif 21944, Saudi Arabia.Department of Molecular and Clinical Parasitology, National Liver Institute, Menoufia University, Menoufia, Egypt. Department of Obstetrics and Gynecology, K ing Faisal Medical Complex, Taif, KSA.Department of Microbiology, King Faisal Medical Complex, Taif, KSA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

35001916

Citation

Hawash, Y, et al. "Ease of Use and Validity Testing of a Point-of-care Fast Test for Parasitic Vaginosis Self-diagnosis." Tropical Biomedicine, vol. 38, no. 4, 2021, pp. 491-498.
Hawash Y, Jaafer N, Alpakistany T. Ease of use and validity testing of a point-of-care fast test for parasitic vaginosis self-diagnosis. Trop Biomed. 2021;38(4):491-498.
Hawash, Y., Jaafer, N., & Alpakistany, T. (2021). Ease of use and validity testing of a point-of-care fast test for parasitic vaginosis self-diagnosis. Tropical Biomedicine, 38(4), 491-498. https://doi.org/10.47665/tb.38.4.094
Hawash Y, Jaafer N, Alpakistany T. Ease of Use and Validity Testing of a Point-of-care Fast Test for Parasitic Vaginosis Self-diagnosis. Trop Biomed. 2021 Dec 1;38(4):491-498. PubMed PMID: 35001916.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ease of use and validity testing of a point-of-care fast test for parasitic vaginosis self-diagnosis. AU - Hawash,Y, AU - Jaafer,N, AU - Alpakistany,T, PY - 2022/1/10/entrez PY - 2022/1/11/pubmed PY - 2022/1/12/medline SP - 491 EP - 498 JF - Tropical biomedicine JO - Trop Biomed VL - 38 IS - 4 N2 - 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. SN - 2521-9855 UR - https://www.unboundmedicine.com/medline/citation/35001916/Ease_of_use_and_validity_testing_of_a_point_of_care_fast_test_for_parasitic_vaginosis_self_diagnosis_ L2 - https://medlineplus.gov/trichomoniasis.html DB - PRIME DP - Unbound Medicine ER -