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. 2020 Dec;31(14):1364-1372.
doi: 10.1177/0956462420956532. Epub 2020 Sep 30.

Performance evaluation and acceptability of point-of-care Trichomonas vaginalis testing in adult female emergency department patients

Yu-Hsiang Hsieh  1 , Mitra K Lewis  1 , Valentina G Viertel  1 , Deanna Myer  1 , Richard E Rothman  1   2 , Charlotte A Gaydos  1   2
Affiliations

Performance evaluation and acceptability of point-of-care Trichomonas vaginalis testing in adult female emergency department patients

Yu-Hsiang Hsieh et al. Int J STD AIDS. 2020 Dec.

Abstract

We evaluated the accuracy and perception of a patient self-administered, tablet-facilitated rapid Trichomonas vaginalis (TV) point-of-care (POC) test in adult female emergency department (ED) patients.ED patients undergoing gynecologic examination were eligible. Each consented participant self-collected a vaginal swab, performed a tablet-facilitated TV rapid test using the OSOM® Trichomonas Rapid Test, and completed pre- and post-test self-surveys. After the self-test, the clinician collected one standard-of-care (SOC) vaginal swab for wet-mount testing and two for research. The research coordinator performed the TV rapid test using the clinician-collected swab, and reported the results to the clinician and patient. If the self- and coordinator-performed results were discordant, a TV nucleic acid amplification test (NAAT) was performed in a clinical laboratory. A survey was later administered to providers to assess their perceptions of the utility of the POC TV test.Of the 136 participants, 134 (98.5%) completed self-testing; two had invalid results. Comparing coordinator-performed TV rapid test adjudicated with NAAT, the sensitivity and specificity of self-administered test was 96.0% and 100%, respectively. The wet mount had a sensitivity of 52.0% and specificity of 100%. TV detection increased from 9.6% with wet mount to 18.4% with the TV rapid test. Most women (82.0%) stated self-testing was "not at all hard" (versus 66.2% before testing, p < 0.001). Clinicians indicated the TV rapid test affected their clinical management in 48.5% of cases, including 82.6% of positive cases and 41.6% of negative cases.ED patients were able to reliably collect, perform, and interpret their own POC TV test using tablet instructions. Both participants and providers reported high levels of acceptability of POC TV testing, which nearly doubled rates of TV detection.

Keywords: Trichomonas vaginalis; emergency departments; point-of-care test; self-collection; self-testing.

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Conflict of interest statement

Declaration of conflicting interests: CAG received grants from Hologic Inc., Cepheid Inc., Binx Health, and Becton Dickinson and a speaking honorarium from Hologic Inc. All other authors declared no potential conflicts of interest.

Figures

Figure 1a:
Figure 1a:
Collecting the vaginal swab.
Figure 1b:
Figure 1b:
OSOM ® Trichomonas Rapid Test procedure.
See this image and copyright information in PMC

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