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<jats:sec><jats:title>Objectives</jats:title><jats:p>Syndromic management of sexually transmitted infections (STIs) omits asymptomatic infections, particularly among women. Accurate point-of-care assays may improve STI care in low- and middle-income countries (LMICs). We aimed to evaluate the diagnostic performance of the Xpert <jats:italic>Chlamydia trachomatis</jats:italic>/<jats:italic>Neisseria gonorrhoeae</jats:italic> (CT/NG) and OSOM <jats:italic>Trichomonas vaginalis</jats:italic> (TV) Test as part of a STI care model for young women in South Africa.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Diagnostic evaluation conducted as part of a prospective cohort study (CAPRISA 083) between May 2016 and January 2017.</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>One large public healthcare facility in central Durban, KwaZulu-Natal, South Africa</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>247 women, aged 18–40 years, attending for sexual and reproductive services to the clinic. Pregnant and HIV-positive women were excluded.</jats:p></jats:sec><jats:sec><jats:title>Outcomes</jats:title><jats:p>Diagnostic performance of the Xpert CT/NG and OSOM TV assays against the laboratory-based Anyplex II STI-7 Detection. All discordant results were further tested on the Fast Track Diagnostics (FTD) STD9 assay.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>We obtained vaginal swabs from 247 women and found 96.8% (239/247) concordance between Xpert and Anyplex for CT and 100% (247/247) for NG. All eight discrepant CT results were positive on Xpert, but negative on Anyplex. FTD STD9 confirmed three positive and five negative results, giving a confirmed prevalence of CT 15.0% (95% CI 10.5 to 19.4), NG 4.9% (2.2–7.5) and TV 3.2% (1.0–5.4). Sensitivity and specificity of Xpert CT/NG were 100% (100-100) and 97.6% (95.6–99.7) for CT and 100% (100-100) and 100% (100-100) for NG. The sensitivity and specificity of OSOM TV were 75.0% (45.0–100) and 100% (100-100).</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>The Xpert CT/NG showed high accuracy among young South African women and combined with the OSOM TV proved a useful tool in this high HIV/STI burden setting. Further implementation and cost-effectiveness studies are needed to assess the potential role of this assay for diagnostic STI testing in LMICs.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT03407586" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results">NCT03407586</jats:ext-link>; Pre-results.</jats:p></jats:sec>

Original publication

DOI

10.1136/bmjopen-2018-026888

Type

Journal article

Journal

BMJ Open

Publisher

BMJ

Publication Date

02/2019

Volume

9