BackgroundThe number of people living with HIV (PLHIV) in need of treatment monitoring in low-and-middle-income countries has been rapidly expanding, placing an increasing burden on laboratories. Promising new point-of-care (POC) test have the potential to reduce laboratory workloads, but the implementation cost is uncertain. We sought to estimate the costs of decentralized POC testing compared to centralized laboratory testing for PLHIV initiating treatment in South Africa.MethodsWe conducted a microcosting analyses comparing clinic-based POC testing to centralized laboratory testing for HIV viral load, creatinine, and CD4 count monitoring. We completed time-and-motion studies to assess staff time for sample collection and processing. Instrument costs were estimated assuming five-year lifespans and we applied a 3% annual discount rate. Total costs and cost per patient were estimated over a five-year period: the first year of ART initiation and four years of routine HIV monitoring, following World Health Organization ART monitoring guidelines.ResultsWe estimated that per-patient costs of POC HIV viral load, CD4, and creatinine tests were USD $25, $11, and $9, respectively, assuming a clinic volume of 50 patients initiated per month. At centralized laboratories, per-patient costs of POC HIV viral load, CD4, and creatinine tests were USD $26, $6, $3. Total monitoring costs of all testing over a 5-year period was $45 higher for POC testing compared to centralized laboratory testing ($210 vs $166).ConclusionsPOC testing for HIV care and treatment can be feasibly implemented within clinics in South Africa, particularly those with larger patient volumes. POC HIV viral load costs are similar to lab-based testing while CD4 count and creatinine testing are more costly as POC tests. Our cost estimates are useful to policymakers in planning resource allocation and can inform cost-effectiveness analyses of POC testing.

ObjectivesSyndromic 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 XpertChlamydia trachomatis/Neisseria gonorrhoeae(CT/NG) and OSOMTrichomonas vaginalis(TV) Test as part of a STI care model for young women in South Africa.DesignDiagnostic evaluation conducted as part of a prospective cohort study (CAPRISA 083) between May 2016 and January 2017.SettingOne large public healthcare facility in central Durban, KwaZulu-Natal, South AfricaParticipants247 women, aged 18–40 years, attending for sexual and reproductive services to the clinic. Pregnant and HIV-positive women were excluded.OutcomesDiagnostic 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.ResultsWe 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).ConclusionThe 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.Trial registration numberNCT03407586; Pre-results.

IntroductionSyndromic management of sexually transmitted infections (STIs), as practised in most poorly resourced countries misses out asymptomatic infections. Affordable nucleic acid amplification tests (NAATs) are needed for accurate STI diagnosis and treatment.MethodsAs part of a cohort study assessing a diagnostic STI care model among young South African women presenting for syndromic care, we evaluated the clinic-based point-of-care (POC) tests Xpert CT/NG and OSOM Trichomonas Rapid Test against the laboratory-based Anyplex II STI-7, a multiplex real-time PCR assay which detects Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), M. genitalium (MG), M. hominis (MH), U. urealyticum (UU) and U. parvum (UP) in a single reaction. All positive and discordant results were confirmed with a third molecular assay, the FTD STD9.ResultsVaginal swabs taken from 247 women were assessed in parallel. 238 of 247 (96.4%) results were in agreement comparing Xpert and Anyplex. All nine discrepant results were positive for CT on Xpert but negative on Anyplex. FTD STD9 confirmed three positive and six negative results. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of Xpert for CT against the two assays was 100%, 97.1%, 86.0%, 100%, respectively; and for NG 100%, 99.6%, 92.3%, 100%. The sensitivity, specificity, PPV and NPV of OSOM for TV against the two assays was 77.8%, 100%, 100%, 99.2%. In addition to the CT, NG and TV detection, the Anyplex identified a prevalence of 4.8% MG, 33.5% MH, 19.1% UU and 51.4% UP in this population.ConclusionThe overall performance of Xpert CT/NG against laboratory-based assays was comparable. A lower PPV may lead to some overtreatment, however, in a high burden STI and HIV region, where STIs are often asymptomatic, the high sensitivity and specificity are reassuring. The widened spectrum of Anyplex targets highlights the high burden of Ureaplasma and Mycoplasma species in this setting, whose clinical significance need further exploration.

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