Rapid diagnostic test for antenatal syphilis screening in low-income and middle-income countries: a systematic review and meta-analysis

Romero, C.P.; James, Marrissa Martyn-St; Hamilton, Jean; Marinho, Daniel Savignon; Castro, Rodolfo; Harnan, S

doi:10.1136/bmjopen-2017-018132

Cited by 22 publications

(25 citation statements)

References 30 publications

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“…As mother-to-child transmission of syphilis remains a leading cause of neonatal death and stillbirth and disproportionally affects women in low-resource settings where syphilis prevalence rates are particularly high and screening rates low, an overview of the impact of different syphilis POCTs on syphilis-related pregnancy outcomes is crucial to improve maternal and new-born healthcare in low-resource settings [5,8,[14][15][16].…”

Section: Resultsmentioning

confidence: 99%

“…As long as effective diagnosis and treatment are provided in an early stage of pregnancy, congenital syphilis and other adverse syphilis-related pregnancy outcomes are efficiently preventable and treatable [ 7 ]. Still, congenital syphilis remains the second most common cause of preventable stillbirth, only outnumbered by malaria, and disproportionally affects women in low-resource settings [ 5 , 8 ].…”

Section: Introductionmentioning

confidence: 99%

“…Because laboratory tests require technical expertise, equipment, electricity and refrigeration, they are often inaccessible in resource-limited settings, which poses a serious problem for diagnosis and treatment in a population where the burden of maternal syphilis remains a serious challenge [ 8 , 21 , 22 ]. A recently developed promising alternative are rapid point-of-care tests (POCT), which constitute a clear advantage in resource-limited settings as they yield results in 10–15 minutes, do not require a laboratory setting or intensive technical training and can be stored at room temperature [ 4 , 21 , 23 ].…”

Section: Introductionmentioning

confidence: 99%

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The impact of antenatal syphilis point of care testing on pregnancy outcomes: A systematic review

Brandenburger

Ambrosino

2021

PLoS ONE

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Background Mother-to-child transmission of syphilis remains a leading cause of neonatal death and stillbirth, disproportionally affecting women in low-resource settings where syphilis prevalence rates are high and testing rates low. Recently developed syphilis point-of-care tests (POCTs) are promising alternatives to conventional laboratory screening in low-resource settings as they do not require a laboratory setting, intensive technical training and yield results in 10–15 minutes thereby enabling both diagnosis and treatment in a single visit. Aim of this review was to provide clarity on the benefits of different POCTs and assess whether the implementation of syphilis POCTs is associated with decreased numbers of syphilis-related adverse pregnancy outcomes. Methods Following the PRISMA guidelines, three electronic databases (PubMed, Medline (Ovid), Cochrane) were systematically searched for intervention studies and cost-effectiveness analyses investigating the association between antenatal syphilis POCT and pregnancy outcomes such as congenital syphilis, low birth weight, prematurity, miscarriage, stillbirth as well as perinatal, fetal or infant death. Results Nine out of 278 initially identified articles were included, consisting of two clinical studies and seven modelling studies. Studies compared the effect on pregnancy outcomes of treponemal POCT, non-treponemal POCT and dual POCT to laboratory screening and no screening program. Based on the clinical studies, significantly higher testing and treatment rates, as well as a significant reduction (93%) in adverse pregnancy outcomes was reported for treponemal POCT compared to laboratory screening. Compared to no screening and laboratory screening, modelling studies assumed higher treatment rates for POCT and predicted the most prevented adverse pregnancy outcomes for treponemal POCT, followed by a dual treponemal and non-treponemal POCT strategy. Conclusion Implementation of treponemal POCT in low-resource settings increases syphilis testing and treatment rates and prevents the most syphilis-related adverse pregnancy outcomes compared to no screening, laboratory screening, non-treponemal POCT and dual POCT. Regarding the benefits of dual POCT, more research is needed. Overall, this review provides evidence on the contribution of treponemal POCT to healthier pregnancies and contributes greater clarity on the impact of diverse diagnostic methods available for the detection of syphilis.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The impact of antenatal syphilis point of care testing on pregnancy outcomes: A systematic review

Brandenburger

Ambrosino

2021

PLoS ONE

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“…We excluded pregnant women from the CAPRISA 083 cohort study, because they were referred for antenatal care, and were not an appropriate population to pilot the EPT intervention in. However, pregnant women may be an important population to offer POC testing to in the future,16 17 and perhaps combine the testing model with a POC syphilis assay 18. A further limitation of our study was that specimens were not available to repeat discordant results on the Xpert CT/NG platform.…”

Section: Discussionmentioning

confidence: 97%

Diagnostic accuracy of the Xpert CT/NG and OSOM Trichomonas Rapid assays for point-of-care STI testing among young women in South Africa: a cross-sectional study

et al. 2019

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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.

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“…In the last decade, the number of studies based in LMICs evaluating the utility of point-of-care tests for the detection and treatment of STIs in pregnancy has increased [ 38 , 77 ], which has influenced the number of economic evaluations conducted on these types of tests. Yet with few cheap, accurate and easy to use point-of-care tests for CT, NG, TV and BV available [ 78 ], there have not been many effectiveness trials conducted in LMIC.…”

Section: Discussionmentioning

confidence: 99%

Economic evaluation of point-of-care testing and treatment for sexually transmitted and genital infections in pregnancy in low- and middle-income countries: A systematic review

et al. 2021

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Background Sexually transmitted and genital infections in pregnancy are associated with adverse pregnancy and birth outcomes. Point-of-care tests for these infections facilitate testing and treatment in a single antenatal clinic visit and may reduce the risk of adverse outcomes. Successful implementation and scale-up depends on understanding comparative effectiveness of such programmes and their comparative costs and cost effectiveness. This systematic review synthesises and appraises evidence from economic evaluations of point-of-care testing and treatment for sexually transmitted and genital infections among pregnant women in low- and middle-income countries. Methods Medline, Embase and Web of Science databases were comprehensively searched using pre-determined criteria. Additional literature was identified by searching Google Scholar and the bibliographies of all included studies. Economic evaluations were eligible if they were set in low- and middle-income countries and assessed antenatal point-of-care testing and treatment for syphilis, chlamydia, gonorrhoea, trichomoniasis, and/or bacterial vaginosis. Studies were analysed using narrative synthesis. Methodological and reporting standards were assessed using two published checklists. Results Sixteen economic evaluations were included in this review; ten based in Africa, three in Latin and South America and three were cross-continent comparisons. Fifteen studies assessed point-of-care testing and treatment for syphilis, while one evaluated chlamydia. Key drivers of cost and cost-effectiveness included disease prevalence; test, treatment, and staff costs; test sensitivity and specificity; and screening and treatment coverage. All studies met 75% or more of the criteria of the Drummond Checklist and 60% of the Consolidated Health Economics Evaluation Reporting Standards. Conclusions Generally, point-of-care testing and treatment was cost-effective compared to no screening, syndromic management, and laboratory-based testing. Future economic evaluations should consider other common infections, and their lifetime impact on mothers and babies. Complementary affordability and equity analyses would strengthen the case for greater investment in antenatal point-of-care testing and treatment for sexually transmitted and genital infections.

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Rapid diagnostic test for antenatal syphilis screening in low-income and middle-income countries: a systematic review and meta-analysis

Cited by 22 publications

References 30 publications

The impact of antenatal syphilis point of care testing on pregnancy outcomes: A systematic review

The impact of antenatal syphilis point of care testing on pregnancy outcomes: A systematic review

Diagnostic accuracy of the Xpert CT/NG and OSOM Trichomonas Rapid assays for point-of-care STI testing among young women in South Africa: a cross-sectional study

Economic evaluation of point-of-care testing and treatment for sexually transmitted and genital infections in pregnancy in low- and middle-income countries: A systematic review

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