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Are Treponema pallidum Specific Rapid and Point-of-Care Tests for Syphilis Accurate Enough for Screening in Resource Limited Settings? Evidence from a Meta-Analysis

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  • Yalda Jafari
  • Rosanna W Peeling
  • Sushmita Shivkumar
  • Christiane Claessens
  • Lawrence Joseph
  • Nitika Pant Pai

Abstract

Background: Rapid and point-of-care (POC) tests for syphilis are an invaluable screening tool, yet inadequate evaluation of their diagnostic accuracy against best reference standards limits their widespread global uptake. To fill this gap, a systematic review and meta-analysis was conducted to evaluate the sensitivity and specificity of rapid and POC tests in blood and serum samples against Treponema pallidum (TP) specific reference standards. Methods: Five electronic databases (1980–2012) were searched, data was extracted from 33 articles, and Bayesian hierarchical models were fit. Results: In serum samples, against a TP specific reference standard point estimates with 95% credible intervals (CrI) for the sensitivities of popular tests were: i) Determine, 90.04% (80.45, 95.21), ii) SD Bioline, 87.06% (75.67, 94.50), iii) VisiTect, 85.13% (72.83, 92.57), and iv) Syphicheck, 74.48% (56.85, 88.44), while specificities were: i) Syphicheck, 99.14% (96.37, 100), ii) Visitect, 96.45% (91.92, 99.29), iii) SD Bioline, 95.85% (89.89, 99.53), and iv) Determine, 94.15% (89.26, 97.66). In whole blood samples, sensitivities were: i) Determine, 86.32% (77.26, 91.70), ii) SD Bioline, 84.50% (78.81, 92.61), iii) Syphicheck, 74.47% (63.94, 82.13), and iv) VisiTect, 74.26% (53.62, 83.68), while specificities were: i) Syphicheck, 99.58% (98.91, 99.96), ii) VisiTect, 99.43% (98.22, 99.98), iii) SD Bioline, 97.95%(92.54, 99.33), and iv) Determine, 95.85% (92.42, 97.74). Conclusions: Rapid and POC treponemal tests reported sensitivity and specificity estimates comparable to laboratory-based treponemal tests. In resource limited settings, where access to screening is limited and where risk of patients lost to follow up is high, the introduction of these tests has already been shown to improve access to screening and treatment to prevent stillbirths and neonatal mortality due to congenital syphilis. Based on the evidence, it is concluded that rapid and POC tests are useful in resource limited settings with poor access to laboratories or screening for syphilis.

Suggested Citation

  • Yalda Jafari & Rosanna W Peeling & Sushmita Shivkumar & Christiane Claessens & Lawrence Joseph & Nitika Pant Pai, 2013. "Are Treponema pallidum Specific Rapid and Point-of-Care Tests for Syphilis Accurate Enough for Screening in Resource Limited Settings? Evidence from a Meta-Analysis," PLOS ONE, Public Library of Science, vol. 8(2), pages 1-8, February.
  • Handle: RePEc:plo:pone00:0054695
    DOI: 10.1371/journal.pone.0054695
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    References listed on IDEAS

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    1. Julia E. Aledort & Allan Ronald & Maria E. Rafael & Federico Girosi & Peter Vickerman & Sylvie M. Le Blancq & Alan Landay & King Holmes & Renee Ridzon & Nicholas Hellmann & Molly V. Shea & Rosanna W. , 2006. "Reducing the burden of sexually transmitted infections in resource-limited settings: the role of improved diagnostics," Nature, Nature, vol. 444(1), pages 59-72, November.
    2. Alessandro Liberati & Douglas G Altman & Jennifer Tetzlaff & Cynthia Mulrow & Peter C Gøtzsche & John P A Ioannidis & Mike Clarke & P J Devereaux & Jos Kleijnen & David Moher, 2009. "The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration," PLOS Medicine, Public Library of Science, vol. 6(7), pages 1-28, July.
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    1. Patricia Mallma & Patricia Garcia & Cesar Carcamo & Sergio Torres-Rueda & Rosanna Peeling & David Mabey & Fern Terris-Prestholt, 2016. "Rapid Syphilis Testing Is Cost-Effective Even in Low-Prevalence Settings: The CISNE-PERU Experience," PLOS ONE, Public Library of Science, vol. 11(3), pages 1-11, March.
    2. Andreas Kuznik & Christine Muhumuza & Henry Komakech & Elsa M R Marques & Mohammed Lamorde, 2015. "Antenatal Syphilis Screening Using Point-Of-Care Testing in Low- and Middle-Income Countries in Asia and Latin America: A Cost-Effectiveness Analysis," PLOS ONE, Public Library of Science, vol. 10(5), pages 1-9, May.
    3. Minh D. Pham & Jason J. Ong & David A. Anderson & Heidi E. Drummer & Mark Stoové, 2022. "Point-of-Care Diagnostics for Diagnosis of Active Syphilis Infection: Needs, Challenges and the Way Forward," IJERPH, MDPI, vol. 19(13), pages 1-9, July.

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