title: 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.
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.
authors.affiliation: Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Canada.
authors.forename: Yalda
authors.initials: Y
authors.lastname: Jafari
authors.forename: Rosanna W
authors.initials: RW
authors.lastname: Peeling
authors.forename: Sushmita
authors.initials: S
authors.lastname: Shivkumar
authors.forename: Christiane
authors.initials: C
authors.lastname: Claessens
authors.forename: Lawrence
authors.initials: L
authors.lastname: Joseph
authors.forename: Nitika Pant
authors.initials: NP
authors.lastname: Pai
mesh_terms: D000328:Adult; D016208:Databases, Factual; D005260:Female; D006295:Health Resources; D006801:Humans; D008297:Male; D008403:Mass Screening; D019095:Point-of-Care Systems / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D060386:Sex Workers; D013587:Syphilis / Q000175:diagnosis* / Q000453:epidemiology; D014210:Treponema pallidum