On-Site Test to Detect Syphilis in Pregnancy: A Systematic Review of Test Accuracy Studies
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Obstetrical and Gynecological Survey
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Syphilis, an infection of the Treponema pallidum bacterium, can easily go undetected. This sexually transmitted infection can affect pregnant women and lead to adverse outcomes through vertical infection including congenital anomalies and neonatal death. The World Health Organization supports screening all pregnant women, and on-site tests are an important tool for effective screening. This review aims to assess immunochromatographic point-of-care treponemal tests for accuracy and compare these tests with the rapid plasma reagin (RPR) card. MEDLINE, EMBASE, Web of Science, Lilacs, and Scopus were searched using terms including “pregnancy,” “antenatal,” “Syphilis,” “Treponema pallidum,” and “gestation.” Articles were screened by 2 independent reviewers, and studies had to recruit pregnant women without symptoms of syphilis and also use a double reference of a nontreponemal test followed by a treponemal test. Studies were excluded if it was not possible to calculate false negatives, true negatives, true positives, and false positives. Seven publications, published between 1993 and 2015 and including 17,546 pregnant women, met eligibility criteria and were used in the study. The seroprevalence of syphilis ranged from 1% to 11%. Four tests were reported on in the publications: immunochromatographic tests Determine, SD BioLine Syphilis 3.0, Visitect Syphilis, and qualitative RPR card. The Determine test was reported on in 2 publications and was found to have a pooled sensitivity of 0.83 (95% confidence interval [CI], 0.58–0.98) and specificity of 0.96 (95% CI, 0.89–1.00). The SD BioLine Syphilis 3.0 was also reported on in 2 studies and had a pooled sensitivity of 0.86 (95% CI, 0.82–0.89) and specificity of 0.99 (95% CI, 0.94–1.00). One study of 712 women reported on the study of Visitect Syphilis, which had a sensitivity of 0.63 (95% CI, 0.31–0.86) and specificity of 0.98 (95% CI, 0.97–0.99). In 5 studies, the RPR test was used as an index and had a pooled sensitivity of 0.70 (95% CI, 0.50–0.85) and pooled specificity of 0.97 (95% CI, 0.96–0.98). Of the 3 immunochromatographic tests, there was not a significant difference in specificity, but SD BioLine Syphilis 3.0 had the highest sensitivity on average and a higher sensitivity compared with the qualitative RPR card. In antenatal testing for syphilis, SD BioLine Syphilis 3.0 and Determine may be acceptable tests, but further research is needed to directly compare accuracy of these tests while controlling for confounders.
AuthorsRogozińska, E; Kara-Newton, L; Zamora, JR; Khan, KS
- Population Health