On-site test to detect syphilis in pregnancy: a systematic review of test accuracy studies.

Abstract

Syphilis in pregnancy can lead to fetal and neonatal death or congenital anomalies. Accurate on-site tests are an essential part of effective prevention of mother-to-child transmission of the disease. This systematic review assessed the accuracy of on-site tests to detect infection with Treponema pallidum in pregnant women. Major databases were searched from inception to January 2016 using terms: 'pregnancy', 'antenatal', 'syphilis', 'Treponema pallidum' with their variations, and the search limit for the relevant study design. We included studies that used dual reference standard (non-treponemal and treponemal tests) to detected syphilis in pregnancy. Extracted accuracy data were tabulated and pooled using hierarchical, bivariate random effects model. Seven studies (combined sample 17 546) reporting the accuracy of four on-site tests met the eligibility criteria. On average, Determine™ and SD BioLine Syphilis 3.0 had the highest sensitivity of all the evaluated tests: 0.83 (95% CI 0.58, 0.98) and 0.86 (95% CI 0.82, 0.89), respectively, with a high specificity 0.96 (95% CI 0.89, 1.00) and 0.99 (95% CI 0.94, 1.00), respectively. The Qualitative Rapid Plasma Reagin card commonly used in clinical practice had a pooled sensitivity of 0.70 (95% CI 0.54, 0.88) and specificity of 0.97 (95% CI 0.96, 0.99). Immunochromatographic tests such as Determine™ and SD BioLine Syphilis 3.0 seem to be acceptable options in antenatal testing for syphilis, especially in resource-limited settings. Future research should seek more evidence to strengthen this claim. On-site test to detect syphilis-options during antenatal care.