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

BACKGROUND: 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. OBJECTIVE: This systematic review assessed the accuracy of on-site tests to detect infection with Treponema pallidum in pregnant women. SEARCH STRATEGY: 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. SELECTION CRITERIA: We included studies that used dual reference standard (non-treponemal and treponemal tests) to detected syphilis in pregnancy. DATA COLLECTION AND ANALYSIS: Extracted accuracy data were tabulated and pooled using hierarchical, bivariate random effects model. MAIN RESULTS: 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). CONCLUSION: 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. TWEETABLE ABSTRACT: On-site test to detect syphilis-options during antenatal care.