TY - JOUR T1 - Improving the coverage and accuracy of syphilis testing: The development of a novel rapid, point-of-care test for confirmatory testing of active syphilis infection and its early evaluation in China and South Africa. AU - Pham,Minh D, AU - Wise,Amy, AU - Garcia,Mary L, AU - Van,Huy, AU - Zheng,Shuning, AU - Mohamed,Yasmin, AU - Han,Yan, AU - Wei,Wan-Hui, AU - Yin,Yue-Ping, AU - Chen,Xiang-Sheng, AU - Dimech,Wayne, AU - Braniff,Susie, AU - Technau,Karl-Günter, AU - Luchters,Stanley, AU - Anderson,David A, Y1 - 2020/06/27/ PY - 2020/04/20/received PY - 2020/06/07/revised PY - 2020/06/11/accepted PY - 2020/7/9/entrez PY - 2020/7/9/pubmed PY - 2020/7/9/medline KW - China KW - Diagnostic accuracy KW - IgA KW - Point of care test KW - South Africa KW - Syphilis SP - 100440 EP - 100440 JF - EClinicalMedicine JO - EClinicalMedicine VL - 24 N2 - BACKGROUND: Current point-of-care tests (POCT) for syphilis, based on the detection of Treponema pallidum (TP) total antibodies, have limited capacity in distinguishing between active and past/treated syphilis. We report the development and early evaluation of a new prototype POCT based on the detection of TP-IgA antibodies, a novel biomarker for active syphilis. METHODS: The TP-IgA POCT (index test) was developed in response to the World Health Organisation (WHO) target product profile (TPP) for a POCT for confirmatory syphilis testing. Two sub-studies were conducted consecutively using 458 pre-characterised stored plasma samples in China (sub-study one, addressing the criteria for the WHO TPP), and 503 venous blood samples collected from pregnant/postpartum women in South Africa (sub-study two, addressing potential clinical utility). Performance of the index test was assessed against standard laboratory-based serology using a combination of treponemal (TPHA) and non-treponemal (rapid plasma reagin [RPR]) tests. FINDINGS: In sub-study one, the index test demonstrated 96·1% (95%CI=91·7%-98·5%) sensitivity and 84·7% (95%CI=80·15-88·6%) specificity for identification of active syphilis (TPHA positive, RPR positive). It correctly identified 71% (107/150) samples of past-treated syphilis (TPHA positive, RPR negative). In sub-study two, the index test achieved 100% (95%CI=59%-100%) sensitivity for active syphilis and correctly identified all nine women with past syphilis. INTERPRETATION: The TP-IgA POCT has met the WHO TPP for a POCT for diagnosis of active syphilis and demonstrated its potential utility in a clinical setting. Future studies are warranted to evaluate field performance of the final manufactured test. FUNDING: Saving Lives at Birth: Grand Challenge for Development, Thrasher Research Fund, and the Victorian Government Operational Infrastructure Scheme. SN - 2589-5370 UR - https://www.unboundmedicine.com/medline/citation/32637904/Improving_the_coverage_and_accuracy_of_syphilis_testing:_The_development_of_a_novel_rapid,_point-of-care_test_for_confirmatory_testing_of_active_syphilis_infection_and_its_early_evaluation_in_China_and_South_Africa. L2 - https://linkinghub.elsevier.com/retrieve/pii/S2589-5370(20)30184-X DB - PRIME DP - Unbound Medicine ER -