Journal article

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

Minh D Pham, Amy Wise, Mary L Garcia, Van Huy, Shuning Zheng, Yasmin Mohamed, Yan Han, Wan-Hui Wei, Yue-Ping Yin, Xiang-Sheng Chen, Wayne Dimech, Susie Braniff, Karl-Gunter Technau, Stanley Luchters, David A Anderson



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 ..

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University of Melbourne Researchers


Awarded by Saving Livesat Birth-A Grand Challenge for Development

Awarded by Thrasher Research Fund

Funding Acknowledgements

This work was jointly funded by Saving Livesat Birth-A Grand Challenge for Development managed by USAID (award number AID-OAA-F-13-00011) and, the Thrasher Research Fund via a project grant (award number: 12617).