Novel Point-of-care Testing for Diagnosis of Active Syphilis in Pregnant Women and Infants in Fiji
BACKGROUND: Congenital syphilis (CS), caused by mother-to-child transmission (MTCT) of spirochete bacterium Treponemal Pallidum, is the second most common infectious cause of stillbirth and affects more newborn than any other infection, including HIV or tetanus. CS is preventable by timely diagnosis and treatment of active syphilis infection in pregnant women; preferably in the first trimester at first antenatal care (ANC) visit. GAP: Diagnosis of active syphilis requires screening and confirmatory testing; however, laboratory-based confirmatory test is often not available in low-resource settings. In 81 countries which account for >95% of maternal deaths and >90% of deaths in children under five, 74% of pregnant women who had at least four ANC visits did not receive syphilis testing. HYPOTHESIS: We developed a novel, prototype point-of-care test for confirmatory testing of active syphilis, which has proven to be effective in identifying active syphilis with >95% sensitivity and >85% specificity in laboratory and clinical settings. The test has been licensed for manufacture (BioPoint® TP-IgA); we hypothesize that it is accurate in diagnosis of maternal syphilis and is able to identify CS in infants born to infected mothers in real-world settings. METHODS: We conduct a prospective clinical validation study to assess clinical utility and feasibility of integrating the TP-IgA in routine ANC services in Fiji. A total of 2,433 pregnant women attending ANC clinics will be recruited into the study. Diagnostic performance of the TP-IgA will be compared with standard laboratory tests and clinical data of mothers and infants to determine clinical utility of the test in diagnosis of active syphilis. Feasibility will be assessed via self-administered questionnaire and interviews with health care staff. RESULTS: Pending. IMPACT: The availability of the TP-IgA will increase the rates of syphilis screening, diagnosis and treatment of active syphilis in pregnant women and infants born to infected mothers, prevent MTCT of syphilis leading to a reduction in the global morbidity and mortality associated with CS. Website Link: https://burnet.edu.au/projects/479_novel_poc_testing_for_diagnosis_of_active_syphilis_in_pregnant_women_and_infants_in_fijiOptional/Additional Comments: Following a successful development and early evaluations of the prototype TP-IgA (with supports from USAID and Thrasher Research Fund), this project will, for the first time, assess clinical utility of the manufactured test, providing essential data to guide the adoption and implementation of the test in real-world settings.