Burnet Institute has developed a novel point-of-care test for confirmation of active syphilis (TP-IgA POCT), which shows excellent diagnostic performance in early evaluations in China and South Africa
The TP-IgA POCT has the further potential to assist early diagnosis of CS in infants (less than 30 days of age).
We will conduct a prospective clinical validation study to assess clinical utility of the TP-IgA in diagnosis of active syphilis in pregnant women and examining the test capacity in diagnosis of CS in infants born to infected mothers.
A total of 2,433 pregnant women attending ANC clinics at the Colonial War Memorial Hospital in Suva, Fiji will be recruited into the study.
The sample size was calculated based on a disease prevalence of 3%, an expected sensitivity of the TP-IgA of 95% with maximum marginal error of estimate ≤5% at 95% confidence level. At least 70 infants will be tested for CS (i.e. infants born to mothers with positive result in the TP screening and/or confirmatory test).
Data from this study will be used for regulatory approvals (CE mark, WHO prequalification) and guide implementation trials of the TP-IgA in a variety of low-resource settings.
- Thrasher Research Fund
- Murdoch Children’s Research Institute, Melbourne, Australia
- Colonial War Memorial Hospital, Suva, Fiji
Meet the project team. Together, we are translating research into better health, for all.
Professor Heidi Drummer
SCIENTIFIC DIRECTOR FOR RESEARCH TRANSLATION (SDRT); SCIENTIFIC DIRECTOR, BURNET DIAGNOSTICS INITIATIVE; PRINCIPAL INVESTIGATOR, BURNET VACCINE INITIATIVE; CO-HEAD, VIRAL ENTRY AND VACCINES GROUP
Professor Heidi Drummer is Scientific Director for Research Translation (SDRT) and co-Head of the Vi...