Novel Point-of-care Testing for Diagnosis of Active Syphilis in Pregnant Women and Infants in Fiji

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.

2021-2024

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.