Article Text
Abstract
Background The detection of schistosome-derived antigens in urine is a highly effective diagnostic approach for controlling schistosomiasis. It offers greater sensitivity compared to parasitological methods and involves a more convenient, user-friendly lab-based method. This diagnostic approach is particularly advantageous for pregnant women and young children, as early detection of active infections can lead to prompt treatment with Praziquantel (PZQ). The freeBILy clinical trial in Gabon (NCT03779347) evaluated the accuracy of the circulating anodic antigen (CAA) test for detecting Schistosoma haematobium (Sh) infections in pregnant women as well as an endpoint measure for PZQ efficacy.
Methods The accuracy of the upconverting particle lateral flow (UCP-LF) CAA urine test was comprehensively evaluated using a cross-sectional design and comparing it against urine filtration (UF) and PCR. Subsequently, Sh-positive pregnant women were enrolled in sub-study and received a single dose of PZQ either immediately (intervention) or after delivery (control) to assess the safety of PZQ use during pregnancy and to monitor the kinetics of CAA levels following PZQ administration. Finally, in an observational, longitudinal study mothers and their newborns were followed to determine the incidence of schistosomiasis in infants with accurate diagnostics.
Results A total of 733 pregnant women were enrolled in this study with mean age 25.3 years. The prevalence of schistosomiasis measured by the respective tests was 18% (UF), 19% (UCP-LF CAA), and 12% (PCR). Compared to the composite reference standard, the sensitivity of UCP-LF CAA was 71.8%, with 64% and 68% for UF and PCR, resp.
Conclusion Preliminary data show a high prevalence of schistosomiasis among pregnant women. Furthermore, the UCP-LF-CAA test was more sensitive than conventional microscopy, which contributed to the improved health of pregnant women as they were treated during pregnancy. PZQ treatment had no deleterious effects on mother nor child, and administrating it to pregnant women can be considered to be safe.