Optimizing hepatitis B diagnosis for mothers in a low-resource setting: A field pilot of Xpert point-of-care viral load testing in Ugandan antenatal clinics.

Mother-to-child transmission accounts for most new hepatitis B (HBV) infections in high-burden regions globally. The World Health Organization recommends antiviral prophylaxis for pregnant women with high hepatitis B viral load levels, but access to viral load testing remains limited and untimely in many countries, due to centralized testing. We assessed the operational feasibility, accessibility, and cost of implementing the Xpert HBV DNA assay in antenatal care settings. This was a two-phase study at 10 high-volume hospitals across nine regions of Uganda. Phase I verified the diagnostic accuracy of Xpert HBV DNA assay against the COBAS Taqman platform, while Phase II assessed feasibility, usability, and cost of integrating PoC testing into routine antenatal care using GeneXpert systems. Quantitative data were extracted from facility registers, entered into ODK, and analysed using SPSS 19 and Excel. Qualitative data, consisting of feedback from study teams, were analysed thematically. Xpert HBV DNA assay demonstrated full concordance with the COBAS platform. Overall, 96.7% of samples were processed, 92% returned to providers, and 61% of mothers received their results on the same day. Of 181 pregnant women provided HBV DNA testing, 12% had viral loads >200,000 IU/mL, thus eligible for antiviral prophylaxis. Among pregnant women eligible for prophylaxis, 14 had received antiviral prophylaxis. Birth records were available for 15 pregnant women, and 73.3% of their newborns had received the hepatitis B birth dose vaccine. Coordination between ANC and laboratory services, including the timely dispatch of results to pregnant women, was generally smooth and enabled prompt decision-making. However, some challenges were reported, such as stockout of screening kits and competing testing priorities within laboratories. At USD 15.37 per test, its cost was comparable to centralized testing (USD 15.26), but it offered advantages such as reduced delays and fewer client visits. The Xpert platform offers a timely, accurate, operationally feasible solution for accessing hepatitis B antiviral prophylaxis or treatment, improving quality of care for hepatitis B-positive mothers. With rapid turnaround time and cost comparable to centralized testing, it presents a valuable tool for improving HBV prevention and treatment in Uganda and similar resource-limited settings.