WHO-approved test panel for HIV, Syphilis and Hepatitis B unveiled in Kigali

A new rapid test panel for HIV, hepatitis B, and syphilis screening in pregnant women was unveiled at the International AIDS Society (IAS) Conference on HIV Science in Kigali on July 15. The test, known as Determine™ Antenatal Care Panel (ANC panel), aims to improve maternal infectious disease detection and treatment. ALSO READ: IAS Conference opens in Kigali amid warnings over HIV funding cuts Abbott, a global healthcare company specializing in medical diagnostics, received World Health Organization (WHO) prequalification on July 10, for its new triple elimination test panel. The company developed the test to screen pregnant women for HIV, hepatitis B, and syphilis using a single finger prick, delivering results within 20 minutes. “The test is designed to fit into busy clinics with limited staff and resources, aiming to reduce delays and help countries achieve WHO’s 2030 elimination targets, said Steven Henn, the head of Global Commercial Operations Rapid Diagnostics at Abbott. Through long-term partnerships with ministries of health, we are working to improve access to essential diagnostics critical for preventing mother-to-child transmission of these infections. Henn explained that each kit contains all components needed for testing, to avoid shortages that often disrupt services. ALSO READ: African countries urged to boost domestic funding to sustain progress in HIV fight He added that it is meant for the settings where the need is highest, adding that the new test also supports national data collection by delivering quicker, combined results. Henn explained that real‑time data from rapid tests help identify gaps in treatment coverage, especially among men and hard‑to‑reach populations. He noted that the triple elimination test was designed based on feedback from frontline health workers, ensuring it meets real-world needs. By packaging everything in a single kit, the risk of missing components or running out of supplies, which often disrupt testing, is reduced. When will Rwanda get the kit? Dr Gallican Rwibasira, the Head of National HIV, STIs and Hepatitis Programmes at Rwanda Biomedical Centre (RBC), said that Rwanda’s timeline for adopting the triple elimination test panel depends on funding availability, among other factors. He said the process prioritizes scientific evidence and accuracy before cost. While collaborating with global funders, the official said, Rwanda negotiates to protect national interests, adding that the use of rapid HIV and hepatitis B tests will ease adding syphilis through the combined panel. Rwibasira described how Rwanda has expanded maternal HIV testing to over 99% coverage among pregnant women and strengthened hepatitis B testing to nearly 97%, supported by the hepatitis elimination campaign launched in 2018, where more than 300,000 pregnant women are tested each year. However, he noted that the syphilis testing coverage remains below 70%, a gap that is mainly due to reliance on laboratory‑based methods, which require separate blood samples and delayed results. “If testing happens at the point of care, we can act immediately and don’t lose patients between testing and treatment,” he said. Dr Rwibasira explained that field evaluations of the new triple test in Rwanda showed nearly all healthcare workers could use it without adding difficulty to routine antenatal care. He added that Rwanda’s approach focuses on bringing services closer to communities and integrating services into primary care, supported by community health workers. “It’s not about showing good numbers on paper. Services must be there every day, even during funding disruptions or emergencies,” he said. Dr Rwibasira proposed extending the use of the triple elimination panel beyond antenatal care to include partner testing during pregnancy, noting that focusing solely on mothers risks overlooking infections in male partners that could otherwise be identified and treated. Dr Missiani Ochwoto, a researcher at the Kenya Medical Research Institute, presented data from a study of a four‑disease panel covering HIV, hepatitis B, syphilis and malaria. Conducted between 2021 and 2023 across four counties and involving 577 pregnant women, the study used a single finger prick to test for all the diseases at once. Dr Ochwoto said the combined test reduced testing time by about 65% and lowered referrals to external laboratories. “For mothers, it meant fewer visits and less travel costs, saving them nearly 10% in time and expenses. The study also showed hepatitis B testing coverage improved when the infection was included in a combined test, addressing gaps linked to cost and inconsistent test availability,” he noted. Dr Ochwoto explained that the digital tools supported the Kenyan pilot, using an Open Data Kit (ODK) system to send results directly to central health databases, which made it possible to react quickly when new HIV cases were found through antigen testing. He proposed further digitising the test process so devices, not people, read results, reducing bias and integrating directly into health information systems. Dr Ochwoto added that real‑world data from studies can convince donors and ministries to support broader rollout. Deborah Birx, the former U.S. Global AIDS Coordinator and a global health expert, explained the importance of WHO prequalification (PQ), which many countries use to decide on introducing new products. “For some, WHO prequalifation is enough; others still do local usability testing. But PQ is the first step that signals a product is safe and works,” she said. Birx noted that while co‑packaging HIV and syphilis tests improved syphilis testing rates in countries like Malawi and Zambia, hepatitis B testing still lags. “Without data, hepatitis B is still invisible, we need more integrated diagnostics to fill these gaps. Over 93% of people in Eastern and Southern Africa now know their HIV status, a figure not seen before for a chronic infection. That came from community‑level programmes that kept running even during COVID‑19,” she said. Birx added that although African HIV programmes have built strong technical expertise and proven resilient even during crises, they still rely heavily on external funding, with limited domestic financial resources to sustain progress. “Maternal infectious disease testing is part of a wider effort to detect other silent conditions, like hypertension and diabetes, using the same community‑level networks. If we can test many people for HIV, we can do the same for other diseases,” she said.

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WHO-approved test panel for HIV, Syphilis and Hepatitis B unveiled in Kigali