On 10 July 2025, the World Health Organization (WHO) prequalified the first bundled set of three in vitro rapid diagnostic tests (RDTs) capable of simultaneously detecting HIV, hepatitis B virus (HBV) and syphilis – three major infections that pose serious risks to maternal and child health.
The prequalification listing of the Determine™ Antenatal Care Panel is expected to facilitate timely and expanded access to testing in communities where pregnant women often face significant barriers to early diagnosis and essential maternal health care. This advancement also supports the global initiative to eliminate mother-to-child transmission of HIV, HBV and syphilis as a public health problem – a critical effort known as triple elimination.
HIV, HBV and syphilis are not only leading causes of preventable illness and death but also carry a high risk of vertical (mother-to-child) transmission during pregnancy, childbirth or breastfeeding. Early diagnosis during pregnancy is therefore crucial. Timely testing allows pregnant women to access appropriate treatment, prophylaxis and supportive care, significantly reducing the risk of complications and transmission to the infant. WHO recommends that all pregnant women be tested at least once for these three pathogens – and as early as possible – during pregnancy.
"Ensuring rapid access to quality-assured diagnostic tests is essential to protecting the health of vulnerable populations, including pregnant women," said Dr Rogério Gaspar, Director of WHO's Department of Prequalification and Regulation of Medicines and Health Products. "This milestone reflects our continued commitment to accelerating the availability of safe, effective and quality health innovations where they are needed most."
To date, WHO has prequalified three dual HIV/syphilis RDTs and continues to monitor a growing pipeline of multiplex diagnostic tools. Assessing these innovations remains a strategic priority, as they offer the potential to further strengthen integrated testing efforts. The newly listed product can build on the successful scale-up of dual HIV/syphilis RDTs and existing WHO guidance to support broader access to integrated antenatal screening.
As health systems face growing resource constraints, integrated approaches such as multiplex testing are increasingly vital. They have the potential to simplify service delivery, reduce costs and improve testing coverage, especially in low-resource and high-burden settings.
WHO is currently developing global guidance on multiplex testing to support countries in effectively deploying this panel, and other emerging multiplex diagnostics. The guidance will offer evidence-based recommendations on when, where, and how to use multiplex tests to maximize impact, and answer questions on the viability of further multiplex self-testing.
"Rapid multiplex tests like this mark a new era for diagnostics as they have potential to transform service delivery and population health. By aligning product prequalification with programmatic guidance, WHO is helping countries implement innovations smarter and faster through working across departments. With our multiplex testing guidelines coming soon, we can turn innovation into impact," said Dr Meg Doherty, WHO Director of the Global HIV, Hepatitis and STI Programmes.
Designed for use by trained health-care providers at the point of care, the Determine™ Antenatal Care Panel is currently intended specifically for pregnant women aged 12 years and older. It enables simultaneous testing for HIV-1/2 antibodies and HIV-1 p24 antigen (Determine™ HIV Early Detect), hepatitis B surface antigen (Determine™ HBsAg 2), and syphilis antibodies to Treponema pallidum (Determine™ Syphilis TP). Each test is qualitative, visually read, and uses capillary whole blood from a finger-prick – providing a practical, efficient tool to aid in the diagnosis of HIV, HBV, and syphilis during pregnancy.
This listing reflects the strong, ongoing collaboration between WHO's Global HIV, Hepatitis and STI Programmes and the Department of Prequalification and Regulation of Medicines and Health Products. Together, they are working to accelerate access to high-impact tools and ensure they reach the people who need them most.
