Regulation Briefs

Africa’s Hepatitis B Fight Needs More Than Tests

By Daisy Marshall
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Female doctor conducting an ultrasound screening on a patient in a medical office.
Female doctor conducting an ultrasound screening on a patient in a medical office. Photo: Pavel Danilyuk/Pexels

Expanding hepatitis B screening in Africa requires more than purchasing diagnostic kits. Health systems must also allocate resources for staff training, reliable supplies, follow-up care, and timely vaccination for newborns. Without this broader investment, identifying infections may not prevent future cases.

Healthcare managers and procurement teams face the challenge of building a full service around existing pregnancy-care visits and ensuring patients receive the necessary follow-up care.

The scale of the need

The World Health Organization estimates that 240 million people were living with chronic hepatitis B in 2024. Its African Region accounted for 68% of new chronic infections that year. These figures represent regional disease-burden estimates, not measures of antenatal screening coverage.

A March 2026 market memo from the Clinton Health Access Initiative (CHAI), updated in May, reports an average 2024 antenatal screening coverage of 44% for hepatitis B, compared with 93% for HIV and 86% for syphilis.

Interpreting these figures requires caution. The assessment covered 16 selected country programs across Africa and Asia. Hepatitis B coverage data were available from eight countries, while HIV and syphilis data came from 15. The percentages reflect different reporting groups, not a representative comparison across Africa.

Nonetheless, the findings highlight an implementation issue: incorporating screening into national policy does not automatically ensure testing at the clinic level.

In written responses, Abbott’s medical team identified fragmented implementation, limited test procurement, and insufficient dedicated funding as recurring barriers. These observations are based on the company’s regional experience rather than a continent-wide survey.

Integration does not require a single device

Integrated screening involves coordinating services for HIV, syphilis, and hepatitis B within antenatal care. This can be achieved through separate rapid tests or a combined HIV/syphilis test alongside a hepatitis B surface antigen test.

A triple-combination product is another option. CHAI emphasizes the broader service model over the emerging market for these products. Procurement decisions should consider the available testing pathway, national requirements, and supply reliability, rather than assuming integration depends on a specific device.

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For clinic managers, practical considerations include who performs testing, how results are recorded, who explains them, and how a positive result triggers further assessment.

The budget must cover the whole pathway

When asked about the cost of adding hepatitis B screening, Abbott did not provide a standard figure. Their team explained that costs vary by country, procurement arrangements, testing volume, and implementation model.

The price of a test kit alone does not determine the cost of delivering a functional screening program. Budget planning should account for staff time, training, quality assurance, stock management, additional assessment, and referral. It should also include medicines and vaccination services where needed.

A positive test must lead to care

The WHO recommends hepatitis B testing for pregnant women to enable consideration of preventive measures. A positive screening result should lead to assessment under the applicable clinical pathway, including evaluation of the mother’s treatment needs and eligibility for antiviral prophylaxis to reduce transmission.

Screening does not replace infant vaccination. The WHO recommends a hepatitis B vaccine dose for all babies as soon as possible after birth, within 24 hours, followed by completion of the vaccination series. The universal birth-dose recommendation is not contingent on a positive maternal test.

Abbott’s responses highlight operational challenges, including home deliveries, births outside normal clinic hours, supply-chain constraints, and delayed doses until discharge. Addressing these issues requires coordination between antenatal services, maternity facilities, and immunization teams.

For funders and healthcare operators, effective performance measures go beyond procurement volumes. They should include screening coverage, stock-outs, completion of follow-up assessment, access to indicated prophylaxis, and timely infant vaccination.

These measures help identify breakdowns in the pathway. A clinic may increase testing while patients remain unable to obtain further assessment, or a maternity service may hold vaccine stock without consistently delivering the birth dose on time.

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