Despite their promise, many digital and molecular technologies remain difficult to deploy in the settings where hepatitis B has the greatest burden.

Advanced diagnostic platforms require specialized laboratories, reliable electricity, expensive reagents, and trained personnel. Digital health systems depend on connectivity, electronic data infrastructure, and health care facilities capable of maintaining these technologies.

Across many parts of sub-Saharan Africa, rural health facilities often depend on central laboratories located far from patients. Blood samples may travel long distances before testing, delaying results and creating additional barriers to care.

Even conventional hepatitis B screening has limitations. Most programs rely on hepatitis B surface antigen (HBsAg) tests because they are affordable and suitable for large-scale screening. However, some infections remain undetected because biological changes in the virus or low levels of detectable antigen can result in negative results despite ongoing infection.

For South African virologist Nondumiso Nkosi, MSc, these gaps highlighted the need for additional diagnostic approaches that can reach patients who remain outside existing systems and might otherwise be overlooked.

During her master’s research, Nkosi encountered a persistent issue. “The patient has all the clinical indications that are pointing to liver disease,” she recalls. “But when they test using the platforms that we have, the results come back negative.”

“We saw that there was a gap,” Nkosi says. “Yes, we do have platforms that diagnose hepatitis B. But what we realized is that there was a huge gap in terms of the people who are actually not informed by these diagnostic tools.”

These experiences shaped her doctoral research and led to the development of HepaSure Diagnostics, a low-cost point-of-care diagnostic platform designed for resource-limited settings.

Nkosi, now a PhD candidate and research scientist at Sefako Makgatho Health Sciences University in South Africa, developed the technology through collaboration with Nagoya City University Hospital in Japan. The platform is currently undergoing validation.

Her research focused on occult hepatitis B infection, a form of infection in which individuals carry hepatitis B virus DNA but test negative using conventional HBsAg assays. Molecular techniques such as polymerase chain reaction (PCR) can detect viral genetic material even when HBsAg tests are negative but can pose challenges. “PCR is far more sensitive because it detects the genetic material of the virus,” Nkosi says. “But it is expensive because of the reagents involved, the expertise required, and the infrastructure needed to run the testing.”

Rather than replacing laboratory or digital diagnostics, Nkosi’s team designed HepaSure as a complementary tool that could extend diagnosis closer to patients.

The portable test is designed to resemble a rapid HIV test and targets a different component of the hepatitis B virus from the marker detected by conventional HBsAg tests. The aim is to identify infections that may otherwise be missed while making testing possible in settings without advanced laboratory infrastructure or connectivity.

“Technology should meet people where they are,” Nkosi says. “If we can diagnose someone earlier in the community, we can improve their chances of receiving treatment before they develop severe liver disease.”

The research team is currently evaluating HepaSure using patient serum and whole-blood samples to assess its analytical and diagnostic sensitivity and specificity.

“By the end of this year, we should have all validation studies compiled with the reporting to say that what we saw in the lab is the same as well in terms of a clinical approach,” Nkosi says.

Beyond scientific validation, Nkosi says funding early-stage health innovation remains a major challenge. “As much as they would say that funding is available and out there, there are so few institutions that are willing to cover the risky stages of research and development,” she says.

Developing a diagnostic tool requires significant investment before it reaches patients, and many researchers struggle to secure support during the earliest stages of development.

If successful, implementation will require health care worker training, quality assurance systems, and regulatory approval to ensure consistent performance across different settings.

As hepatitis B elimination efforts continue, Nkosi’s work highlights the importance of designing technologies around local health care realities.

Digital tools will remain essential for improving data management, monitoring, and continuity of care. However, point-of-care diagnostics can complement these advances by reaching communities where infrastructure and resources remain significant challenges.

“African researchers have the capacity to do it,” Nkosi says. “The ideas that come from Africa are exceptional. Never doubt your idea. Sometimes something that seems small could become something big.”

While HepaSure Diagnostics is still undergoing validation, its development illustrates a broader lesson for digital health: no single technology will close the hepatitis B diagnosis gap alone.

Combining digital innovation with affordable, locally appropriate diagnostics may offer the best opportunity to ensure that more people living with hepatitis B are identified, treated, and connected to care.