POC Testing for Hepatitis B DNA as Effective as Traditional Laboratory Testing

Despite being preventable through vaccination and treatable in its chronic form, hepatitis B causes more than one million deaths each year worldwide. Access to timely and accurate testing remains a major challenge, particularly in low- and middle-income countries and remote regions where laboratory facilities are limited.

Accurate measurement of hepatitis B DNA levels is critical to determine who needs treatment and to monitor whether therapy is working. However, traditional testing often requires venous blood collection, long-distance travel, and extended waiting times for results. Now, new clinical trial findings show that a simpler fingerstick-based approach can deliver comparable accuracy while enabling faster diagnosis and care.

In a study led by the Kirby Institute (Sydney, NSW, Australia), researchers evaluated a point-of-care hepatitis B DNA test designed to work with a small fingerstick blood sample rather than a venous draw processed in centralized laboratories. Point-of-care testing can be performed in small clinics and decentralized settings by a wider range of healthcare workers.

The test provides results within 60 minutes, reducing the need for multiple clinic visits and long delays associated with conventional laboratory testing. While similar approaches are already used for other infectious diseases, their effectiveness for hepatitis B DNA testing using fingerstick blood had not been established until now.

The clinical trial compared the fingerstick point-of-care hepatitis B DNA test directly with standard laboratory-based DNA testing. Results showed that the point-of-care test closely matched the accuracy of traditional methods for measuring viral load. These findings, published in the Journal of Clinical Microbiology, confirm that the fingerstick test can reliably identify patients who may benefit from treatment and support ongoing monitoring.

The results demonstrate that decentralized testing can meet the same accuracy standards as laboratory-based diagnostics. Globally, an estimated 254 million people live with chronic hepatitis B, yet diagnosis and treatment rates remain critically low. Limited access to testing is one of the biggest barriers to improving care and achieving global elimination targets. Faster, decentralized DNA testing could significantly improve linkage to care, particularly in underserved and remote populations.

The findings support recent World Health Organization guidelines that recommend the use of hepatitis B point-of-care DNA fingerstick tests worldwide. Researchers say the evidence paves the way for broader integration of point-of-care testing into hepatitis B programs, helping expand diagnosis, monitoring, and treatment regardless of geography.

“Our research demonstrates that point-of-care testing for hepatitis B DNA using finger stick blood is, indeed, highly accurate and effective,” said the Kirby Institute’s Associate Professor Tanya Applegate. “Given the technology is already in use for a range of other infectious diseases globally, our evidence paves the way for integrating infectious disease care significantly enhancing access to hepatitis B testing, monitoring and treatment, no matter where someone lives.”

Related Links:
Kirby Institute