A clinical trial led by the Kirby Institute at UNSW Sydney has found that point-of-care testing for hepatitis B DNA is as accurate and effective as conventional laboratory testing. The findings, published in the Journal of Clinical Microbiology, mark a significant step toward faster diagnosis and treatment, particularly in hard-to-reach and resource-limited communities.
Study Shows High Accuracy of Fingerstick Testing
Explaining the results, Professor Gail Matthews, who led the research at the Kirby Institute, said the fingerstick point-of-care test demonstrated accuracy closely matching that of traditional laboratory-based methods.
As reported by medicalxpress, she noted that this breakthrough has the potential to dramatically expand access to hepatitis B testing and treatment worldwide, especially in remote areas and low-resource settings where current testing options remain limited.
Hepatitis B Remains a Major Global Health Challenge
Hepatitis B is a viral infection that attacks the liver and causes inflammation. Over time, it can lead to serious complications such as cirrhosis, liver failure, and liver cancer. Although vaccination can prevent the disease and effective treatments are available for chronic infection, hepatitis B still causes more than one million deaths each year.
While high-income countries generally have strong vaccination programmes and better access to care, most people living with chronic hepatitis B reside in low- and middle-income countries, where testing and treatment remain difficult to access. Even in Australia, hepatitis B DNA testing poses challenges for people living in remote regions.
DNA Testing Critical for Treatment Decisions
Highlighting the clinical importance of DNA testing, Associate Professor Behzad Hajarizadeh, the study’s first author, explained that not all individuals with hepatitis B require treatment.
He said patients with higher viral loads are more likely to benefit from therapy, making DNA testing essential to determine virus levels. Additionally, clinicians rely on DNA testing to monitor treatment response once therapy begins.
Limitations of Conventional Laboratory Testing
Currently, hepatitis B DNA testing requires venous blood samples that must be sent to centralised laboratories. As a result, patients often travel long distances for testing and wait days or even weeks for results.
Consequently, these delays and repeated clinic visits can discourage patients from continuing care and delay timely treatment initiation.
Point-of-Care Testing Offers Faster, Accessible Alternative
In contrast, point-of-care testing can be performed in smaller health clinics using a simple fingerstick blood sample. A wider range of healthcare workers can administer the test, and results are available within 60 minutes.
Although point-of-care testing is already widely used for other infectious diseases such as hepatitis C, its effectiveness for hepatitis B DNA using fingerstick blood had not been previously established.
Study Confirms Effectiveness of Point-of-Care Technology
Addressing this gap, Associate Professor Tanya Applegate from the Kirby Institute said the research clearly demonstrates that fingerstick-based point-of-care testing for hepatitis B DNA is both highly accurate and effective.
She added that, since the technology is already used globally for other infectious diseases, the findings pave the way for better integration of hepatitis B care. This integration could significantly enhance access to testing, monitoring, and treatment regardless of geographic location.
WHO Data Highlights Urgent Need for Improved Access
According to the latest World Health Organization (WHO) estimates from 2022, around 254 million people worldwide live with chronic hepatitis B infection. However, only 14% have been diagnosed and just 8% receive treatment.
As a result, no country is currently on track to meet the WHO target of eliminating hepatitis B as a public health threat by 2030. To address this gap, recent WHO guidelines now recommend the global use of hepatitis B point-of-care DNA fingerstick tests—a recommendation strongly supported by data from this study.
Experts Call for Rapid Roll-Out of Testing
Emphasising the broader impact, Associate Professor Thomas Tu from Hepatitis B Voices said limited access to testing remains a major barrier to hepatitis B elimination.
He expressed hope that the study will accelerate the roll-out of point-of-care testing, improve access to care, and ultimately save lives by enabling earlier diagnosis and treatment.