Enhancing Hepatitis B Screening Aiming Towards Elimination Goals

Researchers at Chulalongkorn University have developed a wireless hepatitis B virus (HBV) test kit, designed for rapid hepatitis B screening and seamless integration of results into an online database, addressing the urgent need for improved diagnostic tools in Thailand, a country with a significant burden of liver diseases, including HBV.

In the screening process, merely 2 µl (microliters) of serum extracted from the blood sample is required. This small amount is applied to the electrodes for dripping and incubation. The electrodes are then cleansed with a wash buffer solution and left to dry. The analysis, which observes changes in electrical currents, yields results in as little as 10 minutes.

"The wireless HBV test is an electrochemical biosensor that operates based on the specific reaction between the antigen and the antibody,” according to investigators. “Upon the binding of the antigen to the antibody, there's a detectable change in electrical current through amperometric detection. If the virus or antigen is present, this change in current can indicate the amount of the antigen in a semi-quantitative manner. Unlike other tests that merely show presence or absence, this kit can also provide an approximate quantity of the detected antigen. The process, requiring only a small blood sample, delivers results and related information swiftly."¹

The kit utilizes an electrochemical biosensor technique, a notable advancement over traditional strip tests. This method is based on the specific interaction between HBV antigens and antibodies, with detection achieved through amperometric measurement. This approach allows for not only the detection of HBV presence but also provides semi-quantitative data on the viral load, offering a more comprehensive understanding of the infection.

In phase 2, the research team is collecting data through field visits and conducting clinical trials to comply with Food and Drug Administration (FDA) regulations. This phase includes obtaining FDA certification in preparation for commercial production. The team's expertise in electrochemical biosensors facilitated rapid progress from concept to prototype development.

As the project advances to phase 3 in 2024, the emphasis will shift towards mass production in partnership with the private sector, marking a significant step towards widespread availability. The significance of this development is underscored by the World Health Organization (WHO) campaign to eliminate HBV by 2030, a goal that has faced challenges.

According to recent reporting from Contagion, “The World Health Organization (WHO) has called for the elimination of HBV as a public health threat by 2030, but this progression toward elimination has stalled. Nearly 300 million people globally live with HBV, making it the most common chronic infection. Despite stable mortality rates, 2 people die from HBV every minute. WHO’s goals towards eradication include preventing new infections through vaccination and improving testing, clinical management, and treatment.”²

In conclusion, the innovative HBV test kit developed by Chulalongkorn University signifies a step forward in combating HBV, especially in high-risk regions. By enabling rapid and accessible screening, this tool aligns with the WHO’s goals to eliminate HBV as a global health threat by 2030. As the project moves toward mass production, its success could enhance global HBV management and prevention efforts, marking an achievement in public health.

References

1. Chula Researchers Develop Wireless Hepatitis B Test Kit for Rapid Diagnosis. News-Medical. Published February 15, 2024. Accessed March 20, 2024. https://www.news-medical.net/news/20240215/Chula-researchers-develop-wireless-hepatitis-B-test-kit-for-rapid-diagnosis.aspx
2. Abene, S. What it Will Take to Eliminate Hepatitis B Virus. Contagion. Published January 24, 2024. Accessed March 20, 2024. https://www.contagionlive.com/view/what-it-will-take-to-eliminate-hepatitis-b-virus