Wireless Hepatitis B Test Kit Completes Screening and Data Collection in One Step

Hepatitis B, a significant global health concern, is responsible for chronic liver diseases like cirrhosis and liver cancer which is one of the most common cancers worldwide. The challenge with hepatitis B is that most carriers are asymptomatic, remaining unaware of their infection, which can lead to its unintentional spread. Thus, early diagnosis is vital to halt the spread, initiate timely treatment, and reduce the risk of liver complications primarily caused by the hepatitis B virus. However, conventional tests for hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) are complex, requiring specialized skills and large, expensive machine-based assays typically found in major hospitals. To overcome the problem of inadequate access to screening for Hepatitis B, researchers have developed a wireless, point-of-care test for the Hepatitis B Virus that can make diagnosis simpler and faster.

Researchers from Chulalongkorn University (Bangkok, Thailand) have developed a testing kit that enables healthcare providers in smaller medical facilities or public health centers to independently conduct hepatitis B screenings. This approach simplifies the screening process, yielding results comparable to those of sophisticated machine-based tests. The kit utilizes an electrochemical biosensor based on the specific interaction between antigens and antibodies. The presence of the hepatitis B virus triggers a detectable change in electric current through amperometric detection. This change in current, correlating with the virus's presence, offers a semi-quantitative measurement of the antigen's concentration.

The testing process is quick and requires only a small serum volume (2 µl) from a blood sample for application and incubation on the electrodes. Following a wash with a buffer solution and drying, it takes merely up to 10 minutes to observe the resultant electrical current changes. Unlike traditional tests that merely indicate the presence or absence of the antigen, this wireless test not only confirms infection but also provides an estimated viral load. A low current suggests a higher antigen quantity, and vice versa. In addition to delivering rapid results with an approximate viral count, the innovative test also enables immediate, real-time data upload, linking the information directly to the respective patient. This feature is particularly crucial for hepatitis B, where patient identification is essential due to the prolonged nature of the treatment.

“In the early years, we developed a prototype of a hepatitis B virus test kit using an electrochemical biosensors technique that works with a variety of measuring instruments,” said Dr. Natthaya Chuaypen from Chulalongkorn University. “In the following year, for the kit to have reproducibility, and stability of current, with fast and convenient use, we developed the test kit with Bluetooth capability, so it can work both wirelessly and plugged into a small computer. We’re now in the process of collecting data for field visits, including usage data and conducting clinical trials according to Section 27 of the Food and Drug Administration (FDA), exemption for research, and application for FDA certification before the production of commercialized kits ready for sale in the next phase.”

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Chulalongkorn University