New Low-Cost Test Could Prevent Hepatitis B Transmission from Mothers to Babies in Low-Resource Settings
Developed by an international team led by Kumamoto University and Institut Pasteur, the fingertip blood test shows over 90% accuracy in identifying high-risk pregnancies.
An international research team led by Kumamoto University and Institut Pasteur has validated a groundbreaking rapid diagnostic test (RDT) that may dramatically enhance the prevention of mother-to-child transmission of hepatitis B virus (HBV), particularly in low-income countries where access to standard testing is limited.
The newly developed Hepatitis B core-related antigen rapid diagnostic test (HBcrAg-RDT) uses just a drop of blood from a finger-prick and delivers results within 45 minutes—no electricity, lab equipment, or refrigeration required. The test accurately identifies pregnant women with high HBV viral loads who are at risk of transmitting the virus to their newborns and could benefit from antiviral treatment.
Preventing vertical (mother-to-child) transmission is essential to eliminating hepatitis B globally, a virus that still affects over 250 million people and causes over a million deaths annually. While PCR-based tests can determine high viral loads and inform treatment decisions, they remain expensive and impractical in many regions.
To address this, the research team tested the HBcrAg-RDT in Cambodia, Cameroon, and Burkina Faso—in both lab and real-world rural clinic settings. The study, published in The Lancet Gastroenterology & Hepatology, showed that the test correctly identified 93.1% of women with high viral loads (≥200,000 IU/mL) and ruled out unnecessary treatment in 94.3% of low-risk cases.
“This simple, fast, and inexpensive test could transform hepatitis B care in underserved regions,” said Prof. Yasuhito Tanaka of Graduate School of Medical Sciences, Kumamoto University. “It enables point-of-care decision-making by frontline health workers, allowing timely antiviral treatment possible even in the absence of lab infrastructure.”
Unlike existing HBeAg rapid tests, which have lower sensitivity, the HBcrAg-RDT performed nearly on par with lab-based immunoassays. Its robust design supports use in tropical climates (up to 39°C), and at under $5 per test, it’s accessible for widespread use.
The test supports World Health Organization (WHO)’s 2024 strategy to eliminate hepatitis B and was prequalified by WHO in April for CE marking. As the first CE-marked rapid test for HBeAg under the In Vitro Diagnostic Regulation (IVDR), its enhanced sensitivity marks a major step toward broader application and could help bring faster, targeted care-particularly in underserved communities.
| Authors | Jeanne Perpétue Vincent, Olivier Ségéral, Dramane Kania, Laurence Borand, Jean-Pierre Adoukara, Adeline Pivert, Amariane Koné, Abdoul Salam Eric Tiendrebeogo, Haoua Tall, Laura Schaeffer, Muriel Vray, Armel Moumouni Sanou, Richard Njouom, Gavin Cloherty, Naofumi Hashimoto, Tetsuo Miura, Wataru Sugiura, Saren Sovann, Jee-Seon Yang, Gauthier Delvallez, Françoise Lunel-Fabiani, Yasuhito Tanaka*, Yusuke Shimakawa* |
| Title of original paper | Hepatitis B core-related antigen rapid diagnostic test for point-of-care identification of women at high risk of hepatitis B vertical transmission: a multicountry diagnostic accuracy study |
| Journal | The Lancet Gastroenterology & Hepatology |
| DOI | 10.1016/S2468-1253(25)00015-9 |