Rapid Diagnostic Test to Halt Mother-To-Child Hepatitis B Transmission

Hepatitis B, an inflammation of the liver caused by the hepatitis B virus (HBV), is the second-leading infectious cause of death globally, following tuberculosis. This viral infection can result in serious complications such as cirrhosis and liver cancer. Over 254 million people are living with hepatitis B, placing them at risk of transmitting the virus, which leads to more than 1.1 million deaths annually. The virus spreads through bodily fluids and secretions, with the most common transmission routes being from mother to child and between children. Preventing mother-to-child transmission is a key component in the global effort to eliminate hepatitis B. Current diagnostic tests used to assess the risk of transmission, such as viral load measurement, are often expensive and require specialized laboratory equipment, making them less accessible in resource-limited regions. Researchers have now developed and evaluated a new rapid diagnostic test designed to identify pregnant women at high risk of transmitting hepatitis B to their infants. This new diagnostic tool has the potential to help eliminate hepatitis B by preventing mother-to-child transmission during childbirth, especially in low- and middle-income countries. The results of the study were published in The Lancet Gastroenterology & Hepatology.

Preventing mother-to-child transmission of hepatitis B is a critical strategy in the global fight against hepatitis B. In addition to vaccinating newborns, the World Health Organization (WHO) recommends HBV screening for pregnant women. If the screening test detects HBV, a second test is required to measure the viral load, as women with higher viral loads are at greater risk of transmitting the virus to their babies. Women identified as high-risk can then receive antiviral treatment to reduce the chance of transmission. The first-line screening test, which detects the HBV surface antigen, is affordable and accessible in many low-income countries. However, the second test, which uses PCR to measure the viral load, is rarely available in these regions due to the need for advanced laboratory equipment and expensive reagents. A rapid point-of-care test that can accurately identify women with high viral loads in decentralized settings would provide a practical solution to this challenge.

The new rapid test, evaluated by scientists from the Institut Pasteur (Paris, France) in collaboration with Kumamoto University (Kumamoto, Japan), offers an innovative approach by detecting the "HBV core-related antigen," a reliable marker of active infection. This test can be used even in areas without laboratory facilities or electricity. It is affordable, simple to use, does not require electricity, and remains functional at temperatures up to 39°C, with a quick turnaround time of just 45 minutes. This test’s design makes it ideal for integration into routine antenatal care in resource-limited settings, where healthcare access is often restricted. This breakthrough could significantly impact hepatitis B management in low- and middle-income countries by enabling early detection and timely intervention, thereby reducing the spread of the infection and preventing complications. The research team is continuing to refine the test for larger-scale implementation, and additional studies are being conducted to evaluate its effectiveness among pregnant women in various clinical and geographical settings.

"Results show that this new test is highly effective at identifying women with a high viral load and offers significant advantages in speed and ease of use compared to traditional methods, such as PCR. This test can be used to reliably identify pregnant women who should benefit from preventive antiviral treatment at the point of care," said Yusuke Shimakawa, the lead author of the study and a scientist in the Institut Pasteur's Epidemiology of Emerging Diseases Unit.

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Institut Pasteur
Kumamoto University