Rapid test for hepatitis B core-related antigen to identify people living with hepatitis B having high viral load in Cameroon

• Published in: Virology (New York, N.Y.) N.Y.), 2025-01, Vol.602, p.110316, Article 110316
• Main Authors: Njouom, Richard, Ndiaye, Alassane, Modiyinji, Abdou Fatawou, Lissock, Frederic, Vincent, Jeanne Perpétue, Baba, Masaya, Yamamoto, Naoki, Kaneko, Atsushi, Aoyagi, Katsumi, Hashimoto, Naofumi, Nagai, Mari, Ichikawa, Masato, Miura, Tetsuo, Sugiura, Wataru, Tanaka, Yasuhito, Shimakawa, Yusuke
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Africa; antigens; Cameroon; Cameroon - epidemiology; DNA; DNA, Viral - blood; Elimination; Female; hepatitis B; Hepatitis B - blood; Hepatitis B - diagnosis; Hepatitis B - virology; Hepatitis B Core Antigens - blood; Hepatitis B Core Antigens - immunology; Hepatitis B core-related antigen; Hepatitis B virus; Hepatitis B virus - genetics; Hepatitis B virus - immunology; Hepatitis B virus - isolation & purification; Humans; Male; Middle Aged; people; point-of-care systems; Point-of-care tests; quantitative polymerase chain reaction; rapid methods; reference standards; Retrospective Studies; Sensitivity and Specificity; Validation studies; Viral Load; virology; Young Adult
• ISSN: 0042-6822; 1096-0341; 1096-0341
• DOI: 10.1016/j.virol.2024.110316

This study presents a retrospective assessment of the diagnostic performance of the newly developed hepatitis B core-related antigen rapid diagnostic test (HBcrAg-RDT) in detecting plasma samples with elevated hepatitis B virus (HBV) DNA levels (≥200,000 IU/ml) in Yaoundé, Cameroon. Samples were collected consecutively from treatment-naïve adults living with HBV between January 1, 2021, and June 30, 2023. Analyzing 146 samples from participants with a median age of 36 years, the HBcrAg-RDT exhibited a sensitivity of 97.5% (95% CI: 86.8–99.9) and a specificity of 77.4% (68.2–84.9) when compared to real-time PCR as the reference standard. These findings suggest that HBcrAg-RDT holds promise as a valuable point-of-care tool for diagnosing high HBV DNA levels, particularly in resource-limited settings. Further research will refine its practicality and effectiveness. •We evaluated the accuracy of HBcrAg-RDT in detecting high HBV DNA levels (≥200,000 IU/ml) in Yaoundé, Cameroon.•Among 146 treatment-naïve adults, the HBcrAg-RDT showed 97.5% sensitivity and 77.4% specificity compared to real-time PCR.•HBcrAg-RDT offers promise as a point-of-care tool for high HBV DNA detection, especially in resource-limited settings.