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
Department of Virology, Centre Pasteur of Cameroon, Yaoundé, Cameroon.
Institut Pasteur, Université Paris Cité, Unité d'Épidémiologie des Maladies Émergentes, Paris, France.
Virology. 2025 Jan;602:110316. doi: 10.1016/j.virol.2024.110316. Epub 2024 Nov 26.
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.
本研究对新开发的乙型肝炎核心相关抗原快速诊断检测（HBcrAg-RDT）在喀麦隆雅温得检测乙型肝炎病毒（HBV）DNA水平升高（≥200,000 IU/ml）的血浆样本中的诊断性能进行了回顾性评估。样本于2021年1月1日至2023年6月30日期间连续收集自未接受过治疗的成年HBV感染者。分析了146名年龄中位数为36岁的参与者的样本，与作为参考标准的实时PCR相比，HBcrAg-RDT的灵敏度为97.5%（95% CI：86.8-99.9），特异性为77.4%（68.2-84.9）。这些发现表明，HBcrAg-RDT有望成为诊断高HBV DNA水平的有价值的即时检测工具，特别是在资源有限的环境中。进一步的研究将完善其实用性和有效性。
