Zhu Yongzhe, Xia Binghui, Xu Haizhou, Liu Zengxin, Wang Ru, Cai Qingqing, Zhao Ping, Qi Zhongtian
Department of Microbiology, Naval Medical University, No. 800, Xiangyin Road, Shanghai, 200433, China.
Department of Emergency, Changhai Hospital, Naval Medical University, Shanghai, 200433, China.
Virus Genes. 2024 Feb;60(1):18-24. doi: 10.1007/s11262-023-02044-5. Epub 2024 Jan 4.
Human adenovirus subgroup B (HAdV B) is one of the major pathogens of human respiratory virus infections, which has considerable transmission and morbidity in a variety of populations. Therefore, rapid and specific detection of HAdV B in clinical samples is essential for diagnosis. This study aimed to develop a product for rapid nucleic acid detection of HAdV B using recombinase polymerase amplification assay (RPA) and validate the performance of this method by using clinical samples. Results showed that this method achieved a lower limit of detection (LOD) of 10 copies/μL and had no cross-reactivity with other adenovirus subgroups or respiratory pathogens. In addition to high sensitivity, it can be completed within 30 min at 40 °C. There is no need to perform nucleic acid extraction on clinical samples. Taking qPCR as the gold standard, the RPA assay possessed a high concordance (Cohen's kappa, 0.896; 95% CI 0.808-0.984; P < 0.001), with a sensitivity of 87.80% and a specificity of 100.00%. The RPA assay developed in this study provided a simple and highly specific method, making it an important tool for rapid adenovirus nucleic acid detection and facilitating large-scale population screening in resource-limited settings.
人腺病毒B亚组（HAdV B）是人类呼吸道病毒感染的主要病原体之一，在各类人群中具有相当高的传播率和发病率。因此，临床样本中HAdV B的快速、特异性检测对于诊断至关重要。本研究旨在开发一种利用重组酶聚合酶扩增法（RPA）对HAdV B进行快速核酸检测的产品，并通过临床样本验证该方法的性能。结果表明，该方法的检测下限（LOD）达到10拷贝/μL，与其他腺病毒亚组或呼吸道病原体无交叉反应。除了高灵敏度外，它在40℃下30分钟内即可完成检测，无需对临床样本进行核酸提取。以qPCR作为金标准，RPA检测具有高度一致性（Cohen's kappa系数为0.896；95%置信区间为0.808 - 0.984；P < 0.001），灵敏度为87.80%，特异性为100.00%。本研究开发的RPA检测提供了一种简单且高度特异的方法，使其成为快速腺病毒核酸检测的重要工具，并有助于在资源有限的环境中进行大规模人群筛查。
