Hu Xiaohan, Zhao Liwei, Ou Mingrong, Chen Yuxin, Wei Hongxia, Xia Yanyan, Xu Hongpan, Li Miao, Wang Jun
Department of Laboratory Medicine, Nanjing Drum Tower Hospital Clinical College of Nanjing University of Chinese Medicine, China.
Nanjing Drum Tower Hospital Clinical College of Nanjing Medical University, China.
Heliyon. 2023 Jul 21;9(8):e18557. doi: 10.1016/j.heliyon.2023.e18557. eCollection 2023 Aug.
Chronic hepatitis B virus (HBV) infection is one of the common infectious diseases in the world. HBV covalently closed circular DNA (cccDNA) is the initial template of HBV replication, which can exist in human hepatocytes for a long time and is difficult to be completely removed. It has been shown that HBV RNA can directly respond to the levels and transcriptional activity of cccDNA in hepatocytes and can be used as a surrogate marker of cccDNA transcriptional activity. At present, the detection techniques used for quantitative HBV RNA mainly include reverse transcription quantitative polymerase chain reaction (RT-qPCR) and simultaneous amplification and testing (SAT).
In this study, we verified the performance of the SAT method for detecting HBV RNA and the clinical effectiveness of SAT and RT-qPCR, and compared the correlation and consistency of the two detection methods for HBV RNA detection.
The results showed that the limit of detection for HBV RNA by SAT method was 50 copies/mL, with a linear range of 1 × 10-1 × 10 copies/mL. There was no difference in HBV RNA levels detected by the two methods. The correlation and consistency of the results were good, with the coefficient of determination of 0.7787 in HBeAg positive group and 0.8235 in HBeAg negative group.
Therefore, this study confirmed that the SAT method and RT-qPCR for detecting HBV RNA have good agreement, which are both reliable methods to detect HBV RNA and can replace each other.
慢性乙型肝炎病毒（HBV）感染是世界上常见的传染病之一。HBV共价闭合环状DNA（cccDNA）是HBV复制的初始模板，可长期存在于人类肝细胞中且难以完全清除。研究表明，HBV RNA可直接反映肝细胞中cccDNA的水平和转录活性，可作为cccDNA转录活性的替代标志物。目前，用于定量检测HBV RNA的技术主要包括逆转录定量聚合酶链反应（RT-qPCR）和同步扩增检测（SAT）。
在本研究中，我们验证了SAT法检测HBV RNA的性能以及SAT和RT-qPCR的临床有效性，并比较了两种检测方法在HBV RNA检测中的相关性和一致性。
结果显示，SAT法检测HBV RNA的检测限为50拷贝/毫升，线性范围为1×10 - 1×10拷贝/毫升。两种方法检测的HBV RNA水平无差异。结果的相关性和一致性良好，HBeAg阳性组的决定系数为0.7787，HBeAg阴性组为0.8235。
因此，本研究证实SAT法和RT-qPCR检测HBV RNA具有良好的一致性，都是检测HBV RNA的可靠方法，可相互替代。
