1Eijkman Institute for Molecular Biology, Jakarta, Indonesia.
2Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia.
Am J Trop Med Hyg. 2021 May 17;105(1):117-124. doi: 10.4269/ajtmh.20-1588.
Hepatitis C virus (HCV) infection large-scale diagnosis and treatment are hampered by lack of a simple, rapid, and reliable point-of-care (POC) test, which poses a challenge for the elimination of hepatitis C as a public health problem. This study aimed to evaluate Cepheid Xpert® HCV Viral Load performance in comparison with the Roche Cobas® TaqMan® HCV Test using serum samples of HCV-infected patients in Indonesia. Viral load quantification was performed on 243 anti-HCV positive patients' samples using both Xpert HCV VL and Roche HCV tests, followed by HCV genotyping by reverse hybridization. Strength of the relationship between the assays was measured by Pearson correlation coefficient, while level of agreement was analyzed by Deming regression and Bland-Altman plot analysis using log10-transformed viral load values. Quantifiable viral load was detected in 180/243 (74.1%), with Xpert HCV VL sensitivity of 100% (95% CI 0.98, 1.00) and specificity of 98.4% (95% CI 0.91, 0.99) based on the Roche HCV test, while HCV genotypes were determined in 172/180 (95.6%) samples. There was a good correlation between both assays (r = 0.97, P < 0.001), overall and per genotype, with good concordance by Deming regression and a mean difference of -0.25 log10 IU/mL (95% CI -0.33, -0.18) by Bland-Altman plot analysis. Xpert HCV VL test was demonstrated as a POC platform with good performance for HCV diagnosis and treatment decision that would be beneficial for decentralized services in resource-limited areas. HCV testing sites, alongside additional GeneXpert modular systems distributed toward the fight against COVID-19, could ensure some continuity, once this pandemic is controlled.
丙型肝炎病毒（HCV）感染的大规模诊断和治疗受到缺乏简单、快速和可靠的即时检测（POC）的限制，这对消除丙型肝炎作为公共卫生问题构成了挑战。本研究旨在评估 Cepheid Xpert® HCV 病毒载量检测与罗氏 Cobas® TaqMan® HCV 检测在印度尼西亚 HCV 感染患者血清样本中的性能。使用 Xpert HCV VL 和罗氏 HCV 检测对 243 例抗 HCV 阳性患者的样本进行病毒载量定量检测，随后通过反向杂交进行 HCV 基因分型。使用 Pearson 相关系数衡量两种检测方法之间的关系强度，通过 Deming 回归和 Bland-Altman 图分析（使用对数转换的病毒载量值）分析一致性水平。在 243 例样本中检测到可定量的病毒载量，Xpert HCV VL 检测的敏感性为 100%（95%CI 0.98，1.00），特异性为 98.4%（95%CI 0.91，0.99），基于罗氏 HCV 检测，同时确定了 172/180（95.6%）样本的 HCV 基因型。两种检测方法之间存在良好的相关性（r = 0.97，P < 0.001），总体和各基因型均具有良好的一致性，Deming 回归和 Bland-Altman 图分析的平均差异为-0.25 log10 IU/mL（95%CI -0.33，-0.18）。Xpert HCV VL 检测被证明是一种具有良好性能的 POC 平台，可用于 HCV 诊断和治疗决策，这将有利于资源有限地区的分散服务。随着针对 COVID-19 的额外 GeneXpert 模块化系统的分发，一旦这种大流行得到控制，HCV 检测点可以确保一些连续性。
