Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
J Med Virol. 2024 May;96(5):e29686. doi: 10.1002/jmv.29686.
Comparison of diagnostic accuracy for commercial hepatitis C virus (HCV) genotyping (Abbott RealTime HCV Genotyping II, Roche Cobas Genotyping) and investigational Abbott HCV Genotype plus RUO assays designed to discriminate genotype (GT)-1a, 1b or 6 in cases of ambiguous GT from the Abbott commercial assay remains limited. 743 HCV-viremic samples were subjected to analysis using Abbott and Roche commercial as well as Abbott HCV Genotype plus RUO assays. Next-generation sequencing (NGS) targeting core region was employed as the reference standard. Diagnostic accuracy was reported as the number of participants (percentages) along with 95% confidence intervals (CIs). Using NGS, 741 samples (99.7%) yielded valid genotyping results. The diagnostic accuracies were 97.6% (95% CI: 96.1%-98.5%) and 95.3% (95% CI: 93.4%-96.6%) using Abbott and Roche commercial assays (p = 0.0174). Abbott commercial assay accurately diagnosed HCV GT-6a and 6w, whereas Roche commercial assay accurately diagnosed HCV GT-6a. Both assays demonstrated low accuracies for HCV GT-6b, 6e, 6g, and 6n. Abbott HCV Genotype plus RUO assay discriminated 13 of the 14 samples (92.9%; 95% CI: 64.2%-99.6%) that yielded ambiguous GT. Both assays were capable of diagnosing mixed HCV infections when the minor genotype comprised >8.4% of the viral load. The diagnostic performance of commercial HCV genotyping assays is commendable. Abbott assay demonstrated superior performance compared to Roche assay in diagnosing HCV GT-6. Abbott HCV Genotype plus RUO assay aids in discriminating ambiguous GT. Both commercial assays are proficient in diagnosing mixed HCV infections at a cut-off viral load of 8.4% in minor genotype.
商业丙型肝炎病毒 (HCV) 基因分型检测（雅培实时 HCV 基因分型 II 法、罗氏 Cobas 基因分型）和用于区分雅培商业检测法中不确定基因型（GT）-1a、1b 或 6 的研究性雅培 HCV 基因型加 RUO 检测法的诊断准确性比较仍有限。743 例 HCV 病毒血症样本进行了雅培和罗氏商业检测法以及雅培 HCV 基因型加 RUO 检测法分析。采用靶向核心区域的下一代测序（NGS）作为参考标准。诊断准确性以参与者数量（百分比）及其 95%置信区间（CI）报告。使用 NGS，741 个样本（99.7%）获得有效基因分型结果。雅培和罗氏商业检测法的诊断准确性分别为 97.6%（95%CI：96.1%-98.5%）和 95.3%（95%CI：93.4%-96.6%）（p=0.0174）。雅培商业检测法准确诊断 HCV GT-6a 和 6w，罗氏商业检测法准确诊断 HCV GT-6a。两种检测法对 HCV GT-6b、6e、6g 和 6n 的准确性均较低。雅培 HCV 基因型加 RUO 检测法对 14 个产生不确定 GT 的样本中的 13 个（92.9%；95%CI：64.2%-99.6%）进行了区分。两种检测法均能在次要基因型病毒载量>8.4%时诊断混合 HCV 感染。商业 HCV 基因分型检测法的诊断性能值得称赞。雅培检测法在诊断 HCV GT-6 方面优于罗氏检测法。雅培 HCV 基因型加 RUO 检测法有助于区分不确定 GT。两种商业检测法在次要基因型病毒载量为 8.4%的截定点下均能熟练诊断混合 HCV 感染。
