Department of Microbiology, Queen Mary Hospital , Hong Kong Special Administrative Region, China.
Department of Microbiology, The University of Hong Kong , Hong Kong Special Administrative Region, China.
Expert Rev Mol Diagn. 2020 Dec;20(12):1253-1258. doi: 10.1080/14737159.2020.1820327. Epub 2020 Sep 23.
Accurate assays for hepatitis C virus (HCV) quantitation and genotyping are important for the management of HCV infection. In this study, we evaluated the performance of cobas HCV and cobas HCV GT assays (Roche) for HCV quantitation and genotyping on the cobas 4800 System.
We compared the performance of the cobas HCV assays with another commercial system (Abbott 2000) using a panel of well-characterized patient samples and proficiency testing samples.
The limit-of-detection of the cobas HCV assay in our center was higher (15 IU/mL) than the manufacturer claim (9.2 IU/mL). The assay showed high analytical specificity, accuracy, precision, and linearity. Performance was congruent with the RealTie HCV assay (Abbott). For genotyping, the cobas HCV GT assay only showed moderate agreement with the RealTie HCV Genotype II assay (kappa = 0.550). The cobas assay outperformed the RealTie assay for typing HCV genotypes 1b and 6 (p = 0.033).
Our results confirm that the cobas 4800 System is a reliable platform for HCV quantitation and genotyping. The cobas HCV GT assay is a good choice for genotype 1b/6 endemic areas in east Asia, clearly outperforming the RealTie HCV Genotype II assay.
准确的丙型肝炎病毒（HCV）定量和基因分型检测对于 HCV 感染的管理非常重要。本研究评估了 cobas HCV 和 cobas HCV GT 检测（罗氏）在 cobas 4800 系统上用于 HCV 定量和基因分型的性能。
我们使用经过充分验证的患者样本和能力验证样本的试剂盒，比较了 cobas HCV 检测与另一个商业系统（雅培 2000）的性能。
我们中心 cobas HCV 检测的检测限（15 IU/mL）高于制造商声称的（9.2 IU/mL）。该检测方法具有很高的分析特异性、准确性、精密度和线性。性能与 RealTie HCV 检测（雅培）一致。对于基因分型，cobas HCV GT 检测与 RealTie HCV Genotype II 检测仅有中等一致性（kappa = 0.550）。cobas 检测在 HCV 基因型 1b 和 6 的分型方面优于 RealTie 检测（p = 0.033）。
我们的结果证实 cobas 4800 系统是 HCV 定量和基因分型的可靠平台。cobas HCV GT 检测是东亚 HCV 基因型 1b/6 流行地区的一个不错选择，明显优于 RealTie HCV Genotype II 检测。
