ABSTRACT

Objectives

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.

Methods

We compared the performance of the cobas HCV assays with another commercial system (Abbott m2000) using a panel of well-characterized patient samples and proficiency testing samples.

Results

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 RealTime HCV assay (Abbott). For genotyping, the cobas HCV GT assay only showed moderate agreement with the RealTime HCV Genotype II assay (kappa = 0.550). The cobas assay outperformed the RealTime assay for typing HCV genotypes 1b and 6 (p = 0.033).

Conclusion

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 RealTime HCV Genotype II assay.

中文翻译：

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用于丙型肝炎病毒定量和基因分型的两种商业样品到结果系统的性能比较。

摘要

目标

丙型肝炎病毒 (HCV) 定量和基因分型的准确检测对于 HCV 感染的管理很重要。在本研究中，我们评估了 cobas HCV 和 cobas HCV GT 检测 (Roche) 在 cobas 4800 系统上进行 HCV 定量和基因分型的性能。

方法

我们使用一组充分表征的患者样本和能力验证样本，将 cobas HCV 检测与另一个商业系统 (Abbott m 2000)的性能进行了比较。

结果

我们中心的 cobas HCV 检测的检测限 (15 IU/mL) 高于制造商声称的 (9.2 IU/mL)。该测定显示出高分析特异性、准确度、精密度和线性。性能是用RealTi全等米ëHCV测定（Abbott）中。用于基因分型，所述COBAS HCV GT测定仅显示出与RealTi中等协议米ËHCV基因型II测定（卡帕= 0.550）。在COBAS吸附测定法优于RealTi米打字HCV基因型1b和6（P = 0.033）在线测定。

结论

我们的结果证实，cobas 4800 系统是用于 HCV 定量和基因分型的可靠平台。在COBAS HCV GT测定为基因型一个很好的选择1B / 6流行地区在东亚，明显优于所述RealTi米ëHCV基因型II测定。