GeneXpert用于丙型肝炎病毒载量定量的评价

C. Jasirwan, I. Hasan, A. Sulaiman, R. Gani
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引用次数: 1

摘要

背景:GeneXpert已用于结核分枝杆菌检测,但目前可用于HCV RNA检测。GeneXpert测定法有望更准确、更高效、更经济地用于HCV病毒载量定量。本研究旨在评估GeneXpert与Roche Cobas TaqMan 96作为标准诊断工具的新方法定量血浆HCV RNA。方法:采用GeneXpert法检测54份抗HCV阳性的HCV感染血浆样本,采用Cobas TaqMan 96定量检测HCV RNA。相关性采用Pearson检验(log10),诊断性检验采用卡方检验。通过计算2x2列联表测定GeneXpert检测的敏感性和特异性。生成Bland-Altman图来评估两种分析的平均差异。结果:GeneXpert与Roche Cobas TaqMan 96相关性较强(R=0.993;P值0.001)。GeneXpert的灵敏度为100% (95% CI: 90-100%),特异性为90% (95% CI: 54.1-99.5%)。Bland Altmand图显示,一个样品与Roche Cobas TaqMan 96测量结果有1个对数差。结论:与Cobas TaqMan 96相比,GeneXpert对HCV RNA的检测具有较强的相关性,且其检测方法具有较好的综合性能。因此,它可以被认为是HCV病毒学反应监测的可靠工具。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of GeneXpert for Quantification Viral Load Hepatitis C Virus
Background: GeneXpert has been used for Mycobacterium tuberculosis testing, but is currently available for HCV RNA testing. GeneXpert assay is expected to be more accurate, efficient, and cost-effective for HCV viral load quantification. This study  intended to evaluate the new method quantification of plasma HCV RNA by the GeneXpert in comparison to the Roche Cobas TaqMan 96  as standard diagnostic tools.Method: A total of 54 HCV-infected plasma samples with anti-HCV positive were examined by GeneXpert assay, followed with Cobas TaqMan 96 for quantification of HCV RNA. Correlation was performed by Pearson test (in log10) and diagnostic test by Chi-square test. Sensitivity and specificity of the GeneXpert assay measured by calculating 2x2 contingency table.  Bland-Altman plot were generated to assess the mean difference between the two assays.Results: GeneXpert has strong correlation to the Roche Cobas TaqMan 96 (R=0.993; P value 0.001). GeneXpert has sensitivity of 100% (95% CI: 90–100%) and specificity of 90% (95% CI: 54.1–99.5%). The Bland Altmand plot showed that one sampel has 1 log difference with the Roche Cobas TaqMan 96 measurement result.Conclusion: There was a strong correlation in the measurement of HCV RNA by GeneXpert and moreover its assay also has an excellent overall performance compared to Cobas TaqMan 96. Thus, it can be considered as a reliable tools for HCV virological response monitoring.
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