BACKGROUND Sensitive and accurate hepatitis C virus (HCV) RNA detection and quantification are essential to diagnose and monitor the virological response to antiviral treatment and the emergence of resistance. OBJECTIVE AND STUDY DESIGN The aim of this study was to assess the ability of the new Xpert HCV Viral Load assay to accurately detect and quantify HCV RNA in serum and in whole blood collected on dried blood spot (DBS). Serum and whole blood from a large series of patients chronically infected with different HCV genotypes were tested in parallel for HCV RNA detection and quantification. RESULTS A significant relationship between HCV RNA levels measured with the Xpert HCV Viral Load assay and the two commercial real-time PCR comparators (Abbott RealTime HCV test and Cobas AmpliPrep/Cobas Taqman HCV 2.0 test) was found in serum as well as in whole blood specimens. CONCLUSIONS The Xpert HCV Viral Load assay accurately quantifies HCV RNA regardless of the HCV genotype and can thus confidently be used to detect active HCV infection in serum and in whole blood specimens.

中文翻译：

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新的Xpert HCV病毒载量实时PCR测定法可准确定量血清和全血标本中的丙型肝炎病毒RNA。

背景技术灵敏且准确的丙型肝炎病毒（HCV）RNA检测和定量对于诊断和监测对抗病毒治疗的病毒学应答以及耐药性的出现至关重要。目的和研究设计这项研究的目的是评估新型Xpert HCV病毒载量测定法能够准确检测和定量检测从干血斑（DBS）收集的血清和全血中的HCV RNA的能力。并行测试了来自长期感染不同HCV基因型的大量患者的血清和全血，以检测和定量HCV RNA。结果Xpert HCV病毒载量测定法和两个商业实时PCR比较器（Abbott RealTime HCV测试和Cobas AmpliPrep / Cobas Taqman HCV 2）测得的HCV RNA水平之间存在显着关系。在血清以及全血标本中都发现了0检验）。结论Xpert HCV病毒载量测定可准确定量HCV RNA，而与HCV基因型无关，因此可以放心地用于检测血清和全血样本中的活动性HCV感染。