McHugh M P, Wu A H B, Chevaliez S, Pawlotsky J M, Hallin M, Templeton K E
Specialist Virology Centre, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.
Department of Laboratory Medicine, University of California, San Francisco, San Francisco, California, USA.
J Clin Microbiol. 2017 May;55(5):1550-1556. doi: 10.1128/JCM.02460-16. Epub 2017 Mar 8.
Viral load monitoring for hepatitis C virus (HCV) is necessary to diagnose infection and monitor response to therapy, but the tests involved are currently confined to specialist institutions. There is a need for a fast, accurate assay with limited operator input to enhance the access to viral load monitoring. We evaluated the quantification of HCV RNA in serum and plasma by the Cepheid Xpert HCV Viral Load assay in comparison to the Abbott RealTie HCV assay. Serum and plasma samples were gathered from HCV-infected individuals at four international sites. These were tested with the Xpert HCV Viral Load assay, and results were compared to quantification by the Abbott RealTie HCV assay. An external quality assessment panel of eight samples was also tested. In total, 614 samples were analyzed in the study, and the qualitative results agreed on the two platforms for 588 (95.8%) samples. Further analysis of 396 samples quantified by both tests showed strong correlation (correlation coefficient = 0.99) across the quantifiable range, with Bland-Altman plot data showing a mean difference (±1.96 standard deviation) of 0.03 ± 0.44 log IU/ml. In the external quality assessment panel, the Xpert HCV Viral Load assay results (quantified in log IU per milliliter) were within 1 standard deviation of the target value for all but one sample, which was also similarly misquantified by the Abbott RealTime HCV assay. The Xpert HCV Viral Load assay performs well compared to a market-leading HCV viral load test and should be considered for instances where rapid near-to-patient testing is required.
丙型肝炎病毒（HCV）的病毒载量监测对于诊断感染和监测治疗反应至关重要，但目前所涉及的检测仅限于专业机构。需要一种快速、准确且对操作人员要求有限的检测方法，以增加病毒载量监测的可及性。我们评估了赛沛Xpert HCV病毒载量检测法对血清和血浆中HCV RNA的定量检测，并与雅培RealTime HCV检测法进行了比较。在四个国际地点收集了HCV感染个体的血清和血浆样本。使用Xpert HCV病毒载量检测法对这些样本进行检测，并将结果与雅培RealTime HCV检测法定量结果进行比较。还对一个由八个样本组成的外部质量评估小组进行了检测。该研究共分析了614个样本，两种平台对其中588个（95.8%）样本的定性结果一致。对两种检测方法均进行定量的396个样本的进一步分析显示，在可定量范围内具有强相关性（相关系数 = 0.99），布兰德-奥特曼图数据显示平均差异（±1.96标准差）为0.03 ± 0.44 log IU/ml。在外部质量评估小组中，除一个样本外，赛沛Xpert HCV病毒载量检测法的结果（以每毫升log IU定量）均在目标值的1个标准差范围内，而雅培RealTime HCV检测法对该样本的定量也同样出现错误。与市场领先的HCV病毒载量检测相比，赛沛Xpert HCV病毒载量检测法表现良好，对于需要快速进行床旁检测的情况应予以考虑。
