Multicenter Evaluation of the Cepheid Xpert Hepatitis C Virus Viral Load Assay
Multicenter Evaluation of the Cepheid Xpert Hepatitis C Virus Viral Load Assay
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DOI：
10.1128/jcm.02460-16
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发表时间：
2017-05-01
影响因子：
9.4
通讯作者：
Templeton, K. E.
中科院分区：
文献类型：
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作者：
McHugh, M. P.;Wu, A. H. B.;Templeton, K. E.
丙型肝炎病毒（HCV）的病毒载量监测对于诊断感染和监测对治疗的反应是必要的，但所涉及的测试目前仅限于专科机构。需要一种快速、准确的检测方法，操作员输入有限，以增强对病毒载量监测的访问。我们评价了Cepheid Xpert HCV Viral Load assay与Abbott RealTime HCV assay对血清和血浆中HCV RNA的定量。血清和血浆样本收集HCV感染的个人在四个国际网站。使用Xpert HCV Viral Load assay对这些进行检测，并将结果与Abbott RealTime HCV assay的定量结果进行比较。还测试了由8个样品组成的外部质量评估小组。研究中共分析了614份样品，588份（95.8%）样品的定性结果在两个平台上一致。通过两种检测定量的396份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r = 0.99），Bland-Altman图数据显示平均差异（+/- 1.96标准差）为0.03 +/- 0.44 log（10）IU/ml。在外部质量评估组中，Xpert HCV Viral Load assay结果（定量单位为log（10）IU/mL）在目标值的1个标准差范围内，但有一份样本除外，该样本也同样被Abbott RealTime HCV assay错误定量。与市场领先的HCV病毒载量检测试剂盒相比，Xpert HCV Viral Load assay的性能良好，应考虑用于需要快速近患者检测的情况。
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 RealTime 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 RealTime 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 r = 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(10) IU/ml. In the external quality assessment panel, the Xpert HCV Viral Load assay results (quantified in log(10) 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.