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首页> 外文期刊>Journal of Clinical Microbiology >Performance of the New Aptima HCV Quant Dx Assay in Comparison to the Cobas TaqMan HCV2 Test for Use with the High Pure System in Detection and Quantification of Hepatitis C Virus RNA in Plasma or Serum
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Performance of the New Aptima HCV Quant Dx Assay in Comparison to the Cobas TaqMan HCV2 Test for Use with the High Pure System in Detection and Quantification of Hepatitis C Virus RNA in Plasma or Serum

机译：与用于高纯度系统的Cobas TaqMan HCV2测试相比，新的Aptima HCV Quant Dx分析的性能可用于检测和定量血浆或血清中的丙型肝炎病毒RNA

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Quantitating the level of hepatitis C virus (HCV) RNA is the standard of care for monitoring HCV-infected patients during treatment. The performances of commercially available assays differ for precision, limit of detection, and limit of quantitation (LOQ). Here, we compare the performance of the Hologic Aptima HCV Quant Dx assay (Aptima) to that of the Roche Cobas TaqMan HCV test, version 2.0, using the High Pure system (HPS/CTM), considered a reference assay since it has been used in trials defining clinical decision points in patient care. The assays' performance characteristics were assessed using HCV RNA reference panels and plasma/serum from chronically HCV-infected patients. The agreement between the assays for the 3 reference panels was good, with a difference in quantitation values of <0.5 log. High concordance was demonstrated between the assays for 245 clinical samples (kappa = 0.80; 95% confidence interval [CI], 0.720 to 0.881); however, Aptima detected and/or quantitated 20 samples that HPS/CTM did not detect, while Aptima did not detect 1 sample that was quantitated by HPS/CTM. For the 165 samples quantitated by both assays, the values were highly correlated (R = 0.98; P < 0.0001). The linearity of quantitation from concentrations of 1.4 to 6 log was excellent for both assays for all HCV genotypes (GT) tested (GT 1a, 1b, 2b, and 3a) (R2 > 0.99). The assays had similar levels of total and intra-assay variability across all genotypes at concentrations from 1,000 to 25 IU/ml. Aptima had a greater analytical sensitivity, quantitating more than 50% of replicates at 25-IU/ml target. Aptima showed performance characteristics comparable to those of HPS/CTM and increased sensitivity, making it suitable for use as a clinical diagnostic tool on the fully automated Panther platform.
机译：量化丙型肝炎病毒（HCV）RNA的水平是在治疗期间监测HCV感染患者的护理标准。市售测定的性能在精度，检测限和定量限（LOQ）方面有所不同。在这里，我们将使用高纯系统（HPS / CTM）的Hologic Aptima HCV Quant Dx测定法（Aptima）与Roche Cobas TaqMan HCV测试2.0版的性能进行比较，该方法被视为参考测定法，因为已使用在定义患者护理中临床决策点的试验中。使用HCV RNA参考面板和来自慢性HCV感染患者的血浆/血清评估了测定的性能特征。 3个参考板的测定之间的一致性很好，定量值差异<0.5 log。在245个临床样品的测定之间显示出高度一致性（kappa = 0.80; 95％置信区间[CI]，0.720至0.881）;以及但是，Aptima检测到和/或定量了HPS / CTM未检测到的20个样品，而Aptima未检测到1个通过HPS / CTM定量的样品。通过这两种测定定量的165个样品中，值高度相关（ R = 0.98; P <0.0001）。两种检测的所有HCV基因型（GT 1a，1b，2b和3a）（ R 2

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