Evaluation of the VERSANT HCV RNA 3.0 assay for quantification of hepatitis C virus RNA in serum
Evaluation of the VERSANT HCV RNA 3.0 assay for quantification of hepatitis C virus RNA in serum
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DOI：
10.1128/jcm.40.6.2031-2036.2002
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发表时间：
2002-06-01
影响因子：
9.4
通讯作者：
Fleury, H
中科院分区：
文献类型：
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作者：
Trimoulet, P;Halfon, P;Fleury, H
我们评估了一种用于定量HCV RNA水平的新检测方法（VERSANT HCV RNA 3.0 [bDNA 3.0]检测[拜耳诊断]）的性能，并将bDNA 3.0检测结果与Quantiplex HCV RNA 2.0 （bDNA 2.0）检测结果进行了比较。本研究使用的样本包括来自两个地点（法国波尔多和马赛）不同基因型的丙型肝炎病毒（HCV）感染者的211份血清标本；HCV抗体阴性、HCV rna阴性者血清标本383份；连续稀释世界卫生组织（WHO） HCV RNA标准品，滴度为100,000 IU/ml。bDNA 3.0检测的特异性为98.2%。在WHO标准品的所有稀释度（r = 0.9982）、合并样品的连续稀释度（r = 0.9996）以及不同HCV基因型的稀释血清（r = 0.9930至0.9995）中，预期值与实测值之间存在高度相关性。bDNA 3.0法的组内重现性和组间重现性的标准差（SD）分别小于等于0.2和小于等于0.14。位点间SD范围为0.03 ~ 0.14。bDNA 3.0检测结果与bDNA 2.0检测结果呈正相关（r = 0.9533）。考虑到整体性能，该分析可作为HCV RNA定量的常规工具。
We assessed the performance of a new assay (VERSANT HCV RNA 3.0 [bDNA 3.0] assay [Bayer Diagnostics]) to quantitate HCV RNA levels and compared the results of the bDNA 3.0 assay to results of the Quantiplex HCV RNA 2.0 (bDNA 2.0) assay. Samples used in this study included 211 serum specimens from hepatitis C virus (HCV)-infected persons from two sites (Bordeaux and Marseille, France) with different genotypes; 383 serum specimens from HCV antibody-negative, HCV RNA-negative persons; and serial dilutions of World Health Organization (WHO) HCV RNA standard at a titer of 100,000 IU/ml. The specificity of the bDNA 3.0 assay was 98.2%. A high correlation was observed between expected and observed values in all dilutions of WHO standard (r = 0.9982), in serial dilutions of pooled samples (r = 0.9996), and in diluted sera from different HCV genotypes (r = 0.9930 to 0.9995). The standard deviations (SD) for the within-run and between-run reproducibility of the bDNA 3.0 assay were less than or equal to0.2 and less than or equal to0.14, respectively. The intersite SD ranged from 0.03 to 0.14. The bDNA 3.0 assay results were positively correlated with the bDNA 2.0 assay results (r = 0.9533). Taking in account the overall performance, this assay could be used as a routine tool for the HCV RNA quantification.