HCV基因分型试剂临床应用评价

发布时间：2018-07-16 20:26

【摘要】：目的运用直接测序法和丙型肝炎病毒(HCV)基因分型试剂盒两种方法,诊断HCV基因型并比对它们的结果,以评价HCV基因分型试剂盒的临床使用效果。方法选取购买的2套商业HCV基因型血清盘和收集的45份HCV核糖核酸(RNA)阳性临床样本,用巢式聚合酶链反应(PCR)扩增HCV CORE区、NS5B区,对扩增的序列进行测序以确定基因型别;再通过HCV基因分型试剂盒检测样本以确定基因型,对所得结果进行统计分析。结果 HCV NS5B区、CORE区检测商业HCV基因型血清盘,分别检测出16例(16/19)、15例(15/19);对于HCV基因分型试剂盒检测中国常见的五种型别1b、2a、3a、3b、6a的样本,HCV基因分型试剂盒的准确性为7/7。45份HCV RNA阳性的临床样本中,所检测出的基因型有1a(4份)、1b(6份)、2a(5份)、3a(5份)、3b(14份)、6a(7份)、6n(4份),测序法结果属于五种亚型(1b、2a、3a、3b、6a)的有37份标本,试剂盒检测的结果与测序法一致的有29份,8份标本未检出,一致率为29/37。五种亚型以外的8份标本,测序法与试剂盒检测结果均不一致。结论通过此次对比结果可以看出,所用HCV基因分型试剂盒能够准确检测出国内常见的基因型,并且该方法操作简便,检测时间短,具有较大的临床应用价值。
[Abstract]:Objective to evaluate the clinical efficacy of HCV genotyping kit by using direct sequencing and HCV genotyping kit to diagnose HCV genotypes and compare their results. Methods the HCV core region was amplified by nested polymerase chain reaction (PCR) from two sets of commercial HCV genotypes and 45 HCV RNA positive clinical samples. The amplified sequences were sequenced to determine the genotypes. The genotypes were determined by HCV genotyping kit and the results were statistically analyzed. Results the commercial HCV genotypes were detected in the core region of HCV NS5B region. 16 cases (16 / 19) were detected and 15 cases (15 / 19) were detected respectively, and the accuracy of HCV genotyping kit was 7 / 7.45 clinical samples of HCV RNA positive for 5 common types of HCV genotyping kits in China, the accuracy of which was 7 / 7.45 clinical samples with HCV RNA positive, and the accuracy of HCV genotyping kit was 7 / 7.45 clinical samples which were positive for HCV RNA, and the accuracy of HCV genotyping kit was 7 / 7.45 clinical samples which were positive for HCV RNA. The genotypes were 1a (4), 1b (6), 2a (5), 3a (5), 3b (14), 6a (7), 6n (4). The results of sequencing and Kit were not consistent with 8 samples except five subtypes. Conclusion the results show that the HCV genotyping kit can accurately detect common genotypes in China, and this method is easy to operate, short detection time, and has great clinical application value.
【作者单位】：中国疾病预防控制中心性病艾滋病预防控制中心参比室;
【分类号】：R512.63

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