HCV基因分型试剂临床应用评价  

Clinical evaluation of hepatitis C virus genotype diagnostic kit

作　　者：陈兵[1] 马仲慧 常浩[1] 裴丽健[1] 蒋岩[1] 邱茂锋[1] 肖瑶[1] 邢文革[1] 

机构地区：[1]中国疾病预防控制中心性病艾滋病预防控制中心参比室,北京102206

出　　处：《中国艾滋病性病》2017年第3期186-189,共4页Chinese Journal of Aids & STD

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。Objective To analyze the clinical samples and hepatitis C virus （HCV） genotype panel by both direct sequencing method and evaluate HCV genotype kit performance. Methods 2 sets of commercial HCV genotypes panel were chose and 45 HCV RNA positive clinical samples were collected by using nested PCR amplification of HCV core area and NS5B area to determine genotype, and the samples were tested again by using HCV genotyping kits to determine genotype, with the results statistically analyzed. Results HCV NS5B area and CORE area were detected by commercial HCV genotypes panel, and 16 cases （16/19）, and 15 cases （15/19） were detected respec- tively. With HCV genotyping kit to detect the five kinds of common type （lb/2a/3a/3b/6a） samples in our country, the accuracy of HCV genotyping kit was 7/7.45 HCV RNA positive clinical samples were detected hy genotype la （4 cases）, lb （6 cases） , 2a （5 cases）, 3a （5 cases） and 3b （14 cases）, 6a （7 cases）, and 6n （4）. The results of the sequencing method belonging to the five subtypes （lb/2a/3a/3b/6a） were 37 cases. The kits were consistent with the sequencing method of 29 cases. Eight cases was not detected, with the consistent rate of 29/37. As for the five subtypes of 8 specimens, the results by sequencing method was not consistent with those of the kits. Conclusion Compared with the results, the HCV genotyping kit can accurately detect the domestic common genotypes, and this method is simple, detection time is short, and has great clinical application value.

关 键 词：丙型肝炎病毒 直接测序法 基因分型试剂盒 基因型 

分 类 号：R512[医药卫生—内科学]