国产 HCV RNA 分型试剂盒检测结果分析

摘要

Objective To evaluated the HCV genotyping results which obtained by genotype diagnostic kit in Shenzhen area. Methods 158 samples which ELISA test of anti-HCV were positive were collected from voluntary blood donors from 2014 to 2015,and were tested by PCR fluorescence probe method for viral load.The samples which viral load were greater than 1.0 ×103 IU/mL were then tested by HCV RNA genotype diagnostic kit.To analysis the proportion of different genotypes and the correla-tion between genotypes with vrial load.Results 54 HCV RNA reactive sample were quantity by PCR fluorescence probe method from 158 anti-HCV positive samples.The genotyping data for 45 cases which vrial load greater than 1.0×103 IU/mL were obtained by HCV RNA genotype diagnostic kit.The frequencies HCV genotype 1b,2,3 and 6 were 57.78%(26/45),6.67%(3/45),8.89%(4/45)and 26.67%(12/45),respectively.One-way ANOVA analysis showed that significant difference in viral loads was found be-tween different HCV genotype 1b and 2(F =2.861,P <0.05),and there was a significant difference in viral loads and anti-HCV S/CO by sex(P <0.05).Fisher′s exact test showed the significance difference between age and genotypes(P <0.05 ).Conclusion HCV 1b and 6 were the most predominant genotypes due to the higher viral load than the other subtypes among volunteer blood do-nors in Shenzhen,while the proportion of HCV 2,3 declined.%目的：分析丙型肝炎病毒（HCV）RNA 分型试剂盒检测深圳市抗-HCV 阳性献血者结果。方法收集2014－2015年158份深圳市抗-HCV 阳性献血者血液样本，应用聚合酶链反应（PCR）-荧光探针法进行 HCV RNA 定量检测，病毒载量＞1．0×103 IU／mL 的样本经 HCV RNA 分型试剂盒检测 HCV 基因型，分析不同基因型所占比例，病毒基因型与载量之间的相关性。结果158份抗-HCV 阳性献血者 PCR-荧光探针法检出 HCV RNA 阳性样本54例，病毒载量＞1．0×103 IU／mL 的45例，全部得到分型结果，HCV 1b 型、2型、3型、6型分别占57．78％（26／45）、6．67％（3／45）、8．89％（4／45）、26．67％（12／45）。单因素方差分析结果显示，1b 型与2型病毒载量差异有统计学意义（F ＝2．861，P ＜0．05）；不同性别间 HCV RNA 定量检测结果及抗-HCV S／CO 值结果差异有统计学意义（P ＜0．05）；不同年龄段各基因型分布比例经 Fisher 精确检验，差异有统计学意义（P ＜0．05）。结论 HCV 1b 型、6型仍为深圳市无偿献血人群感染 HCV 的主要基因型，而 HCV 2型和3型比例有所减少。