不同HDV诊断试剂对HBsAg阳性样品的检测分析  

Evaluate the HDV Diagnostic Kits(EIA) with HBV Surface Antigen Positive Sera

作　　者：辜文洁[1] 黄维金[1] 周诚[1] 乔杉 伍波 吴星[1] 姚昕[1] 蓝海云[1] 梁争论[1] 

机构地区：[1]中国食品药品检定研究院,北京100050 [2]北京万泰生物药业有限公司

出　　处：《中国药事》2011年第9期866-868,879,共3页Chinese Pharmaceutical Affairs

基　　金："十一五"科技重大专项(编号2009ZX10004-802)

摘　　要：目的比较HDV抗原,-抗HDV IgM和抗-HDV总抗体诊断试剂在我国HBsAg阳性样品中的检出情况。方法利用7个来自不同厂家的HDV抗原、抗-HDV IgM和抗-HDV总抗体诊断试剂对收集自我国各地的HBsAg阳性样品进行检测,比较分析各血清学试剂的检出差异。对以上血清学指标阳性的样品利用Rt-PCR方法进行HDV RNA核酸检测,PCR产物直接测序,与HDVⅠ、Ⅱ和Ⅲ基因型的序列进行比较,构建进化树划分基因型。结果 687份HBsAg阳性样品中HDV抗原,抗-HDV IgM和抗-HDV总抗体的阳性率范围为0%-5.17%,各试剂间阴性符合率均大于95%,阳性符合率小于50%。34份HDV血清学指标阳性的样品中2份HDV RNA阳性,均为Ⅰa基因型。仅抗-HDV总抗体试剂C1和IgM试剂C2可全部检出该HDV RNA阳性的2份样品。结论本研究发现的HDV均为Ⅰa基因型,我国HDV诊断试剂的质量需要进一步提高。Objective To evaluate the HDV diagnostic kits（EIA） with HBV surface antigen positive sera.Methods Serum samples from 687 chronic hepatitis patients with HBV surface antigen positivity were analyzed for HDV serological marker with different HDV diagnostic kits（EIA）.The sera which have positive result will be extracted RNA and amplified with HDV specific primers.The PCR products will be sequenced directly.Nucleotide sequences of HDV were compared with previously reported sequences and aligned by using Clustal W methods,and the genotype of HDV will be determined with phylogenetic analysis.Results Serological analysis for HDV,0%~5.17% of which were positive.The negative coincidence rate is more than 95%,but the positive coincidence rate is lower than 50%.HDV-RNA was detected in 2 of 34 serological positive samples.Both of them were closely related to HDV genotypeⅠa isolates.Conclusion This study was found to be genotypeⅠa and the diagnostic kits for HDV should be improved further.

关 键 词：丁型肝炎病毒 抗体 RNA 酶联免疫吸附试验 

分 类 号：R446.1[医药卫生—诊断学]