4种丁型肝炎病毒IgG抗体检测试剂的评价  

Evaluation of four reagents for the detection of hepatitis D virus IgG antibody

作　　者：刘玉梅 白洪霞 马亚红 郭小平 张慧敏 王春梅 任姗[5] 蒋永芳[6] 彭锋[6] 刘学恩 庄辉 LIU Yu-mei;BAI Hong-xia;MA Ya-hong;GUO Xiao-ping;ZHANG Hui-min;WANG Chun-mei;REN Shan;JIANG Yong-fang;PENG Feng;LIU Xue-en;ZHUANG Hui(Department of Microbiology and Center of Infectious Diseases,Peking University Health Science Center,Beijing 100191,China;不详)

机构地区：[1]北京大学医学部病原生物学系和感染病中心,北京100191 [2]内蒙古国际蒙医医院,内蒙古呼和浩特010055 [3]赤峰市传染病防治医院,内蒙古赤峰024099 [4]呼和浩特市第二医院,内蒙古呼和浩特010020 [5]首都医科大学附属北京佑安医院,北京100069 [6]中南大学湘雅二医院,湖南长沙410011

出　　处：《中国病毒病杂志》2022年第3期170-174,共5页Chinese Journal of Viral Diseases

基　　金：国家“艾滋病和病毒性肝炎等重大传染病防治”科技重大专项(2018ZX10732401-003)。

摘　　要：目的 评价国内外4种抗-HDV IgG检测试剂的灵敏度和特异度。方法 应用18例抗-HDV IgG真阳性和480例抗-HDV IgG真阴性血清盘,评价国内外4种抗-HDV IgG试剂的灵敏度和特异度;对18例抗-HDV IgG阳性样本进行巢式反转录聚合酶链反应(nested reverse transcription-polymerase chain reaction,nRT-PCR),其中17例HDV RNA阳性,对该17例的nRT-PCR扩增产物进行测序分析,并绘制系统发育树分析其基因型。结果 A、B、C和D抗-HDV IgG试剂的灵敏度分别为94.44%、66.67%、61.11%和55.56%;假阴性率分别为5.56%、33.33%、38.89%和44.44%;特异度均为100.00%;无假阳性。经Kappa检验,A、B、C和D抗-HDV IgG试剂的K值分别为0.970、0.794、0.752和0.707。本研究发现的18例抗-HDV IgG真阳性样本中,有17例HDV RNA阳性,测序分析其nRT-PCR扩增产物,结果显示其均为HDV-1型。结论 本研究中,抗-HDV IgG试剂A检测灵敏度最高,可作为HDV感染的检测试剂。Objective To evaluate the sensitivities and specificities of four hepatitis D virus(HDV) immunoglobulin G(IgG) antibody detection reagents manufactured in China or abroad.Methods The sensitivities and specificities of 4 anti-HDV IgG reagents were evaluated by using a serum panel containing 18 anti-HDV IgG true positive and 480 anti-HDV IgG true negative sera.The HDV RNA of 18 anti-HDV IgG positive samples was detected by nested reverse transcription polymerase chain reaction(nRT-PCR).The nRT-PCR amplification products of 17 HDV RNA positive samples were sequenced for analysis,then the genotypes of these samples were identified by phylogenetic tree analysis.Results The sensitivities of reagents A,B,C and D were 94.44%,66.67%,61.11% and 55.56%,and the corresponding false negative rates were 5.56%,33.33%,38.89% and 44.44%,respectively.The specificities of the four reagents were all 100.00% without false positive.By Kappa(K) test,the K values of reagents A,B,C and D were 0.970,0.794,0.752 and 0.707,respectively.In this study,17 out of the 18 anti-HDV IgG true positive samples were positive for HDV RNA,and their genotypes were all HDV-1 by sequence analysis of the nRT-PCR amplification products.Conclusions In this study,the reagent A presented the highest sensitivity for detection of anti-HDV IgG among the four reagents,and can be used as a detection reagent for HDV infection.

关 键 词：丁型肝炎病毒(HDV) 丁型肝炎 抗-HDV IgG HDV核糖核酸 基因型 

分 类 号：R446.19[医药卫生—诊断学] R512.64[医药卫生—临床医学]