两种戊型肝炎IgG抗体检测试剂的比较  

Comparison of two diagnostic reagents to detect anti-hepatitis E virus IgG antibodies

作　　者：闫强[1] 杜海莲[1] 王颖彬[1] 葛胜祥[1] 黄守杰[1] 江浪[1] 张军[1] 夏宁邵[1] 

机构地区：[1]厦门大学国家传染病诊断试剂与疫苗工程技术研究中心,厦门361005

出　　处：《中国人兽共患病学报》2008年第12期1087-1089,1099,共4页Chinese Journal of Zoonoses

摘　　要：目的比较2种国产戊型肝炎IgG抗体诊断试剂(E2-IgG和X-IgG)的特异性与敏感度。方法利用2种试剂对2006年江苏省某市普通人群的流行病调查血清标本460份和经过巢式逆转录聚合酶链式反应(nest-RT-PCR)鉴定为HEV核酸阳性的临床戊型肝炎患者血清标本72份进行平行检测,并以免疫印迹实验(Westernblot,WB)和中和单抗阻断试验进行验证。结果1.460份流行病调查血清标本中WB阳性188份。2.188份WB阳性标本中E2-IgG的检测敏感度为99.5,特异度为99.6,阳性预测值99.5,阴性预测值99.6,准确性99.6;X-IgG的检测敏感度为21.3,特异度为97.4,阳性预测值85.1,阴性预测值64.1,准确性66.3。3.E2-IgG阴、阳性A450/A620值的分布在临界值附近分界明显,小于临界值的A450/A620值取对数后呈正态分布,而阳性血清A450/A620值的高低与其WB的反应强度正相关。4.E2-IgG阳性、X-IgG阴性的血清共148份,中和单抗阻断阳性率为98,WB阳性率99.3。5.经PCR鉴定为HEV核酸阳性的急性戊型肝炎患者血清中E2-IgG敏感度98.6,X-IgG敏感度80.6(χ2=10.7,P<0.01)。结论E2-IgG在不同人群中均能较好的反映体内戊型肝炎抗体存在的真实情况。The sensitivity and specificity of two diagnostic reagent to detect the presence of anti-hepatitis E virus IgG an- tibodies （E2-IgG and X-IgG） were tested in 460 serum samples taken from population undergoing an epidemiological investigation of Jiangsu province in 2006 and 72 serum samples taken from patients with hepatitis E virus （HEV） infection identified by nest RT-PCR, and the results were also confirmed with Western blot assay and the blocking test with neutralizing monoclonal antibody （mAb） . It was found that the sensitivity, specificity, positive or negative prediction values as well as accuracy of E2 were 99.5% 99.6%, 99.5%, 99.6% and 99.6% ; while those of X-IgG were 21.3%, 97.4%, 85.1%, 64.1% and 66.3% respectively. The positive and negative A450/A620values of E2-IgG were distinct around the cut-off value, and the log value of the A450/A620 smaller than the cut-off value showed a pattern of normal distribution, while the A450/A620 value of the positive serum correlated with the intensity of Western blot assay. In addition, the positive rates of 148 samples of positive E2-IgG but negative X-IgG as demonstrated by neutralizing mAb blocking test and Western blot assay were 98.0% and 99.3%, and the sensitivities of E2-IgG and X-IgG tested in serum samples of patients with acute HEV infection with positive HEV nucleic acid as demonstrated by PCR were 98.6 0% and 80.6 % respectively（x^2= 10.7, P〈0. 01）. It is apparent that the diagnostic reagent E2-IgG in comparison with X-IgG, can reflect a better performance on the real condition of HEV IgG antibodies in different groups of populations.

关 键 词：戊型肝炎 IgG 诊断试剂 免疫印迹 中和单抗 

分 类 号：R373[医药卫生—病原生物学]