摘要
目的了解9个乙型病毒性肝炎(乙肝)监测省(直辖市,下同)实验室,乙肝病毒表面抗原[Hepatitis B Virus(HBV) Surface Antigen,HBsAg]、抗乙肝病毒核心抗原抗体IgM[Antibody to HBV Core Antigen ImmunoglobinM(IgM),Anti-HBcIgM]和甲型病毒性肝炎(甲肝)IgM抗体(Antibody to Hepatitis A Virus IgM,Anti-HAV IgM)三项监测指标的检测质量。方法从9个监测省保存的血清中,随机抽取部份血清标本,采用化学发光微粒子免疫分析法(Chemiluminescence Microparticle Immunoassay,CMIA),运用美国雅培公司生产的ARCHITECTi2000型全自动发光检测仪和检测试剂进行复核检测。以雅培试剂CMIA检测结果做为标准,评价监测点国产酶联免疫吸附试验(Enzyme-linked Immunosorbent Assay,ELISA)试剂检测HBsAg、Anti-HBcIgM、Anti-HAV IgM的灵敏度、特异度、总符合率和约登指数(YodenIndex)。结果法定传染病报告系统报告的乙肝病例中,开展HBsAg检测者占98.53%,进行Anti-HBc IgM检测者占39.49%。监测点对报告病例进行核实检测发现,报告病例的原始诊断和核实诊断差异较大,报告急性乙肝197例,与核实诊断结果一致的仅56例,占28.42%;报告慢性乙肝1046例,与核实诊断结果一致的602例,占57.55%。通过采用雅培试剂CMIA法对部分病例复核发现,核实诊断时采用的国产试剂ELISA法与雅培试剂CMIA法相比,检测结果一致性不高。与雅培试剂CMIA法相比,9个监测省所用检测HBsAg的国产试剂ELISA法灵敏度和总符合率>95%;Kappa值0.439,检测结果中度一致;特异度为50.00%。所用检测Anti-HBc IgM的国产试剂ELISA法灵敏度、特异度和总符合率均为中等水平;Kappa值0.516,检测结果中度一致。所用检测Anti-HAV IgM的国产试剂ELISA法灵敏度仅为20%;特异度和总符合率较高;Kappa值0.033,检测结果一致性差。结论在乙肝监测中,有必要提高乙肝病原学指标的检测水平,以提高乙肝病例报告的准确性。
Objective To assess the test quality of HBsAg,anti-HBc IgM and anti-HAV IgM in the laboratories of Hepatitis B pilot surveillance provinces.MethodsBlood serum from each of the Hepatitis B pilot surveillance provinces were collected to verify the test results.The Chemiluminescence Microparticle Immuno Assay（CMIA）,ARCHITECT？i2000 automatic light detector and test reagents produced by USA Abbott corporation were used in the retest.Using the Abbott reagent CMIA test results as the criteria,the domestic made ELISA reagents sensitivity,specificity,the total coincidence rate and Yoden index of HBsAg,anti-HBc IgM and anti-HAV IgM were evaluated in Hepatitis B pilot surveillance provinces.ResultsIn the National Notifiable Diseases Reporting System（NNDRS） reported Hepatitis B cases,the proportion of detecting HBsAg and anti-HBc IgM was 98.53% and 39.49% respectively.Through the verification test to the reported cases in Hepatitis B pilot surveillance provinces,the original and verification diagnosis of the reported cases was quite different.Among 197 acute Hepatitis B reported cases,56 cases were agreeable with diagnosis cretirea,accounting for 28.42%.Among 1046 chronic Hepatitis B reported cases,the verification diagnosis of 602 cases was consistent with the original diagnosis,accounting for 57.55%.By using Abbott reagent and CMIA method to test again,it was found that the verification test results using domesticmade reagent and ELISA assay were low consistency compared with the test results of Abbott reagent CMIA method.The detection result of home-made reagents by ELISA compared with the Abbott reagents CMIA,the sensitivity and the total coincidence rate of HBsAg were over 95%,Kappa value was 0.439,and specificity was only 50.00%.The sensitivity,the total coincidence rate and the specificity of Anti-HBc IgM were moderate level,Kappa value was 0.516.The sensitivity of Anti-HAV IgM were 20%,and the total coincidence and specificity were higher,Kappa value was 0.033,the consistency of test was poor.ConclusionIt＇s necessary to improve the detection ability of Hepatitis B etiology of indicators in order to improve the accuracy of the report of Hepatitis B cases.
出处
《中国疫苗和免疫》
CAS
2010年第3期203-206,274,共5页
Chinese Journal of Vaccines and Immunization
基金
国家科技重大专项艾滋病和病毒性肝炎等重大传染病防治专项"我国乙型病毒性肝炎免疫预防策略研究"课题(编号:20082X1002-001)
作者简介
王富珍（1974-），女，重庆市铜梁县人，中国疾病预防控制中心免疫规划中心讲师，硕士，从事病毒性肝炎的预防控制工作。
通讯作者：龚晓红
