两种丁型肝炎病毒抗体检测试剂盒的对比分析
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摘要
目的对国外丁型肝炎病毒(HDV)抗体检测试剂盒的性能进行研究和对比分析。方法对采集的1 000份血清样本分别用考核试剂、参比试剂和第三方试剂进行检测后使用统计学方法进行结果处理,并依据S/Co值来判断。结果 Kappa分析显示Kappa值为0.950(P<0.01)。特异性100%,敏感性97.73%,ROC曲线下面积0.986。结论该检测试剂盒的准确性比较高,与目前国内使用比较广泛的诊断试剂盒相比有较高的一致性,通过提高丁型肝炎的临床检出率,对疾病的预防、早期诊断及治疗起到一定的辅助作用。
Objective To conduct the study and comparative analysis on the performance of foreign hepatitis D virus(HDV)antibody test kits.Methods The collected 1 000 serum samples were tested by 3 kinds of different reagent:test reagent,reference reagent and third party reagent.The detection results were processed by the statistical method and the judgement was performed base on the S/Co value.Results The Kappa analysis showed that the Kappa value was 0.950(P<0.01).The specificity was 100%,the sensitivity was 97.73%and the area under ROC was 0.986.Conclusion The test kit has a relatively high accuracy and high consistency compared with the diagnostic reagent kits now widely used in domestic.Increasing the clinical detection rate of HDV can play a helping role on prevention,early diagnosis and treatment of the disease.
Objective To conduct the study and comparative analysis on the performance of foreign hepatitis D virus(HDV)antibody test kits.Methods The collected 1 000 serum samples were tested by 3 kinds of different reagent:test reagent,reference reagent and third party reagent.The detection results were processed by the statistical method and the judgement was performed base on the S/Co value.Results The Kappa analysis showed that the Kappa value was 0.950(P<0.01).The specificity was 100%,the sensitivity was 97.73%and the area under ROC was 0.986.Conclusion The test kit has a relatively high accuracy and high consistency compared with the diagnostic reagent kits now widely used in domestic.Increasing the clinical detection rate of HDV can play a helping role on prevention,early diagnosis and treatment of the disease.
引文
[1]谢立,黄徳庄.用基因重组丁型肝炎病毒抗原检测丁肝病毒IgM抗体及其初步应用[J].天津医药,2004,7(7):423.
[2]Chen PJ,Kalpana G,Goldberg J,et al.Structure and replication of the genome of hepatitis 8virus[J].Proc Natl Acad Sci USA,1986,83(22):8774-8778.
[3]Chao YC,Lee CM,Tang HS,et al.Molecular cloning and characterization of an isolate of hepatitis delta virus from Taiwan[J].Hepatology,1991,13(2):345-352.
[4]Bonino F,Hoyer B,Shih JW,et al.Delta hepatitis agent:structural and antigenic properties of the delta-associated particle[J].Infect Immun,1984,43(3):1000-1005.
[5]Moraleda G,Dingle K,Biswas P,et al.Interaction between hepatitis delta virus proteins[J].J Virol,2000,74(12):5509-5515.
[6]Su CW,Huang YH,Hugo TI,et al.Genotypes and viremia of hepatitis B and D viruses are associated with outcomes of chronic hepatitis D patients[J].Gastroenterology,2006,130(1):1625-1635.
[7]许泼实,韩双印,孙长义,等.乙型肝炎病毒感染者血清中丁型肝炎病毒标志物检测分析[J].中华实验和临床病毒学杂志,2012,26(4):307-309.
[8]Shen L,Gu Y,Sun L,et al.Development of a hepatitis delta virus antibody assay for study of the prevalence of HDV among individuals infected with hepatitis B virus in China[J].J Med Virol,2012,84(3):445-449.
[9]王云龙,王娟.丁型肝炎病毒ORF5基因片段的原核表达及在ELISA中的初步应用[J].动物医学进展,2012,33(5):31-34.
[10]邵惠训.一种缺陷病毒——丁型肝炎病毒[J].首都公共卫生,2011,5(3):115-119.
[11]张庆生.分析方法的验证[J].中国新药与临床药理,1999,10(6):376.
[12]王瑞莲.新药临床研究实用手册2设计、执行和分析[M].北京:化学工业出版社,2003.
[2]Chen PJ,Kalpana G,Goldberg J,et al.Structure and replication of the genome of hepatitis 8virus[J].Proc Natl Acad Sci USA,1986,83(22):8774-8778.
[3]Chao YC,Lee CM,Tang HS,et al.Molecular cloning and characterization of an isolate of hepatitis delta virus from Taiwan[J].Hepatology,1991,13(2):345-352.
[4]Bonino F,Hoyer B,Shih JW,et al.Delta hepatitis agent:structural and antigenic properties of the delta-associated particle[J].Infect Immun,1984,43(3):1000-1005.
[5]Moraleda G,Dingle K,Biswas P,et al.Interaction between hepatitis delta virus proteins[J].J Virol,2000,74(12):5509-5515.
[6]Su CW,Huang YH,Hugo TI,et al.Genotypes and viremia of hepatitis B and D viruses are associated with outcomes of chronic hepatitis D patients[J].Gastroenterology,2006,130(1):1625-1635.
[7]许泼实,韩双印,孙长义,等.乙型肝炎病毒感染者血清中丁型肝炎病毒标志物检测分析[J].中华实验和临床病毒学杂志,2012,26(4):307-309.
[8]Shen L,Gu Y,Sun L,et al.Development of a hepatitis delta virus antibody assay for study of the prevalence of HDV among individuals infected with hepatitis B virus in China[J].J Med Virol,2012,84(3):445-449.
[9]王云龙,王娟.丁型肝炎病毒ORF5基因片段的原核表达及在ELISA中的初步应用[J].动物医学进展,2012,33(5):31-34.
[10]邵惠训.一种缺陷病毒——丁型肝炎病毒[J].首都公共卫生,2011,5(3):115-119.
[11]张庆生.分析方法的验证[J].中国新药与临床药理,1999,10(6):376.
[12]王瑞莲.新药临床研究实用手册2设计、执行和分析[M].北京:化学工业出版社,2003.