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龙润乡, 曹逸云, 周德久, 谭顺革, 陈洪波, 董德祥. 国产HAVAB-E在甲肝疫苗抗体检测中的应用效果[J]. 中国公共卫生, 2002, 18(1): 33-34. DOI: 10.11847/zgggws2002-18-01-17
引用本文: 龙润乡, 曹逸云, 周德久, 谭顺革, 陈洪波, 董德祥. 国产HAVAB-E在甲肝疫苗抗体检测中的应用效果[J]. 中国公共卫生, 2002, 18(1): 33-34. DOI: 10.11847/zgggws2002-18-01-17
LONG Rui-xiang, . Evaluation on Application of Domestic HAVAB-E Kits to Detect Antibody Induced by Live Attenuated Hepatitis A Vaccine[J]. Chinese Journal of Public Health, 2002, 18(1): 33-34. DOI: 10.11847/zgggws2002-18-01-17
Citation: LONG Rui-xiang, . Evaluation on Application of Domestic HAVAB-E Kits to Detect Antibody Induced by Live Attenuated Hepatitis A Vaccine[J]. Chinese Journal of Public Health, 2002, 18(1): 33-34. DOI: 10.11847/zgggws2002-18-01-17

国产HAVAB-E在甲肝疫苗抗体检测中的应用效果

Evaluation on Application of Domestic HAVAB-E Kits to Detect Antibody Induced by Live Attenuated Hepatitis A Vaccine

  • 摘要: 目的评估国产HAVAB-E诊断试剂盒在甲肝减毒活疫苗抗体检测中的应用效果.方法用Abbott实验室的HAVAB-IMx以及中国医学科学院医学生物学研究所(昆明)和浙江省医学科学院普康生物技术公司生产的HAVAB-E3种试剂对184份疫苗接种者的12周血进行检测对比试验.IMx试剂经用WHO甲肝免疫球蛋白标准品标化后定量检测标本的mIU/ml.结果总体GMT为27.2mIU/ml,其中167份(90.8%)抗体水平>10mIU/ml.此结果较接近疫苗的保护效果.国产试剂的阳性率分别为95.1%(175/184,昆明-E)和90.2%(166/184,浙江-E),两试剂结果一致率为92.9%.国产试剂阳性率随抗体水平升高呈增加趋势,当滴度>20mIU/ml时,与IMx的符合率分别为98.1%(105/107,昆明-E)和94.4%(101/107,浙江-E).结论两种国产酶免诊断试剂的定性检测结果真实可靠,在甲肝减毒活疫苗抗体检测中能客观反映疫苗的免疫原性和保护效果,是值得推广使用的诊断试剂.

     

    Abstract: ObjectiveTwelve week sera specimens of vaccinees inoculated with live attenuated hepatitis A vaccine(H2 strain)were tested for evaluating the effect of domestic HAVAB-E kits in detection.MethodsTwo domestic HAVAB-E kits were produced by Institute of Medical Biology,CAMS,Kunming(Kunming-E)and Pukang Biotechnique Company, Zhejiang Provincial Academy of Medical Sciences.The HAVAB-IMx kits was bought from Abbott Laboratory,USA.IMx test system standardized with WHO reference preparation of HAV Ig was applied to determine antibody titers of mIU/ml.ResultsThe GM T of 184 specimens was 27.2mIU/ml.Among them,167 samples(90.8%)showed titers>10mIU/ml.The result was quite close to protective efficacy offered by H2 vaccine.The positive rates detected with 2 domestic kits were 95.1% (175/184,Kunming-E)and 90.2% (166/184,Zhejiang-E),respectively.However,the rate of accordant results derived from these 2 kits reached 92.9% (171/184).Positive rates of 2 domestic kits followed the rise of antibody level towards increase.With titer>20mIU/ml,the correspondence rate between the domestic kits and IMx kit was 94.4%98.1% (101-105/107).ConclusionThe qualitative results provided by the domestic EIA diagnostic kits were reliable and could represent the immunogenicity and efficacy of live attenuated hepatitis A vaccine.

     

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