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 -E 3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 2 7 2mIU/ml,其中 16 7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 % (16 6 /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 >2 0mIU/ml时 ,与IMx的符合率分别为 98 1% (10 5 /10 7,昆明 -E)和 94 4 % (10 1/10 7,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。
Objective Twelve week sera specimens of vaccinees inoculated with live attenuated hepatitis A vaccine (H\-2 strain) were tested for evaluating the effect of domestic HAVAB-E kits in detection.Methods Two 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.Results The GMT 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 H\-2 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).Conclusion The qualitative results provided by the domestic EIA diagnostic kits were reliable and could represent the immunogenicity and efficacy of live attenuated hepatitis A vaccine.
出处
《中国公共卫生》
CAS
CSCD
北大核心
2002年第1期33-34,共2页
Chinese Journal of Public Health
关键词
甲型肝炎疫苗
抗体检测
HAVAB-E
diagnostic EIA kit
HAVAB detection
live attenuated hepatitis A vaccine
