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作 者:王建红[1] 李秀华[2] 尹红章[2] 孟淑芳[2] 万宗举[2] 王佑春[2] 牟振云[3] 公雪杰 崔俊生[1] 陈江婷[1] 尹卫东[1]
机构地区:[1]唐山怡安生物工程有限公司,河北唐山063020 [2]中国药品生物制品检定所,北京100050 [3]河北医科大学,石家庄050017
出 处:《中国计划免疫》2003年第4期222-223,共2页Chinese Journal of Vaccines and Immunization
摘 要:将不同位点的甲型肝炎 (甲肝 )病毒 (HAV)TZ84单克隆抗体 (单抗 )或酶标单抗进行混合做包被和酶 ,代替现有试剂中的多克隆抗体 (多抗 ) ,采用竞争抑制法对试剂的灵敏度和可靠性进行测定 ,并通过 2 2 9份甲肝灭活疫苗临床观察血清甲肝病毒抗体的检测 ,对单抗试剂的应用进行研究 ,并对该单抗试剂进行评价。结果表明 :该单抗试剂的灵敏度为 94 % ,特异度均为 98% ,最低检出浓度的变异系数为 9 3% ;单抗试剂、多抗试剂和雅培试剂的最低检出浓度分别为 5 5、98、31mIU/ml。单抗试剂的灵敏度高于多抗试剂 ,特异度低于多抗试剂。hepatitis A(HA)vaccine immunized serum samples used for clinical study were detected for anti-HAV by the diagnostic reagent composed of MAbs of different HAV TZ 84 strain epitopes.The validity and the reliability of this MAb reagent was determined by the method of competitive inhibition.The results showed that the sensitivity and the specificity of the MAb reagent were 94% and 98% respectively. The limit detection of the MAb reagent was 55mIU/ml while that of the polyclonal antilody reagent and Abbott reagent were 98mIU/ml and 31mIU/ml respectively.The sensitivity of MAb reagent for detecting anti-HAV was higher but specificity was lower than that of the polyclonal antibody reagent.The variety coefficient of the reagent was 9.3%.
关 键 词:甲型肝炎病毒 TZ84株 单克隆抗体 甲型肝炎抗体 检测 应用
分 类 号:R373.21[医药卫生—病原生物学] R446.61[医药卫生—基础医学]
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