【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。更多还原

【Abstract】 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%.更多还原