【摘要】 目的　研制乙型肝炎表面抗原 (HBsAg)胶体金试剂。方法　用未加氢氧化铝佐剂的乙型肝炎血源疫苗原材料免疫BALB/c小鼠制备抗 -HBs单克隆抗体 ;应用胶体金标记抗 -HBs单克隆抗体 ;测定HBsAg胶体金试剂的稳定性 ;对该试剂进行临床考核及检定等。结果　经中国药品生物制品检定所检定 ,其灵敏度达到 1ng/ml,特异度为 10 0 % (2 0 / 2 0 ) ,精密度为 10 0 % (10 / 10 ) ,符合国家对HBsAg试剂盒的要求 ,临床考核合格 ,已通过国家药品监督管理局的新药评审 ,获国家新药证书。结论　HBsAg胶体金试剂可用于献血员HBsAg筛查、健康人群体检、乙型肝炎病毒 (HBV)感染的流行病学调查和临床诊断。更多还原

【Abstract】 Objective To develop the HBsAg colloidal gold strip.Methods Anti HBs monoclonal antibodies were obtained through immunizatgion of BALB/c mice with the plasma derived hepatitis B vaccine,and then purified,and labeled with the colloidal gold.The stability and clinical evaluation,as well as quality control of the HBsAg colloidal gold strip were conducted.The strip was evaluated and approved by the State Drug Administration,China.Conclusion The HBsAg colloidal gold strip can be used for HBsAg screening of blood donors and general populations,and for epidemiological studies and diagnosis of hepatitis B virus infection.更多还原