时间分辨荧光免疫分析法乙型肝炎血清标志物分析灵敏度建.docVIP

时间分辨荧光免疫分析法乙型肝炎血清标志物分析灵敏度的建立与分析 Establishment and analysis of analytic sensitivity of hepatitis B virus serum markers by Time-resolved Fluoroimmunoassay 谭玉华 陈鲜美 卢顺舵 沈 健 （广州市丰华生物工程有限公司，广东 广州 510730） 摘 要 对乙型肝炎表面抗原和表面抗体定量测定试剂盒（时间分辨荧光免疫分析法）的分析灵敏度进行建立与分析，以便更好的指导临床诊断和进行流行病学研究。通过实验研究，乙型肝炎病毒表面抗原定量检测试剂盒和表面抗体定量检测试剂盒的检测低限分别为0.0356ng/mL和0.548 mIU/mL，生物检测限分别为0.200 ng/mL和5.00 mIU/mL，功能灵敏度分别为0.200 ng/mL和5.00 mIU/mL，线性范围分别为0.200 ng/mL-300 ng/mL和5.00 mIU/mL-1200 mIU/mL，并达到中国药品生物制品检定所检定要求。时间分辨荧光免疫分析法乙型肝炎病毒定量检测试剂盒具有灵敏度高，线性范围宽，特异性强的特点，已能有效应用于临床体外诊断和流行病学研究。 关键词 时间分辨荧光免疫分析；乙型肝炎；标志物；分析灵敏 Establishment and analysis of analytic sensitivity of hepatitis B virus serum markers by Time-resolved Fluoroimmunoassay TAN Yu-hua,CHEN Xian-mei,LU Shun-duo,et al. Guangzhou Fenghua Bio-engineering Co.,LTD,Guangzhou 510730 China Abstract To establish and analyse the analytic sensitivity for the quantification kits for hepatitis B virus(HBV) surface antigen(HBsAg) and antibody to HBsAg (anti-HBs),the kits were measured by Time-resolved Fluoroimmunoassay(TRFIA),in order to the better instruction clinical diagnosis and conducts the epidemiology research. Through the study,the lower limit of detection of the quantification kits for HBsAg and anti-HBs for 0.0356ng/mL and 0.548 mIU/mL respectively, the biological limit of detection is 0.200 ng/mL and 5.00 mIU/mL respectively, the function sensitivity is 0.200 ng/mL and 5.00 mIU/mL respectively, the linear scope is 0.200 ng/mL-300 ng/mL and 5.00 mIU/mL-1200 mIU/mL respectively, and passed the examination of the National Institute for Control of Pharmaceutical and Biological Products. The quantification kits for HBV serum markers by TRFIA ,which has the high sensitivity, the wide linear scope,the good specificity,could have the effect to use in the clinical in vitro diagnosis and the epidemiology research. Key words Time-resolved Fluoroimmunoassay; Hepatitis B virus;Marker;Analytic sensitivity 乙型肝炎病毒表面抗原（HBsAg）的检出是乙型肝炎病毒（HBV）感染的金标准。乙型肝炎病毒表面抗体（抗-HBs）是对HBV具有保