摘要
建立乙型肝炎病毒表面抗体（抗-HBs）的时间分辨荧光免疫分析法（TRFIA）.检测体系由纯化的HBsAg包被的微孔板、Eu3＋标记的HBsAg、抗-HBs系列标准品和增强液组成,采用双抗原夹心法定量检测人血清或血浆抗HBs.测定药检所2、5、10 mIU/mL SAb血清盘均可准确检出,阴性血清（20/20）符合率为100%,CV为2.5%.测定范围为5～2000 mIU/mL,正常参考值小于10 mIU/mL.用本法与固相RIA、ELISA和ECLIA对1189份临床血样进行考核,并与参比试剂盒临床符合率一致,具有同等的临床诊断价值.
TRFIA for Anti-HBs in serum was developed using a double antigen sandwich method, in which one HBsAg was coated on microplate and other HBsAg was labeled with Eu^3＋. Anti-HBs standards and fluorescence enhancement solution were also included in the diagnostic kits. The 2, 5, 10 mIU/mL of NICPBP serum standards was exactly tested. The negative accordant ratio was 100% with 20 negative samples, and the intraassay CV was 2.5%. The detection range of Anti-HBs was from 5 to 2000 mlU/mL, and the normal level of Anti-HBs in serum of healthy people was less than 10 mIU/mL. The Anti-HBs levels of 1189 clinical serum samples were tested by TRFIA, and the detected results closely corresponded to those of detection with RIA, ELISA and ECLIA.
出处
《标记免疫分析与临床》
CAS
2007年第1期24-26,共3页
Labeled Immunoassays and Clinical Medicine
