梅毒螺旋体抗体时间分辨荧光免疫分析检测试剂的研制  

Timed-resolved fluoroimmunoassay kit for detection of anti-Treponema pallidum antibody in human serum

作　　者：周颖[1] 邹德亮 董志宁[2] 任志奇[2] 吴英松[2] 

机构地区：[1]广州市疾病预防控制中心,广东广州510440 [2]南方医科大学生物技术学院,广东广州510515

出　　处：《热带医学杂志》2015年第1期46-49,共4页Journal of Tropical Medicine

摘　　要：目的利用时间分辨荧光免疫分析技术(TRFIA)建立人血清中梅毒螺旋体(TP)抗体的检测试剂,适用于体检、TP感染及相关症状的临床检测。方法采用双抗原夹心法建立梅毒螺旋体抗体TRFIA检测试剂,对试剂的各项指标进行评价。结果本试剂国家参考品检测结果,阴性、阳性参考品符合率均为100.00%,最低检出限L1、L2检为阳性,L4检为阴性,精密性研究批内批间变异系数均符合试剂检定要求。本试剂与人类免疫缺陷病毒阳性、乙型肝炎病毒阳性、丙型肝炎病毒阳性、类风湿因子阳性、抗核抗体阳性等血样均无交叉反应。用本试剂与进口的酶免法试剂同时检测1 070份临床血样,结果显示对照试剂检出阳性标本484例,本试剂检出阳性标本486例,阳性符合率为99.59%,总符合率达99.43%。结论试剂各项指标均达到临床检测要求,试剂准确快速,安全可靠,具有较高的临床应用价值。Objective To prepare a time-resolved fluoroimmunoassay（TRFIA） kit for detection of anti-Treponema pallidum（TP） antibody in human serum. Methods A double antigen sandwich TRFIA method for detection of anti-TP antibody was developed. The performance of assay was evaluated in terms of some parameters. Results Detection results of National reference standards were as follows. Twenty of 20 positive national references were detected positive and 10 of 10 negative national references were detected negative. Limit of detection of L1 and L2 were detected positive and L4 was detected negative. The inter- and intra-assay coefficients of variability met the calibration requirements. No cross reactivity was found with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, rheumatoidfactors and antinuclear antibody. One thousand and seventy of clinical blood samples were tested with home-made and imported enzyme-linked immunosorbent assay（ELISA） simultaneously. Results showed 484 and 486 samples were respectively detected positive by ELISA and homemade assay, respectively. The positive ratio was 99.59% and total coincidence rate was 99.43%. Conclusion The developed anti-TP TRFIA in this study was a valuable test for clinical application with better sensitivity,specificity and accuracy.

关 键 词：梅毒螺旋体抗体 时间分辨荧光免疫分析法 双抗原夹心法 

分 类 号：R759.1[医药卫生—皮肤病学与性病学]