梅毒抗体酶联免疫吸附法检测试剂盒性能验证及评价  

Performance Verification of ELISA Kit for Detection of Anti-TP

作　　者：宗春辉 赵辉[1] 马千真[1] 孟伟[1] 辛国辉[1] 

机构地区：[1]泰安出入境检验检疫局

出　　处：《口岸卫生控制》2017年第3期23-26,共4页Port Health Control

摘　　要：目的探讨酶联免疫吸附试验（ELISA）检测中试剂盒的性能验证评价方法,并对该实验室梅毒抗体（anti-TP）检测中所使用的英科新创生产的ELISA试剂盒进行性能验证评价,以判断所用试剂盒是否能满足实验室检测工作的基本要求。方法利用全自动酶标仪进行ELISA检测,从试剂盒最低检出限、重复性、精密度、正确度四个方面,评价该试剂盒的性能指标,并对试剂盒的CUTOFF值进行验证,判断其是否适合本实验室常规检测人群。结果梅毒抗体（anti-TP）ELISA检测中,该实验室所用英科新创试剂盒最低检出限为0.25 NCU/m L,低于厂家声称的0.3 NCU/ml,适合大批量样本筛检,避免了漏检;批内精密度试验中,弱阳性浓度水平（0.5 NCU/m L）和临界值浓度水平的变异系数（CV）分别为4.0%和3.2%;批间精密度实验中,在弱阳性浓度水平（0.5 NCU/m L）和临界值浓度水平的CV为8.5%和7.6%,均低于厂家声明的标准;正确度验证方面,阴阳性符合率达到100%;CUTOFF值验证实验中,检测的样本OD值的x＋3SD=0.027,小于试剂盒提供的CUTOFF值0.105.结论该梅毒抗体检测试剂盒的各项性能指标符合本实验室的要求,CUTOFF值适合本实验室日常检测工作和受检人群。Objective To investigate the ELISA method for performance validation detection kit, and to determine whether the kit can meet the basic requirements of laboratory testing work by testing the performance detection of anti-TP ELISA kit used in the laboratory. Method To evaluate the performance of the kit through the automatic ELISA test in four aspects of the minimum detection limit, repeatability, precision and accuracy. To verify and determine the CUTOFF value of the kit and whether it is suitable for the laboratory test population.Results The laboratory Intec kit, in anti-TP ELISA detection, minimum detection limit was0.3NCU/ml; the CV of weakly positive concentration（0.25NCU/m L） and the critical concentration were 4.0% and 3.2% in repetitive experiments; the CV at the level of weak positive concentration（0.5 NCU/ml） and the critical value concentration in precision test were 8.5% and 7.6%; the positive and negative coincidence rate reached 100% in the accuracy test; the sample OD value of x＋3SD=0.027 is less than the value of 0.105 Kit during the CUTOFF value of the experiments. Conclusion The performance of the anti-TP detection kit is suitable for the routine detection of the laboratory and the tested population.

关 键 词：酶联免疫吸附法 性能验证 全自动酶标仪 梅毒抗体 

分 类 号：R514[医药卫生—内科学]