献血者ELISA法检测梅毒抗体灰区设置的合理性探讨  

Rationality of Grey Area Setting for Detection of Treponema Pallidum Antibody by ELISA in Blood Donors

作　　者：王玲玲[1] 朱传凤 陆荣[1] 王凯[1] WANG Lingling;ZHU Chuanfeng;LU Rong;WANG Kai(Suzhou Central Blood Station,Suzhou,Jiangsu 215000,China)

机构地区：[1]苏州市中心血站,江苏苏州215000

出　　处：《大医生》2019年第19期160-161,共2页Doctor

摘　　要：目的探讨无偿献血者梅毒螺旋体(treponema pallidum,TP)双试剂酶联免疫法(ELISA)双试剂检测结果有无必要设置灰区。方法回顾性分析2015年3月至2016年3月苏州市中心血站收集的97406份献血者标本,留取S/CO≥0.5的258份TP ELISA有反应性标本,送当地疾病控制中心(CDC)经梅毒螺旋体颗粒凝集试验(TPPA)确认。结合试验数据,绘制ROC曲线,分析两种试剂各自最佳S/CO值。结果本站两种试剂检测抗-TP“灰区”有反应性标本中无一例经TPPA确证为阳性,且经ROC曲线分析最佳S/CO值均大于厂家推荐值。结论采用ELISA法测定TP,无需设置“灰区”。Objective To investigate whether it is necessary to set up gray area in the Results of treponema pallidum(TP)ELISA double reagent test for unpaid blood donors.Methods Totally 97406 blood donors were collected from Suzhou Central Blood Station from March 2015 to March 2016.Among them,258 TP ELISA positive specimens with S/CO≥0.5 were collected and sent to the local CDC for confirmation by Treponema pallidum agglutination test(TPPA).Based on the experimental data,the ROC curve was drawn and the optimum S/CO values of the two reagents were analyzed.Results None of the two reagents tested positive for anti-TP"grey area"was confirmed by TPPA,and the optimal S/CO value by ROC curve analysis was higher than the recommended value of the manufacturer.Conclusion It is not necessary to set up"grey area"for the determination of TP by ELISA.

关 键 词：“灰区” 梅毒螺旋体抗体 ROC曲线 S/CO值 

分 类 号：R44[医药卫生—诊断学]