献血者TP抗体ELISA检测屏蔽界限的探讨  

Establishing the Blood Donor Deferral Criterion in TP ELISA Test

作　　者：胡京辉[1] 葛红卫[1] 王瑞[1] 郭瑾[1] 高楠[1] 张婧[1] 吴硕[1] 贾俊杰[1] 刘正敏[1] 李玲 刘忠 HU Jing-Hui;GE Hong-Wei;WANG Rui;GUO Jin;GAO Nan;ZHANG Jing;WU Shuo;JIA Jun-Jie;LIU Zheng-Min;LI Ling;LIU Zhong(Beijing Red Cross Blood Center,Beijing 100088 China;Clinical Transfusion Research Center,Institute of Blood Transfusion,Chinese Academy of Medical Sciences and Peking Union Medical College,Key Laboratory of Transfusion Adverse Reactions Chinese Academy of Medical Sciences,Chengdu 610081,Sichuan Province,China)

机构地区：[1]北京市红十字血液中心,北京100088 [2]中国医学科学院输血研究所临床输血研究中心,中国医学科学院输血不良反应研究重点实验室,四川成都610081

出　　处：《中国实验血液学杂志》2020年第3期956-960,共5页Journal of Experimental Hematology

摘　　要：目的:建立无偿献血者TP抗体ELISA检测屏蔽界限值,以此屏蔽真阳性献血者进入归队管理。方法:通过对本实验室常规检测的517份抗TP ELISA反应性的标本进行梅毒螺旋体颗粒凝集(TPPA)确证试验,确定标本的真实血清学状态。分别使用受试者工作曲线(ROC)99%特异性和百分位数法95%阳性预期值初步确定TP抗体屏蔽界限值。选择本实验室常规检测的283份TP抗体反应性标本,判断两种方法得出的初步屏蔽值的适用性,最终确定TP抗体献血者的屏蔽界限值。结果:试剂A 99%特异性对应S/CO值为13.33-16.18,95%百分位数法对应S/CO值为6.34;试剂B 99%特异性对应S/CO值为13.17-19.85,95%百分位数法对应S/CO值为6.62。经验证,试剂A、B的99%特异性界值屏蔽真阳性率均为100%;95%阳性预期值屏蔽真阳性率分别为98.4%、99%。最终确定99%特异性屏蔽界限低值作为献血者屏蔽界限值;试剂A的屏蔽界限为13.33,试剂B屏蔽界限为13.17。结论:本研究建立的献血者TP抗体ELISA检测的屏蔽界限值有助于减少进入后续献血者归队管理的数量。Objective:To Establish the shielding threshold value of TP antibody ELISA for unpaid blood donors,so as to shield true positive blood donors from returning to team management.Methods:The real serological status of 517 samples with anti-TP ELISA reactivity was determined by confirmation test of Treponema pallidum particle agglutination(TPPA).The shielding threshold of TP antibody was preliminarily determined by using 99%specificity of ROC and 95%positive predictive value of percentile method,respectively.283 TP antibody reactivity specimens routinely tested in our laboratory were selected to determine the applicability of the initial shielding values obtained by the two methods,and finally to determine the shielding threshold values of TP antibody donors.Results:The specific S/CO values of reagent A 99%were 13.33-16.18,that of reagent B 99%was 6.34,that of reagent B 99%was 13.17-19.85,and that of 95%was 6.62.Empirical evidence:99%specific threshold shielding true positive rates of reagents A and B were 100%,95%positive expected value shielding true positive rates were 98.4%,99%.Final determination of 99%specific shielding threshold as a low value of blood donors shielding threshold.The shielding limits of reagent A and B were 13.33 and 13.17.Conclusion:The shielding threshold of TP antibody ELISA for blood donors established in this study can help to reduce the number of blood donors returning to team management.

关 键 词：梅毒螺旋体抗体 献血者屏蔽 ROC曲线 百分位数 

分 类 号：R446.62[医药卫生—诊断学]