[建立TP ELISA检测中献血者延期标准]

[Establishing the Blood Donor Deferral Criterion in TP ELISA Test].

作者信息

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

机构信息

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,E-mail:

出版信息

Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2020 Jun;28(3):956-960. doi: 10.19746/j.cnki.issn.1009-2137.2020.03.039.

DOI:10.19746/j.cnki.issn.1009-2137.2020.03.039

PMID:32552964

Abstract

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.

摘要

目的

建立无偿献血者梅毒螺旋体抗体酶联免疫吸附测定（ELISA）的屏蔽阈值，以屏蔽真阳性献血者重新进入队伍管理。

方法

采用梅毒螺旋体颗粒凝集试验（TPPA）确证试验，确定517例抗-TP ELISA反应性样本的真实血清学状态。分别采用ROC曲线99%特异性和百分位数法95%阳性预测值初步确定TP抗体的屏蔽阈值。选取本实验室常规检测的283例TP抗体反应性标本，确定两种方法获得的初始屏蔽值的适用性，最终确定TP抗体献血者的屏蔽阈值。

结果

试剂A 99%特异性的S/CO值为13.33～16.18，试剂B 99%特异性的S/CO值为6.34，试剂B 95%特异性的S/CO值为13.17～19.85，95%阳性预测值的S/CO值为6.62。实证依据：试剂A和B的99%特异性阈值屏蔽真阳性率均为100%，95%阳性预测值屏蔽真阳性率分别为98.4%、99%。最终确定99%特异性屏蔽阈值为献血者屏蔽阈值下限。试剂A和B的屏蔽限分别为13.33和13.17。