Establishing the Blood Donor Deferral Criterion in TP ELISA Test.
10.19746/j.cnki.issn.1009-2137.2020.03.039
- Author:
Jing-Hui HU
1
;
Hong-Wei GE
1
;
Rui WANG
1
;
Jin GUO
1
;
Nan GAO
1
;
Jing ZHANG
1
;
Shuo WU
1
;
Jun-Jie JIA
1
;
Zheng-Min LIU
1
;
Ling LI
1
;
Zhong LIU
2
Author Information
1. Beijing Red Cross Blood Center,Beijing 100088 China.
2. 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:liuz@ibt.pumc.edu.cn.
- Publication Type:Journal Article
- MeSH:
Blood Donors;
Enzyme-Linked Immunosorbent Assay;
Humans;
Syphilis;
Syphilis Serodiagnosis;
Treponema pallidum
- From:
Journal of Experimental Hematology
2020;28(3):956-960
- CountryChina
- Language:Chinese
-
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.
