Gao Nan, Huang Li-Qin, Wang Rui, Jia Jun-Jie, Wu Shuo, Zhang Jing, Ge Hong-Wei
Beijing Red Cross Blood Center, Beijing 100088, China.
Beijing Red Cross Blood Center, Beijing 100088, China. E-mail:
Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2018 Jun;26(3):905-910. doi: 10.7534/j.issn.1009-2137.2018.03.046.
To evaluate the accuracy and precision of 2 kinds of anti-treponema pallidum (anti-TP) ELISA reagents in our laboratory for detecting the anti-TP in voluntary blood donors, so as to provide the data support for use of ELISA reagents after introduction of chemiluminescene immunoassay (CLIA).
The route detection of anti-TP was performed by using 2 kinds of ELISA reagents, then 546 responsive positive samples detected by anti-TP ELISA were collected, and the infections status of samples confirmed by treponema pallidum particle agglutination (TPPA) test was identified. The confirmed results of responsive samples detected by 2 kinds of anti-TP ELISA reagents were compared, the accuracy of 2 kinds of anti-TP ELISA reagents was analyzed by drawing ROC and comparing area under curve (AUC), and precision of 2 kinds of anti-TP ELISA reagents was compared by statistical analysis of quality control data from 7.1 2016 to 6.30 2017.
There were no statistical difference in confirmed positive rate of responsive samples and weak positive samples between 2 kinds of anti-TP ELISA reagents. The responsive samples detected by 2 kinds of anti-TP ELISA reagents accounted for 85.53%(467/546) of all responsive samples, the positive rate confirmed by TPPA test was 82.87%. 44 responsive samples detected by anti-TP ELISA reagent A and 35 responsive samples detected by anti-TP ELISA reagent B were confirmed to be negative by TPPA test. Comparison of AUC showed that the accuracy of 2 kinds of anti-TP ELISA reagents was more high, the difference between 2 reagents was not statistically significant. The coefficient of variation (CV) of anti-TP ELISA reagent A and B was 14.98% and 18.04% respectively, which met the precision requirement of ELISA test.
The accuracy and precision of 2 kinds of anti-TP ELISA reagents used in our laboratory are similar, and using any one of anti-TP ELISA reagents all can satisfy the requirements of blood screening.
评估本实验室2种梅毒螺旋体抗体（抗-TP）酶联免疫吸附试验（ELISA）试剂检测无偿献血者抗-TP的准确性和精密度，为化学发光免疫分析法（CLIA）引入后ELISA试剂的使用提供数据支持。
采用2种ELISA试剂进行抗-TP的初筛检测，收集546例抗-TP ELISA检测反应性阳性样本，采用梅毒螺旋体颗粒凝集试验（TPPA）鉴定样本的感染状况。比较2种抗-TP ELISA试剂检测反应性样本的确认结果，绘制受试者工作特征曲线（ROC）并比较曲线下面积（AUC）分析2种抗-TP ELISA试剂的准确性，对2016年7月1日至2017年6月30日的质量控制数据进行统计分析比较2种抗-TP ELISA试剂的精密度。
2种抗-TP ELISA试剂检测反应性样本和弱阳性样本的确认阳性率差异无统计学意义。2种抗-TP ELISA试剂检测的反应性样本占所有反应性样本的85.53%（467/546），TPPA试验确认的阳性率为82.87%。抗-TP ELISA试剂A检测的44例反应性样本和抗-TP ELISA试剂B检测的35例反应性样本经TPPA试验确认为阴性。AUC比较显示2种抗-TP ELISA试剂的准确性均较高，2种试剂间差异无统计学意义。抗-TP ELISA试剂A和B的变异系数（CV）分别为14.98%和18.04%，均满足ELISA检测的精密度要求。
本实验室使用的2种抗-TP ELISA试剂准确性和精密度相近，使用任意一种抗-TP ELISA试剂均可满足血液筛查要求。
