2种梅毒螺旋体抗体酶联免疫吸附试剂性能评价

Evaluation of the Performance of Two Kinds of Anti-TP Enzyme-Linked Immunosorbent Assay

目的:评价本实验室2种梅毒螺旋体抗体(treponema pallidum)(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,为引入抗-TP化学发光免疫分析试验(CLIA)检测手段后,选择ELISA试剂提供数据支持。方法:采用2种ELISA试剂对无偿献血者标本进行抗-TP常规检测,共收集546例抗-TP ELISA反应性标本,应用梅毒螺旋体颗粒凝集试验(treponema pallidum particle agglutination,TPPA)确证标本的感染状态。比较2种抗-TP ELISA试剂反应性标本的确证结果;绘制ROC曲线,比较曲线下面积(AUC),分析2种抗-TP ELISA试剂的准确性;通过统计本实验室2016年7月1日-2017年6月30日质控数据,比较2种抗-TP ELISA试剂的精密度。结果:2种抗-TP ELISA试剂对反应性样本和弱阳性标本的确证阳性率无统计学差异。双试剂反应性标本占所有反应性标本的85.53%(467/546),TPPA确证阳性率为82.87%。抗-TP ELISA试剂A单独反应性标本44例,抗-TP ELISA试剂B单独反应性标本35例,经TPPA确证结果均为阴性。ROC曲线下面积(AUC)比较显示,2种抗-TP ELISA试剂准确性较高,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%,符合ELISA试验精密度的要求。结论:本实验室现用2种抗-TP ELISA试剂的准确性和精密度相似,选择其中任何1种抗-TP ELISA试剂均可以满足血液筛查的要求。

Objective： 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）.Methods：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.Results：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.Conclusion： 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.