献血者人类嗜T淋巴细胞病毒电化学发光测定值与免疫印迹确证结果的相关性研究

Correlation between electrochemiluminescence immunoassay and western blot confirmation for human T-lymphotropic virus screening in blood donors

目的研究电化学发光免疫测定技术在献血者人类嗜T淋巴细胞病毒(HTLV)检测中的应用效果,评估发光检测COI值与免疫印迹确证结果的相关性,为血站选择最佳筛查策略并优化确证实验流程提供科学依据。方法将2016~2022年本省参加无偿献血且初筛不合格(HTLV酶免反应性)的1070份献血者血液标本纳入本次研究。所有标本分别使用电化学发光方法和蛋白质印迹方法(金标准)进行检测,对结果进行记录和分析并绘制受检者操作特征曲线(ROC)。利用ROC曲线寻找电化学发光免疫测定的最佳诊断临界值。结果1070份初筛不合格标本经电化学发光检测有285份阳性,阳性率26.64%(285/1070),经蛋白质印迹检测有70份阳性,确证阳性率6.54%(70/1070),该70份标本为发光和印迹双阳性。285份电化学发光阳性标本的平均COI值为81.92,中位数为4.98。按照印迹检测结果分为2组后,印迹阴性组中位数为2.76,印迹阳性组中位数为312.45(Z=-12.53,P<0.01)。根据ROC曲线,最佳诊断临界值为72.10(AUC=1,P<0.01),此时发光检测结果与印迹确证结果的符合率为99.35%。结论电化学发光免疫测定技术是一种灵敏度高、特异性强且适用于大规模检测的技术,合理设置诊断临界值后其检测结果与免疫印迹确证结果有很好的一致性,在献血者HTLV检测方面具有良好的应用前景。

Objective To study the application effect of electrochemiluminescence immunoassay(ECLIA)in the screening of human T-lymphotropic virus(HTLV)in blood donors,explore the correlation between COI and confirmed result by western blot(WB),so as to provide scientific evidence for blood banks to select optimal screening strategy and optimize process flows.Methods A total of 1070 HTLV reactive blood samples by ELISA in preliminary screening in our province from 2016 to 2022 were included in this study.All samples were detected by ECLIA and WB(gold standard),and the receiver operating characteristic curve(ROC)was drawn to find optimal diagnostic critical value of ECLIA.Results Among 1070 samples,285 were positive by ECLIA,with a positive rate of 26.64%(285/1070),with average COI value at 81.92 and the median at 4.98.A total of 70 ECLIA positive samples were confirmed by WB,with a positive rate of 6.54%(70/1070).According to the results of WB,the median of WB-positive group and WB-negative group was 312.45 vs 2.76,respectively(P<0.01).ROC analysis showed that optimal diagnostic critical value was 72.10(P<0.01),with concordance rate of the two detection methods at 99.35%.Conclusion ECLIA,with high sensitivity and specificity is suitable for the detection with large sample size.When the diagnostic threshold is properly set,ECLIA results are in good agreement with those of WB,and it has good application prospect in HTLV screening in blood donors.