包虫病特异性抗体检测试剂盒诊断效能评价及结果判定优化

DIAGNOSTIC EFFICACY AND THEIR OPTIMIZATION OF THREE SPECIFIC ANTIBODY TEST KITS FOR HUMAN ECHINOCOCCOSIS

为评价3种包虫病特异性IgG抗体诊断试剂盒的临床诊断效能,并针对其特异度差的问题进行优化,为包虫病免疫学诊断提供检测结果优化判定的策略,本研究共收集87例包虫病确诊病人血清,78例经排查为非包虫病就诊病人血清。每份血清同时采用3种试剂盒进行检测,对结果进行统计分析,评价各方法的诊断效能。通过受试者工作特征(ROC)曲线寻找各方法最佳诊断界值。采用胶体金免疫渗滤斑点法(DIGFA)对酶联免疫吸附法(ELISA)或胶体金免疫层析法(GICA)所得检测结果低于最佳诊断界值的阳性样本进行重新测定,以DIGFA法最佳诊断界值为结果判定标准。比较结果优化前后的诊断效能。结果显示,3种诊断方法的灵敏度在90.8%~94.3%之间,特异度在75.7%~83.3%之间。ROC曲线所得最佳诊断界值均高于试剂盒的cutoff值。检测结果经优化后,灵敏度保持在90.3%以上,特异度提升至88.5%以上。结果表明,3种诊断方法的特异度均不理想,本次研究通过对检测结果的优化判定,在不影响灵敏度的前提下可减少该部分血清假阳性结果的误判,提高方法的特异度,为包虫病临床诊断提供更为可靠的信息。

In the present study,87 confirmed human echinococcosis cases and 78 non-echinococcosis control were enrolled to test the diagnostic efficacy of three kinds specific IgG antibody test kits.Blood serum were submitted to detect for echinococcosis by the three kits following their own SOP and the optimal diagnostic cutoff value of each kit was calculated from receiver operating characteristic(ROC)curve.To optimize the detection protocol,DIGFA was utilized to re-detect in the positive samples whose ELISA or GICA results were lower than the corresponding diagnostic cutoff value,and the optimal diagnostic cutoff value of DIGFA was used as standard.As a results,the sensitivity of the three kits ranged from 90.8%to 94.3%,and the specificity were shown with variety of 75.7%-83.3%.The optimal cutoff values obtained from ROC curve were higher than their written cutoff values of the three kits.After optimizations,the sensitivity were kept above 90.3%,the specificity were increased to above 88.5%,and the false positive results can be reduced simultaneously.