TG-ROC分析方法在检测试剂质量评价中的应用

目的比较人类T淋巴细胞白血病病毒(HTLV)ELISA检测试剂和Western Blot(简称WB)确认试剂的关系,分析HTLV检测试剂的质量水平。方法通过WB确认试剂对156份ELISA初筛阳性的人血清标本进行HTLV抗体的检测,使用TG-ROC分析方法来选出ELISA最佳CO值(阈值),以2×2列联表分析这两种检测结果的一致性,并用McNemar检验评估检测结果的一致性,综合评价HTLV检测试剂质量水平。结果 156份ELISA初筛阳性的人血清标本经过WB进行确证后仅有40份为阳性,其余116份为阴性。TG-ROC分析结果得出该ELISA检测试剂的敏感性和特异性分别为97.5%和45.7%,McNemar检验也表明ELISA与WB检测结果差异有统计学意义(P0.05)。通过调整阈值,能使ELISA敏感性和特异性同时达到88.8%(参数法)。比较参数法和非参数法,得到曲线下面积为0.923 5(参数法),两者的结论基本一致。结论虽然该ELISA试剂结果与WB结果有差别,但是通过调整阈值,可以提高其敏感性和特异性,继而增加诊断结果的可靠性。

Application of TG-ROC analytical method in detection reagent quality evaluation

Objective To compare the relationship between the enzyme‐linked immunosorbent assay(ELISA) reagent and West‐ern blot(WB) confirmation reagent for analyzing the quality lever of human T‐cell lymphotropic virus(HTLV) detection reagent . Methods The WB confirmation reagent was used to detect anti‐HTLV antibody in 156 human serum samples of ELISA prelimina‐ry screening positive .The ELISA cut‐off value(optimal value) was selected by using the two‐graph receiver operating characteristics (TG‐ROC) analytical method .The two‐by‐two table analysis was constructed to analyze the consistency of results detected by the two methods ,moreover the McNemar test was used to evaluate the consistency of detection results .The quality level of HTLV de‐tection reagent was comprehensively evaluated .Results Among 156 serum samples of ELISA preliminary screening positive ,only 40 samples were positive by the WB confirmation ,and other 116 samples were negative .The sensitivity and specificity of ELISA de‐tection reagent obtained by TG‐ROC analysis were 97 .5% and 45 .7% respectively ,the TG‐ROC test also indicated that the detec‐tion results had significant difference between ELISA and WB(P<0 .05) .By adjusting the cut‐off value ,the sensitivity and specific‐ity of ELISA were increased to 88 .8% (parametric method) .In the comparison of the parametric method and the non‐parametric method ,the obtained areas under the curve(AUC) was 0 .923 5(parametric method) ,their results were basically consistent .Conclu‐sion Although above results indicate that the detection results of ELISA reagent are different from those of WB ,but adjusting the cut off value can increase its sensitivity and specificity ,thus increases the reliability of diagnosis result .