EB病毒急性感染的实验室血清学诊断方法研究

发布时间：2018-11-24 20:56

【摘要】：目的对化学发光免疫分析法(CLIA)测定EB病毒衣壳抗原Ig M(EBV-VCA Ig M)的结果进行方法学评价,并与酶联荧光分析法(ELFA)、酶联免疫吸附试验法(ELISA)诊断EB病毒(EBV)急性感染的效能进行比较。方法选取2011年5月—2012年10月北京大学人民医院不明原因发热患者142例,对受试者使用分离胶真空采血管抽取静脉血3 ml,分离血清,采用CLIA、ELFA和ELISA检测EBV-VCA Ig M,比较3种方法诊断EBV急性感染的价值;并对CLIA进行方法学评价。结果 CLIA低、中和高值(分别为25.8、81.8、184.4 U/ml)血清标本批内变异系数(CV)分别为5.7%、3.9%和2.6%,批间CV分别为11.4%、5.4%和4.2%。理论值与实测值间的回归方程为Y=0.090 4+1.005 2X,相关系数r=0.998(P0.001),回收率为95.3%~104.8%;当标本中血红蛋白水平达8 g/L,三酰甘油达30 000 mg/L时,均不干扰CLIA。CLIA诊断EBV急性感染的灵敏度为94.2%,特异度为91.1%,Youden's指数为0.853;ELFA诊断EBV急性感染的灵敏度为82.7%,特异度为88.9%,Youden's指数为0.716,;ELISA诊断EBV急性感染的灵敏度为80.8%,特异度为91.1%,Youden's指数为0.719。CLIA诊断EBV急性感染ROC曲线下面积(AUC)为0.962〔SE=0.021,95%CI(0.920,1.004)〕;ELFA诊断EBV急性感染的AUC为0.960〔SE=0.015,95%CI(0.911,0.990)〕;ELISA诊断EBV急性感染的AUC为0.882〔SE=0.031,95%CI(0.823,0.942)〕。ROC曲线显示,CLIA诊断EBV急性感染的最佳诊断界值为41 U/ml,灵敏度为96.2%,特异度为99.7%,Youden's指数为0.959。结论 CLIA是目前测定EBV-VCA Ig M较灵敏的定量检测方法,优于ELFA和ELISA,适用于临床EBV感染的早期诊断。
[Abstract]:Objective to evaluate the results of chemiluminescence immunoassay (CLIA) for the detection of capsid antigen (Ig M (EBV-VCA Ig M) of EB virus, and to evaluate the results of chemiluminescence immunoassay (CLIA) and enzyme-linked fluorescence assay (ELFA),). The efficacy of enzyme-linked immunosorbent assay (ELISA) in the diagnosis of acute (EBV) infection of EB virus was compared. Methods 142 patients with fever of unknown origin in Peking University people's Hospital from May 2011 to October 2012 were selected. The venous blood samples were extracted from venous blood by vacuum extraction with seperating glue for 3 ml, and EBV-VCA Ig M was detected by CLIA,ELFA and ELISA. To compare the value of three methods in the diagnosis of acute EBV infection. The methodology of CLIA was evaluated. Results the coefficient of variation (CV) of serum samples with low, moderate and high values (25.80.81.8184.4 U/ml) was 5.7% and 2.6%, and the CV between batches was 11.4% and 4.2%, respectively. The regression equation between the theoretical value and the measured value was Y 0.090 4 1.005 2X, the correlation coefficient was 0.998 (P 0.001), and the recovery rate was 95.33% 104.8%. When the hemoglobin level reached 8 g / L and triacylglycerol reached 30 000 mg/L, the sensitivity was 94.2 and the specificity was 91.1% and the Youdenos index was 0.853 without interfering with CLIA.CLIA in the diagnosis of EBV acute infection. The sensitivity of ELFA in the diagnosis of acute EBV infection was 82.7 and the specificity was 88.9. The sensitivity of ELISA in the diagnosis of acute EBV infection is 80.8 and the specificity is 91.1. The area under the ROC curve of 0.719.CLIA for the diagnosis of EBV acute infection with 0.719.CLIA index is 0.962 (SE=0.021,95%CI (0.920 卤1.004);). AUC in diagnosis of acute EBV infection by ELFA was 0.960 (SE=0.015,95%CI (0.911 卤0.990);) The AUC value of ELISA in the diagnosis of acute EBV infection was 0.882 (SE=0.031,95%CI (0.823 卤0.942). ROC) curve showed that the best diagnostic threshold of CLIA for EBV acute infection was 41 U / ml, the sensitivity was 96.2and the specificity was 99.7%. The Youden's index was 0. 959. Conclusion CLIA is a sensitive quantitative method for the detection of EBV-VCA Ig M, which is superior to ELFA and ELISA, in the early diagnosis of EBV infection.
【作者单位】：北京大学人民医院检验科;
【分类号】：R510

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