ELISA法检测抗HBc和抗HBe的性能研究

Performance evaluation of anti HBc and anti HBe by ELISA testing

目的：对 ELISA 竞争法检测抗 HBc 和抗 HBe 的性能进行科学评价。方法以 ELISA 法初检，以CMIA 法作为确证方法，评价 ELISA 法检测抗 HBc 和抗 HBe 的灵敏度、特异度、阳性预测值、阴性预测值、真阳性率、假阴性率等性能指标。结果 ELISA 法检测抗 HBc 和抗 HBe 的 Se 、Sp 、PV ＋、PV‐分别为0．76、0．88、0．99、0．22和0．77、0．73、0．86、0．58；抗 HBc（＋）／抗 HBe（＋）组抗 HBc 和抗 HBe 的真阳性率分别为1．00和0．99，抗 HBc （＋）／抗 HBe（－）组抗 HBc 真阳性率为0．98而抗 HBe 的真阴性率为0．59，抗 HBc（－）／抗 HBe（＋）组抗 HBc 的真阴性率为0．22而抗 HBe 的真阳性率分别为0．82。结论 ELISA 法检测抗 HBc 特异度良好、灵敏度不足， ELISA 检测阳性可认定为真阳性，主要问题是存在大量假阴性；ELISA 法检测抗 HBe 特异度和灵敏度均相对不佳，存在一定的假阴性和假阳性；在抗 HBc 阳性时，抗 HBe 阳性具有极好的准确性，抗 HBe 阴性约半数呈假阴性，在抗 HBc 阴性时，抗 HBe 阳性对 HBV 既往感染具有重要的提示价值，需采用第二种方法确证。

Objective To evaluate the performance of antiHBc and antiHBe tested by ELISA .Methods HBV‐M were tested by ELISA initially and retested by CMIA to evaluate the performance including Sensitivity ,Specificity , positive predictive value ,negative predictive value ,true positive rate and false negative rate et al .Results Se ,Sp ,PV＋ ,PV‐of antiHBc and antiHBe by ELISA were 0 .76 ,0 .88 ,0 .99 ,0 .22 and 0 .77 ,0 .73 ,0 .86 ,0 .58 ,respectively ;true positive rate of antiHBc and antiHBe were 1 .00 and 0 ,99 in antiHBc（＋ ）/antiHBe（ ＋ ） subgroup ;in antiHBc（ ＋ ）/antiHBe（ - ） subgroup the true positive rate of antiHBc was 0 .98 and true negative rate of antiHBe was 0 .59 ;in an‐tiHBc（ - ）/antiHBe（＋ ） subgroup true negative rate of antiHBc was 0 .22 and true positive rate of antiHBe was 0 . 82 .Conclusion ELISA for antiHBc has high specificity and low sensitivity which means high true positive rate and lots of false negative results ;ELISA for antiHBe has false positive and false negative results because of its low sensi‐tivity and specificity ;there are high accuracy for positive antiHBe with positive antiHBc and half of negative antiHBe with positive antiHBc were confirmed positive .Positive antiHBe with negative antiHBc has suggestive value for pre‐vious HBV infection .