目的：比较 QIAGEN 实时 PCR 与 COBAS TaqMan 检测血清 HBV DNA 水平预测慢性乙型肝炎肝组织病理状态的性能。方法慢性乙型肝炎患者278例，其中 HBeAg 阳性和阴性分别为162例和116例。采用 QIAGEN 实时定量 PCR 和 COBAS TaqMan 系统检测血清 HBV DNA。肝组织病理学诊断采用 Scheuer 评分系统，其中病理学分级和分期包括 G0～G4和 S0～S4。结果血清 HBV DNA（QIAGEN）和 HBV DNA（COBAS）在 HBeAg 阳性患者 G2与 G3，S1、S2、S3与 S4之间的差异有统计学意义（P 均＜0．05）；在 HBeAg 阴性患者 G1与 G2、G3，S1与 S2、S3、S4之间的差异有统计学意义（P 均＜0．05）。血清 HBV DNA（QIAGEN）与 HBV DNA（COBAS）定量的不一致率，在 HBeAg 阳性患者 G1-2、G3和 S1-3、S4分别为4．24％（5／118）、9．09％（4／44）和3．68％（5／136）、7．69％（2／26），在 HBeAg 阴性患者 G1、G2-3和S1、S2-4分别为6．02％（5／83）、3．03％（1／33）和3．29％（2／61）、3．64％（2／55）。血清 HBV DNA（QIAGEN）和 HBV DNA （COBAS）预测 HBeAg 阳性患者≥G3、≥S4的 ROC 曲线下面积分别为0．645和0．695、0．703和0．755，预测 HBeAg 阴性患者≥G2、≥S2的 ROC 曲线下面积分别为0．848和0．817、0．756和0．756。血清 HBV DNA（QIAGEN）和 HBV DNA （COBAS）预测 HBeAg 阳性患者≥S4的最佳截断值分别为≤3．784×106 IU／mL 和≤6．668×107 IU／mL，对应的灵敏度、特异度分别为0．654和1．000、0．735和0．581；预测 HBeAg 阴性患者≥G2的最佳截断值分别为≥5．821×103 IU／mL 和≥9．311×103 IU／mL，对应的灵敏度、特异度分别为0．970和0．909、0．614和0．651。结论血清 HBV DNA 预测肝组织病理状态的特点为预测 HBeAg 阴性患者≥G2的效能最大，并且血清 HBV DNA（QIAGEN）与 HBV DNA（COBAS）预测HBeAg 阴性患者≥G2的性能有高度一致性。%Objective To investigate and compare the performance of QIAGEN real-time PCR and COBAS TaqMan for serum hepatitis B virus (HBV)DNA quantitation in predicting the pathological state of liver tissue from chronic hepatitis B patients.Methods A total of 278 patients with chronic hepatitis B,including 162 HBeAg-positive and 116 HBeAg-negative ones,were enrolled in this study.Serum HBV DNA (QIAGEN)and HBV DNA (COBAS)were detected by real-time quantitative PCR and Roche TaqMan COBAS system,respectively.The Scheuer score system used for pathological diagnosis of liver tissue had 5 grades (G0-G4)and 5 stages (S0-S4),respectively.Results In HBeAg-positive patients, there were statistically significant differences of serum HBV DNA (QIAGEN)and HBV DNA (COBAS)between G2 and G3,S1 and S4,S2 and S4,S3 and S4 (all P <0.05),respectively;in HBeAg-negative patients,there were statistically significant differences between G1 and G2,G1 and G3,S1 and S2,S1 and S3,S1 and S4 (all P <0.05 ),respectively. Rates of disagreement between serum HBV DNA (QIAGEN)and HBV DNA (COBAS)quantitation of G1-2,G3,S1-3 and S4 in HBeAg-positive patients were 4.24% (5/118),9.09% (4/44),3.68%(5/136)and 7.69%(2/26),respectively;and the rates of G1 ,G2-3,S1 and S2-4 in HBeAg-negative patients were 6.02% (5/83),3.03% (1/33),3.29% (2/61 )and 3.64% (2/55 ),respectively.Areas under the receiver operating characteristic (ROC)curves of serum HBV DNA (QIAGEN)and serum HBV DNA (COBAS)for predicting ≥G3 and S4 in HBeAg-positive patients were 0.645 and 0.695, 0.703 and 0.755,respectively;and the areas for predicting ≥G2 and ≥S2 in HBeAg-negative patients were 0.848 and 0. 817,0.756 and 0.756,respectively.Optimal cut-offs of serum HBV DNA (QIAGEN)and serum HBV DNA (COBAS)for predicting S4 in HBeAg-positive patients were ≤3.784 × 106 IU/mL and ≤6.668 × 107 IU/mL,respectively;and the corresponding sensitivities and specificities were 0.654 and 1 .000,0.735 and 0.581 ,respectively;and the optimal cut-offs of serum HBV DNA (QIAGEN)and serum HBV DNA (COBAS)for predicting ≥G2 in HBeAg-negative patients were ≥5.821 ×103 IU/mL and 9.311 ×103 IU/mL,respectively;and the corresponding sensitivities and specificities were 0.970 and 0.909,0.614 and 0.651 ,respectively.Conclusion The most efficiency of serum HBV DNA for predicting the pathological state of liver tissue is characterized by predicting ≥ G2 in HBeAg negative patients,and there is a high consistance of the performance between serum HBV DNA (QIAGEN)and serum HBV DNA (COBAS)for predicting ≥G2 in HBeAg negative patients.
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