Department of Hepatobiliary Medicine, Shanghai Public Health Clinical Center of Fudan University, Shanghai, China.
Research Unit, Shanghai Public Health Clinical Center of Fudan University, Shanghai, China.
Ann Lab Med. 2019 Jan;39(1):67-75. doi: 10.3343/alm.2019.39.1.67.
We examined changes in hepatitis B core-related antigen (HBcrAg) during the four sequential phases of chronic hepatitis B virus (HBV) infection: hepatitis B e antigen (HBeAg)-positive chronic infection (EPCI) and hepatitis (EPCH), followed by HBeAg-negative chronic infection (ENCI) and hepatitis (ENCH). We compared the performance of serum HBcrAg, hepatitis B surface antigen (HBsAg), and HBV DNA in predicting EPCH and ENCH.
We enrolled 492 consecutive patients: 49 with EPCI, 243 with EPCH, 101 with ENCI, and 99 with ENCH. HBcrAg was detected by chemiluminescent enzyme immunoassays. HBsAg and HBeAg were detected by chemiluminescent microparticle immunoassays. HBV DNA was detected by real-time PCR. Predictive performance of HBcrAg, HBsAg, and HBV DNA was evaluated using ROC curves.
Areas under ROC curves (AUCs) of HBcrAg, HBsAg, and HBV DNA for predicting EPCH were 0.738, 0.812, and 0.717, respectively; optimal cutoffs were ≤1.43×10⁵ kU/mL, ≤1.89×10⁴ IU/mL, and ≤3.97×10⁷ IU/mL, with sensitivities and specificities of 66.3% and 77.6%, 65.0% and 93.9%, and 60.5% and 79.6%, respectively. AUCs of HBcrAg, HBsAg, and HBV DNA for predicting ENCH were 0.887, 0.581, and 0.978, respectively; optimal cutoffs were >26.8 kU/mL, >2.29×10² IU/mL, and >8.75×10³ IU/mL, with sensitivities and specificities of 72.7% and 95.1%, 86.9% and 39.6%, and 89.9% and 92.1%, respectively.
HBsAg and HBV DNA were the best predictors of EPCH and ENCH, respectively. HBcrAg is an important surrogate marker for predicting EPCH and ENCH.
我们研究了乙型肝炎病毒(HBV)慢性感染的四个连续阶段中乙型肝炎核心相关抗原(HBcrAg)的变化:乙型肝炎 e 抗原(HBeAg)阳性慢性感染(EPCI)和肝炎(EPCH),随后是乙型肝炎 e 抗原阴性慢性感染(ENCI)和肝炎(ENCH)。我们比较了血清 HBcrAg、乙型肝炎表面抗原(HBsAg)和 HBV DNA 在预测 EPCH 和 ENCH 中的性能。
我们纳入了 492 例连续患者:49 例 EPCI,243 例 EPCH,101 例 ENCI 和 99 例 ENCH。采用化学发光酶免疫分析法检测 HBcrAg,采用化学发光微粒子免疫分析法检测 HBsAg 和 HBeAg,采用实时 PCR 检测 HBV DNA。使用 ROC 曲线评估 HBcrAg、HBsAg 和 HBV DNA 的预测性能。
HBcrAg、HBsAg 和 HBV DNA 预测 EPCH 的 ROC 曲线下面积(AUCs)分别为 0.738、0.812 和 0.717;最佳截断值分别为≤1.43×10⁵ kU/mL、≤1.89×10⁴ IU/mL 和≤3.97×10⁷ IU/mL,敏感性和特异性分别为 66.3%和 77.6%、65.0%和 93.9%以及 60.5%和 79.6%。HBcrAg、HBsAg 和 HBV DNA 预测 ENCH 的 AUCs 分别为 0.887、0.581 和 0.978;最佳截断值分别为>26.8 kU/mL、>2.29×10² IU/mL 和>8.75×10³ IU/mL,敏感性和特异性分别为 72.7%和 95.1%、86.9%和 39.6%以及 89.9%和 92.1%。
HBsAg 和 HBV DNA 分别是预测 EPCH 和 ENCH 的最佳指标。HBcrAg 是预测 EPCH 和 ENCH 的重要替代标志物。