Department of Hepatobiliary Medicine, Shanghai Public Health Clinical Center of Fudan University, China.
Scientific Research Center, Shanghai Public Health Clinical Center of Fudan University, China.
J Virol Methods. 2021 Oct;296:114226. doi: 10.1016/j.jviromet.2021.114226. Epub 2021 Jul 1.
Clinical importance of commercially available quantitative HBV markers has not been fully investigated.
To choice and to evaluate clinically valuable HBV markers for predicting phases of natural history with chronic HBV infection.
472 naïve patients with chronic HBV infection were enrolled, in which 21 and 220 were confirmed as HBeAg-positive inactive and active hepatitis (EPIH and EPAH), respectively, and 106 and 125 were confirmed as HBeAg-negative inactive and active hepatitis (ENIH and ENAH), respectively. HBsAg, HBcrAg and anti- HBc were measured using chemiluminescent immunoassay, and HBV DNA was measured using PCR-fluorescence probing assay.
There were all statistical differences in medians of HBsAg, anti-HBc, HBcrAg and HBV DNA between EPIH and EPAH and between ENIH and ENAH (all P < 0.01). According to binary logistic stepwise regressions, HBsAg and anti-HBc were preferred variables for predicting EPAH, and HBcrAg and HBV DNA were preferred variables for predicting ENAH. Based on normalization for coefficients of preferred variables entering regression equations, a handy model of MEPAH for predicting EPAH and of MENAH for predicting ENAH was constructed, respectively. Area under receiver operating characteristic curves of MEPAH and MENAH for predicting EPAH and ENAH were 0.882 and 0.931, respectively. With standard of MEPAH ≤ 5.997 and MENAH > 10.535, sensitivity or specificity of which for predicting EPAH and ENAH were about 81.0 % and 87.0 %, respectively.
HBsAg and anti-HBc for predicting EPAH and HBcrAg and HBV DNA for predicting ENAH are dependable markers; MEPAH for predicting EPAH and MENAH for predicting ENAH have very good performance.
商业化的定量 HBV 标志物的临床重要性尚未得到充分研究。
选择和评估具有预测慢性 HBV 感染自然史各阶段临床价值的 HBV 标志物。
纳入 472 例慢性 HBV 感染初治患者，其中 21 例和 220 例分别确认为 HBeAg 阳性非活动和活动肝炎（EPIH 和 EPAH），106 例和 125 例分别确认为 HBeAg 阴性非活动和活动肝炎（ENIH 和 ENAH）。使用化学发光免疫分析法检测 HBsAg、HBcrAg 和抗-HBc，使用 PCR-荧光探针法检测 HBV DNA。
EPIH 和 EPAH 以及 ENIH 和 ENAH 之间 HBsAg、抗-HBc、HBcrAg 和 HBV DNA 的中位数均有统计学差异（均 P < 0.01）。根据二项逻辑逐步回归，HBsAg 和抗-HBc 是预测 EPAH 的首选变量，HBcrAg 和 HBV DNA 是预测 ENAH 的首选变量。根据回归方程中首选变量的系数进行归一化，分别构建了预测 EPAH 的 MEPAH 和预测 ENAH 的 MENAH 的便捷模型。MEPAH 和 MENAH 预测 EPAH 和 ENAH 的受试者工作特征曲线下面积分别为 0.882 和 0.931。以 MEPAH≤5.997 和 MENAH＞10.535 为标准，预测 EPAH 和 ENAH 的敏感性或特异性分别约为 81.0%和 87.0%。
HBsAg 和抗-HBc 可用于预测 EPAH，HBcrAg 和 HBV DNA 可用于预测 ENAH，这些标志物具有较高的可信度；MEPAH 预测 EPAH 和 MENAH 预测 ENAH 的性能非常好。
