乙肝 e 抗原（HBeAg）快速检测和基于丙氨酸氨基转移酶水平的算法识别乙型肝炎病毒母婴传播高危孕妇：ANRS 12345 TA PROHM 研究。

Hepatitis B e Antigen (HBeAg) Rapid Test and Alanine Aminotransferase Level-Based Algorithm to Identify Pregnant Women at Risk of HBV Mother-to-Child Transmission: The ANRS 12345 TA PROHM Study.

机构信息

University of Health Sciences/Agence Nationale de Recherche sur le Sida, Phnom Penh, Cambodia.

Epidemiology and Public Health Unit, Institut Pasteur du Cambodge, Phnom Penh, Cambodia.

出版信息

Clin Infect Dis. 2020 Dec 17;71(10):e587-e593. doi: 10.1093/cid/ciaa282.

DOI:10.1093/cid/ciaa282

PMID:32188982

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7744978/

Abstract

BACKGROUND

The paucity of hepatitis B virus (HBV) DNA measurement in low-/middle-income countries hinders the identification of HBV-infected pregnant women at risk of perinatal transmission. This study evaluates the validity of an algorithm selecting HBeAg-positive women and HBeAg-negative women with alanine aminotransferase (ALT) ≥40 IU/L as a predictor of high HBV DNA level.

METHODS

All women with reactive samples for hepatitis B surface antigen (HBsAg) were assessed with an SD BIOLINE HBeAg rapid test and HBV DNA quantification was performed. Validities of HBeAg and of the algorithm to identify HBV DNA >2 thresholds (5.3 and 7.3 log10 IU/mL) were evaluated.

RESULTS

For the 515 HBsAg-positive women, median age was 29 years, 92 (17.9%) were HBeAg positive, 47 (9.1%) were HBeAg negative with ALT ≥40 IU/L, and 144 (28.0%) had an HBV DNA >5.3 log10 IU/mL. Sensitivity and specificity of HBeAg were 61.8% and 99.2% for HBV DNA >5.3 log10 IU/mL and 81.3% and 96.7% for HBV DNA >7.3 log10 IU/mL. For the algorithm, sensitivity and specificity were 79.2% and 93.3% for HBV DNA level >5.3 log10 IU/mL and 92.7% and 88.1% for HBV DNA >7.3 log10 IU/mL. The AUCs for the algorithm (0.92 and 0.94 for HBV DNA >5.3 and 7.3, respectively) were significantly greater (P < .001) than the AUCs for HBeAg (0.81 and 0.89 for HBV DNA >5.3 and 7.3, respectively).

CONCLUSIONS

An algorithm using HBeAg and ALT level could be an effective strategy to identify HBV-infected pregnant women at risk of perinatal transmission in countries where HBV DNA quantification is not routinely available.

摘要

背景

在中低收入国家，乙型肝炎病毒 (HBV) DNA 检测的缺乏阻碍了对有围产期传播风险的 HBV 感染孕妇的识别。本研究评估了一种算法的有效性，该算法选择 HBeAg 阳性和 HBeAg 阴性且丙氨酸氨基转移酶 (ALT) ≥40IU/L 的妇女作为高 HBV DNA 水平的预测因子。

方法

所有 HBsAg 反应性样本的妇女均采用 SD BIOLINE HBeAg 快速检测进行评估，并进行 HBV DNA 定量检测。评估 HBeAg 和算法识别 HBV DNA>2 个阈值（5.3 和 7.3 log10 IU/mL）的有效性。

结果

在 515 名 HBsAg 阳性的妇女中，中位年龄为 29 岁，92 名（17.9%）为 HBeAg 阳性，47 名（9.1%）为 HBeAg 阴性且 ALT≥40IU/L，144 名（28.0%）的 HBV DNA>5.3 log10 IU/mL。HBeAg 对 HBV DNA>5.3 log10 IU/mL 的敏感性和特异性分别为 61.8%和 99.2%，对 HBV DNA>7.3 log10 IU/mL 的敏感性和特异性分别为 81.3%和 96.7%。对于该算法，HBV DNA 水平>5.3 log10 IU/mL 的敏感性和特异性分别为 79.2%和 93.3%，HBV DNA>7.3 log10 IU/mL 的敏感性和特异性分别为 92.7%和 88.1%。该算法的 AUC（HBV DNA>5.3 和 7.3 分别为 0.92 和 0.94）显著大于 HBeAg 的 AUC（HBV DNA>5.3 和 7.3 分别为 0.81 和 0.89）（均<0.001）。