University of Health Sciences/ANRS, Phnom Penh, Cambodia.
Epidemiology and Public Health Unit, Institut Pasteur du Cambodge, Phnom Penh, Cambodia.
J Clin Virol. 2018 Dec;109:29-34. doi: 10.1016/j.jcv.2018.10.007. Epub 2018 Oct 22.
In Cambodia, access to hepatitis B surface antigen (HBsAg) screening is low for pregnant women and Hepatitis B Virus (HBV) DNA quantification is poorly accessible.
To evaluate the performance of a serial algorithm using two HBV rapid diagnostic tests (RDTs), in which samples positive for HBsAg were further tested for HBeAg as a surrogate marker for HBV DNA quantification.
In 2015, we prospectively collected plasma samples from 250 pregnant women consulting for antenatal care in one hospital in Phnom Penh including 128 with a known positive HBsAg status. All specimens were tested with the SD BIOLINE HBsAg RDT and HBsAg ELISA assay. In ELISA-positive samples, HBeAg status was determined using the SD BIOLINE HBeAg RDT and HBV DNA quantification was assessed.
Sensitivity and specificity of HBsAg RDT were 99.2% (97.7-99.9) and 100% (97.0-100), respectively. Among the 128 ELISA-positive samples, 29 (23%) tested HBeAg positive and 34 (26.5%) had HBV DNA > 5.3 Log IU/mL. Sensitivity and specificity of HBeAg RDT in identifying viremic samples were 76.5% (62.2.0-90.7) and 96.8% (93.3-100) for HBV DNA > 5.3 Log IU/mL and 89.3% (77.8-100) and 96.0% (92.2-99.8) for HBV DNA > 7.3 LogIU/mL. Among the 99 negative HBeAg RDT women, 8 had HBV DNA > 5.3 Log10 IU/mL and 7 of them harbored BCP/PC HBV mutants.
A combination of HBsAg and HBeAg RDTs could be a low-cost strategy to identify HBV-infected pregnant women at risk of perinatal transmission in a country were HBV DNA quantification is not routinely available.
在柬埔寨，孕妇进行乙肝表面抗原（HBsAg）筛查的比例较低，且乙肝病毒（HBV）DNA 定量检测也难以获得。
评估使用两种 HBV 快速诊断检测（RDT）的串联算法的性能，其中 HBsAg 阳性样本进一步检测 HBeAg，作为 HBV DNA 定量检测的替代标志物。
2015 年，我们前瞻性地收集了金边一家医院 250 名产前护理孕妇的血浆样本，其中包括 128 名已知 HBsAg 阳性的孕妇。所有标本均采用 SD BIOLINE HBsAg RDT 和 HBsAg ELISA 检测。在 ELISA 阳性样本中，采用 SD BIOLINE HBeAg RDT 检测 HBeAg 状态，并评估 HBV DNA 定量。
HBsAg RDT 的灵敏度和特异性分别为 99.2%（97.7-99.9）和 100%（97.0-100）。在 128 例 ELISA 阳性样本中，29 例（23%）HBeAg 阳性，34 例（26.5%）HBV DNA>5.3 Log IU/mL。在识别病毒血症样本中，HBeAg RDT 的灵敏度和特异性分别为 HBV DNA>5.3 Log IU/mL 时为 76.5%（62.2.0-90.7）和 96.8%（93.3-100），HBV DNA>7.3 Log IU/mL 时为 89.3%（77.8-100）和 96.0%（92.2-99.8）。在 99 例 HBeAg RDT 阴性的女性中，有 8 例 HBV DNA>5.3 Log10 IU/mL，其中 7 例携带 BCP/PC HBV 突变。
在 HBV DNA 定量检测未常规应用的国家，HBsAg 和 HBeAg RDT 联合检测可能是一种低成本策略，用于识别有母婴传播风险的 HBV 感染孕妇。
