Poor Sensitivity of Commercial Rapid Diagnostic Tests for Hepatitis B e Antigen in Senegal, West Africa
Poor Sensitivity of Commercial Rapid Diagnostic Tests for Hepatitis B e Antigen in Senegal, West Africa
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DOI：
10.4269/ajtmh.18-0116
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发表时间：
2018-01-01
影响因子：
3.3
通讯作者：
Shimakawa, Yusuke
中科院分区：
文献类型：
--
作者：
Seck, Abdoulaye;Ndiaye, Fatou;Shimakawa, Yusuke
B型肝炎病毒（HBV）DNA核酸检测的机会有限，是资源匮乏国家有效管理慢性HBV感染的一个重大障碍。或者，HBV e抗原（HBeAg）可以准确地指示高病毒复制。我们评估了三种市售HBeAg快速诊断检测（RDT）（SD Bioline、Insight和OneStep）与定量荧光免疫分析（CLIA，Architect）的诊断性能。使用储存的慢性HBV感染成人血清，我们在塞内加尔的三组（48例HBeAg阳性，196例HBeAg阴性，117例高HBV DNA（>= 10（6）IU/mL））和法国的一组（17例HBeAg阳性东亚人）中检测了RDT。在塞内加尔，SD Bioline检测HBeAg的灵敏度和特异性分别为29.8%和100%，Insight为31.1%和100%，OneStep为42.5%和98.4%。这些RDT的检测下限非常高（> 2.5 log 10 Paul埃利希研究所单位/mL）。在HBeAg阳性的亚洲样本中也证实了其低敏感性（35.3-52.9%）。在高度病毒血症（>= 10（6）IU/mL）的塞内加尔患者中，HBeAg的患病率较低：CLIA为58.1%，RDTs为24.5-37.5%。在一个由28名塞内加尔育龄妇女组成的高病毒载量（>= 10（6）IU/mL）亚组中，B e肝炎抗原流行率同样较低。在非洲，大约有一半的高病毒血症成年人不携带HBeAg，HBeAg RDT的分析和诊断灵敏度非常差。这意味着基于HBeAg的产前筛查，特别是如果使用目前可用的HBeAg RDT，可能会忽视非洲大多数母婴传播高风险的孕妇。
Limited access to nucleic acid tests for hepatitis B virus (HBV) DNA is a significant barrier to the effective management of chronic HBV infection in resource-poor countries. Alternatively, HBV e antigen (HBeAg) may accurately indicate high viral replication. We assessed the diagnostic performance of three commercially available rapid diagnostic tests (RDTs) for HBeAg (SD Bioline, Insight and OneStep) against a quantitative chemiluminescent immunoassay (CLIA, Architect). Using stored sera from adults with chronic HBV infection, we tested RDTs in three groups in Senegal (48 HBeAg-positive, 196 HBeAg-negative, and 117 cases with high HBV DNA (>= 10(6) IU/mL)) and one group in France (17 HBeAg-positive East Asians). In Senegal, the sensitivity and specificity for HBeAg detection were 29.8% and 100% for SD Bioline, 31.1% and 100% for Insight, and 42.5% and 98.4% for OneStep, respectively. The lower limits of detection of these RDTs were very high (> 2.5 log10 Paul Ehrlich Institut units/mL). Their low sensitivity was also confirmed in HBeAg-positive Asian samples (35.3-52.9%). The prevalence of HBeAg in highly viremic (>= 10(6) IU/mL) Senegalese patients was low: 58.1% using CLIA and 24.5-37.5% using RDTs. Hepatitis B e antigen prevalence was similarly low in a subgroup of 28 Senegalese women of childbearing age with a high viral load (>= 10(6) IU/mL). Approximately, half of highly viremic adults do not carry HBeAg in Africa, and HBeAg RDTs had remarkably poor analytical and diagnostic sensitivity. This implies that HBeAg-based antenatal screening, particularly if using the currently available HBeAg RDTs, may overlook most pregnant women at high risk of mother-to-child transmission in Africa.