Poor Sensitivity of Commercial Rapid Diagnostic Tests for Hepatitis B e Antigen in Senegal, West Africa

• DOI: 10.4269/ajtmh.18-0116
• Publication Date: 2018-06-05T07:00:45Z
• Authors: Abdoulaye Seck; Fatou Ndiaye; Sarah Maylin; Babacar Ndiaye; François Simon; Anna L. Funk; Arnaud Fontanet; Kazuaki Takahashi; Sheikh Mohammad F...; Shunji Mishiro; Raymond Bercion; Muriel Vray; Yusuke Shimakawa
• Keywords: HBeAg; Hepatitis B

Limited access to nucleic acid tests for hepatitis B virus (HBV) DNA is a significant barrier the effective management of chronic HBV infection in resource-poor countries. Alternatively, e antigen (HBeAg) may accurately indicate high viral replication. We assessed diagnostic performance three commercially available rapid (RDTs) HBeAg (SD Bioline, Insight and OneStep) against quantitative chemiluminescent immunoassay (CLIA, Architect). Using stored sera from adults with infection, we tested RDTs groups Senegal (48 HBeAg-positive, 196 HBeAg-negative, 117 cases (≥ 106 IU/mL)) one group France (17 HBeAg-positive East Asians). In Senegal, sensitivity specificity detection were 29.8% 100% SD 31.1% Insight, 42.5% 98.4% OneStep, respectively. The lower limits these very (> 2.5 log10 Paul Ehrlich Institut units/mL). Their low was also confirmed Asian samples (35.3-52.9%). prevalence highly viremic IU/mL) Senegalese patients low: 58.1% using CLIA 24.5-37.5% RDTs. Hepatitis similarly subgroup 28 women childbearing age load IU/mL). Approximately, half do not carry Africa, had remarkably poor analytical sensitivity. This implies that HBeAg-based antenatal screening, particularly if currently RDTs, overlook most pregnant at risk mother-to-child transmission Africa.