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

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  • 1 Laboratoire de Biologie Médicale, Institut Pasteur de Dakar, Dakar, Sénégal;
  • | 2 Faculté de Médecine, Pharmacie et d’Odontologie, Université Cheikh Anta Diop de Dakar, Dakar, Sénégal;
  • | 3 Université Paris-Est Créteil, Paris, France;
  • | 4 Laboratoire de Virologie, Hôpital Saint-Louis, AP-HP, Paris, France;
  • | 5 Unité d'Épidémiologie des Maladies Émergentes, Institut Pasteur, Paris, France;
  • | 6 Unité PACRI, Conservatoire National des Arts et Métiers, Paris, France;
  • | 7 Department of Medical Sciences, Toshiba General Hospital, Tokyo, Japan;
  • | 8 Unité d’Épidémiologie des Maladies Infectieuses, Institut Pasteur de Dakar, Dakar, Sénégal
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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 (≥ 106 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 (≥ 106 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 (≥ 106 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.

Author Notes

Address correspondence to Yusuke Shimakawa, Unité d'Épidémiologie des Maladies Émergentes, Institut Pasteur, Paris, 25-28 Rue du Dr Roux, Paris 75015, France. E-mail: yusuke.shimakawa@gmail.com

Financial support: The work was supported by the NéoVac (Neonatal Vaccination against Hepatitis B in Africa) project (funded by the Total Foundation); the Asia–Africa–Oceania Hepatitis Experts Linkage Promotion (AAO-HELP) project (funded by the Viral Hepatitis Research Foundation of Japan); and the Emerging Disease Epidemiology Unit at the Institut Pasteur.

Authors’ addresses: Abdoulaye Seck, Babacar Ndiaye, and Raymond Bercion, Laboratoire de Biologie Médicale, Institut Pasteur de Dakar, Dakar, Sénégal, E-mails: seck@pasteur.sn, nbabacar9@gmail.com, and rbercion@pasteur.sn. Fatou Ndiaye, Université Paris-Est Créteil, Paris, France, E-mail: fatou1.ndiaye@etu.u-pec.fr. Sarah Maylin and François Simon, Laboratoire de Virologie, Hôpital Saint-Louis, AP-HP, Paris, France, E-mails: sarah.maylin@sls.aphp.fr and francois.simon@aphp.fr. Anna L. Funk, Arnaud Fontanet, and Yusuke Shimakawa, Unité d'Épidémiologie des Maladies Émergentes, Institut Pasteur, Paris Cedex, France, E-mails: anna-louise.funk@pasteur.fr, fontanet@pasteur.fr, and yusuke.shimakawa@pasteur.fr. Kazuaki Takahashi, Sheikh Mohammad Fazle Akbar, and Shunji Mishiro, Department of Medical Sciences, Toshiba General Hospital, Tokyo, Japan, E-mails: kazuaki6.takahashi@toshiba.co.jp, sheikh.akbar@toshiba.co.jp, and shunji.mishiro@toshiba.co.jp. Muriel Vray, Unité d’Épidémiologie des Maladies Infectieuses, Institut Pasteur de Dakar, Dakar, Sénégal, E-mail: mvray@pasteur.sn.

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