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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
immunology and microbiology
Poor sensitivity of commercial rapid diagnostic tests for hepatitis be antigen in Senegal, West Africa
American Journal of Tropical Medicine and Hygiene, Volume 99, No. 2, Year 2018
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Description
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 (3 106 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 (3 106 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 (3 106 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. Copyright © 2018 by The American Society of Tropical Medicine and Hygiene.
Authors & Co-Authors
Seck, Abdoulaye
France
Université Cheikh Anta Diop de Dakar
N’Diaye, Fatou Samba Diago
France, Creteil
Université Paris-est Créteil Val de Marne
Maylin, Sarah
France, Paris
Ap-hp Assistance Publique - Hopitaux de Paris
France, Paris
Institut Pasteur, Paris
Ndiaye, Babacar Mbaye
Unknown Affiliation
Simon, Franćois
France, Paris
Ap-hp Assistance Publique - Hopitaux de Paris
Funk, Anna Louise
France, Paris
Institut Pasteur, Paris
Fontanet, A. L.
France, Paris
Conservatoire National Des Arts et Metiers
France, Paris
Institut Pasteur, Paris
Takahashi, Kazuaki
Japan, Tokyo
Tokyo Shinagawa Hospital
Akbar, Sheikh Mohammad Fazle
Japan, Tokyo
Tokyo Shinagawa Hospital
Mishiro, Shunji
Japan, Tokyo
Tokyo Shinagawa Hospital
Bercion, Raymond
Unknown Affiliation
Vray, Muriel M.
France, Paris
Institut Pasteur, Paris
Shimakawa, Yusuke
France, Paris
Institut Pasteur, Paris
Statistics
Citations: 19
Authors: 13
Affiliations: 6
Identifiers
Doi:
10.4269/ajtmh.18-0116
ISSN:
00029637
Research Areas
Genetics And Genomics
Health System And Policy
Infectious Diseases
Maternal And Child Health
Study Design
Cross Sectional Study
Study Approach
Quantitative
Study Locations
Multi-countries
Senegal
Participants Gender
Female