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

Am J Trop Med Hyg. 2018 Aug;99(2):428-434. doi: 10.4269/ajtmh.18-0116. Epub 2018 May 31.

Abstract

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.

MeSH terms

  • Adult
  • Case-Control Studies
  • DNA, Viral / isolation & purification
  • Female
  • Hepatitis B / diagnosis
  • Hepatitis B / epidemiology*
  • Hepatitis B e Antigens / blood*
  • Hepatitis B virus / isolation & purification
  • Hepatitis B, Chronic / diagnosis
  • Hepatitis B, Chronic / epidemiology
  • Humans
  • Immunoassay
  • Infectious Disease Transmission, Vertical / prevention & control
  • Limit of Detection
  • Male
  • Middle Aged
  • Pregnancy
  • Pregnancy Complications, Infectious / diagnosis
  • Pregnancy Complications, Infectious / epidemiology
  • Pregnancy Complications, Infectious / virology
  • Prevalence
  • Reagent Kits, Diagnostic / standards*
  • Senegal
  • Sensitivity and Specificity
  • Viral Load / methods
  • Virus Replication
  • Young Adult

Substances

  • DNA, Viral
  • Hepatitis B e Antigens
  • Reagent Kits, Diagnostic