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

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.

Figure 1.

Flow diagram of study samples in Senegal. CLIA = chemiluminescent immunoassay; HBeAg = hepatitis B e antigen; HBV = hepatitis B virus.

Figure 2.

Proportion of Hepatitis B e antigen (HBeAg)–positive samples successfully detected by each rapid diagnostic test (RDT) at various quantitative HBeAg levels in Senegal (N = 116).

Figure 3.

Prevalence of Hepatitis B e antigen (HBeAg) by different HBeAg assays at various hepatitis B virus (HBV) DNA levels in Senegal (N = 361).

Figure 4.

Correlation between quantitative HBeAg (log PEIU/mL) and hepatitis B virus (HBV) DNA levels (log IU/mL) in HBeAg-positive samples in Senegal (N = 116). HBeAg = hepatitis B e antigen, PEIU = Paul Ehrlich Institut unit.