Usefulness of a serial algorithm of HBsAg and HBeAg rapid diagnosis tests to detect pregnant women at risk of HBV mother-to-child transmission in Cambodia, the ANRS 12328 pilot study

J Clin Virol. 2018 Dec;109:29-34. doi: 10.1016/j.jcv.2018.10.007. Epub 2018 Oct 22.

Abstract

Background: In Cambodia, access to hepatitis B surface antigen (HBsAg) screening is low for pregnant women and Hepatitis B Virus (HBV) DNA quantification is poorly accessible.

Objectives: To evaluate the performance of a serial algorithm using two HBV rapid diagnostic tests (RDTs), in which samples positive for HBsAg were further tested for HBeAg as a surrogate marker for HBV DNA quantification.

Study design: In 2015, we prospectively collected plasma samples from 250 pregnant women consulting for antenatal care in one hospital in Phnom Penh including 128 with a known positive HBsAg status. All specimens were tested with the SD BIOLINE HBsAg RDT and HBsAg ELISA assay. In ELISA-positive samples, HBeAg status was determined using the SD BIOLINE HBeAg RDT and HBV DNA quantification was assessed.

Results: Sensitivity and specificity of HBsAg RDT were 99.2% (97.7-99.9) and 100% (97.0-100), respectively. Among the 128 ELISA-positive samples, 29 (23%) tested HBeAg positive and 34 (26.5%) had HBV DNA > 5.3 Log10 IU/mL. Sensitivity and specificity of HBeAg RDT in identifying viremic samples were 76.5% (62.2.0-90.7) and 96.8% (93.3-100) for HBV DNA > 5.3 Log10 IU/mL and 89.3% (77.8-100) and 96.0% (92.2-99.8) for HBV DNA > 7.3 Log10IU/mL. Among the 99 negative HBeAg RDT women, 8 had HBV DNA > 5.3 Log10 IU/mL and 7 of them harbored BCP/PC HBV mutants.

Conclusions: A combination of HBsAg and HBeAg RDTs could be a low-cost strategy to identify HBV-infected pregnant women at risk of perinatal transmission in a country were HBV DNA quantification is not routinely available.

Keywords: Cambodia; Hepatitis B virus; Mother-to-child transmission; Pregnant women; Rapid diagnostic tests.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Algorithms
  • Cambodia
  • DNA, Viral / blood
  • Diagnostic Tests, Routine
  • Female
  • Hepatitis B / blood
  • Hepatitis B / diagnosis*
  • Hepatitis B Surface Antigens / blood*
  • Hepatitis B e Antigens / blood*
  • Hepatitis B virus / immunology
  • Hepatitis B virus / isolation & purification*
  • Humans
  • Infectious Disease Transmission, Vertical / prevention & control*
  • Pilot Projects
  • Pregnancy
  • Pregnancy Complications, Infectious / diagnosis*
  • Pregnancy Complications, Infectious / virology
  • Pregnant Women
  • Sensitivity and Specificity
  • Viremia / diagnosis

Substances

  • DNA, Viral
  • Hepatitis B Surface Antigens
  • Hepatitis B e Antigens