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

Olivier Ségéral; Dieynaba S N'Diaye; Sophearot Prak; Janin Nouhin; Samsorphea Chhun; Wootichai Khamduang; Kenrena Chim; Anne-Marie Roque-Afonso; Patrice Piola; Laurence Borand; Nicole Ngo-Giang-Huong; François Rouet; ANRS 12328 12345 Study Group

doi:10.1016/j.jcv.2018.10.007

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.

Affiliations

¹ University of Health Sciences/ANRS, Phnom Penh, Cambodia. Electronic address: olivier_segeral@uhs.edu.kh.
² Epidemiology and Public Health Unit, Institut Pasteur du Cambodge, Phnom Penh, Cambodia.
³ Virology Unit, Institut Pasteur du Cambodge, Phnom Penh, Cambodia.
⁴ Maternity Department, Hôpital Calmette, Phnom Penh, Cambodia.
⁵ Faculty of Associated Medical Sciences, Institut de Recherche pour le Développement (IRD), UMI 174/Programs for HIV Prevention and Treatment (PHPT), Chiang Mai, Thailand.
⁶ Virologie Hôpitaux Universitaires Paris Sud - INSERM U1193, Villejuif, France.

PMID: 30388664
DOI: 10.1016/j.jcv.2018.10.007

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