Literature DB >> 30388664

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 Ségéral1, Dieynaba S N'Diaye2, Sophearot Prak3, Janin Nouhin3, Samsorphea Chhun4, Wootichai Khamduang5, Kenrena Chim4, Anne-Marie Roque-Afonso6, Patrice Piola2, Laurence Borand2, Nicole Ngo-Giang-Huong5, François Rouet3.   

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.
Copyright © 2018 Elsevier B.V. All rights reserved.

Entities:  

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

Mesh:

Substances:

Year:  2018        PMID: 30388664     DOI: 10.1016/j.jcv.2018.10.007

Source DB:  PubMed          Journal:  J Clin Virol        ISSN: 1386-6532            Impact factor:   3.168


  5 in total

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Journal:  Vaccines (Basel)       Date:  2021-06-01
  5 in total

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