1921
Volume 99, Issue 2
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645

Abstract

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 (≥ 10 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 (≥ 10 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 (≥ 10 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.

Loading

Article metrics loading...

The graphs shown below represent data from March 2017
/content/journals/10.4269/ajtmh.18-0116
2018-06-04
2020-09-19
Loading full text...

Full text loading...

/deliver/fulltext/14761645/99/2/tpmd180116.html?itemId=/content/journals/10.4269/ajtmh.18-0116&mimeType=html&fmt=ahah

References

  1. Stanaway JD et al., 2016. The global burden of viral hepatitis from 1990 to 2013: findings from the Global Burden of Disease Study 2013. Lancet 388: 10811088.
    [Google Scholar]
  2. WHO, 2016. Global Health Sector Strategy on Viral Hepatitis 2016–2021. Geneva, Switzerland: World Health Organization, 1–56.
  3. Schweitzer A, Horn J, Mikolajczyk RT, Krause G, Ott JJ, 2015. Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013. Lancet 6736: 110.
    [Google Scholar]
  4. Nayagam S, Thursz M, Sicuri E, Conteh L, Wiktor S, Low-Beer D, Hallett TB, 2016. Requirements for global elimination of hepatitis B: a modelling study. Lancet Infect Dis 16: 13991408.
    [Google Scholar]
  5. Shimakawa Y et al., 2016. Natural history of chronic HBV infection in West Africa: a longitudinal population-based study from the Gambia. Gut 65: 20072016.
    [Google Scholar]
  6. World Health Organization, 2009. Hepatitis B vaccines. Wkly Epidemiol Rec 84: 405419.
    [Google Scholar]
  7. Keane E, Funk AL, Shimakawa Y, 2016. Systematic review with meta-analysis: the risk of mother-to-child transmission of hepatitis B virus infection in sub-Saharan Africa. Aliment Pharmacol Ther 44: 10051017.
    [Google Scholar]
  8. Wen WH, Chang MH, Zhao LL, Ni YH, Hsu HY, Wu JF, Chen PJ, Chen DS, Chen HL, 2013. Mother-to-infant transmission of hepatitis B virus infection: significance of maternal viral load and strategies for intervention. J Hepatol 59: 2430.
    [Google Scholar]
  9. Visvanathan K et al., 2016. Managing HBV in pregnancy. Prevention, prophylaxis, treatment and follow-up: position paper produced by Australian, UK and New Zealand key opinion leaders. Gut 65: 340350.
    [Google Scholar]
  10. Lemoine M, Thursz MR, 2017. Battlefield against hepatitis B infection and HCC in Africa. J Hepatol 66: 645654.
    [Google Scholar]
  11. WHO, 2017. Global Hepatitis Report, 2017. Geneva, Switzerland: World Health Organization, 1–68.
  12. WHO, 2018. World Health Organization Model List of Essential In Vitro Diagnostics, 1st edition. Geneva, Switzerland: World Health Organization, 1–35.
  13. Kramvis A, 2016. The clinical implications of hepatitis B virus genotypes and HBeAg in pediatrics. Rev Med Virol 26: 285303.
    [Google Scholar]
  14. Bossuyt PM et al., 2015. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. Radiology 277: 826832.
    [Google Scholar]
  15. Clement F, Dewint P, Leroux-Roels G, 2002. Evaluation of a new rapid test for the combined detection of hepatitis B virus surface antigen and hepatitis B virus e antigen. J Clin Microbiol 40: 46034606.
    [Google Scholar]
  16. Lau DT-Y, Ma H, Lemon SM, Doo E, Ghany MG, Miskovsky E, Woods GL, Park Y, Hoofnagle JH, 2003. A rapid immunochromatographic assay for hepatitis B virus screening. J Viral Hepat 10: 331334.
    [Google Scholar]
  17. Akanmu AS, Esan OA, Adewuyi JO, Davies AO, Okany CC, Olatunji RO, Babalola T, 2006. Evaluation of a rapid test kit for detection of HBsAg/eAg in whole blood: a possible method for pre-donation testing. Afr J Med Med Sci 35: 58.
    [Google Scholar]
  18. Mainet-González D, Palenzuela-Gardon DO, Aguilar Rubido JC, 2009. Comparison between an immunochromatographic test with an amplified ELISA for detecting e antigen and anti-e antigen antibodies in chronic hepatitis B. Biotecnol Apl 26: 143145.
    [Google Scholar]
  19. Vray M, Debonne J, Sire J-M, Tran N, Chevalier B, Plantier J-C, Fall F, Vernet G, Mb PS, Simon F, 2006. Molecular epidemiology of hepatitis B virus in Dakar, Sénégal. J Med Virol 78: 329334.
    [Google Scholar]
  20. Burk RD, Hwang L-Y, Ho GYF, Shafritz DA, Beasley RP, 1994. Outcome of perinatal hepatitis B virus exposure is dependent on maternal virus load. J Infect Dis 170: 14181423.
    [Google Scholar]
  21. Pan CQ, Duan Z, Bhamidimarri KR, Zou H, Liang X, Li J, Tong MJ, 2012. An algorithm for risk assessment and intervention of mother to child transmission of hepatitis B virus. Clin Gastroenterol Hepatol 10: 452459.
    [Google Scholar]
  22. Terrault NA, Bzowej NH, Chang K-M, Hwang JP, Jonas MM, Murad MH, 2016. AASLD guidelines for treatment of chronic hepatitis B. Hepatology 63: 261283.
    [Google Scholar]
  23. European Association for the Study of the Liver, 2017. EASL 2017 clinical practice guidelines on the management of hepatitis B virus infection. J Hepatol 67: 370398.
    [Google Scholar]
  24. Andriamandimby SF, Olive M, Shimakawa Y, Rakotomanana F, Razanajatovo IM, Andrianinarivomanana TM, Ravalohery J, Andriamamonjy S, Rogier C, Heraud J-M, 2017. Prevalence of chronic hepatitis B virus infection and infrastructure for its diagnosis in Madagascar: implication for the WHO’s elimination strategy. BMC Public Health 17: 636.
    [Google Scholar]
  25. Kubo A, Shlager L, Marks AR, Lakritz D, Beaumont C, Gabellini K, Corley DA, 2014. Prevention of vertical transmission of hepatitis B. Ann Intern Med 160: 828.
    [Google Scholar]
  26. Thompson AJV et al., 2010. Serum hepatitis B surface antigen and hepatitis B e antigen titers: disease phase influences correlation with viral load and intrahepatic hepatitis B virus markers. Hepatology 51: 19331944.
    [Google Scholar]
  27. Fujiko M et al., 2015. Chronic hepatitis B in pregnant women: is hepatitis B surface antigen quantification useful for viral load prediction? Int J Infect Dis 41: 8389.
    [Google Scholar]
  28. Ducancelle A, Abgueguen P, Birguel J, Mansour W, Pivert A, Le Guillou-Guillemette H, Sobnangou JJ, Rameau A, Huraux JM, Lunel-Fabiani F, 2013. High endemicity and low molecular diversity of hepatitis B virus infections in pregnant women in a rural district of north Cameroon. PLoS One 8: 1012.
    [Google Scholar]
  29. Shimakawa Y, Toure-Kane C, Mendy M, Thursz M, Lemoine M, 2016. Mother-to-child transmission of hepatitis B in sub-Saharan Africa. Lancet Infect Dis 16: 1920.
    [Google Scholar]
  30. Dumpis U, Mendy M, Hill A, Thursz M, Hall A, Whittle H, Karayiannis P, 2001. Prevalence of HBV core promoter/precore/core mutations in Gambian chronic carriers. J Med Virol 65: 664670.
    [Google Scholar]
  31. Wursthorn K, Zacher BJ, Jaroszewicz J, Darnedde M, Manns M, Wedemeyer H, 2011. Development of a protocol for the quantitative determination of HBeAg using the Elecsys® HBeAg immunoassay. J Viral Hepat 18: 179183.
    [Google Scholar]
  32. Maylin S et al., 2013. Quantification of hepatitis B e antigen between Elecsys HBeAg and Architect HBeAg assays among patients infected with hepatitis B virus. J Clin Virol 56: 306311.
    [Google Scholar]
  33. Maylin S et al., 2012. Kinetics of hepatitis B surface and envelope antigen and prediction of treatment response to tenofovir in antiretroviral-experienced HIV–hepatitis B virus-infected patients. AIDS 26: 939949.
    [Google Scholar]
  34. Mendy ME, McConkey SJ, van der Sande MAB, Crozier S, Kaye S, Jeffries D, Hall AJ, Whittle HC, 2008. Changes in viral load and HBsAg and HBeAg status with age in HBV chronic carriers in the Gambia. Virol J 5: 49.
    [Google Scholar]
  35. Lemoine M et al., 2016. Acceptability and feasibility of a screen-and-treat programme for hepatitis B virus infection in the Gambia: the Prevention of Liver Fibrosis and Cancer in Africa (PROLIFICA) study. Lancet Glob Health 4: e559e567.
    [Google Scholar]
  36. Shimakawa Y, Seck A, Nayagam S, Toure-Kane C, Lemoine M, 2018. Screening strategies to prevent mother-to-child transmission of hepatitis B in sub-Saharan Africa. Lancet Gastroenterol Hepatol 3: 222223.
    [Google Scholar]
http://instance.metastore.ingenta.com/content/journals/10.4269/ajtmh.18-0116
Loading
/content/journals/10.4269/ajtmh.18-0116
Loading

Data & Media loading...

Supplemental Figures and Tables

  • Received : 08 Feb 2018
  • Accepted : 23 Apr 2018
  • Published online : 04 Jun 2018
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error