Yusuke Shimakawa1, Gibril Ndow2,3, Ramou Njie4, Harr Freeya Njai2, Kazuaki Takahashi5, Sheikh Mohammad Fazle Akbar6, Damien Cohen7, Shevanthi Nayagam3, Adam Jeng2, Amie Ceesay2, Bakary Sanneh8, Ignatius Baldeh8, Masayasu Imaizumi9, Kazushige Moriyama9, Katsumi Aoyagi9, Umberto D'Alessandro2, Shunji Mishiro5, Isabelle Chemin6, Maimuna Mendy10, Mark R Thursz3, Maud Lemoine3. 1. Unité d'Épidémiologie des Maladies Émergentes, Institut Pasteur, Paris, France. 2. Medical Research Council (MRC) Unit, London School of Hygiene and Tropical Medicine, Fajara, The Gambia. 3. Liver Unit, Department of Surgery and Cancer, Imperial College London, United Kingdom. 4. The Gambia Hepatitis Intervention Study, International Agency for Research on Cancer (IARC), MRC Unit, Fajara, The Gambia. 5. Department of Medical Sciences, Toshiba General Hospital, Tokyo. 6. Department of Pathology, Ehime University Graduate School of Medicine, Japan. 7. Institut national de la santé et de la recherche médicale U1052, Centre national de la recherche scientifique UMR5286, Centre de Recherche en Cancérologie, Université Claude Bernard, Lyon, France. 8. National Public Health Laboratory, Banjul, The Gambia. 9. Research and Development Division, Fujirebio Inc, Tokyo, Japan. 10. International Agency for Research on Cancer, Lyon, France.
Abstract
BACKGROUND: To eliminate hepatitis B virus (HBV) infection, it is essential to scale up testing and treatment. However, conventional tools to assess treatment eligibility, particularly nucleic acid testing (NAT) to quantify HBV DNA, are hardly available and affordable in resource-limited countries. We therefore assessed the performance of a novel immunoassay, hepatitis B core-related antigen (HBcrAg), as an inexpensive (US$ <15/assay) alternative to NAT to diagnose clinically important HBV DNA thresholds (≥2000, ≥20 000, and ≥200 000 IU/mL) and to select patients for antiviral therapy in Africa. METHODS: Using a well-characterized cohort of treatment-naive patients with chronic HBV infection in The Gambia, we evaluated the accuracy of serum HBcrAg to diagnose HBV DNA levels and to indicate treatment eligibility determined by the American Association for the Study of Liver Diseases, based on reference tests (HBV DNA, hepatitis B e antigen, alanine aminotransferase, liver histopathology, and/or FibroScan). RESULTS: A total of 284 treatment-naive patients were included in the analysis. The area under the receiver operating characteristic curve (AUROC), sensitivity, and specificity of serum HBcrAg were 0.88 (95% confidence interval [CI], .82-.93), 83.3%, and 83.9%, respectively, to diagnose HBV DNA ≥2000 IU/mL; and 0.94 (95% CI, .88-.99), 91.4%, and 93.2% for ≥200 000 IU/mL. A simplified treatment algorithm using HBcrAg without HBV DNA showed high AUROC (0.91 [95% CI, .88-.95]) with a sensitivity of 96.6% and specificity of 85.8%. CONCLUSIONS: HBcrAg might be an accurate alternative to HBV DNA quantification as a simple and inexpensive tool to identify HBV-infected patients in need of antiviral therapy in low- and middle-income countries.
BACKGROUND: To eliminate hepatitis B virus (HBV) infection, it is essential to scale up testing and treatment. However, conventional tools to assess treatment eligibility, particularly nucleic acid testing (NAT) to quantify HBV DNA, are hardly available and affordable in resource-limited countries. We therefore assessed the performance of a novel immunoassay, hepatitis B core-related antigen (HBcrAg), as an inexpensive (US$ <15/assay) alternative to NAT to diagnose clinically important HBV DNA thresholds (≥2000, ≥20 000, and ≥200 000 IU/mL) and to select patients for antiviral therapy in Africa. METHODS: Using a well-characterized cohort of treatment-naive patients with chronic HBV infection in The Gambia, we evaluated the accuracy of serum HBcrAg to diagnose HBV DNA levels and to indicate treatment eligibility determined by the American Association for the Study of Liver Diseases, based on reference tests (HBV DNA, hepatitis B e antigen, alanine aminotransferase, liver histopathology, and/or FibroScan). RESULTS: A total of 284 treatment-naive patients were included in the analysis. The area under the receiver operating characteristic curve (AUROC), sensitivity, and specificity of serum HBcrAg were 0.88 (95% confidence interval [CI], .82-.93), 83.3%, and 83.9%, respectively, to diagnose HBV DNA ≥2000 IU/mL; and 0.94 (95% CI, .88-.99), 91.4%, and 93.2% for ≥200 000 IU/mL. A simplified treatment algorithm using HBcrAg without HBV DNA showed high AUROC (0.91 [95% CI, .88-.95]) with a sensitivity of 96.6% and specificity of 85.8%. CONCLUSIONS: HBcrAg might be an accurate alternative to HBV DNA quantification as a simple and inexpensive tool to identify HBV-infectedpatients in need of antiviral therapy in low- and middle-income countries.
Authors: Anne Loarec; Aude Nguyen; Lucas Molfino; Mafalda Chissano; Natercia Madeira; Barbara Rusch; Nelly Staderini; Aleny Couto; Iza Ciglenecki; Natalia Tamayo Antabak Journal: Bull World Health Organ Date: 2021-12-02 Impact factor: 9.408
Authors: Charly Mayran; Vincent Foulongne; Philippe Van de Perre; Chantal Fournier-Wirth; Jean-Pierre Molès; Jean-François Cantaloube Journal: Diagnostics (Basel) Date: 2022-03-02