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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$ 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.

Despite infrastructure and capacity challenges in Africa, significant development has been made in the number of laboratories supporting immunological and safety studies required for large-scale HIV/AIDS vaccine or intervention trials. In Uganda, cohorts participating in HIV intervention trials are often recruited from rural areas. To avoid transporting samples from intervention trial areas over long distances (120 km) to central laboratories in Entebbe, we set up a standardized peripheral blood mononuclear cells (PBMCs) processing laboratory at a field station in Masaka, southwest Uganda. The laboratory was well equipped and enrolled into the International AIDS Vaccine Initiative (IAVI) Quality Assurance (QA) program. Staff was trained in laboratory techniques and Good Clinical Laboratory Practice (GCLP). The laboratory received IAVI and GCLP accreditation in 2008. In this paper we describe the process and achievements of measures taken to overcome challenges, to build staff capacity, and to optimize the quality of the cells yielded. * PBMCs : peripheral blood mononuclear cells IAVI : International AIDS Vaccine Initiative QA : quality assurance GCLP : Good Clinical Laboratory Practice CTL : cytotoxic T lymphocytes Th : T helper UVRI : Uganda Virus Research Institute SOPs : standard operating procedures SPARTAC : short pulse anti-retroviral treatment at seroconversion S101 : sample 1, operator 1 S1O2 : sample 1, operator 2 S2O1 : sample 2, operator 1 S2O2 : sample 2, operator 2 ELISPOT : enzyme-linked immunosorbent spot CLS : Clinical Support laboratory DAIDS : division of AIDS