Validation of Rapid Point-of-Care (POC) Tests for Detection of Hepatitis B Surface Antigen in Field and Laboratory Settings in the Gambia, Western Africa

Abstract

f Hepatitis B virus (HBV) infection is a leading cause of death in sub-Saharan Africa (SSA). Point-of-care tests for hepatitis B surface antigen (HBsAg) could be an ideal tool for a large-scale HBV screening/treatment program in SSA. Using data from the PROLIFICA (Prevention of Liver Fibrosis and Cancer in Africa) program, we conducted a cross-sectional study to assess the diagnostic accuracy of three point-of-care tests (Determine, Vikia, and Espline) for the detection of HBsAg in the field or a laboratory setting in the Gambia. In the field, we used finger-prick whole blood for the Determine and Vikia tests and dried blood spots for the reference standard test (AxSYM HBsAg enzyme-linked immunosorbent assay [ELISA]). In the laboratory we used serum for the Determine, Espline, and reference test (Architect chemiluminescent microparticle immunoassay). Of 773 participants recruited at the community and 227 known chronic HBV carriers (1,000 subjects in total), 293 were positive for HBsAg. The sensitivity and specificity of the Determine test were 88.5% and 100% in the field and 95.3% and 93.3% in the laboratory setting, respectively. The sensitivity and specificity were 90.0% and 99.8% for the Vikia test (in the field) and 93.9% and 94.7% for the Espline test (in the laboratory). There was no evidence that one kit was better than another. Most of the patients with false-negative results (18/19) were classified as inactive chronic carriers. In summary, the three point-of-care tests had acceptable ranges of diagnostic accuracy. These tests may represent accurate, rapid, and inexpensive alternatives to serology testing for the screening of HBV infection at field level in SSA.

Impact of Antiretroviral Therapy on Liver Fibrosis Among Human Immunodeficiency Virus-Infected Adults With and Without HBV Coinfection in Zambia

“…The rate of HBsAg loss (12.1%) we observed was higher than what has been listed in many reports from HIV-HBV-coinfected and CHB patients in high-income countries [32][33][34] but similar to the 17.6% reported by Hamers et al [29] and lower than the 36% observed by Anderson et al [35]. Our rate of HBsAg loss may be slightly overestimated due to our use of a rapid test on whole blood that has lower sensitivity than serum assays [36].…”

Natural history of chronic HBV infection in West Africa: a longitudinal population-based study from The Gambia

“…HBsAg was detected by radioimmunoassay (Ausria-I, Abbott, USA) in 1974,12 reverse passive haemagglutination assay (Wellcotest, Wellcome Diagnostics, UK) in 1980–1998,15 immunochromatography (Determine, Abbott) in 2003–2008,20 and chemiluminescent microparticle immunoassay (Architect, Abbott) in 2012–2013 21. HBsAg-positive samples were tested for HBeAg by radioimmunoassay in 1980–199815 and later by enzyme immunoassay (EIA) (Diasorin, Biomedica, Italy) 20.…”

Seroprevalence of Hepatitis B Virus Infection (HBsAg) in Rural Blood Donors, Moba, Tanganyika Province, Democratic Republic of Congo (2014 to 2016)

“…Indeed, in addition to the fact that the NBTP recommends the use of a single rapid diagnostic test (RDT) to assess the risk of HBV infection, Determine HBsAg tests are recognized to be less sensitive in some studies [53] [54] [55]. The ELISA chain can be considered as an alternative for confirmation of the results [25] [26] [34].…”