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.