Diagnostic performance of four hepatitis-B surface antigen conformité Européenne (CE) marked and one WHO prequalified...

Globally, over 254 million people are infected with chronic Hepatitis B (HBV). Eighty million of these reside in sub-Saharan Africa (SSA). HBV claims an estimated one million lives annually. Efforts to eradicate it from SSA have been slow, partly due to a lack of affordable, accurate screening tools. The diagnostic accuracy of the commonly used rapid diagnostic tests (RDTs) in SSA is poorly understood; hence a need to characterize the validity of five RDTs being used for HBV diagnosis using the Hepatitis B surface antigen (HBsAg) serologic marker.

In this case-control study with 1:1 case: control matching, and a prevalence of 50%, 200 samples of residual donor blood were tested using RDTs against the reference test Fortress Diagnostic, 2016 Enzyme-Linked Immunosorbent Assay (ELISA). They were subsequently subjected to five RDT kits: the SD Bioline (Abbott Diagnostics Korea Inc.), a World Health Organization (WHO) pre-qualified test kit, and four Conformité Européenne (CE) Marked RDTs: One-Step, NOVA (Atlas Link Technology), Astracare (Astra Biotech GmbH), and Accurate (Pharmagen Uganda Ltd). Sensitivity and specificity were computed using ELISA as the reference test. The Statistical Program for Social Sciences (SPSS) was used for statistical analysis.

All five RDT brands demonstrated a sensitivity of 93% (95% CI 93%- 93%). Their specificity, however, ranged from 95% (95% CI 94.9%- 97.8%) for Astracare to 98% (95% CI 94.9%- 98.0%) for SD Bioline.

All the RDTs demonstrated good specificity and good performance characteristics. CE-marked RDTs thus present an opportunity for massive screening of the at-risk populations in the WHO-led campaign to eliminate HBV as a public health threat in Uganda and other low-resource settings by 2030.