Diagnostic Performance of Four Hepatitis B Surface Antigen Conformité Européenne (CE) Marked and One WHO Prequalified Rapid Diagnostic Tests in Uganda

Abstract Background Globally, over 296 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. Methods In this cross-sectional study, 200 samples of residual donor blood were screened for HBsAg using the Chemiluminescent Microparticle Immunoassay (CMIA) and results confirmed by Enzyme-Linked Immunosorbent Assay (ELISA). They were subsequently subjected to five RDT kits; the SD Bioline, a World Health Organization (WHO) pre-qualified test kit, and four Conformité Européenne (CE) Marked RDTs: One-Step, NOVA, Astracare and Accurate. The sensitivity, specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) were computed using ELISA as the reference test. The Statistical Program for Social Sciences (SPSS 20.0 for Windows; SPSS Inc. Chicago, IL) was used for statistical analysis. Results 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. Similarly, their positive PPV ranged from 94.89% (95% CI 94.9%-97.7%) for Astracare to 97.89% (95% CI 94.9%-98.0%) for SD Bioline and NPV ranged from 93.14% (95% CI 93.1%-93.3%) for Astracare and 93.33% (95% CI 93.1% -93.3%) for SD Bioline. Conclusion SD Bioline had the best diagnostic accuracy for HBV infection. Nevertheless, the less expensive CE-marked RDTs had 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.