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Background: Hepatitis B virus, as a member of the Hepadnaviridae family, causes acute and chronic hepatitis in humans. In low-income countries with a high burden of hepatitis B and C viruses, it is important to develop inexpensive but effective strategies to diagnose and treat hepatitis. The aim of this study is to evaluate the sensitivity and specificity of the serum hepatitis B surface antigen (HBsAg) and that of the HBeAg envelope of the different tests used in the south of the DR Congo compared to the reference laboratory method.

Methods: This is a cross-sectional descriptive study conducted in the Democratic Republic of Congo precisely in the province of Haut-Katanga, the case of the city of Lubumbashi, Likasi and that of Likasi. By identifying tests in medical structures and collecting data on the principle of the test, antigen preparation, manufacturer, sensitivity, and specificity. These tests were further evaluated using samples previously evaluated by DNA PCR, sixty-five of which had non-detected results and twenty-one detected for the calculation of the evaluation parameters of a diagnostic test.

Results: 17 HBsAg tests were identified, 12 of which had a mention of antigenic preparation consisting of monoclonal and polyclonal AntiHBsAg antibodies and for which the Sensitivity for the test was 93.65%, specificity of 99.35% for a PPV of 97.92% and an NPV of 97.97%; and for the 5 which did not mention it, the values are respectively: 90% for sensitivity, 92.87% for specificity, 87.09% for PPV and 92.87% NPV. The evaluation of the HBeAg test compared to the HBV DNA PCR gave a sensitivity of 61.84%, a specificity of 78.55%, a PPV of 18.65% and an NPV of 96.28% for the tests including antigenic preparation mentioned and 57.14% of sensitivity, 76.689% specificity, 7.61% PPV and 097.55% NPV for tests which do not mention any.

Conclusion: The rapid tests used for HBsAg screening have low sensitivity compared to WHO recommendations and specificity within the standards. In low-income countries with a hepatitis B virus load, such as DR Congo, it is necessary to choose a screening test that is highly effective, easy to use, less expensive and gives rapid and accurate results. There is an urgent need to develop HBeAg RDTs with improved sensitivity, suitable for use in sub-Saharan Africa and validated with locally prevalent HBV genotypes, to facilitate effective screening programs, treatment, and prevention of HBV.