Towards 2030 Target for Hepatitis B and C Viruses Elimination: Assessing the Validity of Predonation Rapid Diagnostic Tests versus Enzyme-linked Immunosorbent Assay in State Hospitals in Kaduna, Nigeria.

INTRODUCTION: Sub-Saharan Africa accounts for 25% of the estimated global 325 million people with chronic hepatitis B and C virus infections. Weak blood transfusion systems facilitate the spread of both hepatitis B and C virus infections. This is worsened by the absence of sustainable quality assurance programs and perennial shortage of sensitive screening kits. We aim to compare the validity of rapid diagnostic tests (RDTs) with the World Health Organization-recommended quality-assured enzyme-linked immunosorbent assay (ELISA) screening method for these viruses. MATERIALS AND METHODS: We conducted a cross-sectional study on consecutive blood donor samples. Two hundred and sixty-four blood donor samples screened for hepatitis B and C viruses using RDTs were retested at a National blood transfusion service, Kaduna, Nigeria. Data were analyzed using OpenEpi version 3.01 to determine the sensitivity, specificity, and predictive values of RDTs versus ELISA. RESULTS: The sensitivities of the RDTs at 95% confidence interval (CI) were low - 40% (19.8-64.3) and 50.0% (18.8-81.2) - for hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) antibody, respectively. The specificities and 95% CI were high - 99.9% (97.8-99.9) and 100.0% (98.5-100) for HBsAg and HCV antibody, respectively. CONCLUSION: Predonation RDTs screening of blood donor samples for hepatitis B virus and HCV in hospital donation units performed poorly compared to quality-assured ELISA screening in Kaduna. The risk of transmitting viral hepatitis through blood transfusion still exists. We recommend quality-assured ELISA screening of all donated units for HBsAg and HCV antibody to reduce the risk of these transfusion-transmitted infections.

Towards 2030 target for hepatitis B and C viruses elimination: assessing the validity of predonation rapid diagnostic tests versus enzyme-linked immunosorbent assay in state hospitals in Kaduna, Nigeria

ntroduction: Sub-Saharan Africa accounts for 25% of the estimated global 325 million people with chronic hepatitis B and C virus infections. Weak blood transfusion systems facilitate the spread of both hepatitis B and C virus infections. This is worsened by the absence of sustainable quality assurance programs and perennial shortage of sensitive screening kits. We aim to compare the validity of rapid diagnostic tests (RDTs) with the World Health Organization-recommended quality-assured enzyme-linked immunosorbent assay (ELISA) screening method for these viruses. Materials and Methods: We conducted a cross-sectional study on consecutive blood donor samples. Two hundred and sixty-four blood donor samples screened for hepatitis B and C viruses using RDTs were retested at a National blood transfusion service, Kaduna, Nigeria. Data were analyzed using OpenEpi version 3.01 to determine the sensitivity, specificity, and predictive values of RDTs versus ELISA. Results: The sensitivities of the RDTs at 95% confidence interval (CI) were low ­ 40% (19.8­64.3) and 50.0% (18.8­81.2) ­ for hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) antibody, respectively. The specificities and 95% CI were high ­ 99.9% (97.8­99.9) and 100.0% (98.5­100) for HBsAg and HCV antibody, respectively. Conclusion: Predonation RDTs screening of blood donor samples for hepatitis B virus and HCV in hospital donation units performed poorly compared to quality-assured ELISA screening in Kaduna. The risk of transmitting viral hepatitis through blood transfusion still exists. We recommend quality-assured ELISA screening of all donated units for HBsAg and HCV antibody to reduce the risk of these transfusion-transmitted infections