Diagnostic Performance of Rapid Screening and ELISA Methods in the Detection of Hepatitis B Virus Surface Antigen among Patients Attending Tertiary Healthcare Facilities in Nasarawa State, Nigeria

Abstract

Background: Hepatitis B Virus (HBV) infection is a global public health problem. It is estimated that 820,000 deaths occur every year and 3.6% of the global population including over 6 million children under the age of 5 is affected by chronic HBV infection and approximately 2 billion people suffer from HBV infection and around 280 million are carriers of HBsAg with virus harboured in their liver. In Nasarawa State Nigeria, a prevalence of 13.63% has been reported. The primary marker for diagnosis of HBV infection is hepatitis B surface antigen (HBsAg). Rapid Diagnostic Test (RDT) kits and Enzyme-Linked Immunosorbent Assay (ELISA) are the most frequently used for the detection of HBsAg. Aim: The present study compared the diagnostic performance of RDT and ELISA methods in detecting Hepatitis B virus surface antigen among patients in the study area. Study Design: The study was a cross-sectional study. Place and Duration of Study: The study was carried out at Federal Medical Centre Keffi and Federal University Teaching Hospital Lafia in Nasarawa State, Nigeria from June 2024 to December 2024. Methodology: A total of 200 samples were collected and screened for HBsAg using both DIALAB DIAQUICK HBsAg Dipstick rapid screening kits (DIALAB Austria) and DIALAB HBsAg ELISA test kit (DIALAB Austria) according to the manufacturer’s instructions. Data were analysed using the Statistical Package for Social Sciences (SPSS) Version 21.0. The differences were considered significant only when P ≤ 0.05. Results: Out of the 200 samples screened for HBsAg using RDT and ELISA techniques, 19(9.5%) were positive while 181(90.5%) were negative using the RDT method. For the ELISA method, 23(11.5%) were positive while 177 (88.5%) were negative. Using ELISA as a standard for the RDT method, the following were obtained: sensitivity 82.61%, specificity 100%, positive predictive value 100%, negative predictive value 97.79% and the kappa level of agreement between the two methods was 0.89 respectively. Conclusion: The study highlights the high endemicity of HBV infection in Nasarawa State, Nigeria. Also, in comparing both methods, the ELISA method was found to be more sensitive than the RDT kit device. We recommend that the RDT screening kits be combined with the ELISA method to ensure timely and accurate detection of HBsAg among HBV-infected patients.