Comparison of Immunochromatographic Test and Electrochemiluminescence Assay with PCR for the Detection of Hepatitis B Virus: A Cross-sectional Study

Abstract

Introduction: Hepatitis B Virus (HBV) infection remains a significant public health concern globally, necessitating accurate and timely diagnostic methods. Immunochromatographic Tests (ICTs) and Electrochemiluminescence Assays (ECLIAs) are widely used assays for HBV detection due to their rapidity and cost-effectiveness. However, their diagnostic performance should be evaluated to ascertain their reliability. Aim: To detect the presence of Hepatitis B Surface Antigen (HBsAg) in the selected samples using ICT and ECLIA and to compare it with HBV Deoxyribonucleic Acid (DNA) using a molecular assay. Materials and Methods: A cross-sectional study was done with serum samples collected from patients visiting the hospital over a period of six months with prior ethical clearance. Serum samples were obtained from 57 patients suspected of HBV infection. The results of ICT, ECLIA, and HBV DNA viral load (by Polymerase Chain Reaction (PCR)) were cross-tabulated and assessed for differences in diagnostic sensitivity. The positivity and correlation of the ICT and ECLIA with PCR were estimated. All statistical analyses were performed using the R programming language. Results: Out of 57 samples, 53 (92.98%) tested positive in the ICT card test, and 54 (94.74%) were positive in the ECLIA method. McNemar’s test showed that the sensitivity of ICT and ECLIA differed significantly compared to HBV DNA PCR. There was a significant positive correlation between ECLIA and HBV-DNA PCR (Spearman correlation, r-value=0.28, p-value=0.035). Conclusion: The findings suggest that in settings where accurate diagnosis is critical, particularly for screening and monitoring treatment efficacy, molecular assays remain the preferred choice despite their higher cost and complexity. However, in resource-limited settings, ECLIAs can still play a valuable role in HBV screening programs.

Keywords

• chemiluminescence
• immunochromatography
• polymerase chain reaction