Comparative Evaluation of Rapid Card Test And Enzyme Linked Immunosorbent Assay For The Detection Of Hepatitis B Surface Antigen In A Tertiary Care Hospital

Abstract

Background: Hepatitis B virus (HBV) infection is one of the leading causes of death in developing countries. The most importantmarker for HBV diagnosis is detection of Hepatitis B surface antigen in blood.Objective: The aim of this study was to compare the analytical sensitivity of a rapid card test in comparison to Enzyme-LinkedImmunosorbent Assay (ELISA) which is considered a Gold Standard technique for the detection of HBsAg in blood samplesreceived for HBsAg test in serology section of Microbiology Department, Central Laboratory, Sharda Hospital.Methods: Cross-sectional observational study was conducted at the Department of Microbiology, School of Medical Sciences &Research for a period of 12 months from 1st November 2020 to 31st October 2021. The two different brands by which multipleparameters were analyzed were HEPACARD and Erba Lisa SEN HBsAg.Results: A total of 13939 blood samples were received for HBsAg diagnosis. For the study purpose, from the total of 13939samples, 386 were randomly selected to be included in the study with 193 positive samples and 193 negative samples. Thesensitivity and specificity of Rapid card were 95.83% and 100% respectively. The Positive predictive value and Negativepredictive value of Rapid card were 100% and 95.65% respectively for HBsAg detection.Conclusion: It can be concluded that, an ideal rapid test is a boon in time-saving situations. Since HBsAg screening by a rapidtest is easier, cost effective, time saving can be easily performed by any trained health care worker at any time of need. Hence,HBsAg screening can be preferable done by a Rapid card test followed by a supplemental ELISA and Polymerase chain reactionfor further confirmation. Good sensitivity and specificity of Immuno-chromatography test (ICT) for early detection of HBsAgwas observed.