National Journal of Laboratory Medicine (Jan 2022)
A Comparison of Rapid Screening Test and ELISA for the Diagnosis of Hepatitis B Surface Antigen in Patients Attending a Tertiary Care Hospital, Tamil Nadu, India
Abstract
Introduction: Hepatitis B virus infection is a major public health problem and leading cause of death worldwide. World Health Organisation (WHO) estimates that in 2015 about 257 million population were living with chronic Hepatitis B virus infection with a global prevalence of 3.5%. Among the several viral antigens of Hepatitis B, Hepatitis B Surface Antigen (HBsAg) is an important viral antigen which is recognised as a superior marker for Hepatitis B virus detection. For proper diagnosis of infection as well as disease management and prevention, identification of appropriate test kit is necessary. Aim: To compare the results of rapid screening tests and ELISA for the diagnosis of HBsAg. Materials and Methods: A cross-sectional study was conducted from July 2019-August 2019 in a tertiary care hospital. A total of 200 blood samples received for HBsAg testing were centrifuged. Serum of all the 200 blood samples were tested for HBsAg using both rapid Immuno Chromatographic Card (ICT) method (HEPAVIEW - one step test for HBsAg, Viola Diagnostic System, A Division of Tulip Diagnostics Pvt., Ltd.) and Enzyme Linked Immuno Sorbent Assays (ELISA) (Merilisa HBsAg- Meril Diagnostics Pvt., Ltd.) method. Data for rapid card method and ELISA were noted and entered into MS excel spread sheet and analysed. Results: Among the total 200 blood samples tested by HbsAg rapid card, five samples were positive and the remaining 195 were negative. For rapid card test, the sensitivity was 83.4%, specificity 100%, Positive Predictive Value (PPV) 100% and Negative Predictive Value (NPV) 99.4% and for ELISA the sensitivity, specificity, PPV and NPV were all 100%. Conclusion: The overall performance of the rapid ICT for HBsAg was less sensitive to ELISA. So, only ELISA can be encouraged in all setups irrespective of their developmental and economical status not only to prevent the complications of Hepatitis B infection but also for early diagnosis and better treatment of patients.
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