Evaluation of rapid diagnostic test compared with ELISA for detection of hepatitis B surface antigen

Authors : Rakesh Kumar Shrivastava, Deepti Chaurasia

DOI : 10.18231/j.ijmr.2020.036

Volume : 7

Issue : 2

Year : 2020

Page No : 203-206

Background: Hepatitis B is a serious type of viral infection affecting millions of people throughout the
world. Some of those who become Chronic carriers may progress to develop hepatocellular carcinoma
and end stage liver disease. Therefore, early diagnosis and management is the need of time. Present study
was aimed to compare the relative sensitivity and specificity of rapid ICT with ELISA for the detection of
HBsAg.
Materials and Methods: One step rapid test for detection of HBsAg was performed on samples by
Meriscreen HBsAg test from Meril Diagnostics. HbsAg ELISA was done by using SD HBsAg ELISA
3.0 from SD Biostandard diagnostics Private Ltd. This is assay for qualitative detection of HBsAg from
human serum and plasma. Total 526 samples were analysed.
Results: Out of 64 positive samples, 62 were positive by rapid card test, and 2 were negative. Out of 462
negative samples, 461 were negative by rapid card test, and one was positive. We found the sensitivity and
specificity of rapid ICT was 96.8% and 99.7% as compared to ELISA.
Conclusions: The results are very much similar to several previous studies done in India and other parts
of world. It would be wise to validate this point of care tests with a standard ELISA or other specific tests
whenever feasible.

Keywords: Rapid test, ELISA, HBsAg.


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