Comparison of Rapid Immunochromatography and Enzyme-Linked Immunosorbent Assay Techniques for Hepatitis C Virus Serodiagnosis: A Study from Mumbai, Maharashtra

Objectives: Hepatitis C virus (HCV) belongs to the Flaviviridae family. It is a small, enveloped, positive-sense single-stranded ribonucleic acid (RNA) virus. It leads to both acute (30%) and chronic (70%) infections. The methods of HCV diagnosis are by detection of anti-HCV antibodies using immunoassays, followed by detection of HCV RNA in serum or plasma on those antibody-reactive specimens. Anti-HCV detection is done by rapid diagnostic test (RDT) and enzyme-linked immunosorbent assay (ELISA); both have different test principles with advantages and disadvantages. Material and Methods: The aims and objectives of the study are to determine the sensitivity and specificity of RDT based on the principle of rapid immunochromatography and its comparison with ELISA for serodiagnosis of HCV, considering ELISA as the gold standard. Blood specimens of patients of both genders and all age groups received in the emergency laboratory for rapid anti-HCV testing were included; they were also tested by the ELISA method. After scrutinizing the laboratory registers, both the test results were recorded and analyzed. Results: Out of the total 6955 samples tested, 77 (1.1%) were positive by RDT, while 46 (0.66%) were positive by the ELISA test. A total of 32 samples were both RDT and ELISA positive; of them, 22 (69%) were male and 10 (31%) were female with the most common age group affected being 41–60 years. As per this study, anti-HCV RDT had a sensitivity and specificity of 69.57% and 99.35% with positive predictive value of 41.55% and negative predictive value of 99.15%, while the kit manufacturer claimed relative sensitivity and specificity of 99.1% and 99.5%. Conclusion: It is important to know the sensitivity and specificity of RDT kits used for interim reporting of HCV during emergency hours. This needs to be followed by an ELISA test which will help in confirmation and also prevent the complications associated with false negativity reported by the rapid assay.