Comparison of Rapid Anti-HCV Multi-sure Kit with Gold Standard ELISA

Abstract

Objective: To compare the diagnostic yield of Multi-sure rapid HCV (hepatitis C virus) kit with ELISA. Study Design: Comparative study. Place and Duration of Study: Pakistan Health Research Council, specialised research center for gastroenterology and hepatology, from August 2016 to January 2017. Methodology: A modified rapid anti-HCV kit was compared with ELISA. This rapid kit is multi-parameter qualitative immune chromatographic kit for the in-vitro detection of antibodies to HCV in human blood. Patients who came to PHRC, were tested using anti-HCV ELISA, and their test was run simultaneously on multi-sure HCV rapid kit were included in the study. Each positive and negative sample was included in this study. SPSS software was adapted for data analysis. Results: A total of 420 samples were collected. Among them, 255 (61%) were of male and 165 (39%) were of female patients. Mean age was 35 ±14.33 years. All the samples run for anti-HCV on ELISA were also run on multi-sure rapid kit. It is evident that 22.4% were reactive on ELISA and 23.6% were reactive on rapid kit, while 75.5% were non-reactive on ELISA and 68.1% were non-reactive on rapid kit. Borderline positive results were seen in 2.1% on ELISA and 5.0% on rapid kit. Sensitivity of rapid kit was 87.2%, specificity 89.3% with 82.8% positive predictive value and 98.9% negative predictive value. Conclusion: Multi-sure kit showed significantly, less non-reactive and more borderline results as compared to ELISA. Comparison of multi-sure rapid kit with ELISA showed that core antibody can be used as an alternate marker for ELISA. Other non-structural proteins including NS3, NS4 and NS5 were found to be less significant. So, it is concluded that this rapid kit may not be recommended as an alternative of ELISA, except for places where ELISA is not available