A COMPARATIVE STUDY OF EFFICACY BETWEEN THIRD GENERATION ELISA AND FOURTH GENERATION TRI-DOT TEST TO DETECT SEROPREVALENCE OF HEPATITIS-C INFECTION IN PATIENTS ON HAEMODIALYSIS

Abstract

Introduction: The detection of anti-HCV antibodies is based on the use of third generation Enzyme Immunoassay (EIA) that detects antibodies directed against various HCV epitopes. HCV TRI-DOT test is a rapid, protein A immunofiltration assay for the qualitative detection of anti HCV antibodies in serum or plasma with a sensitivity of 100% and specificity of 91.5%. The study was conducted to compare the efficacy between 3rd generation ELISA and 4th generation TRI-DOT test to detect the seroprevalence of HCV and to assess the risk factors associated with HCV infection in the patients who are on haemodialysis. Material and Methods: The study was conducted to compare the efficacy between 3rd generation ELISA and 4th generation TRI-DOT test to detect the seroprevalence of HCV and to assess the risk factors associated with HCV infection in the patients who are on haemodialysis. Sera of 150 adult CRF patients on >2 months haemodialysis tested by TRIDOT test and then by ELISA. Demographic data of all included patients reviewed for risk factors. Statistical analysis was performed by the SPSS program for Windows, version 17.0. Results: Out of 150 cases, 17 were found seropositive for HCV by TRI-DOT test and 16 were found seropositive for HCV by ELISA. One hundred and one patients were males and 49 were females. Maximum positive patients fell in 36-55 years age group. Duration of haemodialysis, mean blood transfusion, number of dialysis centre changed found almost double in HCV reactive patients than in non reactive. Sensitivity of HCV TRI-DOT is 100% and specificity is 99.3%, positive predictive value is 94.1% and negative predictive value is 100% in comparison of ELISA. Conclusion: Seroprevalence of Hepatitis C in haemodialysis patients in our institute is 10.7%. Risk factors for HCV infection in haemodialysis patients included duration of haemodialysis, number of haemodialysis centre changed, number of blood transfusion unit transfused, male gender and middle age. The sensitivity of HCV TRI-DOT is equal to HCV ELISA but the specificity is slightly less.