Evaluation of a novel enzyme-linked immuno assay model to detect E2 antigen and antibodies against core, NS3, NS4, and NS5 antigens of hepatitis C virus

Abstract

Background: The serological measurement of the anti-hepatitis C virus antibody is a widely used tool in the first-line diagnosis of HCV infection. Therefore, increasing the testing criteria of these tests is of crucial importance for screening HCV infection. Objectives: The current study aimed to optimize a novel enzyme-linked immuno assay model to detect E2 antigen with or without sample pretreatment in combination with antibodies against core, NS3, NS4, and NS5 antigens of the hepatitis C virus and to compare the performances of these assays with indirect antigen (Ag), biotin/HRP labeled Antigen Sandwichandmethodsof enzymelinked immunosorbent assay (ELISA) for their ability to detect HCV. Methods: Atotal of 107 positiveand415 negative controlsfromvolunteerwholeblood donors in Blood Transfusion Organizationand 204 blood samples from patients under hemodialysis treatment in Tehran and Bandar Abbas hemodialysis centers are investigated. Six different methods of ELISA test were used to detect anti-HCV antibodies and/or HCV antigens in serum samples. Results: Regarding sensitivity, specificity, and accuracy, E2 Antigen detection alone or combined with antibody detection have the highest accuracy value (99% and98%, respectively)comparedto othermethodsfor antibodies detection. The results of thecombined Ag/Ab ELISA test were closer to the results of real-time PCR. Conclusions: This new approach to the detection of antigen and antigen/antibody has better performance criteria concerning the serologic detection of HCV, especially in HD patients who might experience a longer window period.