The Qualitative And Quantitative Detection Of HCV Core Antigen In The Serum Of The Patients With Chronic Hepatitis C By Homemade Enzyme Linked Immunoadsorbent Assay

Objective: To analyse and evaluate the detection of the qualitative HCV core antigen, total HCV core antigen and quantitative HCV core antigen in serum by homemade enzyme linked immunoadsorbent assay. To realize the specificity and sensitivity of homemade enzyme linked immunoadsorbent assay(homemade ELISA) for qualitative HCV core antigen, total HCV core antigen and quantitative HCV core antigen assay.Methods: The sera from 275 patients with chronic hepatitis C, 20 health volunteer and 35 patients of chronic hepatitis B, were detected for HCV core antigen, total HCV core antigen and quantitative HCV core antigen by homemade ELISA. Meanwhile, the serum HCV RNA were detected by real time fluorescent quantitative RT-PCR, and HCV antibody were detected by ELISA. The results of qualitative HCV core antigen detected by homemade ELISA was compared with that detected by Othro-clinical diagnostics immunoadsorbent agent for HCV core antigen assay.Results: 1. Qualitative HCV core antigen, total HCV core antigen and quantitative HCV core antigen in the sera from 20 health volunteer and 35 patients of chronic hepatitis B were negative and their OD values were 0.022±0.017,0.003±0.011 ; 0.007±0.015,0.014±0.018 and 0.004±0.012, 0.012±0.018, respectively. 2. There was 87 cases (31.64%) positive for qualitative HCV core antigen in 275 sera of patients with chronic hepatitis C. The coincidence was about 91.38% between the homemade ELISA and Othro-clinical diagnostics immunoadsorbent agents for qualitative HCV core antigen detection. 3. The positive rates of total HCV core antigen detection were 32.54%(41/126), that was significantly higher than the results of qualitative HCV core antigen detection (11.7%; 15/126) (P<0.05). 4. HCV core antigen can be qualitatively detectable in the serum with HCV-RNA copies betweenl0~4～10~6 copies/ml. Thirty-nine cases (30.95%) were detected positive for rates of quantitative HCV core antigen in 126 sera of patients with chronic hepatitis C, that had same sensitivity with total HCV core antigen assay. 5. The coincidence of detective results between HCV RNA and qualitative HCV core antigen was 60% in 275 sera of patients with chronic hepatitis C(P<0.01) and the coincidence between HCV RNA and total HCV core antigen or quantitative HCV core antigen detection was 88.10% and 86.51% in 126 sera of patients with chronic hepatitis C, respectively. 6. There was a good correlation between the positive of HCV RNA and total HCV core antigen(r=0.478, P<0.01) or quantitative HCV core antigen((r=0.615, P<0.01) respectively.Conclusions: 1. Qualitative HCV core antigen, detected by ELISA has a high specificity, and has a high coincidence with Othro-clinical diagnostics immunoadsorbent. 2.Total HCV core antigen and quantitative HCV core antigen detection have the same sensitivity, that is significantly higher than that of qualitative HCV core antigen detection. 3. Total HCV core antigen and quantitative HCV core antigen detection have a good correlation with HCV RNA and both are as valuable markers as HCV RNA in clinical management of chronic hepatitis C virus infection. It could promote the diagnosis of viramia of chronic hepatitis C by combination use of total HCV core antigen or quantitative HCV core antigen detection and HCV RNA assay with real time fluorescent quantitative RT-PCR.