Abstract
Objective: To explore the diagnostic value of anti-HCV and HCV RNA so as to provide an accurate and efficient detection strategy for the diagnosis of HCV in intravenous drug users. Methods: 527 plasma samples from intravenous drug users were collected, and preliminary anti-HCV ELISA screening test was performed. A recombinant immunoblot assay (RIBA) was used as confirmatory assay for reactive antibody samples. All samples were tested for HCV RNA, followed by analysis of anti-HCV screening test, RIBA and HCV nucleic acid test results. Results: Anti-HCV ELISA results were reactive in 386 out of 527 intravenous drug users and non-reactive in 141. Among the 386 reactive antibody samples detected by RIBA, 370 cases were anti-HCV positive, 6 cases were anti-HCV indeterminate and 10 cases were anti-HCV negative. Anti-HCV ELISA and RIBA positive coincidence detection rate was 95.85% (370/386), and 70.21% (370/527) among intravenous drug users. HCV RNA was negative in all 10 anti-HCV RIBA non-reactive samples. 376 anti-HCV RIBA-positive and indeterminate samples were tested for HCV RNA, of which 56.93% (300/527) were current HCV infection, and 14.42% (76/527) were past HCV infection. Among 141 anti-HCV ELISA negative samples, the residual risk by anti-HCV ELISA screening for HCV RNA was 1.52% (8/527). HCV viral load distribution among intravenous drug users showed that the high viral load value (>10(7) IU/ml) and low viral load values (< 10(2) IU/ml) accounted for 1.95% and 2.27%, respectively, while the samples with viral load value of 1×10(2) ~ 1×10(7) IU/ mL accounted for 95.78% (295/308), and were mainly distributed in 1×10(5) ~ 1×10(6) IU/ml (37.99%). ELISA + RIBA + NAT assay detection strategies had differentiated 300 cases of current HCV infection, 76 cases of past HCV infection and 10 cases of false positive anti-HCV results, while ELISA+NAT assay detection strategies had only detected 300 cases of current HCV infection. However, of the 386 positive subjects screened for antibodies, 10 (2.59%) were undifferentiated false positives. Conclusion: Intravenous drug users are the high-risk population of HCV infection with high prevalence and high viral load. Anti-HCV screening for intravenous drug users will have a certain degree of residual risk. Therefore, anti-HCV ELISA screening and nucleic acid detection strategy can accurately diagnose the current infected patients; however, it cannot distinguish the false positive results of antibody screening.