Тhe informative value of the HCV core antigen in the diagnosis of HCV infection

Abstract

The aim of the study was to evaluate the informative value of the HCV core antigen in the diagnosis of HCV infection. Materials and methods. HCV core antigen was detected by immunoassay using an ARCHITECT ABBOTT i1000SR automated immunoassay analyzer (Abbott, USA, 2013) in three groups of patients: group 1 — 201 patients with HCV monoinfection without HIV or HBV coinfections and without prior antiviral treatment for HCV infection with direct-acting antiviral drugs (DAA); group 2 — 53 patients with HIV/HCV coinfection and no prior DAA treatment; group 3 — 51 patients with HCV monoinfection without HIV or HBV coinfections after DAA antiviral treatment. The diagnosis of HCV infection was confirmed by PCR isolation. Results and discussion. The sensitivity of the HCV-sAG test in the study group for confirming the diagnosis of HCV infection in anti-HCV-positive individuals was 87.8%, and the specificity was 58.8%. Discrepancies between the results of HCV-sAG and HCV RNA determination were observed in patients with low HCV viral loads — Me (Q1; Q3) — 1100 (0; 4450) IU/ml. No influence was found on the accuracy of of the HCV core antigen determination by parameters such as patient age, gender, HCV genotype, stage of liver fibrosis, liver cirrhosis, AST, ALT, bilirubin levels, or blood test parameters. Conclusion. A positive of the HCV core antigen result can be used as a confirmatory test for HCV infection in anti-HCV-positive patients. If a negative of the HCV core antigen result is obtained, individuals with a positive anti-HCV test should be tested for HCV RNA (PCR) to exclude false negative results.