Tools for the diagnosis of hepatitis C virus infection and hepatic fibrosis staging

Abstract

Hepatitis C virus (HCV) infection represents a major public health issue. Hepatitis C can be cured by therapy, but many infected individuals are unaware of their status. Effective HCV screening, fast diagnosis and characterization, and hepatic fibrosis staging are highly relevant for controlling transmission, treating infected patients and, consequently, avoiding end-stage liver disease. Exposure to HCV can be determined with high sensitivity and specificity with currently available third generation serology assays. Additionally, the use of point-of-care tests can increase HCV screening opportunities. However, active HCV infection must be confirmed by direct diagnosis methods. Additionally, HCV genotyping is required prior to starting any treatment. Increasingly, high-volume clinical laboratories use different types of automated platforms, which have simplified sample processing, reduced hands-on-time, minimized contamination risks and human error and ensured full traceability of results. Significant advances have also been made in the field of fibrosis stage assessment with the development of non-invasive methods, such as imaging techniques and serum-based tests. However, no single test is currently available that is able to completely replace liver biopsy. This review focuses on approved commercial tools used to diagnose HCV infection and the recommended hepatic fibrosis staging tests.

Systematic review of the accuracy of antibody tests used to screen asymptomatic adults for hepatitis C infection

“…16 Antibody tests include the third-generation enzyme-linked immunosorbent assay (ELISA), chemiluminescent immunoassay (CLIA), electrochemiluminescent immunoassay (ECLIA), chemiluminescent microparticle immunoassay (CMIA) and microparticle enzyme immunoassay (MEIA). Each commercial antibody testing kit uses slightly different sets of HCV antigens to bind and detect host antibodies (Table 1).…”

“…Molecular techniques that detect HCV RNA, such as polymerase chain reaction and nucleic acid amplification testing, are recommended as confirmatory tests, 18 even though immunocompromised patients and those undergoing hemodialysis may have false-negative results. 16 RNA-based testing can detect HCV before antibodies are produced (early infection) and can differentiate between current and resolved infection (i.e., fewer false-positive results). There is no perfect reference standard for HCV infection, and the US Centers for Disease Control and Prevention have recommended a testing strategy in which the initial test is an antibody test and the confirmatory test may be either RNA detection or serological methods similar to the index test.…”

“…16 False-positive results can cause harm (e.g., through labelling and anxiety). People with a positive screening result typically undergo further testing, which has resource implications and may carry additional inherent risk.…”

Diagnosis and Management of Hepatitis C Virus Infection

“…Therefore, more extensive biomarker panel assays have been developed to properly stage liver disease in a minimally invasive manner. 18 Examples include the FibroTest and ActiTest (Biopredictive, Paris, France), which both measure patient serum levels of α-2-macroglobulin, haptoglobin, apolipoprotein A1, gamma-glutamyl transpeptidase (GGT), and total bilirubin. In addition, the ActiTest measures ALT as a sixth biomarker.…”

Hepatitis C Virus and Hepatitis C-Infection

“…Anti-HCV antibody and HCV RNA testing are keys to diagnosing correctly acute and chronic hepatitis C, and to determine the indication and duration of treatment. (4) Besides hepatocytes, HCV infects different cells.…”