Clinical Usefulness of HCV Core Antigen Assay for the Management of Patients with Chronic Hepatitis C

Abstract

The Architect HCV core Ag assay might be an alternative for the diagnosis of active HCV infection if molecular tests are not available, and a useful method for the evaluation of sustained virological response in treated patients.

Utility of enzyme‐linked immunosorbent assays to test core antigen in the diagnosis and antiviral therapy management of hepatitis C virus infections

“…During the window period of infection, anti‐HCV levels were undetected in two patients with positive HCV Ag, which confirmed that anti‐HCV detection is not sensitive in the window period of HCV infection . HCV Ag levels had a strong correlation with HCV RNA concentrations in patients with an active HCV infection, which was consistent with the previous reports, and Pearson's correlation coefficient was 0.891. The results of HCV Ag in two patients were in the gray zone (S/CO value: 0.82, 0.87) with HCV RNA level of 6600 and 6900 IU/mL.…”

“…HCV infections are a serious public health issue, with approximately 160‐170 million people infected worldwide, and early detection and treatment are key for preventing its transmission and providing effective treatment. Currently, anti‐HCV testing remains the preferred screening tool for HCV infections, but it is not sensitive during the window period of infections and hemodialysis; false positives are often observed in pregnancy and patients with autoimmune diseases, and it also cannot distinguish between active and past HCV infections . HCV RNA detection is used to confirm and manage antiviral therapy for HCV infections.…”

“…In recent years, assays for HCV Ag have been developed, such as enzyme immunoassays (EIAs) or chemiluminescent immunoassays (CMIA) . Previous studies showed that the limit of detection of HCV Ag using CMIA is approximately 0.06 pg/mL (or 3 fmol/L), which corresponds to a viral load range of 428‐2700 IU/mL; in addition, there is an excellent correlation between HCV Ag concentrations and HCV RNA levels . With high analytical sensitivity and a short turn‐around time, the quantificationation of HCV Ag by means of CMIA has been suggested as an alternative to HCV RNA testing in the diagnosis and treatment monitoring of HCV infections .…”

Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection

“…Overall, genotype distribution was reported for 18 studies (Data Supplement Table 1) with genotype 1b being the most prevalent and genotypes 5 and 6 only minimally studied. In the univariate analysis, there were three outlier studies (25, 44, 45). In the Ergünay study from Turkey, HIV and HBV co-infection status were unknown and the genotype distribution was overall similar to other studies that reported data: 60.2% of participants had HCV genotype 1b infection, 2.2% genotype 1a, 0.8% genotypes 3 and 4, and 35.8% were unknown (Data Supplement Table 1).…”

Implications of grey zone results for routine hepatitis C virus screening with the ARCHITECT HCV‐Ag assay

“…In addition, maintaining a low cutoff value partially counteracts the lack of sensitivity compared to HCV-RNA. According to the literature Laperche et al (2003), Krajden et al (2004), Valcavi et al (2004), Soffredini et al (2004), Chevaliez et al (2014), Florea et al (2014), the sensitivity of the technique decreases significantly in those samples with viral loads below 10 4 IU ml À1 , Therefore, it would be a mistake to consider negatives without retesting the samples with these results, since they can be either HCV-Ag negative or positive values associated with low viral load.…”