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Updated: Mar 19, 2026
A Protocol for Analyzing Hepatitis C Virus Replication
Published on: June 26, 2014
Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection: A Systematic Review and Meta-analysis
Insights
Hepatitis C virus core antigen (HCVcAg) tests show high accuracy for diagnosing active hepatitis C virus (HCV) infection. These assays may replace nucleic acid testing (NAT) in high-prevalence areas.
Area of Science:
- Hepatology
- Infectious Diseases
- Diagnostic Accuracy
Background:
- Diagnosis of chronic hepatitis C virus (HCV) infection relies on antibody screening and nucleic acid testing (NAT).
- Hepatitis C virus core antigen (HCVcAg) testing presents a potential alternative diagnostic method to NAT.
Purpose of the Study:
- To evaluate the diagnostic accuracy of five HCVcAg tests compared to NAT for active HCV infection in adults and children.
- Assess the performance of HCVcAg assays as a diagnostic tool for hepatitis C.
Main Methods:
- Systematic review and meta-analysis of case-control, cross-sectional, cohort, or randomized trials.
- Searched EMBASE, PubMed, Web of Science, Scopus, and Cochrane Library (1990-March 2016).
- Two reviewers extracted data and assessed study quality using the QUADAS-2 tool.
Main Results:
- 44 studies evaluated five HCVcAg tests; Abbott ARCHITECT and Hunan Jynda Bioengineering Group HCV Ag ELISA showed varying quality.
- Abbott ARCHITECT demonstrated high sensitivity (93.4%) and specificity (98.8%).
- HCVcAg levels correlated with HCV RNA levels >3000 IU/mL in quantitative studies.
Conclusions:
- HCVcAg assays with signal amplification offer high sensitivity and specificity.
- These assays show potential to replace NAT in settings with high HCV prevalence.
- Limitations include insufficient data on covariates and limited data for certain HCV genotypes.
Background:
Diagnosis of chronic hepatitis C virus (HCV) infection requires both a positive HCV antibody screen and confirmatory nucleic acid testing (NAT). Testing for hepatitis C virus core antigen (HCVcAg) is a potential alternative to NAT.
Purpose:
To evaluate the accuracy of diagnosis of active HCV infection among adults and children for 5 HCVcAg tests compared with NAT.
Data Sources:
EMBASE, PubMed, Web of Science, Scopus, and Cochrane Database of Systematic Reviews from 1990 through 31 March 2016.
Study Selection:
Case-control, cross-sectional, cohort, or randomized trials that compared any of 5 HCVcAg tests with an NAT reference standard.
Data Extraction:
2 independent reviewers extracted data and assessed quality using an adapted QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies 2) tool.
Data Synthesis:
44 studies evaluated 5 index tests. Studies for the Abbott ARCHITECT HCV Ag assay had the highest quality, whereas those for the Ortho HCV Ag enzyme-linked immunosorbent assay (ELISA) had the lowest quality. From bivariate analyses, the sensitivity and specificity of the assays were as follows: Abbott ARCHITECT, 93.4% (95% CI, 90.1% to 96.4%) and 98.8% (CI, 97.4% to 99.5%); Ortho ELISA, 93.2% (CI, 81.6% to 97.7%) and 99.2% (CI, 87.9% to 100%); and Hunan Jynda Bioengineering Group HCV Ag ELISA, 59.5% (CI, 46.0% to 71.7%) and 82.9% (CI, 58.6% to 94.3%). Insufficient data were available for a meta-analysis about the Fujirebio Lumipulse Ortho HCV Ag and Eiken Lumispot HCV Ag assays. In 3 quantitative studies using Abbott ARCHITECT, HCVcAg correlated closely with HCV RNA levels greater than 3000 IU/mL.
Limitations:
Insufficient data were available on covariates, such as HIV or hepatitis B virus status, for subgroup analyses. Few studies reported genotypes of isolates, and data for genotypes 4, 5, and 6 were scant. Most studies were conducted in high-resource settings and reference laboratories.
Conclusion:
The HCVcAg assays with signal amplification have high sensitivity, high specificity, and good correlation with HCV RNA levels greater than 3000 IU/mL and have the potential to replace NAT in settings with high HCV prevalence.
Primary Funding Source:
National Institutes of Health.
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