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Updated: Apr 22, 2026

A Protocol for Analyzing Hepatitis C Virus Replication
Published on: June 26, 2014
[Hepatitis C diagnostics: clinical evaluation of the HCV-core antigen determination]
1MVZ Dr. Stein und Kollegen, Mönchengladbach.
Insights
Hepatitis C virus (HCV) core antigen testing shows high correlation with HCV RNA levels, offering a sensitive and specific method for diagnosing and monitoring HCV infections, including acute and chronic cases.
Area of Science:
- Virology
- Immunology
- Diagnostic Medicine
Background:
- Hepatitis C virus (HCV) diagnostics traditionally rely on antibody detection, with HCV RNA PCR used for monitoring treatment and viral activity.
- The clinical utility of HCV-core antigen testing in routine diagnostics requires further investigation.
Purpose of the Study:
- To evaluate the relevance and effectiveness of HCV-core antigen testing in the daily diagnosis and monitoring of HCV infections.
- To compare HCV-core antigen assay performance with established methods like HCV RNA PCR and antibody testing.
Main Methods:
- Analysis of routine HCV-core antigen test requests from a private laboratory over a two-year period.
- Correlation analysis between HCV-core antigen levels and quantitative HCV RNA measurements.
- Assessment of diagnostic window, sensitivity, and specificity of the HCV-core antigen assay.
Main Results:
- HCV-core antigen determination showed a strong correlation with quantitative HCV RNA (r=0.73, p=0.0003).
- The diagnostic window for HCV-core antigen was comparable to HCV RNA PCR (27.1±12.8 days vs. 23.9±9.2 days, p=0.11).
- The assay demonstrated high sensitivity (99.0%) and specificity (99.2%), with 54.3% of antibody-positive samples also testing antigen-positive.
Conclusions:
- HCV-core antigen assay is a valuable tool for detecting chronic active HCV infections.
- It aids in the early diagnosis of acute HCV infections and testing in immunocompromised patients.
- The HCV-core antigen assay serves as a valuable complement to existing serological testing for HCV.
Background:
The aim of the evaluation was to investigate the relevance of the HCV-core antigen testing for the diagnosis and monitoring of HCV infections in the daily routine. Up to now, most of the serological diagnostics was performed as determination of antibodies while the determination of activity and the monitoring of antiviral therapy were checked by HCV RNA PCR.
Methods:
The routine requests for HCV-core antigen of a private laboratory were analyzed for a period of two years.
Results:
The determination of HCV antigen highly correlates with the quantitative measurement of HCV RNA (r = 0.73), p = 0.0003). The diagnostic window is comparable with that of the HCV PCR (27.1 ± 12.8 d vs. 23.9 ± 9.2 d, p = 0.11). The sensitivity of the HCV antigen assay was 99.0 % with a specificity of 99.2 %. 54.3 % of the confirmed antibody positive samples were also antigen positive. Only in 3 of 560 HCV-RNA positive samples HCV antigen was not detectable, but 3 samples without HCV antibodies were confirmed positive for HCV antigen.
Conclusions:
The HCV antigen assay is a suitable tool for the detection of chronic active HCV infections, for the early diagnosis of acute infections and for testing of HCV in patient with immunodeficiency. The HCV antigen assay valuable completion of serological testing for HCV.
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