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Published on: July 9, 2014
[Clinical significance and problems in HCV measurement--comparison of CLEIA method with PCR method]
Hirotoshi Ohta1, Masao Takemura, Nobuyuki Furuta
1Department of Informative Clinical Medicine, Gifu University Graduate school of Medicine, Gifu 501-1194.
Insights
Detecting hepatitis C virus (HCV) core antigen is a useful, time-saving method for diagnosing HCV infection. However, clinicians must be aware of potential false-negative results, especially during interferon treatment.
Area of Science:
- Hepatology
- Virology
- Clinical Diagnostics
Background:
- Hepatitis C virus (HCV) infection diagnosis relies on detecting HCV antibodies or HCV-RNA.
- Recent advancements have introduced highly sensitive HCV core antigen detection methods.
Purpose of the Study:
- To evaluate the clinical significance of HCV core antigen determination.
- To compare HCV core antigen levels with established HCV infection markers.
Main Methods:
- Serum samples (n=225) were analyzed for HCV core antigen, HCV-RNA (AMPLICOR), and HCV antibody (third generation).
- Three patients undergoing interferon treatment were also monitored for these markers.
Main Results:
- A significant correlation (r=0.734, p<0.0001) was found between HCV-RNA and HCV core antigen levels in 102 HCV-RNA positive samples.
- A small percentage (2.9%) of cases showed HCV core antigen within the negative range despite being HCV-RNA positive.
- HCV core antigen levels in patients on interferon treatment paralleled HCV-RNA levels.
Conclusions:
- HCV core antigen determination using CLEIA is a valuable and efficient diagnostic tool.
- Attention is required for potential false-negative results in HCV core antigen testing.
- Monitoring HCV core antigen alongside HCV-RNA is beneficial, particularly during antiviral therapy.
Abstract:
Infection of a hepatitis C virus (HCV) is confirmed by the presence of HCV antibody or HCV-RNA. Recently, a highly sensitive method to examine HCV-core antigen has been developed. In this study, to evaluate the clinical significance of HCV-core antigen determination, we examined serum HCV infection markers, HCV-core antigen, HCV-RNA (AMPLICOR) and HCV-antibody (third generation) concentrations. We determined 225 serum samples, and three patients receiving the treatment with interferon. In 102 HCV-RNA positive samples, significant correlation was observed between HCV-RNA and HCV-core antigen (r=0.734, p<0.0001). However, three out of 102 (2.9%) cases were included within the negative range of HCV-core antigen (20 fmol/l). The HCV-core antigen value in three patients receiving the treatment with interferon paralleled with the amount of HCV-RNA. The determination of HCV-core antigen by CLEIA is a useful and time-saving method, but an attention should be paid to the presence of false-negative cases.

