Comparison of a Newly Developed Automated and Quantitative Hepatitis C Virus (HCV) Core Antigen Test with the HCV RNA Assay for Clinical Usefulness in Confirming Anti-HCV Results

Hepatitis C virus infection is a constant worldwide public health concern. The prevalence of HCV infection is higher in patients on chronic haemodialysis (HD) than in the general population. Despite the control of blood products, hepatitis C virus transmission is still being observed among patients undergoing dialysis. Detection systems for serum HCV antibodies are insensitive in the acute phase because of the long serological window. Direct detection of HCV depends on PCR test but this test is not suitable for routine screening. The objective of this study was to determine prevalence of HCV, genotyping and if HCV core antigen test could be a better alternative to NAT techniques for the diagnosis of HCV infection during the window period and whether the sensitivity for antibody detection is preserved. We screened 159 patients on long-term dialysis by HVC antibodies test, PCR HCV-RNA and HCV core antigen test by commercial tests. The prevalence of HCV was 10.7% (17 patients) and genotype 4 was the most common one (64.7%). The sensitivity of HCV core antigen test was 94.1%, the specificity 100%, the positive predictive power 100%, and the negative predictive power 97.9%. In conclusions; patients on maintenance HD in Yemen have a high prevalence of HCV infection comparing with general population; and genotype 4 is predominant. The performance of serological detection of HCV core antigen was better than that of HCV antibodies test and may be an alternative to nucleic acid amplification technology (NAT) for routine monitoring of patients on chronic dialysis.

Download Full-text

Hepatitis C Virus Core Antigen Test in Monitoring of Dialysis Patients

Hepatitis Research and Treatment ◽

10.1155/2012/832021 ◽

2012 ◽

Vol 2012 ◽

pp. 1-4 ◽

Cited By ~ 5

Author(s):

Gioacchino Li Cavoli ◽

Carmela Zagarrigo ◽

Onofrio Schillaci ◽

Francesca Servillo ◽

Angelo Tralongo ◽

...

Keyword(s):

Hepatitis C Virus ◽

Hepatitis C ◽

Predictive Power ◽

Hcv Infection ◽

Health Concern ◽

Core Antigen ◽

Antigen Test ◽

Dialysis Patients ◽

Hcv Core Antigen ◽

Routine Monitoring

Hepatitis C virus infection is a persistent worldwide public health concern. The prevalence of HCV infection is much higher in patients on chronic haemodialysis (HD) than in the general population. HCV infection can detrimentally affect patients throughout the spectrum of chronic kidney disease. Despite the control of blood products, hepatitis C virus transmission is still being observed among patients undergoing dialysis. Detection systems for serum HCV antibodies are insensitive in the acute phase because of the long serological window. Direct detection of HCV depends on PCR test but this test is not suitable for routine screening. Recent studies have highlighted the importance of HCV core antigen detection as an alternative to PCR. Few studies exist about the efficacy of HCV core antigen test in dialysis population. We studied the utility of HCV core antigen test in routine monitoring of virological status of dialysis patients. We screened 92 patients on long-term dialysis both by PCR HCV-RNA and HCV core antigen test. The sensitivity of HCVcAg test was 90%, the specificity 100%, the positive predictive power 100%, the negative predictive power 97%, and the accuracy 97%. We think serological detection of HCV core antigen may be an alternative to NAT techniques for routine monitoring of patients on chronic dialysis.

Download Full-text

Evaluation of a new enzyme immunoassay for hepatitis C virus(HCV) core antigen with clinical sensitivity approximating that of genomic amplification of HCV RNA

Hepatology ◽

10.1053/jhep.2000.9112 ◽

2000 ◽

Vol 32 (2) ◽

pp. 388-393 ◽

Cited By ~ 78

Author(s):

Eiji Tanaka ◽

Chiharu Ohue ◽

Katsumi Aoyagi ◽

Kenjiro Yamaguchi ◽

Shintaro Yagi ◽

...

Keyword(s):

Hepatitis C Virus ◽

Hepatitis C ◽

Enzyme Immunoassay ◽

Core Antigen ◽

Hcv Rna ◽

Genomic Amplification ◽

Clinical Sensitivity ◽

Hcv Core Antigen

Download Full-text

Hepatitis C Virus Core Mutations Reduce the Sensitivity of a Fluorescence Enzyme Immunoassay

Journal of Clinical Microbiology ◽

10.1128/jcm.38.9.3450-3452.2000 ◽

2000 ◽

Vol 38 (9) ◽

pp. 3450-3452 ◽

Cited By ~ 12

Author(s):

Hajime Tokita ◽

Gilbert R. Kaufmann ◽

Mamoru Matsubayashi ◽

Isao Okuda ◽

Tsukasa Tanaka ◽

...

Keyword(s):

Hepatitis C Virus ◽

Hepatitis C ◽

Enzyme Immunoassay ◽

Core Region ◽

Core Antigen ◽

Nucleotide Sequencing ◽

Hcv Rna ◽

Virus Core ◽

Hcv Core Antigen ◽

Rna Levels

Four of 107 samples obtained from hepatitis C virus (HCV) carriers showed lower HCV core antigen levels in a fluorescence enzyme immunoassay (FEIA) than expected from corresponding HCV RNA levels. Nucleotide sequencing revealed a mutation in the HCV core region (Thr49Pro) that appears to have reduced the FEIA sensitivity.

Download Full-text

Can Hepatitis C Virus Antigen Testing Replace Ribonucleic Acid Polymearse Chain Reaction Analysis for Detecting Hepatitis C Virus? A Systematic Review

Open Forum Infectious Diseases ◽

10.1093/ofid/ofw252 ◽

2017 ◽

Vol 4 (2) ◽

Cited By ~ 8

Author(s):

Harun Khan ◽

Andrew Hill ◽

Janice Main ◽

Ashley Brown ◽

Graham Cooke

Keyword(s):

Hepatitis C Virus ◽

Hepatitis C ◽

Ribonucleic Acid ◽

Scale Up ◽

Virus Antigen ◽

Core Antigen ◽

Hcv Rna ◽

Antigen Test ◽

Chain Reaction ◽

Antigen Tests

Abstract The complexity and cost of current diagnostics for hepatitis C virus (HCV) may act as a prevention to the scale-up of treatment in the developing world. Currently, ribonucleic acid (RNA)-polymerase chain reaction tests are the gold standard. However, there is potential for the use of simpler and cheaper antigen tests to confirm HCV infection in different clinical settings. We evaluated the sensitivity and specificity of antigen assays. This was compared with the reference-standard RNA assays. A subanalysis also assessed Architect core antigen test, which is the only commercially available antigen test on the market. In 24 datasets, evaluating HCV-antigen assays in 8136 samples, the percentage of HCV-antigen positive, HCV-RNA negative was 0.57%. The percentage HCV-antigen negative, HCV-RNA positive was 3.52%. There is strong evidence that antigen detection performs as well as RNA-based assays for HCV management. The use of antigen tests could improve access to HCV care in underresourced healthcare settings.

Download Full-text