title: Utility of a commercial quantitative hepatitis C virus core antigen assay in a diagnostic laboratory setting.
abstract: In this study, the utility and impact of hepatitis C virus (HCV) core antigen (Cag) detection via a commercial assay have been evaluated in diagnostic laboratory conditions. In a total of 272 samples from 226 individuals, HCV RNA was detected in 81.3% and anti-HCV antibody prevalence was 86.4%. HCV Cag reactivity was identified in 59.9% of the samples and in 75.8% with detectable RNA. The sensitivity and specificity of HCV Cag assay have been calculated as 75.8% and 95.1%, respectively, and agreement between HCV RNA and HCV Cag was moderate (κ = 0.554). HCV Cag and RNA levels were highly correlated (r = 0.915 and 0.937). A viral load threshold of 10(3) IU/mL has been recognized, above which the correlation with RNA became statistically significant and sensitivity increased to 90.9%. Detection and quantification of HCV core antigen have been observed as a strong alternative to nucleic acid testing for HCV monitorization.
authors.affiliation: Department of Medical Microbiology, Faculty of Medicine, Hacettepe University, Ankara, Turkey. ekoray@hacettepe.edu.tr
authors.forename: Koray
authors.initials: K
authors.lastname: Ergünay
authors.forename: Burçin
authors.initials: B
authors.lastname: Sener
authors.forename: Alpaslan
authors.initials: A
authors.lastname: Alp
authors.forename: Jale
authors.initials: J
authors.lastname: Karakaya
authors.forename: Gülşen
authors.initials: G
authors.lastname: Hasçelik
mesh_terms: D000293:Adolescent; D000328:Adult; D000956:Antigens, Viral / Q000097:blood*; D002648:Child; D002675:Child, Preschool; D019411:Clinical Laboratory Techniques / Q000379:methods*; D006526:Hepatitis C / Q000175:diagnosis*; D018937:Hepatitis C Antibodies / Q000097:blood; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D012367:RNA, Viral / Q000097:blood; D012680:Sensitivity and Specificity; D014758:Viral Core Proteins / Q000097:blood*; D019562:Viral Load
chemical_list: D000956:Antigens, Viral; D018937:Hepatitis C Antibodies; D012367:RNA, Viral; D014758:Viral Core Proteins; C069130:nucleocapsid protein, Hepatitis C virus