title: Novel assay using total hepatitis C virus (HCV) core antigen quantification for diagnosis of HCV infection in dialysis patients.
abstract: Dialysis patients remain a high-risk group for hepatitis C virus (HCV) infection. The current diagnosis of HCV infection among dialysis patients includes serological assays and nucleic acid amplification technology (NAT) for assessing serum anti-HCV antibody and HCV viremia, respectively. However, current NAT techniques are expensive and labor-intensive and often lack standardization. An assay prototype designed to detect and quantify total HCV core antigen (total HCV core Ag) protein in serum and plasma in the presence or absence of anti-HCV antibodies has been recently developed. A comparison between a total anti-HCV core Ag enzyme-linked immunosorbent assay (ELISA) and a quantitative HCV RNA assay based on reverse transcription-PCR (RT-PCR) (Amplicor HCV Monitor test) was performed using a large (n = 305) cohort of ELISA HCV 3.0 HCV-negative and -positive patients on maintenance dialysis. The concentrations of HCV core Ag and HCV RNA levels (measured by RT-PCR) were significantly correlated (r = 0.471, P = 0.0001) over a wide range of HCV RNA levels and were maintained among different HCV genotypes (HCV genotype 1, r = 0.862, P = 0.0001; HCV genotype 2, r = 0.691, P = 0.0001). We estimated that 1 pg of total HCV core Ag per ml is equivalent to approximately 19.952 IU of HCV RNA per ml, even if the wide range in the ratio of core Ag to HCV RNA (95% confidence intervals, 2.8 x 10(3) to 1.6 x 10(5) IU/ml) precluded definitive conclusions. In summary, total HCV core Ag proved to be useful for performing HCV RNA measurement among dialysis patients in routine laboratories without the need for special equipment or training. The present study supports the use of the total anti-HCV core Ag ELISA for assessing viral load among dialysis patients with HCV infection.
authors.affiliation: Division of Nephrology, Maggiore Hospital, IRCCS, via Commenda 15, 20122 Milan, Italy. fabrizi@policlinico.mi.it
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Fabrizi
authors.forename: Giovanna
authors.initials: G
authors.lastname: Lunghi
authors.forename: Filippo
authors.initials: F
authors.lastname: Aucella
authors.forename: Stefano
authors.initials: S
authors.lastname: Mangano
authors.forename: Francesco
authors.initials: F
authors.lastname: Barbisoni
authors.forename: Sergio
authors.initials: S
authors.lastname: Bisegna
authors.forename: Domenico
authors.initials: D
authors.lastname: Vigilante
authors.forename: Aurelio
authors.initials: A
authors.lastname: Limido
authors.forename: Paul
authors.initials: P
authors.lastname: Martin
mesh_terms: D000368:Aged; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D016174:Hepacivirus / Q000302:isolation & purification*; D006526:Hepatitis C / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D006435:Renal Dialysis / Q000009:adverse effects*; D020133:Reverse Transcriptase Polymerase Chain Reaction; D014758:Viral Core Proteins / Q000097:blood*; D019562:Viral Load; D014766:Viremia / Q000175:diagnosis / Q000821:virology
chemical_list: D012367:RNA, Viral; D014758:Viral Core Proteins; C069130:nucleocapsid protein, Hepatitis C virus