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Journal of Clinical Microbiology, January 2005, p. 414-420, Vol. 43, No. 1
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.1.414-420.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Novel Assay Using Total Hepatitis C Virus (HCV) Core Antigen quantification for Diagnosis of HCV Infection in Dialysis Patients

Fabrizio Fabrizi,^1* Giovanna Lunghi,² Filippo Aucella,³ Stefano Mangano,⁴ Francesco Barbisoni,⁵ Sergio Bisegna,⁶ Domenico Vigilante,⁷ Aurelio Limido,⁸ and Paul Martin⁹

Division of Nephrology and Dialysis,¹ Hygiene Institute, Maggiore Hospital, IRCCS, Milan,² Nephrology Unit, San Giovanni Rotondo Hospital, San Giovanni Rotondo,³ Nephrology Unit, Como Hospital, Como,⁴ Nephrology Unit, Lodi Hospital, Lodi,⁵ Nephrology Unit, Melegnano Hospital, Melegnano,⁶ Nephrology Unit, Vasto Hospital, Vasto,⁷ Nephrology Unit, Gallarate Hospital, Gallarate, Italy,⁸ The Center for Liver and Kidney Diseases and Transplantation, Cedars-Sinai Medical Center and UCLA School of Medicine, Los Angeles, California⁹

Received 12 July 2004/ Returned for modification 23 August 2004/ Accepted 2 September 2004

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 10³ to 1.6 x 10⁵ 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.

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* Corresponding author. Mailing address: Divisione Nefrologia e Dialisi, Pad. Croff, Ospedale Maggiore, IRCCS, via Commenda 15, 20122 Milano, Italy. Phone: (2) 55034552. Fax: (2) 55034550. E-mail: fabrizi{at}policlinico.mi.it.

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Journal of Clinical Microbiology, January 2005, p. 414-420, Vol. 43, No. 1
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.1.414-420.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.