Original Article

Korean J Lab Med 2010; 30(6): 654-659

Published online December 1, 2010

Copyright © Korean Society for Laboratory Medicine.

Evaluation of ARCHITECT HCV Core Antigen Assay

Dual Song, M.D.1, Jeong Eun Kang, M.D.1, Shine Young Kim, M.D.1, Sang-Hyun Hwang, M.D.1, Hyung Hoi Kim, M.D.1,2, Eun Yup Lee, M.D.1, and Han Chul Son, M.D.1

Department of Laboratory Medicine1, Pusan National University School of Medicine; Medical Research Institute2, Pusan National University Hospital, Busan, Korea

Correspondence to: Hyung Hoi Kim, M.D.
Department of Laboratory Medicine, Pusan National University School of Medicine, 305 Gudeok-ro, Seo-gu, Busan 602-739, Korea
Tel : +82-51-240-7403, Fax : +82-51-247-6560
E-mail :

Received: March 8, 2010; Revised: July 23, 2010; Accepted: September 19, 2010

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.


Background: Hepatitis C virus (HCV) core antigen (Ag) levels are known to be well correlating with HCV RNA levels, and may be used as an alternative marker of HCV replication for monitoring the response to HCV treatment. However, the low sensitivity of HCV core Ag assay has been an obstacle for clinical use. In this study, recently developed ARCHITECT HCV Ag assay (Abbott Laboratories, USA) was evaluated for analytical performance and clinical usefulness.
Methods: A total of 109 sera from HCV infected patients including various genotypes of HCV (1b, 2, 2a/2c, 2b, and 3a) and 20 sera from healthy donors were used for evaluating the sensitivity, precision, and linearity of the HCV core Ag assay. The cross reactivity with HIV, hepatitis B virus and myeloma proteins (N=5, each) and correlation with HCV RNA PCR assay were also evaluated.
Results: The sensitivity of the HCV core Ag assay was 97.2% (106/109) and there were no false positive results and cross reactivity. The within-run, between-run and between-day CVs were 3.0%, 2.5% and 3.0%, respectively. The levels of HCV core antigen showed a good correlation with those of HCV RNA quantification (r=0.940). The HCV Ag assay showed an excellent linearity in the range from 0.63 to 17,114 fmol/L (r=0.999).
Conclusions: The ARCHITECT HCV Ag assay was good in sensitivity, precision, and linearity and its results well correlated with HCV RNA levels. This assay could be used as a good marker of viral replication for monitoring the therapy response in chronically HCV infected patients.

Keywords: HCV core antigen, Hepatitis C virus, RNA, PCR