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Journal of Clinical Microbiology, September 2004, p. 4054-4059, Vol. 42, No. 9
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.9.4054-4059.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Evaluation of the Core Antigen Assay as a Second-Line Supplemental Test for Diagnosis of Active Hepatitis C Virus Infection

Mel Krajden,^1* Rishma Shivji,¹ Kingsley Gunadasa,¹ Annie Mak,¹ Gail McNabb,¹ Michel Friesenhahn,² David Hendricks,² and Lorraine Comanor³

British Columbia Center for Disease Control, Vancouver, British Columbia, Canada,¹ Bayer Healthcare LLC, Berkeley, California,² Independent Research Consultant, Palo Alto, California³

Received 24 February 2004/ Returned for modification 12 April 2004/ Accepted 9 May 2004

The British Columbia Center for Disease Control laboratory performs approximately 95% of all hepatitis C virus (HCV) antibody tests for the province's 4 million inhabitants. In 2002, the laboratory tested 96,000 specimens for anti-HCV antibodies, of which 4,800 (5%) were seroreactive and required confirmation of active infection. Although HCV RNA assays with a sensitivity of 50 IU/ml or less are recommended for the confirmation of active HCV infection, given the large number of seroreactive specimens tested annually, we evaluated the Ortho trak-C assay (OTCA) as a second-line confirmatory test and determined its limit of detection (LoD). Of 502 specimens from treatment-naïve anti-HCV-positive individuals, 478 had sufficient volumes for evaluation by the OTCA and HCV RNA tests. Core antigen was not detected in 147 of 478 (30.8%) of these specimens, of which 37 of 147 (25.2%) were shown to be viremic by the VERSANT HCV (version 3.0) (branched-DNA) assay and/or the VERSANT HCV qualitative assay. Testing of 144 replicates of a World Health Organization standard dilution series indicated that the LoD of OTCA was 27,000 IU/ml. This LoD is consistent with the inability of OTCA to detect core antigen in clinical specimens with low viral loads. We conclude that OTCA has limited value as a confirmatory test for the diagnosis of active HCV infection because 37 of 367 (10%) of viremic specimens had undetectable core antigen. Qualitative HCV RNA testing remains the present standard for the confirmation of active HCV infection in the diagnostic setting.

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* Corresponding author. Mailing address: British Columbia Center for Disease Control, 655 W. 12th Ave., Vancouver, BC V5Z4R4, Canada. Phone: (604) 660-6044. Fax: (604) 660-6073. E-mail: mel.krajden{at}bccdc.ca.

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Journal of Clinical Microbiology, September 2004, p. 4054-4059, Vol. 42, No. 9
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.9.4054-4059.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

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