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Evaluation of a total hepatitis C virus (HCV) core antigen assay for the detection of antigenaemia in anti-HCV positive individuals

✍ Scribed by Pierpaolo Valcavi; Maria Cristina Medici; Francesca Casula; Maria Cristina Arcangeletti; Flora De Conto; Federica Pinardi; Adriana Calderaro; Carlo Chezzi; Giuseppe Dettori

Publisher
John Wiley and Sons
Year
2004
Tongue
English
Weight
211 KB
Volume
73
Category
Article
ISSN
0146-6615

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✦ Synopsis

Abstract

A new, sensitive enzyme immunoassay has been developed for detecting and quantifying total hepatitis C virus (HCV) core antigen in anti‐HCV positive or negative sera (“trak‐C™”, Ortho Clinical Diagnostics, Raritan, NJ). The purpose of this study was to evaluate the performance of trak‐C as an additional laboratory diagnostic marker of viraemia. The performance was compared to HCV‐RNA detection in the “screening” of sera from a large heterogeneous population of hospitalised patients and outpatients. Six hundred and eighteen anti‐HCV negative sera, 405 anti‐HCV positive/HCV‐RNA negative sera, 604 anti‐HCV positive/HCV‐RNA positive sera and 67 anti‐HCV negative sera containing antigens or antibodies potentially interfering with the performance of the assay were analysed. Supplemental HCV antibody testing was performed using a commercial strip immunoblot assay. HCV‐RNA was investigated using a qualitative commercial assay. A quantitative commercial RT‐PCR was used for the analysis of selected samples. Sensitivity and specificity values were 94.7 and 100%, respectively. The latter was also confirmed when anti‐HCV negative samples containing potentially interfering antigens/antibodies were examined. Sensitivity below 100% was probably due to an antigenaemia below the detection limit of trak‐C. Besides, because 65.6% of HCV‐RNA positive/trak‐C negative samples presented specific antibodies against all four RIBA antigens, the hypothesis was raised that, in some cases, the dissociation step efficiency could be sub‐optimal. In conclusion, trak‐C seems suitable for identifying HCV infection on large based populations. It is a rapid to perform, reliable and specific assay that can be adapted to any laboratory setting. J. Med. Virol. 73:397–403, 2004. © 2004 Wiley‐Liss, Inc.

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