Performance and clinical utility of a novel fully automated quantitative HCV-core antigen assay

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• 作者：Ingmar Mederacke ; Heiner Wedemeyer ; S ; ra Ciesek ; Eike Steinmann ; Regina Raupach ; Karsten Wursthorn ; Michael P. Manns ; Hans Ludger Tillmann
• 刊名：Journal of Clinical Virology
• 出版年：2009
• 出版时间：November 2009
• 年：2009
• 卷：46
• 期：3
• 页码：210-215
• 全文大小：921 K

文摘

Background

Recently, a novel quantitative HCVcoreAg immunoassay developed for commercialisation by Abbott has become available in Europe and Asia.

Objectives

We evaluated the correlation of HCV-RNA and HCVcoreAg and investigated the stability of HCVcoreAg and HCV-RNA.

Study design

HCVcoreAg was quantified by a novel fully automated immunoassay (Architect HCVAg, Abbott, Germany). HCV-RNA quantification was performed either using the Cobas-TaqMan assay or Amplicor-HCV-Monitor (Roche-Diagnostics, Germany). Correlation of HCVcoreAg with HCV-RNA was studied cross-sectionally and longitudinally in untreated patients followed for up to 8 years. Stability of HCVcoreAg and HCV-RNA was evaluated in plasma and whole blood stored for up to 96 h at different conditions.

Results

HCVcoreAg showed good correlation with HCV-RNA in all 118 cross-sectional tested samples irrespective of the HCV genotype (r = 0.75). In the majority but not all of the 10 longitudinally studied patients HCVcoreAg also demonstrated a good correlation with HCV-RNA. HCVcoreAg was stable in plasma at 4, 20, and 37 °C for up to 96 h, whereas HCV-RNA significantly declined at 37 °C. In whole blood, HCVcoreAg and HCV-RNA levels declined at all conditions with exception of HCVcoreAg at 37 °C. HCVcoreAg was stable after 1–5 freezing/thawing cycles and not light-sensitive.

Conclusions

HCVcoreAg represents a stable and reliable marker of viral replication showing a good correlation with HCV-RNA irrespective of the HCV genotype. HCVcoreAg determination can be used to confirm viral replication and monitor viral load or acquisition of HCV over time.