ARCHITECT HCV Ag 检测在慢性丙型肝炎病毒 1 型感染患者早期治疗监测中的临床应用。
Clinical utility of the ARCHITECT HCV Ag assay for early treatment monitoring in patients with chronic hepatitis C genotype 1 infection.
机构信息
Medizinische Klinik 1, Klinikum der JW Goethe-Universität, Frankfurt am Main, Germany.
出版信息
J Clin Virol. 2012 Sep;55(1):17-22. doi: 10.1016/j.jcv.2012.05.008. Epub 2012 Jun 13.
BACKGROUND
Virologic response-monitoring is essential for determining therapy duration in patients with chronic hepatitis C virus (HCV) infection. This is usually performed using highly sensitive HCV-RNA assays. However, HCV-RNA assays are time-consuming, expensive and require highly trained personnel. Quantitative determination of HCV core-antigen (HCVAg) levels may be used to supplement treatment monitoring.
OBJECTIVES
The clinical utility of the ARCHITECT HCV Ag assay (Abbott Diagnostics) for response-guided therapy was investigated.
STUDY DESIGN
We analyzed serum from 160 patients with HCV genotype 1 infection who had been treated with peg-interferon alfa-2b/ribavirin. HCVAg levels were determined at baseline, weeks 1, 2, 4 and 12. HCVAg levels were compared to those obtained with HCV-RNA assays: VERSANT HCV Quantitative 3.0 (bDNA) and Qualitative (TMA, both Siemens Healthcare) assay and the Abbott RealTime HCV assay (ART; Abbott Diagnostics).
RESULTS
Baseline HCVAg levels correlated well with HCV-RNA as assessed by bDNA (r=0.91; p<0.0001) and ART (r=0.92; p<0.0001), respectively. Patients with undetectable HCVAg levels at week 1 had a 90.9% probability (positive predictive value) to achieve a rapid virologic response (HCV-RNA undetectable at week 4) based on TMA and 86.4% based on ART, respectively. Patients with less than 1 log(10) reduction in HCVAg between baseline and week 12 had a 90% probability (negative predictive value) to achieve a nonresponse (<2 log(10) decline in HCV-RNA between baseline and week 12) based on bDNA and 100% based on ART, respectively.
CONCLUSIONS
Determination of HCVAg may be useful for antiviral response-monitoring in patients with HCV genotype 1 infection.
背景
病毒学反应监测对于确定慢性丙型肝炎病毒（HCV）感染患者的治疗持续时间至关重要。这通常使用高度敏感的 HCV-RNA 检测来完成。然而，HCV-RNA 检测既耗时、昂贵，又需要高度训练有素的人员。定量测定 HCV 核心抗原（HCVAg）水平可用于补充治疗监测。
目的
研究 Abbott Diagnostics 的 ARCHITECT HCV Ag 检测（ARCHITECT HCV Ag 检测）在基于应答的治疗中的临床应用。
研究设计
我们分析了 160 例 HCV 基因型 1 感染患者的血清，这些患者接受了聚乙二醇干扰素 alfa-2b/利巴韦林治疗。在基线、第 1、2、4 和 12 周时测定 HCVAg 水平。将 HCVAg 水平与 HCV-RNA 检测结果进行比较：VERSANT HCV Quantitative 3.0（bDNA）和定性（TMA，均来自 Siemens Healthcare）检测以及 Abbott RealTime HCV 检测（ART；Abbott Diagnostics）。
结果
基线 HCVAg 水平与 bDNA（r=0.91；p<0.0001）和 ART（r=0.92；p<0.0001）评估的 HCV-RNA 相关性良好。第 1 周 HCVAg 水平不可检测的患者基于 TMA 的快速病毒学应答（第 4 周 HCV-RNA 不可检测）的概率为 90.9%（阳性预测值），基于 ART 的概率为 86.4%。第 12 周时 HCVAg 水平较基线降低<1log10 的患者基于 bDNA 的无应答（第 12 周时 HCV-RNA 较基线降低<2log10）的概率为 90%（阴性预测值），基于 ART 的概率为 100%。
结论
在 HCV 基因型 1 感染患者中，测定 HCVAg 可能有助于抗病毒反应监测。
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