商业定量丙型肝炎病毒核心抗原检测在诊断实验室中的应用。

Utility of a commercial quantitative hepatitis C virus core antigen assay in a diagnostic laboratory setting.

机构信息

Department of Medical Microbiology, Faculty of Medicine, Hacettepe University, Ankara, Turkey.

出版信息

Diagn Microbiol Infect Dis. 2011 Aug;70(4):486-91. doi: 10.1016/j.diagmicrobio.2011.04.011.

DOI:10.1016/j.diagmicrobio.2011.04.011

Abstract

In this study, the utility and impact of hepatitis C virus (HCV) core antigen (Cag) detection via a commercial assay have been evaluated in diagnostic laboratory conditions. In a total of 272 samples from 226 individuals, HCV RNA was detected in 81.3% and anti-HCV antibody prevalence was 86.4%. HCV Cag reactivity was identified in 59.9% of the samples and in 75.8% with detectable RNA. The sensitivity and specificity of HCV Cag assay have been calculated as 75.8% and 95.1%, respectively, and agreement between HCV RNA and HCV Cag was moderate (κ = 0.554). HCV Cag and RNA levels were highly correlated (r = 0.915 and 0.937). A viral load threshold of 10(3) IU/mL has been recognized, above which the correlation with RNA became statistically significant and sensitivity increased to 90.9%. Detection and quantification of HCV core antigen have been observed as a strong alternative to nucleic acid testing for HCV monitorization.

摘要

在这项研究中，评估了在诊断实验室条件下通过商业检测检测丙型肝炎病毒 (HCV) 核心抗原 (Cag) 的效用和影响。在来自 226 个人的总共 272 个样本中，81.3% 的样本中检测到 HCV RNA，抗 HCV 抗体的流行率为 86.4%。在 59.9%的样本和 75.8%的可检测 RNA 样本中发现了 HCV Cag 反应性。HCV Cag 检测的敏感性和特异性分别计算为 75.8%和 95.1%，HCV RNA 和 HCV Cag 之间的一致性为中度 (κ=0.554)。HCV Cag 和 RNA 水平高度相关 (r=0.915 和 0.937)。已经认识到 10(3) IU/mL 的病毒载量阈值，超过该阈值，与 RNA 的相关性变得具有统计学意义，敏感性增加到 90.9%。HCV 核心抗原的检测和定量已被观察到是 HCV 监测替代核酸检测的有力方法。