Comanor Lorraine, Hendricks David
Clinical Research Counsultant, Palo Alto, CA 94301, USA.
Expert Rev Mol Diagn. 2003 Nov;3(6):689-702. doi: 10.1586/14737159.3.6.689.
The diagnostic market is driven by the burden of disease in the population and the ease or difficulty of disease diagnosis. The efficacy of available therapeutics determines the need for monitoring. Hepatitis C virus currently affects approximately 3% of the world's population, although the overall response rate to the best available therapies is 56%. Research regarding hepatitis C virus remains elusive due to lack of an efficient cell culture system. Diagnosis and monitoring of active hepatitis C virus infection therefore rely on sophisticated molecular tests. This review will focus on current molecular tests for hepatitis C virus RNA and the performance attributes that these tests require for accurate diagnosis and monitoring of infection.
诊断市场受到人群中疾病负担以及疾病诊断的难易程度的驱动。现有治疗方法的疗效决定了监测的必要性。丙型肝炎病毒目前影响着全球约3%的人口，尽管对现有最佳治疗方法的总体应答率为56%。由于缺乏有效的细胞培养系统，关于丙型肝炎病毒的研究仍然难以捉摸。因此，丙型肝炎病毒感染的诊断和监测依赖于复杂的分子检测。本综述将聚焦于目前用于检测丙型肝炎病毒RNA的分子检测方法，以及这些检测方法为准确诊断和监测感染所需的性能特征。
