Division of Gastrointestinal and Liver Diseases, University of Southern California, Los Angeles.
J Infect Dis. 2024 May 8;229(Supplement_3):S322-S327. doi: 10.1093/infdis/jiad299.
In November 2021, the United States Food and Drug Administration reclassified 2 types of hepatitis C virus (HCV) diagnostic tests (HCV antibody and HCV nucleic acid) from class III to class II, providing a less burdensome pathway to market for diagnostic companies. This down-classification is anticipated to facilitate innovation in HCV diagnostics, particularly for new point-of-care viral detection assays, and ultimately support HCV elimination efforts by increasing the ease of screening as well as test-and-treat models of HCV care.
2021 年 11 月，美国食品和药物管理局将 2 种丙型肝炎病毒 (HCV) 诊断检测（HCV 抗体和 HCV 核酸）从 III 类降为 II 类，为诊断公司提供了一条负担较小的进入市场的途径。这种降级预计将促进 HCV 诊断的创新，特别是对于新的即时病毒检测检测，最终通过提高 HCV 筛查的便利性以及 HCV 护理的检测和治疗模式来支持 HCV 的消除工作。
