Department of Pathology & Cell Biology, Columbia University College of Physicians and Surgeons, New York, New York, USA
Laboratory of Viral Diseases, Wadsworth Center, New York State Department of Health, Albany, New York, USA.
J Clin Microbiol. 2018 Sep 25;56(10). doi: 10.1128/JCM.00711-18. Print 2018 Oct.
Rapid antigen tests for influenza, here referred to as rapid influenza diagnostic tests (RIDTs), have been widely used for the diagnosis of influenza since their introduction in the 1990s due to their ease of use, rapid results, and suitability for point of care (POC) testing. However, issues related to the diagnostic sensitivity of these assays have been known for decades, and these issues gained greater attention following reports of their poor performance during the 2009 influenza A(H1N1) pandemic. In turn, significant concerns arose about the consequences of false-negative results, which could pose significant risks to both individual patient care and to public health efforts. In response to these concerns, the FDA convened an advisory panel in June 2013 to discuss options to improve the regulation of the performance of RIDTs. A proposed order was published on 22 May 2014, and the final order published on 12 January 2017, reclassifying RIDTs from class I to class II medical devices, with additional requirements to comply with four new special controls. This reclassification is a landmark achievement in the regulation of diagnostic devices for infectious diseases and has important consequences for the future of diagnostic influenza testing with commercial tests, warranting the prompt attention of clinical laboratories, health care systems, and health care providers.
快速抗原检测试剂（rapid influenza diagnostic tests，RIDTs），简称流感快速诊断检测试剂，自上世纪 90 年代问世以来，由于其使用方便、检测结果快速、适合现场检测（point of care，POC）等特点，已被广泛应用于流感的诊断。然而，这些检测方法的诊断灵敏度问题已存在数十年之久，在 2009 年甲型 H1N1 流感大流行期间，这些检测方法的性能不佳的报道引起了人们对其性能的广泛关注。因此，人们对假阴性结果的后果产生了重大担忧，这可能会对个体患者护理和公共卫生工作带来重大风险。为了应对这些担忧，FDA 于 2013 年 6 月召集了一个顾问小组，讨论改进 RIDTs 性能监管的选择方案。2014 年 5 月 22 日发布了一份拟议命令，2017 年 1 月 12 日发布了最终命令，将 RIDTs 从 I 类医疗器械重新分类为 II 类医疗器械，并增加了遵守四个新特殊控制的要求。这一重新分类是传染病诊断设备监管的一个里程碑式成就，对未来商业检测的流感诊断检测具有重要影响，值得临床实验室、医疗保健系统和医疗保健提供者的及时关注。
