Zhang Jane Y, Bender Andrew T, Boyle David S, Drain Paul K, Posner Jonathan D
Department of Mechanical Engineering, University of Washington, USA.
Analyst. 2021 Apr 21;146(8):2449-2462. doi: 10.1039/d0an01988g. Epub 2021 Apr 7.
The COVID-19 pandemic has put the spotlight on the urgent need for integrated nucleic acid tests (NATs) for infectious diseases, especially those that can be used near patient ("point-of-care", POC), with rapid results and low cost, but without sacrificing sensitivity or specificity of gold standard PCR tests. In the US, the Clinical Laboratory Improvement Amendments Certificate of Waiver (CLIA-waiver) is mandated by the Food and Drug Administration (FDA) and designated to any laboratory testing with high simplicity and low risk for error, suitable for application in the POC. Since the first issuance of CLIA-waiver to Abbot's ID NOW Influenza A&B in 2015, many more NAT systems have been developed, received the CLIA-waiver in the US or World Health Organization (WHO)'s pre-qualification, and deployed to the front line of infectious disease detection. This review highlights the regulatory process for FDA and WHO in evaluating these NATs and the technology innovation of existing CLIA-waived systems. Understanding the technical advancement and challenges, unmet needs, and the trends of commercialization facilitated through the regulatory processes will help pave the foundation for future development and technology transfer from research to the market place.
新冠疫情凸显了对传染病综合核酸检测（NAT）的迫切需求，尤其是那些可在患者附近使用（“即时检测”，POC）、结果快速且成本低廉，但又不牺牲金标准PCR检测灵敏度或特异性的检测方法。在美国，临床实验室改进修正案豁免证书（CLIA豁免）由美国食品药品监督管理局（FDA）授权，适用于任何操作高度简单且出错风险低的实验室检测，适用于即时检测应用。自2015年首个CLIA豁免授予雅培的ID NOW甲型和乙型流感检测以来，又开发了更多的NAT系统，在美国获得CLIA豁免或获得世界卫生组织（WHO）的预认证，并部署到传染病检测一线。本综述重点介绍了FDA和WHO评估这些NAT的监管流程以及现有CLIA豁免系统的技术创新。了解技术进步与挑战、未满足的需求以及通过监管流程推动的商业化趋势，将有助于为未来发展以及从研究到市场的技术转移奠定基础。
