Department of Bioengineering, University of California Berkeley, CA, USA.
Department of Radiology, Stanford University, CA, USA.
Biosens Bioelectron. 2019 Sep 15;141:111448. doi: 10.1016/j.bios.2019.111448. Epub 2019 Jun 18.
Over the last decade, nucleic acid amplification tests (NAATs) including polymerase chain reaction (PCR) were an indispensable methodology for diagnosing cancers, viral and bacterial infections owing to their high sensitivity and specificity. Because the NAATs can recognize and discriminate even a few copies of nucleic acid (NA) and species-specific NA sequences, NAATs have become the gold standard in a wide range of applications. However, limitations of NAAT approaches have recently become more apparent by reason of their lengthy run time, large reaction volume, and complex protocol. To meet the current demands of clinicians and biomedical researchers, new NAATs have developed to achieve ultrafast sample-to-answer protocols for the point-of-care testing (POCT). In this review, ultrafast NA-POCT platforms are discussed, outlining their NA amplification principles as well as delineating recent advances in ultrafast NAAT applications. The main focus is to provide an overview of NA-POCT platforms in regard to sample preparation of NA, NA amplification, NA detection process, interpretation of the analysis, and evaluation of the platform design. Increasing importance will be given to innovative, ultrafast amplification methods and tools which incorporate artificial intelligence (AI)-associated data analysis processes and mobile-healthcare networks. The future prospects of NA POCT platforms are promising as they allow absolute quantitation of NA in individuals which is essential to precision medicine.
在过去的十年中，由于核酸扩增测试（NAATs）包括聚合酶链反应（PCR）具有高灵敏度和特异性，因此成为诊断癌症、病毒和细菌感染的不可或缺的方法。由于 NAATs 可以识别和区分甚至少量的核酸（NA）和物种特异性 NA 序列，因此 NAATs 已成为广泛应用的金标准。然而，由于其运行时间长、反应体积大且方案复杂，最近 NAAT 方法的局限性变得更加明显。为了满足临床医生和生物医学研究人员的当前需求，已经开发出了新的 NAAT 来实现即时护理检测（POCT）的超快速样本到答案协议。在这篇综述中，讨论了超快速 NA-POCT 平台，概述了它们的 NA 扩增原理，并阐述了超快速 NAAT 应用的最新进展。重点是提供关于 NA-POCT 平台的概述，涉及 NA 的样品制备、NA 扩增、NA 检测过程、分析解释以及平台设计评估。将越来越重视将人工智能（AI）相关数据分析过程和移动医疗网络相结合的创新、超快速扩增方法和工具。NA POCT 平台的未来前景是有希望的，因为它们允许对个体中的 NA 进行绝对定量，这对精准医学至关重要。
