Sun Antao, Vopařilová Petra, Liu Xiaocheng, Kou Bingqian, Řezníček Tomáš, Lednický Tomáš, Ni Sheng, Kudr Jiří, Zítka Ondřej, Fohlerová Zdenka, Pajer Petr, Zhang Haoqing, Neužil Pavel
Ministry of Education Key Laboratory of Micro and Nano Systems for Aerospace; School of Mechanical Engineering, Northwestern Polytechnical University, 127 West Youyi Road, Xi'an, Shaanxi 710072 P. R. China.
Department of Chemistry and Biochemistry, Mendel University in Brno, Zemědělská 1, 61300 Brno, Czech Republic.
Microsyst Nanoeng. 2024 May 23;10:66. doi: 10.1038/s41378-024-00677-6. eCollection 2024.
This study presents a rapid and versatile low-cost sample-to-answer system for SARS-CoV-2 diagnostics. The system integrates the extraction and purification of nucleic acids, followed by amplification via either reverse transcription-quantitative polymerase chain reaction (RT-qPCR) or reverse transcription loop-mediated isothermal amplification (RT-LAMP). By meeting diverse diagnostic and reagent needs, the platform yields testing results that closely align with those of commercial RT-LAMP and RT‒qPCR systems. Notable advantages of our system include its speed and cost-effectiveness. The assay is completed within 28 min, including sample loading (5 min), ribonucleic acid (RNA) extraction (3 min), and RT-LAMP (20 min). The cost of each assay is ≈ $9.5, and this pricing is competitive against that of Food and Drug Administration (FDA)-approved commercial alternatives. Although some RNA loss during on-chip extraction is observed, the platform maintains a potential limit of detection lower than 297 copies. Portability makes the system particularly useful in environments where centralized laboratories are either unavailable or inconveniently located. Another key feature is the platform's versatility, allowing users to choose between RT‒qPCR or RT‒LAMP tests based on specific requirements.
本研究展示了一种用于严重急性呼吸综合征冠状病毒2（SARS-CoV-2）诊断的快速、通用且低成本的样本到答案系统。该系统集成了核酸的提取和纯化，随后通过逆转录定量聚合酶链反应（RT-qPCR）或逆转录环介导等温扩增（RT-LAMP）进行扩增。通过满足不同的诊断和试剂需求，该平台产生的检测结果与商业RT-LAMP和RT-qPCR系统的结果高度一致。我们系统的显著优势包括其速度和成本效益。该检测在28分钟内完成，包括样本加载（5分钟）、核糖核酸（RNA）提取（3分钟）和RT-LAMP（20分钟）。每次检测的成本约为9.5美元，这一定价与美国食品药品监督管理局（FDA）批准的商业替代品相比具有竞争力。尽管在芯片上提取过程中观察到一些RNA损失，但该平台的潜在检测限仍低于297拷贝。便携性使该系统在没有集中实验室或集中实验室位置不便的环境中特别有用。另一个关键特性是该平台的通用性，允许用户根据特定要求在RT-qPCR或RT-LAMP检测之间进行选择。
