A rapid, accurate, scalable, and portable testing system for COVID-19 diagnosis

作者：Guanhua Xun, Stephan Lane, Vassily Andrew Petrov, Brandon Elliott Pepa, Huimin Zhao · 发表于：Nature Communications · 年份：2021 · DOI：10.1038/s41467-021-23185-x · 被引用次数：185 · 研究领域：SARS-CoV-2 detection and testing、Advanced biosensing and bioanalysis techniques、Biosensors and Analytical Detection

The need for rapid, accurate, and scalable testing systems for COVID-19 diagnosis is clear and urgent. Here, we report a rapid Scalable and Portable Testing (SPOT) system consisting of a rapid, highly sensitive, and accurate assay and a battery-powered portable device for COVID-19 diagnosis. The SPOT assay comprises a one-pot reverse transcriptase-loop-mediated isothermal amplification (RT-LAMP) followed by PfAgo-based target sequence detection. It is capable of detecting the N gene and E gene in a multiplexed reaction with the limit of detection (LoD) of 0.44 copies/μL and 1.09 copies/μL, respectively, in SARS-CoV-2 virus-spiked saliva samples within 30 min. Moreover, the SPOT system is used to analyze 104 clinical saliva samples and identified 28/30 (93.3% sensitivity) SARS-CoV-2 positive samples (100% sensitivity if LoD is considered) and 73/74 (98.6% specificity) SARS-CoV-2 negative samples. This combination of speed, accuracy, sensitivity, and portability will enable high-volume, low-cost access to areas in need of urgent COVID-19 testing capabilities.