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

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-loopmediated isothermal amplification (RT-LAMP) followed by Pf Ago-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/mu L and 1.09 copies/mu L, 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.

Automated summary

The SPOT system is a rapid, sensitive, and accurate COVID-19 diagnostic system that can detect virus samples quickly with high sensitivity and specificity. Its portability enables high-volume, low-cost testing capabilities in areas in urgent need of COVID-19 testing.