A gamepad-like nucleic acid testing device for rapid detection of SARS-CoV-2 via visible nested RPA amplification

Abstract Nucleic acid tests are essential for the accurate diagnosis and control of infectious diseases. However, current assays are not easily scalable for a large population, due to the requirement of laboratory settings or special equipment. Here, we developed an integrated box for instant nucleic acid screening (BINAS) which fully integrates nucleic acid release, amplification, and results visualization for self-service standalone test. Importantly, operation of BINAS runs on a novel gamepad-like interface, which allows deployment of BINAS in home settings and operation by users without any prior professional training. Performance of BINAS is empowered by a RNA extraction-free sample inactivation process and a newly developed Nest-RPA chemistry and exhibits sensitivity comparable to RT-qPCR with high specificity for SARS-Cov-2 RNA in a reaction time of 30 minutes directly from fresh swab sample to results. These innovations make BINAS a novel platform for a convenient, accurate, and deployable point-of-care testing scheme.