The COVID-19 pandemic is a global health emergency characterized by the high rate of transmission and ongoing increase of cases globally Rapid point-of-care (PoC) diagnostics to detect the causative virus, SARS-CoV-2, are urgently needed to identify and isolate patients, contain its spread and guide clinical management In this work, we report the development of a rapid PoC diagnostic test (&lt;20 min) based on reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) and semiconductor technology for the detection of SARS-CoV-2 from extracted RNA samples The developed LAMP assay was tested on a real-time benchtop instrument (RT-qLAMP) showing a lower limit of detection of 10 RNA copies per reaction It was validated against extracted RNA from 183 clinical samples including 127 positive samples (screened by the CDC RT-qPCR assay) Results showed 91% sensitivity and 100% specificity when compared to RT-qPCR and average positive detection times of 15 45 ± 4 43 min For validating the incorporation of the RT-LAMP assay onto our PoC platform (RT-eLAMP), a subset of samples was tested (n = 52), showing average detection times of 12 68 ± 2 56 min for positive samples (n = 34), demonstrating a comparable performance to a benchtop commercial instrument Paired with a smartphone for results visualization and geolocalization, this portable diagnostic platform with secure cloud connectivity will enable real-time case identification and epidemiological surveillance © 2021 The Authors Published by American Chemical Society
Handheld Point-of-Care System for Rapid Detection of SARS-CoV-2 Extracted RNA in under 20 min