Handheld Point-of-Care System for Rapid Detection of SARS-CoV‑2 Extracted RNA in under 20 min

• Published in: ACS central science Vol. 7; no. 2; pp. 307 - 317
• Main Authors: Rodriguez-Manzano, Jesus, Malpartida-Cardenas, Kenny, Moser, Nicolas, Pennisi, Ivana, Cavuto, Matthew, Miglietta, Luca, Moniri, Ahmad, Penn, Rebecca, Satta, Giovanni, Randell, Paul, Davies, Frances, Bolt, Frances, Barclay, Wendy, Holmes, Alison, Georgiou, Pantelis
• Format: Journal Article
• Language: English
• Published: United States American Chemical Society 24-02-2021
• ISSN: 2374-7943; 2374-7951
• DOI: 10.1021/acscentsci.0c01288

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 (<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.