期刊
ACS CENTRAL SCIENCE
卷 7, 期 2, 页码 307-317出版社
AMER CHEMICAL SOC
DOI: 10.1021/acscentsci.0c01288
关键词
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资金
- Imperial College COVID19 Research Fund [G38041, PSH819]
- NIHR Imperial Biomedical Research Centre [P80763]
- EPSRC HiPEDS CDT [EP/L016796/1]
- EPSRC DTP [EP/N509486/1]
- National Institute for Health Research Health Protection Research Unit (NIHR HPRU) in Healthcare Associated Infections and Antimicrobial Resistance at Imperial College London
- Public Health England (PHE)
- MRC [MR/T005254/1] Funding Source: UKRI
The study presents a rapid PoC diagnostic test based on RT-LAMP and semiconductor technology for detecting SARS-CoV-2 in less than 20 minutes. The test demonstrates high sensitivity and specificity in clinical samples, showing promise as a rapid detection tool for tackling the COVID-19 pandemic.
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.
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