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Anal Chem . Development of a Lateral Flow Strip Membrane Assay for Rapid and Sensitive Detection of the SARS-CoV-2

tetano

Editor, Senior Moderator
Anal Chem


. 2020 Sep 23.
doi: 10.1021/acs.analchem.0c03202. Online ahead of print.
Development of a Lateral Flow Strip Membrane Assay for Rapid and Sensitive Detection of the SARS-CoV-2

Sangheon Yu, Satish Balasaheb Nimse, Junghoon Kim, Keum-Soo Song, Taisun Kim

Abstract

The infection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes the coronavirus disease 2019 (COVID-19) has threatened public health worldwide. The easy human-to-human transmission of this virus has rapidly evolved into a global pandemic. Therefore, to control the community spread of the virus, it is crucial to identify the infected individuals, including asymptomatic people. Hence, a specific and rapid assay is crucial for the early diagnosis and active monitoring of indi-viduals potentially exposed to SARS-CoV-2 for controlling the COVID-19 outbreak. In this study, we have developed the novel LFSM assay that allows the simultaneous detection of RdRp, ORF3a, and N genes using the PCR product obtained by a using single-tube RT-PCR. The LFSM assay allows detection of SARS-CoV-2 in 30 min at 25 ?C after RT-PCR with the detection limits of 10 copies/test for each gene. The clinical performance of the LFSM assay for the detection of SARS-Cov-2 was evaluated using 162 clinical samples previously detected by using the commercial assay. the PPA, PNA and OPA of the LFSM assay with the commercial assay were 100% (94.2% - 100%), 99.0% (94.6% - 100%), and 99.4% (96.6% - 100%). Therefore, the results of the LFSM assay showed significantly high concordance with the commercial assay for the detection of SARS-CoV-2 in clinical specimens. Therefore, we conclude that the developed LFSM assay can be used alone or as complementary to the RT-PCR or other methods for the diagnosis and monitoring of the patients to curb community transmission and pandemic.
 
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