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Development of a Lateral Flow Strip Membrane Assay for Rapid and Sensitive Detection of the SARS-CoV-2.
Anal Chem. 2020 10 20; 92(20):14139-14144.AC

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 individuals potentially exposed to SARS-CoV-2 for controlling the COVID-19 outbreak. In this study, we have developed the novel lateral flow strip membrane (LFSM) assay that allows the simultaneous detection of RdRp, ORF3a, and N genes using the PCR product obtained by using the single-tube reverse transcription polymerase chain reaction (RT-PCR). The LFSM assay allows detection of SARS-CoV-2 in 30 min at 25 °C after the RT-PCR with the detection limit 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 percent positive agreement, percent negative agreement, and overall percent agreement of the LFSM assay with the commercial assay were 100% (94.2-100%), 99.0% (94.6-100%), and 99.4% (96.6-100%), respectively. 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 complementary to the RT-PCR or other methods for the diagnosis and monitoring of the patients to curb community transmission and the pandemic.

Authors+Show Affiliations

Biometrix Technology, Inc., 2-2 Bio Venture Plaza 56, Chuncheon 24232, Korea.Institute of Applied Chemistry and Department of Chemistry, Hallym University, Chuncheon 24252, Korea.Institute of Applied Chemistry and Department of Chemistry, Hallym University, Chuncheon 24252, Korea.Biometrix Technology, Inc., 2-2 Bio Venture Plaza 56, Chuncheon 24232, Korea.Institute of Applied Chemistry and Department of Chemistry, Hallym University, Chuncheon 24252, Korea.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32967427

Citation

Yu, Sangheon, et al. "Development of a Lateral Flow Strip Membrane Assay for Rapid and Sensitive Detection of the SARS-CoV-2." Analytical Chemistry, vol. 92, no. 20, 2020, pp. 14139-14144.
Yu S, Nimse SB, Kim J, et al. Development of a Lateral Flow Strip Membrane Assay for Rapid and Sensitive Detection of the SARS-CoV-2. Anal Chem. 2020;92(20):14139-14144.
Yu, S., Nimse, S. B., Kim, J., Song, K. S., & Kim, T. (2020). Development of a Lateral Flow Strip Membrane Assay for Rapid and Sensitive Detection of the SARS-CoV-2. Analytical Chemistry, 92(20), 14139-14144. https://doi.org/10.1021/acs.analchem.0c03202
Yu S, et al. Development of a Lateral Flow Strip Membrane Assay for Rapid and Sensitive Detection of the SARS-CoV-2. Anal Chem. 2020 10 20;92(20):14139-14144. PubMed PMID: 32967427.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development of a Lateral Flow Strip Membrane Assay for Rapid and Sensitive Detection of the SARS-CoV-2. AU - Yu,Sangheon, AU - Nimse,Satish Balasaheb, AU - Kim,Junghoon, AU - Song,Keum-Soo, AU - Kim,Taisun, Y1 - 2020/10/06/ PY - 2020/9/25/pubmed PY - 2020/10/29/medline PY - 2020/9/24/entrez SP - 14139 EP - 14144 JF - Analytical chemistry JO - Anal Chem VL - 92 IS - 20 N2 - 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 individuals potentially exposed to SARS-CoV-2 for controlling the COVID-19 outbreak. In this study, we have developed the novel lateral flow strip membrane (LFSM) assay that allows the simultaneous detection of RdRp, ORF3a, and N genes using the PCR product obtained by using the single-tube reverse transcription polymerase chain reaction (RT-PCR). The LFSM assay allows detection of SARS-CoV-2 in 30 min at 25 °C after the RT-PCR with the detection limit 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 percent positive agreement, percent negative agreement, and overall percent agreement of the LFSM assay with the commercial assay were 100% (94.2-100%), 99.0% (94.6-100%), and 99.4% (96.6-100%), respectively. 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 complementary to the RT-PCR or other methods for the diagnosis and monitoring of the patients to curb community transmission and the pandemic. SN - 1520-6882 UR - https://www.unboundmedicine.com/medline/citation/32967427/Development_of_a_Lateral_Flow_Strip_Membrane_Assay_for_Rapid_and_Sensitive_Detection_of_the_SARS_CoV_2_ L2 - https://doi.org/10.1021/acs.analchem.0c03202 DB - PRIME DP - Unbound Medicine ER -