Monoclonal Antibodies against Nucleocapsid Protein of SARS-CoV-2 Variants for Detection of COVID-19

Mitigation strategies of the coronavirus disease 2019 (COVID-19) pandemic have been greatly hindered by the continuous emergence of SARS-CoV-2 variants. New sensitive, rapid diagnostic tests for the wide-spectrum detection of viral variants are needed. We generated a panel of 41 monoclonal antibodie...

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Autores principales:	Ruei-Min Lu, Shih-Han Ko, Wan-Yu Chen, Yu-Ling Chang, Hsiu-Ting Lin, Han-Chung Wu
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	COVID-19 SARS-CoV-2 antibody nucleocapsid protein rapid test LFIA Biology (General) QH301-705.5 Chemistry QD1-999
Acceso en línea:	https://doaj.org/article/48a723907e214b449fcf2ffaf9e493f8
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spelling	oai:doaj.org-article:48a723907e214b449fcf2ffaf9e493f82021-11-25T17:56:24ZMonoclonal Antibodies against Nucleocapsid Protein of SARS-CoV-2 Variants for Detection of COVID-1910.3390/ijms2222124121422-00671661-6596https://doaj.org/article/48a723907e214b449fcf2ffaf9e493f82021-11-01T00:00:00Zhttps://www.mdpi.com/1422-0067/22/22/12412https://doaj.org/toc/1661-6596https://doaj.org/toc/1422-0067Mitigation strategies of the coronavirus disease 2019 (COVID-19) pandemic have been greatly hindered by the continuous emergence of SARS-CoV-2 variants. New sensitive, rapid diagnostic tests for the wide-spectrum detection of viral variants are needed. We generated a panel of 41 monoclonal antibodies against the SARS-CoV-2 nucleocapsid protein (NP) by using mice hybridoma techniques. Of these mAbs, nine exhibited high binding activities and were applied in latex-based lateral flow immunoassays (LFIAs). The LFIAs utilizing NP-mAb-7 and -40 had the best sensitivity and lowest limit of detection: 8 pg for purified NP and 625 TCID<sub>50</sub>/mL for the authentic virus (hCoV-19/Taiwan/4/2020). The specificity tests showed that the NP-mAb-40/7 LFIA strips did not cross-react with five human coronavirus strains or 20 other common respiratory pathogens. Importantly, we found that 10 NP mutants, including alpha (B.1.1.7), beta (B.1.351), gamma (P.1), and delta (B.1.617.2) variants, could be detected by NP-mAb-40/7 LFIA strips. A clinical study (<i>n</i> = 60) of the NP-mAb-40/7 LFIA strips demonstrated a specificity of 100% and sensitivity of 90% in infected individuals with cycle threshold (Ct) values < 29.5. These anti-NP mAbs have strong potential for use in the clinical detection of SARS-CoV-2 infection, whether the virus is wild-type or a variant of concern.Ruei-Min LuShih-Han KoWan-Yu ChenYu-Ling ChangHsiu-Ting LinHan-Chung WuMDPI AGarticleCOVID-19SARS-CoV-2antibodynucleocapsid proteinrapid testLFIABiology (General)QH301-705.5ChemistryQD1-999ENInternational Journal of Molecular Sciences, Vol 22, Iss 12412, p 12412 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	COVID-19 SARS-CoV-2 antibody nucleocapsid protein rapid test LFIA Biology (General) QH301-705.5 Chemistry QD1-999
spellingShingle	COVID-19 SARS-CoV-2 antibody nucleocapsid protein rapid test LFIA Biology (General) QH301-705.5 Chemistry QD1-999 Ruei-Min Lu Shih-Han Ko Wan-Yu Chen Yu-Ling Chang Hsiu-Ting Lin Han-Chung Wu Monoclonal Antibodies against Nucleocapsid Protein of SARS-CoV-2 Variants for Detection of COVID-19
description	Mitigation strategies of the coronavirus disease 2019 (COVID-19) pandemic have been greatly hindered by the continuous emergence of SARS-CoV-2 variants. New sensitive, rapid diagnostic tests for the wide-spectrum detection of viral variants are needed. We generated a panel of 41 monoclonal antibodies against the SARS-CoV-2 nucleocapsid protein (NP) by using mice hybridoma techniques. Of these mAbs, nine exhibited high binding activities and were applied in latex-based lateral flow immunoassays (LFIAs). The LFIAs utilizing NP-mAb-7 and -40 had the best sensitivity and lowest limit of detection: 8 pg for purified NP and 625 TCID<sub>50</sub>/mL for the authentic virus (hCoV-19/Taiwan/4/2020). The specificity tests showed that the NP-mAb-40/7 LFIA strips did not cross-react with five human coronavirus strains or 20 other common respiratory pathogens. Importantly, we found that 10 NP mutants, including alpha (B.1.1.7), beta (B.1.351), gamma (P.1), and delta (B.1.617.2) variants, could be detected by NP-mAb-40/7 LFIA strips. A clinical study (<i>n</i> = 60) of the NP-mAb-40/7 LFIA strips demonstrated a specificity of 100% and sensitivity of 90% in infected individuals with cycle threshold (Ct) values < 29.5. These anti-NP mAbs have strong potential for use in the clinical detection of SARS-CoV-2 infection, whether the virus is wild-type or a variant of concern.
format	article
author	Ruei-Min Lu Shih-Han Ko Wan-Yu Chen Yu-Ling Chang Hsiu-Ting Lin Han-Chung Wu
author_facet	Ruei-Min Lu Shih-Han Ko Wan-Yu Chen Yu-Ling Chang Hsiu-Ting Lin Han-Chung Wu
author_sort	Ruei-Min Lu
title	Monoclonal Antibodies against Nucleocapsid Protein of SARS-CoV-2 Variants for Detection of COVID-19
title_short	Monoclonal Antibodies against Nucleocapsid Protein of SARS-CoV-2 Variants for Detection of COVID-19
title_full	Monoclonal Antibodies against Nucleocapsid Protein of SARS-CoV-2 Variants for Detection of COVID-19
title_fullStr	Monoclonal Antibodies against Nucleocapsid Protein of SARS-CoV-2 Variants for Detection of COVID-19
title_full_unstemmed	Monoclonal Antibodies against Nucleocapsid Protein of SARS-CoV-2 Variants for Detection of COVID-19
title_sort	monoclonal antibodies against nucleocapsid protein of sars-cov-2 variants for detection of covid-19
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/48a723907e214b449fcf2ffaf9e493f8
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Monoclonal Antibodies against Nucleocapsid Protein of SARS-CoV-2 Variants for Detection of COVID-19

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