4.7 Article

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

Journal

Publisher

MDPI
DOI: 10.3390/ijms222212412

Keywords

COVID-19; SARS-CoV-2; antibody; nucleocapsid protein; rapid test; LFIA

Funding

  1. Academia Sinica
  2. Emerging Infectious and Major Disease Research Program [AS-KPQ-110-EIMD]
  3. Ministry of Science and Technology [MOST- 108-3114-Y-001-002, MOST-108-2823-8-001-001, MOST 109-3114-Y- 001-001]

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Mitigation strategies for the COVID-19 pandemic have been hindered by the emergence of SARS-CoV-2 variants. A panel of 41 monoclonal antibodies against SARS-CoV-2 NP was generated, with 9 high-binding antibodies used in a new rapid diagnostic test showing high sensitivity and specificity for detecting viral variants. The developed LFIA strips have the capability to detect 10 NP mutants, including the alpha, beta, gamma, and delta variants.
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 TCID50/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 (n = 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.

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