Abstract

The outbreak and worldwide pandemic of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have a significant impact on global economy and human health. In order to reduce the disease spread, 16 monoclonal antibodies (McAbs) again SARS-CoV-2 were generated by immunized mice with the spike protein receptor binding domain (RBD), which was expressed in Chinese hamster ovary cell (CHO). A colloidal gold-based immunochromatographic strip was developed with two McAbs to detect SARS-CoV-2 spike protein, which can play a potential role in monitoring vaccine quality. The strip is highly specific, detecting only SARS-CoV-2 spike protein, and does not show any non-specific reactions with syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV) and other coronavirus and influenza viruses. The strip detected subunit vaccine in our laboratory with a detection limit of spike protein of 62.5 ng/mL. This strip provides an effective method in monitoring vaccine quality by detecting the antigen content of spike protein.

Highlights

  • The coronavirus disease 2019 (COVID-19) caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is spreading to more than 200 countries/regions with 50 million infections and 1,263,844 deaths according to statistics from the World Health Organization [1]

  • The recombinant spike protein receptor binding domain (RBD) of SARS-CoV-2 was produced from the transfected CHO cells

  • Since the outbreak of the COVID-19 pandemic in December 2019, we have been committed to the research and development of the SARS-CoV-2 subunit vaccine

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Summary

Introduction

The coronavirus disease 2019 (COVID-19) caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is spreading to more than 200 countries/regions with 50 million infections and 1,263,844 deaths (as of Nov. 12) according to statistics from the World Health Organization [1]. Rapid antigen detection (RAD) tests plays an important role in reducing the disease spread [2]. RAD tests has the potential to be an important tool for early diagnosis of SARS-CoV-2, especially in cases where molecular methods are limited [3]. RT-PCR and Viral culture are the current gold standards in the diagnosis of SARS-CoV-2 infection, several factors such as skilled staff, requirement of special equipment and price of the reagent limit the use of these time-consuming molecular techniques [4]. Researches of different immunochromatographic strips for COVID-19 detection are encouraged [5]

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