Abstract

Since the Coronavirus disease 2019 (COVID-19) pandemic outbreak, many methods have been used to detect antigens or antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), including viral culture, nucleic acid test, and immunoassay. The shear-horizontal surface acoustic wave (SH-SAW) biosensor is a novel pathogen detection platform with the advantages of high sensitivity and short detection time. The objective of this study is to develop a SH-SAW biosensor to detect the anti-SARS-CoV-2 nucleocapsid antibody. The rabbit sera collected from rabbits on different days after SARS-CoV-2 N protein injection were evaluated by SH-SAW biosensor and enzyme-linked immunosorbent assay (ELISA). The results showed that the SH-SAW biosensor achieved a high correlation coefficient (R = 0.9997) with different concentrations (34.375–1100 ng/mL) of the “spike-in” anti-N protein antibodies. Compared to ELISA, the SH-SAW biosensor has better sensitivity and can detect anti-N protein IgG signals earlier than ELISA on day 6 (p < 0.05). Overall, in this study, we demonstrated that the SH-SAW biosensor is a promising platform for rapid in vitro diagnostic (IVD) testing, especially for antigen or antibody testing.

Highlights

  • Since the COVID-19 outbreak in late 2019, there have been more than 200 million confirmed cases

  • Since point-of-care testing (POCT) must be a key technology in the recent COVID-19 pandemic, we present our shear-horizontal surface acoustic wave (SH-SAW) biosensor as one of the candidates

  • We evaluated the production of rabbit sera collected on different days after injection of SARS-CoV-2 N protein

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Summary

Introduction

Since the COVID-19 outbreak in late 2019, there have been more than 200 million confirmed cases (https://covid19.who.int accessed on 21 May 2021). The disease is caused by SARS-CoV-2, which is a member of the Coronaviridae family. It possesses a single-stranded and positive sense RNA genome. The genome size ranges from 26 to 32 kilobases [1,2,3,4]. SARS-CoV-2 contains four major structural proteins, including spike (S) protein, envelop (E). Protein, membrane (M) protein, and nucleocapsid (N) protein [5,6]. Since the S protein and Nprotein are the most immunogenic proteins in SARS-CoV-2, antibodies to the S and N proteins are usually detected in serological assays. SARS-CoV-2 contains large amount of N protein. The N protein is highly expressed during infection [7,8,9,10]

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